WO2025215375A1 - Wound care textiles - Google Patents
Wound care textilesInfo
- Publication number
- WO2025215375A1 WO2025215375A1 PCT/GB2025/050780 GB2025050780W WO2025215375A1 WO 2025215375 A1 WO2025215375 A1 WO 2025215375A1 GB 2025050780 W GB2025050780 W GB 2025050780W WO 2025215375 A1 WO2025215375 A1 WO 2025215375A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- substrate layer
- wound
- substance
- wound dressing
- substances
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F13/00—Bandages or dressings; Absorbent pads
- A61F13/00051—Accessories for dressings
- A61F13/00063—Accessories for dressings comprising medicaments or additives, e.g. odor control, PH control, debriding, antimicrobic
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F13/00—Bandages or dressings; Absorbent pads
- A61F13/00987—Apparatus or processes for manufacturing non-adhesive dressings or bandages
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F13/00—Bandages or dressings; Absorbent pads
- A61F13/02—Adhesive bandages or dressings
- A61F13/0203—Adhesive bandages or dressings with fluid retention members
Definitions
- the present disclosure relates generally to wound care, and more particularly to wound dressings or debridement tools having a defined substance surface coverage and/or substance deposition depth.
- the disclosure further relates to printing methods, and more particularly to a method of applying one or more substance(s) to substrate layers of an article.
- BACKGROUND [0002] Owing to an aging population and growing prevalence of vasculopathy, the incidence of chronic wounds is increasing worldwide. Chronic wounds are a major burden on healthcare systems and patient quality of life, often leading to loss of function and amputation.
- a wound is classed as chronic if it fails to progress through this sequence within 4 ⁇ 6 weeks.
- Wound chronicity is often attributed to diabetes and vascular diseases.
- the resulting nerve damage and poor perfusion to extremities alter the wound microenvironment and delay healing.
- Chronic wound healing stalls in the inflammatory phase due to an imbalance of cytokines, proteases, and their inhibitors.
- Prolonged inflammation leads to the accumulation of slough, a fibrinous substance composed of dead leukocytes and degraded proteins.
- Microbial infection occurs in almost all wounds and is a significant cause of chronicity. Bacteria adhere to necrotic tissue in the wound bed and form microcolonies that secrete extracellular polymeric substances (EPS).
- EPS extracellular polymeric substances
- Biofilm sequesters antimicrobials and inhibits the activation of phagocytes, providing resistance to both antimicrobials and the host immune system. Moreover, biofilm in the wound bed impedes the
- Biofilm is believed to exist in up to 80% of chronic wounds and is a direct cause of wound chronicity. Slough, and other non ⁇ viable matter, delays the formation of granulation tissue and facilitates the development of biofilm. It is evident that for any wound to successfully heal, biofilm and necrotic tissue must be removed from the wound bed.
- Ideal wound management involves the reduction of microorganisms and necrotic tissue to levels that can be managed by the host immune system, without inducing damage to healthy tissues nor bacterial resistance.
- Standard wound care involves cleansing the wound to remove loosely attached debris and bacteria, followed by the removal of necrotic tissue (debridement), and finally dressing application.
- Dressings optimise the healing environment by balancing moisture levels, preventing infection, and removing debris.
- wounds should be irrigated between dressing changes to remove any debris and biofilm that may have sloughed off onto the dressing. With little clinical evidence supporting the use of more specialised cleansing materials, normal saline is often used to irrigate wounds due to its high biocompatibility.
- WO 2021/186188 A1 describes a wound dressing or debridement tool comprising an absorbent layer impregnated or coated with a composition comprising a chelating agent, an amphoteric surfactant, and an anionic surfactant.
- a wound dressing or debridement tool to ensure good uniformity and consistency in manufactured articles, and during use, for example when saturated with wound exudate.
- Preparation of wound dressing or debridement tool typically requires printing of various substances on fabrics or other sheet ⁇ based materials, which may be carried out in a substantially direct or indirect manner, by discharge or by resist independently of the type of process used.
- the direct printing method consists of applying a formulation directly onto the material and subsequently fixing said formulation onto the fibres of the material. Particularly, direct printing may be carried out by using conventional roller printing or flat screen printing procedures.
- roller printing methods e.g.
- the method utilises equipment generally consists of a plurality of cylinders and/or rollers on which a number of engraved rollers may apply a particular formulation to an interceding material, such as a fabric material or other sheet ⁇ based materials.
- an interceding material such as a fabric material or other sheet ⁇ based materials.
- roller printing methods such as a Gravure printing process or a Rotary Pad printing process
- the formulation is typically provided to the printing roller by passing through an underlying tray, where the printing roller takes up the formulation from the underlying tray, while a doctor blade eliminates any excess ink.
- This printing typology allows the application of substances on a material in a rapid and economical manner.
- This technology is often used for applying substances onto fabrics, such as woven or nonwoven fabrics, and sheet ⁇ based materials, such as foams or plastic sheet materials.
- fabrics such as woven or nonwoven fabrics, and sheet ⁇ based materials, such as foams or plastic sheet materials.
- drawbacks to the previously described methods when the substance is to be applied in an accurate manner, particularly where precise volumes or doses of a substance are to be deposited on a substrate. For example, it is known that with nonwoven fabrics are uneven, porous, stretchable and easily creased materials.
- wound dressings may have utility in a wide variety of applications, such as medical device articles.
- wound dressings debridement tools, ostomy systems, compression articles or epidermal dressings.
- wound dressings and debridement tools comprising a substrate layer, that is at least partially impregnated or coated with a wound cleansing or debridement solution having physical modes of action against biofilms and the microorganisms comprised therein, while exhibiting a balance of efficacy and biocompatibility.
- the present disclosure seeks to address these needs with the various aspects and embodiments defined herein.
- a wound dressing or a debridement tool comprising one or more substrate layers, wherein one or more substances are at least partially impregnated or coated on a first surface of at least one of the substrate layers, and wherein the one or more substances are at least partially impregnated or coated on about 1 % to about 20 % of the total surface area of the first surface of the substrate layer.
- a wound dressing or a debridement tool comprises one or more substrate layers, wherein one or more substances are at least partially impregnated on a first surface of at least one of the substrate layers, and wherein the one or more substances are impregnated on the first surface of the substrate layer to a depth of from about 1% to about 50% of the total transverse cross ⁇ section of the substrate layer.
- a method of applying one or more substance(s) to one or more substrate layers of an article comprising: (a) providing at least one transfer means comprising an impression member and a transfer member, wherein the transfer member comprises one or more cells with outward facing apertures, and wherein the transfer member is provided on the exterior of the impression member; (b) introducing the one or more substance(s) into the one or more cells of the transfer member; and (c) contacting the substrate layer with the transfer member as the substrate layer is conveyed along a transport path in a machine direction, wherein force applied by the impression member to at l east the one or more cells comprised within the transfer member causes the one or more substance(s) comprised within the one or more cells to transfer to the substrate layer.
- a wound dressing or a debridement tool comprising at least one substrate layer, wherein the substrate layer is at least partially impregnated or coated with one or more substance(s) as defined herein.
- a method of applying one or more substance(s) to one or more substrate layers of a wound dressing or debridement tool as described herein wherein the method comprises: (a) applying one or more substances to a first surface of at least one of the substrate layers; (b) optionally applying a compressed source gas via a gas feed to the first surface of the substrate layer; (c) optionally applying at least one drying means to the first surface of the substrate layer.
- a system for applying one or more substance(s) to one or more substrate layers of a wound dressing or debridement tool according to the method defined herein.
- the use of the wound dressing or debridement tool as defined herein is provided to prevent or minimise slough accumulation in a wound or to de ⁇ slough a wound, the use comprising contacting said wound dressing or debridement tool with said wound or contacting said wound with said wound dressing or debridement tool, preferably wherein the wound is a chronic wound, acute wound, or burn.
- a system for applying one or more substance(s) to one or more substrate layer(s) of an article as defined herein comprising: (a) at least one transfer means comprising an impression member and a transfer member, wherein the transfer member comprises one or more cells with outward facing apertures, wherein the transfer member is provided on the exterior of the impression member, and wherein the one o r more cells are configured to be reversibly compressible under force exerted by the impression member; (b) at least one reservoir comprising the substance; (c) a pump configured to draw the substance from the reservoir and introduce it into the one or more cells of the transfer member; (d) optionally a component configured to remove excess substance from the transfer member. [0023] In a further aspect, there is provided a process for preparing an article as defined in herein, said process comprising, in order, the steps of:
- Fig. 1 Representation of the equipment used in the art for screen printing.
- Fig. 2 Illustration of printing technique deposition mechanism.
- Fig. 3 Surface coverage printing pattern – 1mm and 0.50mm printing pattern.
- Fig. 4 Surface coverage printing pattern – Hexagonal (LH) and Circular Offset (RH).
- Fig. 5 Surface coverage printing pattern – Slotted Hole (LH) and Circular Hole (RH).
- Fig. 6 Surface coverage printing pattern – Parabolic distribution printing pattern.
- Fig. 7 Open area pattern on a 120T (thread) screen. Black dots show the open area where ink will be printed onto a 10x10 cm AQUACEL® Extra dressing. Printed dots: 2.5mm diameter 4.908 mm 2 ; Open Area: 961 mm 2 , equating to 9.61% surface area coverage.
- Fig. 8 Graphical relationship between the mass of ink added to a 10x10 cm dressing sample (per side) and the efficacy of samples on a simulated non ⁇ viable matter model compared to an AQUACEL Extra control. Fig.
- Fig. 13 Comparative analysis of average weight of transferred formulation mass using maximum airblade setting and no airblade setting.
- Fig. 14 Comparative analysis of % area of ink transfer using maximum airblade setting and no airblade setting.
- Fig. 15 Comparative analysis of formulation deposition depth relative to substrate thickness.
- Fig. 16 Schematic illustration of a Gravure printing process.
- Fig. 17 Schematic illustration of a Rotary Pad printing process.
- Fig. 18 Schematic illustration of an exemplary printing method according to the present invention.
- Fig. 19 Illustrative example of a plurality of cells capable of reversibly collapsing under force.
- Fig. 20 Image of a 2mm printed dot pattern on a foam material using the printing method according to the present invention.
- Fig. 21 Image of a 2mm printed dot pattern on a nonwoven fabric material using the printing method according to the present invention.
- Fig. 22 Image of a 2mm printed dot pattern on a woven material using the printing method according to the present invention.
- Fig. 23 Image of a 500 ⁇ m dot pattern on a nonwoven fabric material using the printing method according to the present invention.
- Fig. 24 Image of a 250 ⁇ m dot pattern on a nonwoven material using the printing method according to the present invention.
- Fig. 25 Image of a 250 ⁇ m dot pattern on a polymer film material using the printing method according to the present invention.
- Fig. 26 Image of a 500 ⁇ m dot pattern on a nonwoven fabric material using a rotary pad printing process and a high viscosity substance.
- Fig. 23 Image of a 500 ⁇ m dot pattern on a nonwoven fabric material using the printing method according to the present invention.
- Fig. 24 Image of a 250 ⁇ m dot pattern on a nonwoven material using the printing method according to the present invention.
- Fig. 25 Image of a 250 ⁇ m dot pattern on a poly
- FIG. 27 Image of a 500 ⁇ m dot pattern on a nonwoven fabric material using a rotary pad printing process and a low viscosity substance.
- Fig. 28 Images of nonwoven fabric materials with a printed 500 ⁇ m dot pattern using Formulation A applied by alternative printing techniques (cf. Examples 1 ⁇ 1 to 5 ⁇ 1).
- Fig. 29 Images of nonwoven fabric materials with a printed 500 ⁇ m dot pattern using Formulation B applied by alternative printing techniques (cf. Examples 1 ⁇ 2 to 5 ⁇ 2).
- Fig. 30 Images of nonwoven fabric materials with a printed 500 ⁇ m dot pattern using Formulation C applied by alternative printing techniques (cf. Examples 1 ⁇ 3 to 5 ⁇ 3).
- Fig. 28 Images of nonwoven fabric materials with a printed 500 ⁇ m dot pattern using Formulation A applied by alternative printing techniques (cf. Examples 1 ⁇ 1 to 5 ⁇ 1).
- Fig. 29 Images of nonwoven fabric materials with a printed 500 ⁇ m dot pattern using Formulation B applied by alternative printing techniques (cf. Examples 1 ⁇ 2 to 5 ⁇ 2).
- the term “about” modifying the quantity of a component refers to variation in the numerical quantity that can occur, for example, through typical measuring and handling procedures used for making concentrates, mixtures or solutions in the real world; through inadvertent error in these procedures; through differences in the manufacture, source, or purity of the materials employed, or to carry out the methods; and the like.
- the term “about” also encompasses amounts that differ due to different equilibrium conditions for a composition or substance resulting from a particular initial mixture. Whether or not modified by the term “about”, the claims include equivalents to the quantities.
- the term “at least” includes the end value of the range that is specified. For example, “at least 10 wt%” includes the value 10 wt%.
- gel ⁇ forming fibres and “gelling fibres” may be used interchangeably.
- references in this specification and the claims to “non ⁇ gel forming fibres” and “non ⁇ gelling fibres” can be used interchangeably.
- the ranges provided herein provide exemplary amounts of each of the components. Each of these ranges may be taken alone or combined with one or more other component ranges.
- wt% means “weight percentage” as the basis for calculating a percentage. Unless indicated otherwise, all % values are calculated on a weight basis, and are provided with reference to the total weight of the product in which the substance is present.
- w/w means “weight by weight” as the basis for calculating a percentage. Unless otherwise indicated, reference to "% by weight” (or “% by weight”) of a product, substance or composition reflects the total wet weight of the product or composition (i.e., including water). [0031] In various embodiments described herein, amounts may be described as an area density using the units g/m2. In such embodiments, the area density refers to the area of a substrate layer or an absorbent layer as further described herein and the weight of the specified component comprised in or on said substrate or absorbent layer. For example, in various embodiments the composition may be applied to a wound dressing or debridement tool as described herein with an area density of 30
- An exemplary wound dressing may comprise a substrate and/or an absorbent layer of dimensions 10 x 10 cm, giving an area of 0.01 m 2 .
- a composition as described herein would be applied to the substrate layer and/or absorbent layer to obtain an area density of 30 g/m 2 .
- the composition may be applied to a single surface of the absorbent layer, for example in embodiments wherein the absorbent layer is comprised in a multi ⁇ layer wound dressing.
- the composition may be applied to a first surface of the absorbent layer and to a second surface of the absorbent layer opposite to the first surface of the absorbent layer.
- the composition may be applied to the wound dressing or debridement tool as described herein to contribute 15 g/m 2 on each of the first and second surfaces, i.e. such that the total area density applied to the absorbent layer is 30 g/m 2 .
- the area densities recited herein refer to the total area density of composition applied to the absorbent layer, calculated on the basis of the area defined by the dimensions (width and length) of the absorbent layer and the total amount of the composition applied thereto, whether applied only to a single surface of the absorbent layer or applied to both a first surface and a second surface of the absorbent layer.
- the absorbent layer has an area of 0.01 m 2 (10 x 10 cm)
- 1.5 g of a composition as described herein could be applied to the first surface of the absorbent layer and 1.5 g of the composition applied to the second surface of the absorbent layer to obtain a total area density of 30 g/m 2 .
- substantially free means no more than trace amounts, i.e. the amount of the substance(s) concerned is negligible. In various embodiments, “substantially free” means no more than 1000 ppm, preferably no more than 100 ppm, more preferably no more than 10 ppm, even more preferably no more than 1 ppm of the substance(s) concerned. [0033] In all aspects of the present disclosure, the disclosure includes, where appropriate, all enantiomers and tautomers of the compounds disclosed herein. A person skilled in the art will recognise compounds that possess optical properties (one or more chiral carbon atoms) or tautomeric characteristics.
- enantiomers and/or tautomers may be isolated/prepared by methods known in the art.
- Some of the compounds disclosed herein may exist as stereoisomers and/or geometric isomers – e.g. they may possess one or more asymmetric and/or geometric centres and so may exist in two or more stereoisomeric and/or geometric forms.
- the present disclosure contemplates the use of all the individual stereoisomers and geometric isomers of those compounds, and mixtures thereof.
- the terms used in the claims encompass these forms.
- wound may include an injury to living tissue and may be caused by a cut, blow, or other impact, abrasion, pressure, heat or chemical; typically, one in which the skin is cut or broken.
- a wound may often be described as chronic or acute. Acute wounds may occur as a result of surgery or trauma. Typically, when not too severe and where the victim is otherwise in good health, wounds progress through well ⁇ defined stages of healing within a predicted timeframe. Chronic wounds begin as acute wounds. An acute wound can become a chronic wound when it does not follow the normal healing pathway resulting in a lengthened recovery.
- Chronic wounds may include for example: venous ulcers (such as those that occur in the legs due to venous insufficiency), which account for the majority of chronic wounds and mostly affect the elderly; diabetic ulcers (for example, foot or ankle ulcers); arterial ulcers (due to peripheral arterial disease); and pressure injuries due to immobility.
- 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.
- NPUAP National Pressure Ulcer Advisory Panel
- wounds 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.
- the term "slough” is known to the skilled person and may be defined as a layer or mass of dead tissue separated from surrounding living tissue, or tissue that is adhered to a wound but capable of being removed as in a wound, sore, or inflammation WOUND DRESSING OR DEBRIDEMENT TOOL
- Acute wounds occur as a result of surgery or trauma, typically when not too severe and where the subject is otherwise in good health. Wounds progress through well ⁇ defined stages of healing. Chronic wounds begin as acute wounds.
- an acute wound can become a chronic wound when it does not follow the normal healing pathway resulting in a lengthened recovery. It is believed that the transition from acute to chronic can be due to an inadequate immune response, for example the patient being immuno ⁇ compromised, the wound being insufficiently perfused or being highly contaminated.
- Chronic wounds may include venous ulcers, diabetic ulcers, arterial ulcers, and pressure injuries due to immobility. Wounds may also include a deep tissue injury; this is an expression used to describe a unique form of pressure ulcers.
- Wound dressings and debridement tools are articles suitable for placement in direct contact with a wound.
- a wound dressing may typically debride by autolysis.
- Autolytic debridement refers to the lysis or breakdown of necrotic debris and devitalised tissues from a wound through the body’s own mechanisms, such as moist environments and endogenous enzymes.
- the wound dressing comprises at least one layer comprising a foam, fabric (preferably a nonwoven fabric), or technical substrate.
- the substrate or absorbent layer may be a nonwoven or woven fibrous layer, a gel ⁇ forming fibre, or gauze.
- Gauze may be made from a cellulose, such as cotton or viscose.
- the substrate layer and/or absorbent layer comprises one or more gel ⁇ forming fibres.
- the substances and compositions of the present disclosure are useful for the treatment of wounds, including initial treatment in first response settings, as well as in ongoing wound management such as in primary care settings.
- the substances and compositions described herein may be used in cleansing and/or irrigating a wound.
- the use of nonwoven fabrics in wound dressings or debridement tools is well known, with several products available on the market, such as the AQUACEL® ExtraTM range of dressings manufactured and sold by Convatec Ltd and Convatec Inc.
- the fabric structure requires a flat surface to ensure a controlled dose of excipients can be applied to and delivered by the fabric surface, while the fabric should also maintain a high degree of wet and dry tensile strength, absorbency, and conformability.
- solvent flooding it is known in the art to use solvent flooding to manufacture wound dressings or debridement tools because it is efficacious in the delivery of excipients to the dressing. This process may involve saturating a layer of the wound dressings or debridement tools with an excipient ⁇ containing solution, and removing excess solution. This technique requires a suitable solvent system that is able to dissolve all of the excipients to be delivered, without remaining on the dressing itself.
- the solvent system may comprise multiple components, for example a mixture of organic solvents or an aqueous:organic mixture, the integrity of the dressing must be maintained.
- gel ⁇ forming fibres are employed, for example in an absorbent layer, the water content of the excipient ⁇ containing solution may be minimised in order to avoid premature gelling of the fibres or reduction in absorbency of the absorbent layer. Consequently the solvent used in the flooding process is primarily organic, e.g. an alcohol, and this can limit its application for large ⁇ scale manufacture both because of cost implications for infrastructure design and process controls, and safety implications surrounding the use of high volumes of volatile solvents. [0043] It would be desirable to manufacture substrate layers on a large scale with improved considerations for safety, feasibility and efficacy. Printing processes, such as Gravure, rotary pad and
- the inventors found that one or more substances can be applied to a surface of a wound dressing or debridement tool substrate material in a discontinuous fashion without negatively impacting efficacy, such that the surface area of the substrate material is only partially coated or impregnated with the substance.
- a wound dressing or debridement tool is provided herein, where the wound dressing or debridement tool comprises one or more substrate layers, where one or more substances are at least partially impregnated or coated on a first surface of at least one of the substrate layers, where the one or more substances are at least partially impregnated or coated on about 0.1 % to about 75 % of the total surface area of the first surface of the substrate layer.
- the inventors found that one or more substances can be applied to a surface of a wound dressing or debridement tool substrate material to a specific depth of the substrate material in order to provide optimal dissolution of the substance from the wound dressing or debridement tool and further improve the manufacturing efficiency of the wound dressing or debridement tool.
- a wound dressing or debridement tool comprising one or more substrate layers, where one or more substances are at least partially impregnated on a first surface of at least one of the substrate layers, and where the one or more substances are impregnated on the first surface of the substrate layer to a depth of from about 0.1% to about 50% of the total transverse cross ⁇ section of the substrate layer.
- the one or more substances are at least partially impregnated or coated in a discontinuous configuration.
- the one or more substances are at least partially impregnated or coated on about 0.5 % to about 75 % of the total surface area of the first surface of the substrate layer.
- the one or more substances are at least partially impregnated or coated on about 0.5 % to about 50 % of the total surface area of the first surface of the substrate layer.
- the one or more substances are at least partially impregnated or coated on about 0.5 % to about 30 % of the total surface area of the first surface of the substrate layer. In various embodiments, the one or more substances are at least partially impregnated or coated on about 1 % to about 20 % of the total surface area of the first surface of the substrate layer. In various embodiments, the one or more substances are at least partially impregnated or coated on about 5 % to about 15 % of the total surface area of the first surface of the substrate layer. In various preferred embodiments, the one or more substances are at least partially impregnated or coated on about 8 % to about 12 % of the total surface area of the first surface of the substrate layer.
- the one or more substances are impregnated on the first surface of the substrate layer to a depth of from about 0.5% to about 40% of the total transverse cross ⁇ section of the substrate layer. In various embodiments, the one or more substances are impregnated on the first surface of the substrate layer to a depth of from about 1% to about 30% of the total transverse cross ⁇ section of the substrate layer. In various embodiments, the one or more substances are impregnated on the first surface of the substrate layer to a depth of from about 5% to about 25% of the total transverse cross ⁇ section of the substrate layer.
- the one or more substances are impregnated on the first surface of the substrate layer to a depth of from about 10% to about 25% of the total transverse cross ⁇ section of the substrate layer. In various preferred embodiments, the one or more substances are impregnated on the first surface of the substrate layer to a depth of from about 15% to about 20% of the total transverse cross ⁇ section of the substrate layer. [0052] In some embodiments, the one or more substances are at least partially impregnated on about 0.5 % to about 75 % of the total surface area of the first surface of the substrate layer. In various embodiments, the one or more substances are at least partially impregnated on about 0.5 % to about
- the one or more substances are at least partially impregnated on about 0.5 % to about 30 % of the total surface area of the first surface of the substrate layer. In various embodiments, the one or more substances are at least partially impregnated on about 1 % to about 20 % of the total surface area of the first surface of the substrate layer. In various embodiments, the one or more substances are at least partially impregnated on about 5 % to about 15 % of the total surface area of the first surface of the substrate layer. In various preferred embodiments, the one or more substances are at least partially impregnated on about 8 % to about 12 % of the total surface area of the first surface of the substrate layer.
- the one or more substances are at least partially impregnated or coated on the first surface of the substrate layer in discrete units, wherein the discrete unit surface area for each unit differs.
- the one or more substances are at least partially impregnated on the first surface of the substrate layer in discrete units, wherein the discrete unit surface area for each unit differs.
- the discrete unit surface area for each unit increases and decreases across an axis of the substrate layer surface in a parabolic distribution (see for example, Figure 6).
- the one or more substances are at least partially impregnated or coated on the first surface of the substrate layer in discrete units, wherein the discrete unit surface area is equivalent for each unit. [0057] In some embodiments, the one or more substances are at least partially impregnated on the first surface of the substrate layer in discrete units, wherein the discrete unit surface area is equivalent for each unit. [0058] In various embodiments, the one or more substances are at least partially impregnated or coated on the first surface of the substrate layer in discrete units of from 0.08 mm 2 to about 20.00 mm2. In various preferred embodiments, the one or more substances are at least partially impregnated or coated on the first surface of the substrate layer in discrete units of from 0.60 mm 2 to about 1.75 mm 2 .
- the at least one substrate layer comprises a material selected from: fibres, fabrics or yarns, gels, foams, films, plastics, resins, rubber, collagen, decellularized tissue or a combination thereof.
- the at least one substrate layers comprises a material selected from: fibres, fabrics or yarns, foams, films or a combination thereof.
- the at least one substrate layer is a fabric material.
- the substrate layer is a nonwoven fabric material.
- the fabric material is a nonwoven fabric material consisting of gel forming fibres and/or non ⁇ gel forming fibres.
- the fabric material is a nonwoven fabric material consisting of gel ⁇ forming fibres and non ⁇ gel forming fibres; or the fabric material is a nonwoven fabric material consisting of gel ⁇ forming fibres.
- the at least one substrate layer is a foam material, preferably a polyurethane foam, a polypropylene foam, a polyester foam or a polyvinyl alcohol (PVA) foam.
- the one or more substances are impregnated on the first surface of the substrate layer to a depth of from about 100 ⁇ m to about 500 ⁇ m of the total transverse cross ⁇ section of the substrate layer.
- the one or more substances is impregnated on the first surface of the substrate layer to a depth of from about 200 ⁇ m to about 400 ⁇ m of the total transverse cross ⁇ section of the substrate layer.
- the at least one substrate layer has a surface energy of about 45 to about 1000 mJ/m 2 .
- the dissolution rate of the one or more substances is of from 10 to 90 % per day.
- the one or more substances are impregnated on the first surface of the substrate layer to a depth of from about 1% to about 50% of the total transverse cross ⁇ section of the substrate layer.
- the one or more substances are impregnated on the first surface of the substrate layer to a depth of from about 15% to about 20% of the total transverse cross ⁇ section of the substrate layer.
- the substrate layer(s) has a basis weight of about 150 – 200 gsm. In various preferred embodiments, the substrate layer(s) has a basis weight of about 160 – 185 gsm.
- the wound dressing or debridement tool has a basis weight of about 150 – 200 gsm. In various preferred embodiments, the wound dressing or debridement tool has a basis weight of about 160 – 185 gsm.
- the substrate layer disclosed herein may have a thickness between about 0.5mm to about 20mm. In various embodiments, the substrate layer disclosed herein may have a thickness between about 1mm to about 10mm. In various embodiments, the substrate layer disclosed herein may have a thickness between about 1.5mm to about 7 mm. [0071] In various embodiments, the substrate layer(s) has a bulk density of about 25 – 100 kg/m 3 .
- the substrate layer(s) has a bulk density of about 35 – 90 kg/m3. In various embodiments, the substrate layer(s) has a bulk density of about 40 – 80 kg/m 3 .
- the wound dressing or debridement tool has a bulk density of about 25 – 100 kg/m 3 . In various embodiments, the wound dressing or debridement tool has a bulk density of about 35 – 90 kg/m 3 . In various embodiments, the wound dressing or debridement tool has a bulk density of about 40 – 80 kg/m 3 .
- the substrate layer has a fluid absorbency of about 0.05g/cm2 or more.
- the substrate layer has a fluid absorbency of about 0.10g/cm 2 or more. In various embodiments, the substrate layer has a fluid absorbency of about 0.15g/cm 2 or more. In various embodiments, the substrate layer has a fluid absorbency of about 0.20g/cm2 or more. In various embodiments, the substrate layer has a fluid absorbency of about 0.25g/cm2 or more. In various embodiments, the substrate layer has a fluid absorbency of about 0.30g/cm2 or more. In various embodiments, the substrate layer has a fluid absorbency of about 0.35g/cm2 or more. In various embodiments, the substrate layer has a fluid absorbency of about 0.40g/cm2 or more.
- the wound dressing or debridement tool has a fluid absorbency of about 0.30g/cm2 or more. In various embodiments, the wound dressing or debridement tool has a fluid absorbency of about 0.35g/cm2 or more. In various embodiments, the wound dressing or
- the substrate layer has a fluid retention of at least about 45%. In various embodiments, the substrate layer has a fluid retention of at least about 55%. In various embodiments, the substrate layer has a fluid retention of at least about 65%. In various embodiments, the substrate layer has a fluid retention of at least about 75%. In various embodiments, the substrate layer has a fluid retention of at least about 85%. In various embodiments, the substrate layer has a fluid retention of at least about 90%.
- the substrate layer has a fluid retention of at least about 95%.
- the wound dressing or debridement tool has a fluid retention of at least about 45%. In various embodiments, the wound dressing or debridement tool has a fluid retention of at least about 55%. In various embodiments, the wound dressing or debridement tool has a fluid retention of at least about 65%. In various embodiments, the wound dressing or debridement tool has a fluid retention of at least about 75%. In various embodiments, the wound dressing or debridement tool has a fluid retention of at least about 85%. In various embodiments, the wound dressing or debridement tool has a fluid retention of at least about 90%.
- the wound dressing or debridement tool has a fluid retention of at least about 95%.
- the substrate layer has a lateral wicking distance of no more than about 40 mm in the machine direction and in the transverse direction. In various embodiments, the substrate layer has a lateral wicking distance of no more than about 30 mm in the machine direction and in the transverse direction. In various embodiments, the substrate layer has a lateral wicking distance of no more than about 25 mm in the machine direction and in the transverse direction. In various embodiments, the substrate layer has a lateral wicking distance of no more than about 20 mm in the machine direction and in the transverse direction.
- the substrate layer has an absorption under compression of at least about 0.10 g/cm 2 . In various embodiments, the substrate layer has an absorption under compression of at least about 0.12 g/cm2. In various embodiments, the substrate layer has an absorption under compression of at least about 0.14 g/cm2. In various embodiments, the substrate layer has an absorption under compression of at least about 0.16 g/cm 2 . In various embodiments, the substrate layer has an absorption under compression of at least about 0.18 g/cm 2 . In various embodiments, the substrate layer has an absorption under compression of at least about 0.20 g/cm2. In various embodiments, the substrate layer has an absorption under compression of at least about 0.22 g/cm 2 .
- the substrate layer has an absorption under compression of at least about 0.24 g/cm 2 . In various embodiments, the substrate layer has an absorption under compression of at least about 0.26 g/cm 2 . [0079] In various embodiments, the substrate layer(s) has a dimensional shrinkage of no greater than about 25 % in the machine direction and in the transverse direction. In various embodiments, the substrate layer(s) has a dimensional shrinkage of no greater than about 20 % in the machine direction and in the transverse direction. In various embodiments, the substrate layer(s) has a dimensional shrinkage of no greater than about 15 % in the machine direction and in the transverse direction.
- the substrate layer(s) has a dimensional shrinkage of no greater than about 10 % in the machine direction and in the transverse direction. [0080] In various embodiments, the substrate layer(s) has a wet tensile strength of at least about 1.0 N/cm. In various embodiments, the substrate layer(s) has a wet tensile strength of at least about 2.0 N/cm. In various embodiments, the substrate layer(s) has a wet tensile strength of at least about 3.0 N/cm. In various embodiments, the substrate layer(s) has a wet tensile strength of at least about 4.0 N/cm.
- the substrate layer(s) has a wet tensile strength of at least about 5.0 N/cm.
- the wound dressing or debridement tool has a wet tensile strength of at least about 1.0 N/cm. In various embodiments, the wound dressing or debridement tool has a wet tensile strength of at least about 2.0 N/cm. In various embodiments, the wound dressing or debridement tool has a wet tensile strength of at least about 3.0 N/cm. In various embodiments, the wound dressing or debridement tool has a wet tensile strength of at least about 4.0 N/cm.
- the wound dressing or debridement tool has a wet tensile strength of at least about 5.0 N/cm.
- the substrate layer(s) has a dry tensile strength of at least about 5.0 N/cm. In various embodiments, the substrate layer(s) has a dry tensile strength of at least about 9.0 N/cm. In various embodiments, the substrate layer(s) has a dry tensile strength of at least about 13.0 N/cm. In various embodiments, the substrate layer(s) has a dry tensile strength of at least about 17.0 N/cm.
- the substrate layer(s) has a dry tensile strength of at least about 21.0 N/cm. [0083] In various embodiments, the substrate layer(s) is needle punched. In various embodiments, the substrate layer(s) has a needle punch density of about 25 to about 150 per cm2. In various embodiments,
- the substrate layer(s) has a needle punch density of about 30 to about 80 per cm 2 .
- the substrate layer(s) has a needle punch depth of about 1mm to about 20mm. In various embodiments, the substrate layer(s) has a needle punch depth of about 5mm to about 20mm. In various embodiments, the substrate layer(s) has a needle punch depth of about 5mm to about 15mm. In various embodiments, the substrate layer(s) has a needle punch depth of about 5mm to about 10mm.
- the wound dressing or debridement tool consists of one or more substrate layers. In various embodiments, the wound dressing or debridement tool consists of a plurality of substrate layers.
- the wound dressing or debridement tool consists of one substrate layer.
- the wound dressing or debridement tool consists of the substrate layer.
- the one or more substrate layers are selected from: an absorbent layer, a transmission layer, an adhesive layer, a soluble medicated film layer, an odour ⁇ absorbing layer, a spreading layer, a keying layer, a distribution layer, a superabsorbent layer or combinations thereof.
- the one or more substrate layers is an absorbent layer.
- the wound dressing or debridement tool is of a monolayer construction, or wherein the wound dressing or debridement tool is of a multi ⁇ layer construction.
- the multi ⁇ layer construction comprises one or more functional layers.
- the wound dressing or debridement tool is of a monolayer construction, i.e. the wound dressing or debridement tool consists of a single substrate layer.
- the at least one substrate layer comprises a second surface opposite the first surface.
- the wound dressing or debridement tool consists of one or more substrate layers and one or more functional layers selected from: an absorbent layer, a wound contacting, an outer cover layer, a transmission layer, an adhesive layer, a support layer, a distribution layer, a soluble medicated film layer, an odour ⁇ absorbing layer, a spreading layer, a keying layer, a superabsorbent layer or combinations thereof; preferably wherein the one or more further functional
- the wound dressing or debridement tool consists of the substrate layer, where the substrate layer consists of the nonwoven fabric.
- the wound dressing or debridement tool consists of the substrate layer, where the substrate layer consists of the nonwoven fabric and the nonwoven fabric consists of the gelling fibres and the non ⁇ gelling fibres; preferably wherein the gelling fibres are present in an amount of from about 60 to about 95 wt% of the substrate layer and the non ⁇ gelling fibres are present in an amount of from about 5 to about 40 wt% of the substrate layer.
- a wound dressing or debridement tool comprising a substrate layer, wherein the substrate layer comprises a nonwoven fabric, the nonwoven fabric comprising gelling fibres and non ⁇ gelling fibres, wherein the gelling fibres are present in an amount of from about 60 to about 95 wt% of the substrate layer and the non ⁇ gelling fibres are present in an amount of from about 5 to about 40 wt% of the substrate layer.
- the gelling fibres are present in an amount of from about 65 to about 95 wt% of the substrate layer and the non ⁇ gelling fibres are present in an amount of from about 5 to about 35 wt% of the substrate layer.
- the gelling fibres are present in an amount of from about 70 to about 95 wt% of the substrate layer and the non ⁇ gelling fibres are present in an amount of from about 5 to about 30 wt% of the substrate layer. In various embodiments, the gelling fibres are present in an amount of from about 75 to about 95 wt% of the substrate layer and the non ⁇ gelling fibres are present in an amount of from about 5 to about 25 wt% of the substrate layer. In various embodiments, the gelling fibres are present in an amount of from about 80 to about 95 wt% of the substrate layer and the non ⁇ gelling fibres are present in an amount of from about 5 to about 20 wt% of the substrate layer.
- the gelling fibres are present in an amount of from about 85 to about 95 wt% of the substrate layer and the non ⁇ gelling fibres are present in an amount of from about 5 to about 15 wt% of the substrate layer. In various embodiments, the gelling fibres are present in an amount of from about 90 to about 95 wt% of the substrate layer and the non ⁇ gelling fibres are present in an amount of from about 5 to about 10 wt% of the substrate layer. In various embodiments, the gelling fibres are present in an amount of from about 65 to about 90 wt% of the substrate layer and the non ⁇ gelling fibres are present in an amount of from about 10 to about 35 wt% of the substrate layer. In various embodiments, the gelling fibres are present in an amount of from about 70 to about 90 wt% of the substrate layer and the non ⁇ gelling fibres are present
- the gelling fibres are present in an amount of from about 75 to about 90 wt% of the substrate layer and the non ⁇ gelling fibres are present in an amount of from about 10 to about 25 wt% of the substrate layer. In various embodiments, the gelling fibres are present in an amount of from about 80 to about 90 wt% of the substrate layer and the non ⁇ gelling fibres are present in an amount of from about 10 to about 20 wt% of the substrate layer.
- the gelling fibres are present in an amount of from about 85 to about 90 wt% of the substrate layer and the non ⁇ gelling fibres are present in an amount of from about 10 to about 15 wt% of the substrate layer. In various embodiments, the gelling fibres are present in an amount of from about 65 to about 85 wt% of the substrate layer and the non ⁇ gelling fibres are present in an amount of from about 15 to about 35 wt% of the substrate layer. In various embodiments, the gelling fibres are present in an amount of from about 70 to about 85 wt% of the substrate layer and the non ⁇ gelling fibres are present in an amount of from about 15 to about 30 wt% of the substrate layer.
- the gelling fibres are present in an amount of from about 75 to about 85 wt% of the substrate layer and the non ⁇ gelling fibres are present in an amount of from about 15 to about 25 wt% of the substrate layer. In various embodiments, the gelling fibres are present in an amount of from about 80 to about 85 wt% of the substrate layer and the non ⁇ gelling fibres are present in an amount of from about 15 to about 20 wt% of the substrate layer. In various embodiments, the gelling fibres are present in an amount of from about 90 to about 85 wt% of the substrate layer and the non ⁇ gelling fibres are present in an amount of from about 15 to about 10 wt% of the substrate layer.
- the gelling fibres are present in an amount of from about 65 to about 80 wt% of the substrate layer and the non ⁇ gelling fibres are present in an amount of from about 20 to about 35 wt% of the substrate layer. In various embodiments, the gelling fibres are present in an amount of from about 70 to about 80 wt% of the substrate layer and the non ⁇ gelling fibres are present in an amount of from about 20 to about 30 wt% of the substrate layer. In various embodiments, the gelling fibres are present in an amount of from about 75 to about 80 wt% of the substrate layer and the non ⁇ gelling fibres are present in an amount of from about 20 to about 25 wt% of the substrate layer.
- the gelling fibres are present in an amount of from about 85 to about 80 wt% of the substrate layer and the non ⁇ gelling fibres are present in an amount of from about 20 to about 15 wt% of the substrate layer. In various embodiments, the gelling fibres are present in an amount of from about 90 to about 80 wt% of the substrate layer and the non ⁇ gelling fibres are present in an amount of from about 20 to about 10 wt% of the substrate layer. In various embodiments, the gelling fibres are present in an amount of from about 65 to about 75 wt% of the substrate layer and the non ⁇ gelling fibres are present in an amount of from about 25 to about 35 wt% of the substrate layer. In various embodiments, the gelling fibres are present in an
- the gelling fibres are present in an amount of from about 80 to about 75 wt% of the substrate layer and the non ⁇ gelling fibres are present in an amount of from about 25 to about 20 wt% of the substrate layer. In various embodiments, the gelling fibres are present in an amount of from about 85 to about 75 wt% of the substrate layer and the non ⁇ gelling fibres are present in an amount of from about 25 to about 15 wt% of the substrate layer.
- the gelling fibres are present in an amount of from about 90 to about 75 wt% of the substrate layer and the non ⁇ gelling fibres are present in an amount of from about 25 to about 10 wt% of the substrate layer.
- gelling fibres or gel forming fibres it is meant hygroscopic fibres that upon the uptake of wound exudate become moist slippery or gelatinous.
- the gel forming fibres can be of the type that retain their structural integrity on absorption of exudate or can be of the type that lose their fibrous form and become an amorphous or structureless gel.
- the gel forming fibres are typically sodium carboxymethylcellulose fibres, chemically modified cellulosic fibres, alkyl sulphonate modified cellulosic fibres, such as those described in WO2012/061225, pectin fibres, alginate fibres, chitosan fibres, hyaluronic acid fibres, or other polysaccharide fibres or fibres derived from gums, as well as non ⁇ cellulose synthetic fibres such as poly(vinyl alcohol) and polyacrylate.
- the gelling fibres are typically chemically modified cellulosic fibres in the form of a fabric and in particular carboxymethylated cellulose fibres, as described in PCT WO00/01425.
- Sodium carboxymethylcellulose fibres typically have a degree of substitution of at least 0.05 carboxymethyl groups per glucose unit.
- the gelling fibres typically have an absorbency of at least 2 grams (or at least 8 grams, or at least 10 grams), 0.9% saline solution (Solution A) per gram of fibre (as measured by BS EN 13726 ⁇ 1 (2002) "Test methods for primary wound dressings", section 3.2 "Free swell absorptive capacity”).
- the carboxymethylated cellulosic fabrics typically have a degree of substitution between 0.12 to 0.35 (as defined in WO00/01425), more typically a degree of substitution of between 0.20 and 0.30, such that the absorbency of a fabric produced from is increased when compared to the unmodified cellulose.
- Fabrics may consist solely of cellulosic fibre, but may contain a proportion of a textile fibre or gel forming fibre.
- This textile fibre may be for example a cellulose fibre of a known kind and may comprise continuous filament yarn and/or staple fibre.
- the gelling fibres are selected from: carboxymethylcellulose fibres and derivatives thereof, modified cellulosic fibres, alkyl sulphonate modified cellulosic fibres, pectin fibres, alginate fibres, chitosan fibres, hyaluronic acid fibres, fibres derived from gums, non ⁇ cellulose synthetic fibres, superabsorbent fibres, such as polyacrylate fibres, and combinations thereof.
- the gelling fibres are carboxymethylcellulose fibres or derivatives thereof (e.g. HYDROCELTM).
- the non ⁇ gelling fibres are selected from: cellulosic fibres, modified cellulosic fibres, polyester fibres, polypropylene fibres, polyamide fibres, or combinations thereof.
- the non ⁇ gelling fibres are cellulosic fibres, modified cellulosic fibres, or a combination thereof.
- Highly preferred non ⁇ gelling fibres are lyocell fibres (e.g. LYOCELLTM).
- the gelling fibres and non ⁇ gelling fibres are present in the nonwoven fabric at a weight ratio of from about 85:15 to about 65:35.
- the gelling fibres and non ⁇ gelling fibres are present in the nonwoven fabric at a weight ratio of about 80:20 to about 70:30. In a preferred embodiment the gelling fibres and non ⁇ gelling fibres are present in the nonwoven fabric at a weight ratio of about 75:25.
- METHODS & PROCESSES [0104] Uniform deposition of substances in substrate materials was challenging where a specific depth of deposition was required. The characteristics of the substance and substrate often dictate the depth of deposition, based upon gravitational and capillary forces. However, the inventors identified a method where substance deposition depth could be provided in a repeatable fashion while simultaneously improving the efficiency of the manufacturing process.
- a method of applying one or more substance(s) to one or more substrate layers of a wound dressing or debridement tool comprises: (a) applying one or more substances to a first surface of at least one of the substrate layers; (b) optionally applying at least one drying means to the first surface of the substrate layer.
- the method comprises: (a) applying one or more substances to a first surface of at least one of the substrate layers;
- the one or more substances are applied to the first surface of the substrate layer by a printing process; preferably wherein the printing process is a screen printing process, a gravure printing process, a soft gravure printing process, a rotary pad printing process or a needle dosing process.
- the substrate layer is conveyed in a machine direction at a rate of about 0.01 to about 35.00 cm/sec.
- the substrate layer is conveyed in a machine direction at a rate of about 0.05 to about 20 cm/sec.
- the one or more substances are applied to the first surface of the substrate layer by a printing process; preferably wherein the printing process is a screen printing process, a gravure printing process, a soft gravure printing process, a rotary pad printing process or a needle dosing process.
- the compressed gas feed is an air knife.
- Air knives also know as air blades
- Air knives are known in the art to be a system capable of producing a pressurized air plenum chamber with a continuous aperture through which pressurized air exits in a laminar (uniform) flow pattern.
- the exit air velocity creates an impact air velocity onto the surface of products that the air is directed toward.
- the compressed gas feed outlet is positioned at a height of about 0.1cm to about 100cm above the first surface of the substrate layer.
- the compressed gas feed is positioned at a height of about 1cm to about 30cm above the first surface of the substrate layer.
- the source gas is selected from: air, helium, nitrogen, oxygen, hydrogen, argon, nitrogen oxide or combinations thereof. [0113] In some embodiments, the source gas is a filtered source gas. [0114] In various embodiments, the pressure of the compressed gas feed is from greater than about 0 to about 150 psi. In various preferred embodiments, the pressure of the compressed gas feed is from about 40 to about 100 psi.
- the temperature of the compressed gas feed is from about 0 to about 100 o C. In various embodiments, the temperature of the compressed gas feed is from about 0 to about 50 o C. In various embodiments, the temperature of the compressed gas feed is from about 1 to about 40 oC. In various preferred embodiments, the temperature of the compressed gas feed is from about 5 to about 30 o C. [0116] In various embodiments, wherein at least one drying means is applied to the first surface of the substrate layer. Preferably wherein the at least one drying means is an air knife.
- a substance or composition described herein is comprised in a wound dressing or debridement tool as defined herein, wherein said wound dressing or debridement tool comprises a substrate layer at least partially impregnated or coated with said substance or composition.
- said wound dressing or debridement tool comprises a substrate layer at least partially impregnated or coated with said substance or composition.
- Various methods by which the substance or composition is at least partially impregnated or coated in or on the substrate layer are known in the art and discussed herein.
- Inclusion of the disclosed technology in a wound dressing or similar wound treatment device can be achieved by addition to the material from which the dressing or device is constructed or by addition to the finished dressing/device.
- the substance or composition may be added to the dope (the liquid from which the fibres are spun (extruded)).
- the substance or composition may be co ⁇ extruded in a hot melt process.
- the substance or composition may be washed into the fibre by a soaking process.
- the substance or composition may be coated onto the formed fibre by passing through a bath containing the technology in a liquid or solution form (where the solute may be removed by a drying process known in the art, such as by forced air or any other gas, particularly nitrogen if flammable solvents are involved, or by heat, or by heat and forced air) or as a molten liquid.
- the substance or composition may be sprayed onto the formed fibre in a liquid form or from a solution (where the solute may be removed by a drying process known in the art such as by forced air or any other gas, particularly nitrogen if flammable solvents are involved, or by heat, or by heat and forced air) or as a molten liquid in a hot ⁇ melt inkjet process.
- the substance or composition may be added as a powder coating where adhesion could be encouraged by electrostatic effects or by increasing the adhesive tack properties of the receiving fibre (say by partial hydration using humidity or by pre ⁇ treating the fibre with a viscous liquid such as an alcohol (for example hexanol), a polyol (for example propan ⁇ 1,2 ⁇ diol or glycerol), a hydrophilic hydrocarbon (for example a polyethylene oxide) or by the order of addition of the substance or composition itself (for example a liquid surfactant such as liquid fatty acid or fatty acid salt or a liquid fatty acid that will form the salt in situ).
- a viscous liquid such as an alcohol (for example hexanol), a polyol (for example propan ⁇ 1,2 ⁇ diol or glycerol), a hydrophilic hydrocarbon (for example a polyethylene oxide) or by the order of addition of the substance or composition itself (for example a liquid surfactant such as liquid fatty acid or fatty
- the technology may be added via similar washing, coating, spraying or powder coating. Additionally, the substance or composition may be added by suspending the substance or composition in a non ⁇ solvent and passing this through the wound dressing/debridement tool such that the suspended technology is mechanically trapped (i.e. positively added by filtration). [0120] In further embodiments, the substance or composition may be added as an ink or pigment by a printing process, for example a screen ⁇ printing process, where the addition can be closely controlled by use of the screen.
- the print could be a continuous, for example as achieved by flood ⁇ coating, or, more preferably as a discontinuous coating (regular or random patterned) as it has less impact on porosity/breathability, flexibility, absorbency and ability to contour to the complex topography of the wound bed and both the macroscopic (physiology) and microscopic (cellular) levels.
- the substance or composition may be added as a separate layer, for example as a gel coating directly onto the wound dressing/debridement tool, for example by way of a knife ⁇ over ⁇ roll or gravure coating technique.
- the substance or composition may be cast as a film by a similar coating technique and then adhered to the wound device by tackifying the device or the film by, for example humidification, or by the addition of an adhesive.
- the direct printing method consists of applying a formulation directly onto the material and subsequently fixing said formulation onto the fibres of the material. Particularly, direct printing may be carried out by using conventional roller printing or flat screen ⁇ printing procedures.
- roller printing methods e.g.
- the method utilises equipment generally consists of a plurality of cylinders and/or rollers on which a number of engraved rollers may apply a particular formulation to an interceding material, such as a fabric material or other sheet ⁇ based materials.
- an interceding material such as a fabric material or other sheet ⁇ based materials.
- roller printing methods such as a Gravure printing process or a Rotary Pad printing process
- the formulation is typically provided to the printing roller by passing through an underlying tray, where the printing roller takes up the formulation from the underlying tray, while a doctor blade eliminates any excess ink.
- This printing typology allows the application of substances on a material in a rapid and economical manner.
- the aforementioned techniques are often used for applying substances onto fabrics, such as woven or nonwoven fabrics, and sheet ⁇ based materials, such as foams or plastic sheet materials.
- the substance or compositions of the present disclosure are particularly suited for the above discussed processes, and in particular processes for producing discontinuous coatings such as regular or random patterns such as dot arrays.
- the substance or compositions of the present disclosure are particularly suitable for screen ⁇ printing.
- the substance or compositions of the present disclosure are also specifically adapted for novel printing processes, such as the process disclosed herein.
- the process of screen printing involves pressing an ink or pigment (1) through a stencilled mesh (4) using a rubber blade or squeegee (2) (see Figure 1).
- the mesh (4) is stretched over a frame (5) and remains under tension in order to act as the ‘screen’.
- a design or pattern (3) may be created by making areas of the mesh (4) impermeable to the ink (1). This may be carried out using an emulsion as is known in the art.
- the blade or squeegee is moved across the screen to fill the open mesh apertures with ink (excipients fully dissolved in a liquid) or pigment (particles suspended in a liquid carrier), and a reverse stroke causes the screen to touch the substrate momentarily along a line of contact.
- the dimensions of the cells dictate the quantities of the substance applied to the substrate material.
- the Gravure cylinder typically sits partially immersed in a formulation container or tray (6), where it picks up the substance to fill its recessed cells on each rotation of the press.
- the substance fill the cells i.e. the cells are loaded with a substance, and the non ⁇ printing portions of the cylinder are wiped or scraped free of the formulation using a doctor blade (5).
- the substrate is then conveyed in a machine direction and pressed against the loaded Gravure cylinder on a rotary press using an impression roller (1).
- the pattern is transferred directly to the substrate surface by the Gravure cylinder, unlike in an offset printing method e.g. Rotary Pad printing, which uses an interim cylinder.
- Rotary pad printing (as illustrated in Figure 17) is similar to that of Gravure but, as mentioned above, this method involves an interim cylinder (4) positioned between the Gravure cylinder (3) and the impression roller (1).
- This interim cylinder (4) is a smooth uniform surface and is often formed from a soft flexible material, such as a rubber ⁇ based material.
- the Gravure cylinder (3) has a plurality of recessed cells etched onto it, where said cells are capable of taking up a substance to fill the cells on each rotation of the press.
- a doctor blade (5) removes the excess substance from the Gravure cylinder (3) and, as the Gravure cylinder (3) rotates, the substance is transferred from the Gravure cylinder (3) to the interim cylinder (4) surface, which subsequently transfers the substance directly onto a substrate surface (2) when pressed against the impression roller (1).
- the present invention provides a solution, where a method of applying one or more substance(s) to one or more substrate layers of a wound dressing or debridement tool, as described herein, is provided, wherein the method comprises:
- FIG. 29 (a) providing at least one transfer means comprising an impression member and a transfer member, wherein the transfer member comprises one or more cells with outward facing apertures, and wherein the transfer member is provided on the exterior of the impression member; (b) introducing the one or more substance(s) into the one or more cells of the transfer member; and (c) contacting the substrate layer with the transfer member as the substrate layer is conveyed along a transport path in a machine direction, wherein force applied by the impression member to at l east the one or more cells comprised within the transfer member causes the one or more substance(s) comprised within the one or more cells to transfer to the substrate layer.
- Figure 18 illustrates such an exemplary method.
- Figures 20 ⁇ 25 illustrate the high quality results of printing substances on a variety of different substrate material, including foam, nonwoven fabrics, woven fabrics and polymer films.
- the abovementioned method may be referred to as a “soft gravure printing” method or process.
- TRANSFER MEANS [0136]
- the transfer means comprises of an impression member and a transfer member.
- impression members are configured to apply a force to an opposing member or substrate, whereas the transfer member comprises one or more cells with outward facing apertures that are capable of being loaded with one or more substances, which can be transferred to a substrate material.
- the configuration of a transfer member provided on the exterior of the impression member results in a force being applied to at least the one or more of the cells comprised within the transfer member, causing the substance(s) comprised within the cells to transfer to the substrate layer.
- the one or more cells are constructed such that they can contain a substance described herein.
- the cell construction is compressible, preferably reversibly compressible, such that the boundary of each cell collapses when force is applied and reverts to it original configuration when force is removed.
- the action of the cell boundary forces all of the substance contained within the cell through the outward facing apertures and on to the substrate material, i.e. substantially no substance remains in the cell after step (c). This is advantageous because precise quantities of substance can be deposited on the substrate surface in a uniform manner.
- the properties of the substrate upon which the substance is to be applied must also be considered carefully.
- a substrate material with an irregular surface structure, i.e. an uneven surface, such as nonwoven fibres are notoriously difficult to apply precise and uniform amounts of a substance to using traditional printing techniques.
- the inventors found that by using a transfer member comprising collapsible cells, one or more substances could be forced from the cells, through the outward facing apertures, and on to the substrate surface. The results were found to be particularly good for nonwoven fabrics. Traditional techniques were found to produce a diffuse pattern when printed onto nonwoven fabrics, whereas the method of the invention produced a well resolved print pattern in a uniform manner.
- the transfer means consists of an impression member and a transfer member. In various embodiments the transfer means consists of the impression member and the transfer member wherein the transfer member is in the form of a layer of the one or more cells. [0142] In various embodiments at least two transfer means are provided. In various embodiments at least two transfer means are provided, each comprising an impression member and a transfer member. In various embodiments at least two transfer means are provided, each comprising an impression member and a transfer member, wherein each of the transfer members comprise one or more cells with outward facing apertures and are provided on the exterior of the impression members.
- At least two transfer means are provided, each comprising an impression member and a transfer member, wherein each of the transfer members comprise one or more cells with outward facing apertures and are provided on the exterior of the impression members, and wherein the transfer means are positioned in proximity to each other such that pressure is formed on each transfer member by the corresponding impression members as the substrate layer is conveyed along a transport path in a machine direction.
- two transfer means are provided.
- two transfer means are provided, each comprising an impression member and a transfer member.
- two transfer means are provided, each comprising an impression member and a transfer member, wherein each of the transfer members comprise one or more cells with outward facing apertures and are provided on the exterior of the impression members.
- two transfer means are provided, each comprising an impression member and a transfer member, wherein each of the transfer members comprise one or more cells with outward facing apertures and are provided on the exterior of the impression members, and wherein the transfer means are positioned in proximity to each other such that pressure is formed on each transfer member by the
- the transfer means is a cylinder. In some embodiments the transfer means is stadium ⁇ shaped.
- the transfer means comprises an impression member and a transfer member, wherein the transfer member is provided on the exterior of the impression member and wherein the transfer member partially surrounds the impression member in a longitudinal direction of the impression member.
- the transfer means comprises of impression member and a transfer member, wherein the transfer member completely encompasses the impression member in a longitudinal direction.
- TRANSFER MEMBER [0147] As described herein, the transfer member comprises one or more cells with outward facing apertures that are capable of being loaded with one or more substances, which can be transferred to a substrate material.
- the one or more cells of the transfer member reversibly compress under force applied by the impression member to at least the one or more cells in step (c) of the above detailed method, so as to cause the one or more substance(s) comprised within the one or more cells to transfer to the substrate layer.
- Figure 19 depicts an elastomeric product comprising cells that reversibly compress as a force is applied to them.
- the transfer member comprises an elastomeric material. In a preferred embodiment, the transfer member consists of an elastomeric material. [0151] In various embodiments, the transfer member comprises a silicone ⁇ based material, an ethylene propylene diene monomer (EPDM) based material, a polypropylene material, a polyethylene terephthalate material, a thermoplastic polyurethane material or combinations thereof. In various embodiments, the transfer member comprises a silicone ⁇ based material, an ethylene propylene diene monomer (EPDM) based material, or combinations thereof. In various embodiments, the transfer member comprises a silicone ⁇ based material. In various embodiments, the transfer member consists of a silicone ⁇ based material.
- EPDM ethylene propylene diene monomer
- the transfer member comprises an ethylene propylene diene monomer (EPDM) based material. In various embodiments, the transfer member consists of an ethylene propylene diene monomer (EPDM) based material. In various embodiments, the transfer member comprises a silicone ⁇ rubber foam material. In various embodiments, the transfer member consists of a silicone ⁇ rubber foam material. [0152] As described herein, the transfer member has certain characteristics that ensure its suitability as a material for the transfer member(s) of the present invention, particularly for reversible compressibility of the one or more cells comprised within the transfer member(s). [0153] In some embodiments, the transfer member(s) have a Shore A hardness value of from about 5 to about 30.
- the transfer member(s) have a Shore A hardness value of from about 5 to about 25. In some embodiments, the transfer member(s) have a Shore A hardness value of from about 5 to about 20. In some embodiments, the transfer member(s) have a Shore A hardness value of from about 7 to about 20. In some embodiments, the transfer member(s) have a Shore A hardness value of from about 7 to about 15. [0154] Shore A hardness values can be determined, for example, using an industry standard Durometer in accordance with ASTM D2240. [0155] In some embodiments, the transfer member(s) have a density of from about 100 to about 500 g/cm 3 .
- the transfer member(s) have a density of from about 100 to about 400 g/cm 3 . In some embodiments, the transfer member(s) have a density of from about 150 to about 400 g/cm 3 . In some embodiments, the transfer member(s) have a density of from about 200 to about 300 g/cm 3 . [0156] In some embodiments, the transfer member(s) have a compressive stress 40% strain of from about 30 to about 150 KPa. In some embodiments, the transfer member(s) have a compressive stress
- the transfer member(s) have a compressive stress 40% strain of from about 70 to about 110 KPa.
- the transfer member(s) have a compression set value (22 hours @ 70 o C) of about 20% or less. In some embodiments, the transfer member(s) has a compression set value (22 hours @ 70oC) of about 15% or less. In some embodiments, the transfer member(s) has a compression set value (22 hours @ 70 o C) of about 12% or less.
- the transfer member(s) have a tensile strength of about 0.5 N/mm 2 or more.
- the transfer member(s) have a tensile strength of about 0.6 N/mm 2 or more. In some embodiments, the transfer member(s) have a tensile strength of about 0.7 N/mm 2 or more. [0159] In some embodiments, the transfer member(s) have an elongation to failure of at least about 80%. In some embodiments, the transfer member(s) have an elongation to failure of at least about 100%. In some embodiments, the transfer member(s) have an elongation to failure of at least about 150%.
- the transfer member(s) have: (a) a Shore A hardness value of from about 5 to about 30; (b) a density of from about 100 to about 500 g/cm 3 ; (c) a compressive stress 40% strain of from about 30 to about 150 KPa; (d) a compression set value (22 hours @ 70 o C) of about 20% or less; (e) a tensile strength of about 0.5 N/mm 2 or more; (f) an elongation to failure of at least about 80%.
- a pattern or design can be provided in the transfer member(s), which will dictate the pattern or design that will be conveyed to the substrate material.
- a pattern can be provided in the transfer member(s) by acid etching, laser etching, injection moulded or mechanical engraving.
- a pattern can be provided in the transfer member(s) by laser etching or injection moulded.
- a pattern can be provided in the transfer member(s) by 3D printing the transfer member(s).
- a wound cleanser may be an aid in debridement – removing deeply adherent, dead or contaminated tissue from a wound ⁇ but a debridement solution is not a wound cleanser.
- Dakin s solution, a buffered 0.5 percent solution of sodium or potassium hypochlorite, is for example a debridement agent rather than a cleansing one because it is injurious to tissues.
- a desirable wound cleanser should be biocompatible and physiologically compatible with the body tissue. Wound irrigation is the act of flushing a wound with a stream or flow of a solution across an open wound surface. A wound cleanser may also provide additional benefits such as moisturising, which may occur during irrigating or rinsing a wound with the cleanser.
- the substances and compositions of the present disclosure disrupt and lift the loose components of wounds from the surface. Surprisingly the substances and compositions further disrupt one or more biofilms.
- microbe means bacteria, protozoa, fungi, algae, amoeba, and slime molds.
- the bacterial infection is associated with Staphylococcus aureus or Pseudomonas aeruginosa.
- biofilm means a syntrophic consortium of microorganisms in which cells stick to each other and optionally also to a surface. These adherent cells become embedded within a slimy extracellular matrix that is composed of extracellular polymeric substances (EPSs).
- EPSs extracellular polymeric substances
- the wound comprises one or more biofilms, wherein “biofilm” is as defined herein.
- the wound cleansing dressing for use as described herein the wound comprises one or more biofilms and treating the wound comprises disrupting said
- the substances of the present invention are advantageous for the treatment of all wounds.
- Wounds suitable for treatment may, for example, be acute, surgical, or traumatic wounds.
- Such wounds may be irrigated by the substances of the present invention to remove contamination and debris, and to clean the surrounding skin so that suitable dressings may be applied.
- wounds may be cleansed e.g. between dressing changes, to remove excess exudates, debris, non ⁇ viable tissues, and to reduce the surface/skin bioburden (e.g. bacteria, thereby reducing infection risk).
- the substance of the present invention may be used to cleanse a wound that appears to be on a healing pathway in order to prevent opportunistic pathogens from forming biofilm. Cleansing with the substances of the present invention is particularly advantageous after debridement. Wound cleansing may also be performed to assist appropriate inspection and diagnosis. Cleansing with the substances of the present invention is particularly advantageous for the treatment of long ⁇ standing, non ⁇ healing, so ⁇ called chronic wounds.
- the one or more substance(s) can be applied in the form of a solid, a gel, a wax, a liquid, a suspension, or an emulsion. In a preferred embodiment, the substance(s) are applied in the form of a liquid.
- the one or more substance(s) are selected from: one or more of a wound cleansing or debridement composition, medicament, an adhesive, a deodorant, a chelating agent, a surfactant, an amphoteric surfactant, an anionic surfactant, a cationic surfactant, a thickening agent, an electrically conductive formulation, a thermoresponsive agent, an exothermic agent, an endothermic agent, or a combination thereof.
- the medicament comprises one or more agents selected from: antimicrobials, analgesics, coagulants, anti ⁇ inflammatories or a combination thereof.
- the one or more substance(s) comprises a wound cleansing or debridement composition.
- the one or more substance(s) comprises a wound cleansing or debridement composition comprising a chelating agent, an amphoteric surfactant, and an anionic surfactant.
- the one or more substance(s) comprises a wound cleansing or debridement composition, preferably wherein the composition comprises: i. a chelating agent; ii. an amphoteric surfactant; iii. an anionic surfactant; and iv. a thickening agent, wherein the thickening agent comprises at least one poly(meth)acrylic acid and/or salt thereof.
- the chelating agent may be selected from citrates, tartrates, tartramides, tartrimides, gluconates, lactates, glycolates, oxalates, phosphates, salts of ethylenediaminetetraacetic acid, and mixtures thereof.
- the chelating agent may be selected from citrates, phosphates, oxalates, salts of ethylenediaminetetraacetic acid, and mixtures thereof.
- the salts are metal ion or ammonium salts. The metal ion of said salts is not limited.
- metal ion salts are preferred and may be selected from sodium and/or potassium salts.
- the salts are sodium salts.
- the chelating agent comprises a salt of ethylenediaminetetraacetic acid.
- the ethylenediaminetetraacetate salt may be a mixture of di ⁇ , tri ⁇ , or tetra ⁇ basic salts of ethylenediaminetetraacetate (EDTA).
- the EDTA salt may, for instance, be a di ⁇ sodium salt of EDTA, or calcium di ⁇ sodium salt of EDTA, or tetra ⁇ sodium salt of EDTA.
- the salt of EDTA is a mixture of salts of EDTA. It is believed that EDTA, when present, will have a form which is dependent on the pH of the wound site.
- EDTA may be added to the wound cleansing or debridement composition as a tetra ⁇ basic salt of EDTA such as tetrasodium EDTA. In some embodiments, EDTA is not in the form of the disodium salt.
- the citrate salt may similarly be a mono ⁇ , di ⁇ or tri ⁇ citrate salt. In various embodiments the citrate salt may be mono ⁇ , di ⁇ or tri ⁇ potassium citrate or mono ⁇ , di ⁇ or tri ⁇ sodium citrate. In preferred embodiments, the citrate salt is a tri ⁇ citrate salt such as trisodium citrate.
- the tartrate may be a mono ⁇ , or di ⁇ tartrate salt.
- the tartrate salt may be mono ⁇ or di ⁇ potassium tartrate; or mono ⁇ or di ⁇ sodium tartrate. In specific embodiments, the tartrate salt is a di ⁇ tartrate salt such as disodium tartrate.
- the gluconate may be potassium gluconate or sodium gluconate. In specific embodiments, the gluconate salt is sodium gluconate.
- the lactate may be potassium lactate or sodium lactate. In specific embodiments, the lactate salt is sodium lactate.
- the glycolate may be potassium glycolate or sodium glycolate. In specific embodiments, the glycolate salt is sodium glycolate.
- the oxalate may be a mono ⁇ , or di ⁇ oxalate salt.
- the oxalate salt may be mono ⁇ or di ⁇ potassium oxalate; or mono ⁇ or di ⁇ sodium oxalate.
- the oxalate salt is a di ⁇ oxalate salt such as disodium oxalate.
- the phosphate salt may be an ortho ⁇ phosphate, a pyrophosphate, a tripolyphosphate or a derivatised phosphate.
- the phosphate is typically in the form of a potassium or sodium salt.
- the chelating agent may be present in the substance in an amount of up to about 10 wt%, up to about 8 wt%, or up to about 6 wt% of the total weight of the substance. In various embodiments, the chelating agent may be present in the substance in an amount of at least about 0.5 wt%, at least about 1.0, or at least about 1.2 wt% of the total weight of the substance.
- the amphoteric surfactant is selected from hydrocarbyl ⁇ amphoacetates, alkenyl ⁇ amphoacetates, hydrocarbyl ⁇ amphodiacetates, alkenyl ⁇ amphodiacetates, hydrocarbylampho ⁇ propionates, hydrocarbylampho ⁇ diproprionates, hydrocarbylamphohydroxypropyl sultaines, and mixtures thereof.
- the hydrocarbyl and alkenyl groups are C6 to C24, C8 to C24, or C10 to C20, hydrocarbyl or alkenyl groups.
- the amphoteric surfactant has a counter ⁇ ion of an alkali metal such as sodium or potassium, or an ammonium ion.
- the amphoteric surfactant has an alkali metal counter ⁇ ion, and more preferably the counter ⁇ ion is sodium.
- the term “hydrocarbyl” includes a group such as alkyl, aryl, aralkyl, alkaryl, cycloalkyl or alkenyl, which may be linear or branched, and/or saturated or unsaturated. In one embodiment, the hydrocarbyl may be a linear or branched alkyl or alkenyl group.
- the amphoteric surfactant is a hydrocarbyl ⁇ amphoacetate salt, preferably a fatty acid amphoacetate.
- the fatty acid or salt thereof may be a C6 ⁇ C24 fatty acid or salt thereof, or a mixture thereof.
- the fatty acid or salt thereof may be saturated or unsaturated. When unsaturated, the unsaturated fatty acid or salt thereof may be mono ⁇ or di ⁇ unsaturated.
- the unsaturated fatty acid or salt thereof may comprise cis ⁇ or trans ⁇ double bonds or mixtures thereof.
- the fatty acid or salt thereof is a C12 ⁇ C18 monounsaturated fatty acid or salt thereof.
- fatty acids examples include stearic acid, ricinoleic acid, oleic acid, eladic acid, petrolselinic acid, palmitic acid, erucic acid, behenic acid, lauric acid, myristic acid, or linoleic acid.
- the amphoteric surfactant comprises a cocoamphoacetate.
- the counter ⁇ ion of the cocoamphoacetate is preferably sodium.
- Sodium cocoamphoacetate is commercially available, for example under the trade name Dehyton® MC (BASF) or Amphosol® 1C (Stepan®). Such commercial preparations are typically solutions of sodium cocoamphoacetate, typically containing from about 30 to about 40 wt% sodium cocoamphoacetate on an actives basis.
- the metal ions of the salt of the chelating agent and the salt of the amphoteric surfactant are the same.
- both the chelating agent and surfactant are sodium salts.
- the amphoteric surfactant may be present in the substance in an amount of up to about 15 wt%, up to about 10 wt% or up to about 5 wt% of the total weight of the substance. In various embodiments, the amphoteric surfactant may be present in the substance in an amount of at least about 1 wt% of the total weight of the substance.
- the anionic surfactant may include all forms of lipophilic oligomeric hydrocarbon and/or polyethoxylate with a negatively charged hydrophilic head group such as carboxylate, sulphate, sulphonate, sulphonated ester, sulphated ester, sulphated amide, carboxylated amide, or phosphate anionic head group.
- the fatty acid may comprise 6 to 24 carbon atoms, such as 10 to 20 carbon atoms, preferably 12 to 18 carbon atoms.
- the anionic surfactant comprises a fatty acid or salt thereof.
- the fatty acid may comprise 6 to 24 carbon atoms, such as 10 to 20 carbon atoms, preferably 12 to 18 carbon atoms.
- Examples of fatty acids include stearic acid, ricinoleic acid, oleic acid, eladic acid, petrolselinic acid, palmitic acid, erucic acid, behenic acid, lauric acid, myristic acid, or linoleic acid.
- the anionic surfactant may be a fatty acid or salt thereof which is a C6 ⁇ C24 fatty acid or salt thereof, or a mixture thereof.
- the salt may be an alkali metal or alkaline earth metal salt, preferably an alkali metal salt.
- the alkali metal is sodium or potassium, more preferably sodium.
- the fatty acid or salt thereof may be saturated or unsaturated. When unsaturated, the unsaturated fatty acid or salt thereof may be mono ⁇ or di ⁇ unsaturated. The unsaturated fatty acid or salt thereof may comprise cis ⁇ or trans ⁇ double bonds or mixtures thereof.
- the fatty acid or salt thereof is a C12 ⁇ C18 monounsaturated fatty acid or salt thereof.
- the fatty acid or salt thereof is oleic acid or a salt thereof.
- the salt of oleic acid is not limited and may be a metal salt of oleic acid.
- the salt of oleic acid may be sodium oleate.
- the salt of oleic acid may be formed by adding oleic acid to the substance such that the metal ions, e.g. sodium ions, are provided by provided by the chelating agent, the thickening agent and/or the amphoteric surfactant.
- the amount of anionic surfactant in the substance is not necessarily limited.
- the anionic surfactant may, for example, be present in the substance in an amount of up to about 15 wt%, up to about 10 wt%, or up to about 8 wt% of the total weight of the substance.
- the anionic surfactant may be present in an amount of at least about 1 wt%, or at least about 1.5 wt% of the total weight of the substance.
- the anionic surfactant is present in the substance in an amount of from about 1 wt% to about 15 wt%, preferably from about 1 wt% to about 10 wt%, more preferably from about 1.5 wt% to about 8 wt% of the total weight of the substance.
- poly(meth)acrylic acids may be homopolymers, copolymers, or interpolymers.
- homopolymeric poly(meth)acrylic acids comprise a polymer backbone consisting of repeat units formed from (meth)acrylic acid.
- Poly(meth)acrylic acid copolymers comprise repeat units formed from (meth)acrylic acid and may comprise further repeat units derived from other monomers.
- Non ⁇ limiting examples of such monomers include (meth)acrylate esters, (meth)acrylamides, olefins, maleic anhydrides, vinyl esters, vinyl ethers, and styrenics; as well as unsaturated carboxylic acids other than (meth)acrylic acid.
- a poly(meth)acrylic acid copolymer may comprise repeat units formed from (meth)acrylic acid and at least one alkyl acrylate.
- a non ⁇ limiting example of a commonly used alkyl acrylate in such copolymers is C 10 ⁇ C 30 alkyl acrylate.
- the poly(meth)acrylic acid and/or salt thereof is an interpolymer.
- the term “interpolymer” refers to a complex comprising at least two polymers. In such interpolymers, one or more of the constituent polymers may be a homopolymer or a copolymer.
- At least one of the constituent polymers of the interpolymer may be a copolymer of acrylic acid and C 10 ⁇ C 30 alkyl acrylate.
- the complex between the at least two polymers arises due to non ⁇ covalent interactions.
- one polymer may be entangled within the other and/or be associated via hydrogen bonding.
- the at least one poly(meth)acrylic acid and/or salt thereof is an interpolymer that comprises a block copolymer comprising polyethylene glycol and a fatty acid ester.
- the fatty acid ester is 12 ⁇ hydroxystearic acid.
- the poly(meth)acrylic acid and/or salt thereof may be cross ⁇ linked.
- Common cross ⁇ linking agents are known in the art.
- the at least one poly(meth)acrylic acid and/or salt thereof may be cross ⁇ linked with an allyl ether cross ⁇ linking agent.
- the allyl ether cross ⁇ linking agent is selected from allyl sucrose and allyl pentaerythritol.
- Interpolymeric polyacrylic acids and/or salts thereof are described in e.g. US Patent Nos. 5,288,814 and 5,349,030, the contents of both being incorporated herein by reference.
- Examples of commercially available interpolymeric polyacrylic acids and/or salts thereof suitable for use in the present disclosure include Carbopol® ETD 2020 and Carbopol® Ultrez 10.
- the salts of the at least one poly(meth)acrylic acid are not limited.
- Poly(meth)acrylic acids are polyanionic polymers, i.e. the carboxylic acid side ⁇ groups of the polymer chain can be deprotonated and thereby acquire negative charge.
- the at least one poly(meth)acrylic acid when deprotonated may be associated with any compatible cation, for example when supplied in salt form, or when formulated in the substance or composition as described herein such that cationic species are provided by other components present in the substance or composition.
- the poly(meth)acrylic acid and/or salt thereof comprises a sodium salt of poly(meth)acrylic acid.
- counter ⁇ ions such as sodium ions may be provided by the chelating agent, the amphoteric surfactant and/or the anionic surfactant.
- the degree of deprotonation of the poly(meth)acrylic acid will depend on various factors including the pH of the substance or composition, and thus the poly(meth)acrylic acid may be present in the substance or composition of the present disclosure in varying proportions of free acid and (poly)anionic forms thereof.
- the pH of the substance or composition is from about pH 4 to about pH 10, from about pH 5 to about pH8, or from about pH 5.5 to about pH 6.5.
- the at least one poly(meth)acrylic acid and/or salt thereof is present in the substance of the present disclosure in an amount of at least about 0.1 wt%, at least about 0.2 wt%, or at least about 0.3 wt% of the total weight of the substance .
- the at least one poly(meth)acrylic acid and/or salt thereof is present in the substance of the present disclosure in an amount of up to about 2 wt%, up to about 1.5 wt%, up to about 1 wt%, or up to about 0.5 wt% of the total weight of the substance .
- the at least one poly(meth)acrylic acid and/or salt thereof is present in the substance of the present disclosure in an amount of from about 0.1 to about 2 wt%, from about 0.2 to about 1.5 wt%, or from about 0.3 to about 1 wt% of the total weight of the substance .
- the one or more substance(s) comprises a non ⁇ antimicrobial composition, said composition comprising (i) at least about 50 wt% of a carrier which is glycerol, triglycerol, or a combination thereof, (ii) a solvent which is one or more C 1 ⁇ 4 alcohol, and (iii) one or more excipients, wherein the weight ratio of (i) to (ii) in the composition is from about 2:1 to about 5:1.
- (i) is glycerol or a combination of glycerol and triglycerol.
- the combination of glycerol and triglycerol may have a parts by weight ratio of about 99:1 to about 50:50 parts. This range may be combined with the above weight ratio ranges for (i):(ii) as well as the concentration ranges described herein.
- the non ⁇ antimicrobial composition may comprise (i) and (ii) at a weight ratio of from about 2.5:1 to about 4:1, wherein (i) is glycerol or a combination of glycerol and triglycerol, the combination having a parts by weight ratio of about 99:1 to about 50:50.
- (i) in the non ⁇ antimicrobial composition is glycerol.
- the concentration of (i) glycerol, triglycerol, or combination thereof is not critical to the present disclosure. As will be appreciated from the scope of the appended claims and the Examples, it is the relative amount of (i) to (ii) the one or more C 1 ⁇ 4 alcohol which is important (from about 2:1 to about 5:1, preferably from about 2.5:1 to about 4:1, more preferably from about 13:4 to about 4:1), and the concentrations of (i) and (ii) will depend on the concentration of the one or more excipients. Should the skilled person require a lower limit for (i), (i) may be included in the non ⁇ antimicrobial composition in an amount of at least about 50 wt% and preferably about 55 wt%.
- (i) may be included in the non ⁇ antimicrobial composition in an amount of no more than about 90 wt% and preferably no more than about 85 wt%. Combining these lower and upper limits provides a general range of at least about 50 wt% to no more than about 90 wt%, and a preferred range of at least about 55 wt% to no more than about 85 wt%.
- the carrier (i) is glycerol or a combination of glycerol and triglycerol, wherein the combination has a parts by weight ratio of about 99:1 to about 50:50, and wherein (i) is present in the non ⁇ antimicrobial composition in an amount of at least about 50 wt% to no more than about 90 wt%.
- (i) is glycerol, and glycerol is present in the non ⁇ antimicrobial composition in an amount of at least about 50 wt% to no more than about 90 wt%.
- (i) in the non ⁇ antimicrobial composition is glycerol or a combination of glycerol and triglycerol, wherein the combination has a parts by weight ratio of about 99:1 to about 50:50, and wherein (i) is present in the non ⁇ antimicrobial composition in an amount of at least about
- (i) is glycerol, and glycerol is present in the non ⁇ antimicrobial composition in an amount of at least about 55 wt% to no more than about 85 wt%.
- the one or more C1 ⁇ 4 alcohol is included in the non ⁇ antimicrobial composition to assist the glycerol, triglycerol, or combination thereof, in the solubilisation of the one or more excipients. As the alcohol is volatile, it can be evaporated off the substrate layer after printing.
- the one or more C 1 ⁇ 4 alcohol is selected from methanol, ethanol and propanol, or isomers and mixtures thereof, preferably wherein the one or more C1 ⁇ 4 alcohol comprises ethanol.
- industrial denatured alcohol is employed but the present disclosure is not limited to this specific form of the one or more C 1 ⁇ 4 alcohol.
- (i) in the non ⁇ antimicrobial composition is glycerol or a combination of glycerol and triglycerol, wherein the combination has a parts by weight ratio of about 99:1 to about 50:50; wherein (i) is present in the non ⁇ antimicrobial composition in an amount of at least about 50 wt% to no more than about 90 wt%; and wherein (ii) the one or more C1 ⁇ 4 alcohol is selected from methanol, ethanol and propanol, or isomers and mixtures thereof.
- (i) is glycerol, and glycerol is present in the non ⁇ antimicrobial composition in an amount of at least about 50 wt% to no more than about 90 wt%.
- (i) is glycerol, present in the non ⁇ antimicrobial composition in an amount of at least about 50 wt% to no more than about 90 wt% and the one or more C 1 ⁇ 4 alcohol comprises ethanol.
- (i) in the non ⁇ antimicrobial composition is glycerol or a combination of glycerol and triglycerol, wherein the combination has a parts by weight ratio of about 99:1 to about 50:50; wherein (i) is present in the non ⁇ antimicrobial composition in an amount of at least about 55 wt% to no more than about 85 wt%; and wherein the one or more C 1 ⁇ 4 alcohol comprises ethanol.
- (i) is glycerol, and glycerol is present in the non ⁇ antimicrobial composition in an amount of at least about 55 wt% to no more than about 85 wt%.
- (i) is glycerol, present in the non ⁇ antimicrobial composition in an amount of at least about 55 wt% to no more than about 85 wt% and the one or more C 1 ⁇ 4 alcohol comprises ethanol.
- the weight ratio of (i) to (ii) in the non ⁇ antimicrobial composition may be from about 2.5:1 to about 4:1, preferably from about 13:4 to about 4:1.
- the substances of the present disclosure are non ⁇ antimicrobial.
- the substances of the present disclosure do not comprise an non ⁇ antimicrobial agent.
- the non ⁇ antimicrobial agent is not limited and includes silver compounds, hypochlorous acid, polyhexamethylene biguanide (also known as polyhexanide biguanide), chlorhexidine and salts thereof.
- the generally accepted criterion for an non ⁇ antimicrobial cleanser solution is a 3 ⁇ log10 reduction in microbial cell number in a given contact time period.
- the non ⁇ antimicrobial wound cleansing compositions described herein cause less than about a 3 ⁇ log10 reduction in the number of microbial cells in the wound when contacted with the wound for about 10 minutes.
- the non ⁇ antimicrobial wound cleansing compositions described herein cause less than about a 2 ⁇ log10 reduction in the number of microbial cells in the wound when contacted with the wound for about 10 minutes.
- the non ⁇ antimicrobial wound cleansing compositions described herein cause less than about a 1 ⁇ log10 reduction in the number of microbial cells in the wound when contacted with the wound for about 10 minutes.
- the substances may be thickened with a thickening agent.
- Exemplary thickening agents include gums, polysaccharides such as starch, agar, carboxymethylcellulose, hydroxyethylcellulose, gelatin, pectin, chitosan, alginate, clay, synthetic thickeners such as polyethylene glycols, poloxamers (as defined herein above), polyvinyl alcohol/acetate, polyvinylpyrrolidone, polyacrylates, silicates/silica, carbomers. Any of the preceding forms may alternatively be prepared extemporaneously, e.g. by a clinician, healthcare practitioner, or pharmacist. In various embodiments, the substances may be supplied as a concentrate for dilution, e.g.
- the substances of the present invention do not contain further components other than those already described above.
- the substances are preferably supplied as a sterile solution, e.g. wherein such solutions are prepared from sterilised components in a sterile environment, or wherein the final solution is sterilised by methods commonly known in the art.
- the substances of the present invention may comprise one or more additional components selected from preservatives, anti ⁇ oxidants, osmotic adjusters and surfactants.
- Suitable preservatives are known in the art, such as polyhexamethylene biguanide (PHMB). Preservatives may advantageously have a mild bacteriostatic effect in the wound.
- Anti ⁇ oxidants are also well known and a person skilled in the art of the present invention will be able to select suitable anti ⁇ oxidants. Anti ⁇ oxidants may advantageously aid preservation and reduce the prevalence of reactive oxygen species in the wound environment that are typically elevated in chronically inflamed wounds and associated with retarded healing.
- Osmotic adjusters may be included in the solutions of the present invention to adjust the tonicity (ionic strength) of said substances. For example, pain can be minimised by the use of isotonic substances (i.e.
- the wound cleansing composition is an isotonic or hypertonic solution.
- one or more surfactants in addition to those described above may be included, e.g.
- the wound cleansing composition may have a surface tension of less than about 35 mN/m to facilitate loosening and cleansing.
- one substance is applied to the substrate layer.
- multiple substances are applied to the substrate layer.
- the one or more substance(s) are applied to a single surface of the substrate layer.
- different substances are applied to different surfaces of the substrate layer.
- a combination of substances are applied to a single surface of the substrate layer.
- a combination of substances are applied to multiple surfaces of the substrate layer.
- two or more substance(s) are applied to the first surface of the at least one substrate layer.
- a combination of substance(s) are applied to the first surface of the at least one substrate layer.
- a combination of substance(s) are applied to the first surface and a second surface of the at least one substrate layer.
- the at least one substrate layer comprises a second surface opposite the first surface and the second surface comprises the same substance(s) impregnated at the same depth as the first surface.
- the two or more substances may produce, for example, a physical, physiological or physiochemical response between the two substances when applied to a wound site that is in essence activated or initiated by contact with a wound. For example, activation of endothermic excipients or initiation of electrochemical substances.
- the two or more substances provide a synergistic effect when applied to a user.
- Exemplary applications of the substances in this regard can be seen in Figure 4, where (A) and (B) designate different substances deposited on the substrate surface, although this is not limiting on the potential scope for these applications.
- the mass of substance comprised in the at least one substrate layer is of from about 0.10 to about 50.00 g/m2 per surface; preferably wherein the mass of substance comprised in the at least one substrate layer is of from about 0.5 to about 20.00 g/m 2 per surface.
- the wound dressing or debridement tool is of a multi ⁇ layer construction. In various embodiments, the wound dressing or debridement tool is of a multi ⁇ layer construction wherein the multilayer construction further comprises one or more functional layers, as described above. [0235] In various embodiments, the wound dressing or debridement tool comprises an outer cover layer, a support layer, a superabsorbent layer, a wound contacting layer and a transmission layer. [0236] In various embodiments, the wound dressing or debridement tool comprises an outer cover layer, a support layer, a superabsorbent layer, and a wound contacting layer.
- the wound dressing or debridement tool comprises an outer cover layer and a wound contacting layer.
- the one or more substance(s) transferred to the substrate layer is at least partially impregnated within the substrate layer.
- the one or more substance(s) transferred to the substrate layer is coated on or at least partially impregnated within the substrate layer.
- the one or more substance(s) transferred to the substrate layer is at least partially impregnated within the substrate layer.
- the one or more substance(s) transferred to the substrate layer is coated on the substrate layer.
- the wound dressings or debridement tools of the present disclosure are useful for the treatment of wounds, including initial treatment in first response settings, as well as in ongoing wound management such as in primary care settings.
- the wound dressing or debridement tool described herein may be used in cleansing and/or irrigating a wound.
- the use of the wound dressing or debridement tool as disclosed herein may prevent or minimise slough accumulation in a wound or to de ⁇ slough a wound, the use comprising contacting said wound dressing or debridement tool with said wound or contacting said wound with said wound dressing or debridement tool, preferably wherein the wound is a chronic wound, acute wound, or burn.
- the wound is a chronic wound.
- the wound is an acute wound.
- the wound is a burn.
- a system for applying one or more substance(s) to one or more substrate layer(s) of an article comprising: (a) at least one transfer means comprising an impression member and a transfer member, wherein the transfer member comprises one or more cells with outward facing apertures, wherein the transfer member is provided on the exterior of the impression member, and wherein the one or more cells are configured to be reversibly compressible under force exerted by the impression member; (b) at least one reservoir comprising the substance; (c) a pump configured to draw the substance from the reservoir and introduce it into the one or more cells of the transfer member; (d) optionally a component configured to remove excess substance from the transfer member.
- a further advantage is that multiple substance can be applied to a single transfer means/transfer member using multiple reservoirs and pumps. This is particularly advantageous, given that Gravure and rotary pad printing typically require multiple cylinders to apply multiple formulations to a single substrate material. Thus, efficiency is improved.
- a process for preparing an article as disclosed herein comprises, in order, the steps of: (a) conveying a substrate layer along a transport path in a machine direction toward at least one transfer means comprising an impression member and a transfer member, wherein the transfer m ember comprises one or more cells with outward facing apertures, wherein the transfer member is provided on the exterior of the impression member, and wherein the one or more cells are configured to be reversibly compressible under force exerted by the impression member;
- the process for preparing an article comprises the preparation of an article that is of a multilayer construction comprising: (a) the substrate layer comprising the one or more substance(s) configured as a wound or epidermis contacting layer; (b) at least one substrate layer comprising the one or more substance(s) adhered or affixed to one or more additional functional layers that are configured as a wound or epidermis contacting layer, p referably wherein the one or more additional functional layers are selected from the group consisting of: an absorbent layer, a transmission layer, an adhesive layer, a support layer, a soluble medicated film layer, an odour ⁇ absorbing layer, a spreading layer
- Base weight can be calculated using the following formulae:
- This area is used to calculate the weight required to exert 40mmHg of compression over the dressing pad.
- the test sample is weighed [W1] and placed onto a perforated plate within absorption container.
- a compression load (a weight equivalent to 40 mmHg as commonly applied with a high compression bandage therapy) is applied evenly over the surface of the test sample.
- Warmed hydrating fluid (Solution A at 37°C ⁇ 2°C) is added to the container at a volume such that the perforated plate is covered. Samples are then incubated for 24 hours at 20°C( ⁇ 2°C). After incubation, the hydrating fluid is drained off prior to removing the weights. Each sample is removed from the solution and the sample is weighed again [W2].
- a 10x10 cm AQUACEL® Extra dressing was placed onto the loading tray, which is moved under the screen with a bottom switch. Approximately 5 ml of ink formulations were poured onto the screen between the squeegee and open pattern. An upper switch moved the squeegee across the screen, pushing ink through the mesh. The mass deposited equated to 0.15 g per 10 x 10 cm dressing (15 g/m 2 ). Samples were left to dry for 24 hours, 2x2 cm squares were then cut from the 10x10 cm printed samples and tested using the simulated non ⁇ viable matter model described below (cf Efficacy Testing).
- Figure 8 illustrates the relationship between the mass of AQUACEL Clean excipients (g) per side of a 10x10 cm sample when different surface areas are covered and the efficacy of these samples on the simulated non ⁇ viable matter model compared to an AQUACEL Extra control.
- Figure 9 illustrates the relationship between the mass of formulation excipients (g) per side of a 10x10 cm sample when printed with a high (55T), medium (2.8 g/m2) and low (Nominal) concentration ink, and the efficacy of these samples on the simulated non ⁇ viable matter model compared to an AQUACEL Extra control.
- EXAMPLE 2 Prototypes printed with glycerol ⁇ based inks were found to take up to three days to “dry”. The ink deposits do not truly dry, they remain liquid because glycerol is a non ⁇ volatile humectant. A better definition is that ink stops visibly transferring onto any other surface it encounters. This can be understood as the migration of the liquid residue into the voids within the dressing fabric as opposed to remaining on the surface of the fabric as initially deposited. Changing the diameter of the printed dots in the pattern will increase the relative surface area of ink and will more closely match the size of the voids within the fabric. Therefore, it is hypothesised that decreasing the diameter of the dots without having to decrease the open area (area covered by ink) may decrease the drying time.
- a pilot plant was prepared where the following settings could be manipulated: compressed air pressure (0 ⁇ 90psi), height of the air knife above the dressing (4cm – 15cm) and speed of the dressing moving below the air knife (20 ⁇ 100, 0.08 ⁇ 1.87cm/sec). A range of air knife settings were used and assessed during the development of the test method. [0287] The experimental method involved the following qualitative and quantitative steps:
- the mass differential of the Bristol paper before and after ink transfer was assessed, as was the transferred ink % area.
- the ink transfer samples on Bristol paper were photographed using a digital camera (Canon EOSM50) in the Just Normlicht Basic Color Viewing cabinet (Asset ID 1307) on the daylight setting.
- Step 1 Capture image
- Step 2 Maximise view of image
- Step 3 Define maximum test area that is free from aberrations
- Step 4 Improve image quality
- e Select optimum colour channel
- f Step 6 Set threshold
- Step 6 Analyse
- This section of textile is then mounted onto a petri dish by placing the edge of the section onto the petri dish so the edge is perpendicular to the petri dish, the ends of the section are then taped to secure the textile in place.
- the depth of the ink is measured from the top surface of the textile to the bottom of the ink deposit, and the width of the printed ink is measured from one edge of the ink deposit to the other edge of the ink deposit.
- the ink depth and textile width are measured in millimetres.
- the assessed printing techniques include the method of the invention (Examples 1 ⁇ 1 to 1 ⁇ 6), Flat Screen printing (Examples 2
- Formulation D I ngredient Concentration in Ink (% w/w) Sodium Cocoamphoacetate 20.93 Tetrasodium EDTA 6.20 Oleic Acid 22.87 Glycerin 49.50 Poly(meth)acrylic Acid 0.5 TOTAL 100 [0314] Substance Preparation: A 1L thick wall glass beaker along with the propeller blade shaft is weighed and recorded tare weight of the beaker + shaft.
- 64 motor is used to formulate a Na4EDTA/Sodium Cocoamphoacetate premix.
- 154.3g of Amphosol 1C (Sodium Cocoamphoacetate, Stepan) was placed in the glass jar and turned on the mixer. Added 45.7g of Na 4 EDTA and continued mixing and raised the temperature to 54°C. After 30 min, QS the lost wt. with deionised water and mixed for an additional 10 min before removing the shaft and closing the jar. Turned off heating and added 20.47g of Oleic Acid, 5.55g of Na4EDTA and 18.75g of Amphosol 1C. Continued mixing for an additional 30 min and transferred the contents to a 16 Oz glass jar.
- Amphosol 1C Sodium Cocoamphoacetate, Stepan
- Table 12 1 ⁇ 6 2 ⁇ 6 3 ⁇ 6 4 ⁇ 6 5 ⁇ 6 Printability EXCELLENT EXCELLENT GOOD FAIR GOOD VERY Print Consistancy EXCELLENT EXCELLENT FAIR FAIR GOOD VERY Resolution Tolerance EXCELLENT GOOD POOR POOR GOOD VERY Coat Weight Range EXCELLENT EXCELLENT GOOD POOR GOOD VERY Depth/Placement GOOD GOOD FAIR GOOD FAIR Speed EXCELLENT GOOD EXCELLENT EXCELLENT FAIR [0324] The results of the printing tests are illustrated in Figures 28, 29, 30, 31, 32 and 33. The inventive method was found to possess many advantages over comparable techniques known in the art, including superior printability, print consistency, resolution tolerance, coat weight range, depth/placement and speed.
- Figure 18 Component List (2) Substrate (7) Reservoir (8) Pump (9) Transfer Member (10) Cells with outward facing aperture (11) Impression Member (12) Transfer Means (13) Channel Feeder (14) Squeegee Blade (15) Formulation impregnated and/or coated on substrate [0326]
- the invention will be described in further detail in the following numbered embodiments.
- a wound dressing or debridement tool wherein the dressing or tool comprises one or more substrate layers, wherein one or more substances are at least partially impregnated on a first s urface of at least one of the substrate layers, and wherein the one or more substances are impregnated on the first surface of the substrate layer to a depth of from about 1% to about 50% of the total transverse cross ⁇ section of the substrate layer. 2).
- the fabric material is a n onwoven fabric material consisting of gel forming fibres and/or non ⁇ gel forming fibres; preferably wherein the fabric material is a nonwoven fabric material consisting of gel ⁇ forming fibres and non ⁇ gel forming fibres; or wherein the fabric material is a nonwoven fabric material consisting of gel ⁇ forming fibres.
- the wound dressing or debridement tool according to any one of clauses 1 to 9, wherein the at least one substrate layer has a thickness of about 0.5 – 20.0 mm; preferably wherein the at least one substrate layer has a thickness of about 1.0 – 10.0 mm. 1).
- the wound dressing or debridement tool according to clauses 1 to 17, wherein the dissolution rate of the one or more substances is of from 10 to 90 % per day. ).
- the wound dressing or debridement tool according to clause 19, wherein the medicament comprises one or more agents selected from: antimicrobials, analgesics, coagulants, anti ⁇ inflammatories or a combination thereof. ).
- the wound dressing or debridement tool according to any one of clauses 1 to 20, wherein the one or more substances comprises a wound cleansing or debridement composition; preferably wherein the composition comprises: (i). a chelating agent; (ii). an amphoteric surfactant; (iii). an anionic surfactant; and (iv). a thickening agent, wherein the thickening agent comprises at least one poly(meth)acrylic acid and/or salt thereof. ).
- the one or more substances comprises a non ⁇ antimicrobial composition
- said composition comprising (i) at least about 50 wt% of a carrier which is glycerol, triglycerol, or a combination thereof, (ii) a solvent which is one or more C 1 ⁇ 4 alcohol, and (iii) one or more excipients, wherein the weight ratio of (i) to (ii) in the composition is from about 2:1 to about 5:1. ).
- the wound dressing or debridement tool according to clauses 1 to 22, wherein the one or more substance is applied in the form of a solid, a gel, a wax, a liquid, a suspension, or an emulsion; preferably wherein the substance is applied in the form of a liquid. ).
- the wound dressing or debridement tool according to any one of clauses 1 to 24, wherein the w ound dressing or debridement tool is of a monolayer construction, or wherein the wound dressing or debridement tool is of a multi ⁇ layer construction; preferably wherein the multi ⁇ layer construction comprises one or more functional layers. ).
- the wound dressing or debridement tool according to clause 25, wherein at least one substrate layer is configured between two or more functional layers; preferably, wherein the one or more functional layers are selected from: an absorbent layer, a transmission layer, an adhesive layer, a support layer, a soluble medicated film layer, an odour ⁇ absorbing layer, a spreading layer, a keying layer, a protective layer, a packaging layer, an outer cover layer, a distribution layer, a superabsorbent layer or combinations thereof. ).
- the wound dressing or debridement tool according to any one of clauses 1 to 27, wherein at least one substrate layer is a wound or epidermis contacting layer. ).
- the wound dressing or debridement tool according to any one of clauses 1 to 28, wherein one substance is applied to the at least one substrate layer. ).
- the wound dressing or debridement tool according to any one of clauses 1 to 34 wherein different substances are applied to the first surface and a second surface of the at least one substrate layer. ).
- a method of applying one or more substance(s) to one or more substrate layers of a wound dressing or debridement tool comprises: (a) applying one or more substances to a first surface of at least one of the substrate layers; (b) applying a compressed source gas via a gas feed to the first surface of the substrate layer; (c) optionally applying at least one drying means to the first surface of the substrate layer. ).
- the method according to clause 37 wherein according to step (b) the substrate layer is conveyed in a machine direction at a rate of about 0.01 to about 35.00 cm/sec; preferably according to step (b) the substrate layer is conveyed in a machine direction at a rate of about 0.05 to about 20 cm/sec. ).
- a wound dressing or debridement tool wherein the dressing or tool comprises one or more substrate layers, wherein one or more substances are at least partially impregnated or coated on a first surface of at least one of the substrate layers, and wherein the one or more substances are at least partially impregnated or coated on about 1 % to about 20 % of the total surface area of the first surface of the substrate layer. 2).
- the wound dressing or debridement tool according to any one of clauses 1 or 2, wherein the one or more substances are at least partially impregnated or coated on about 5 % to about 15 % of the total surface area of the first surface of the substrate layer; preferably wherein the one or more substances are at least partially impregnated or coated on about 8 % to about 12 % of the total surface area of the first surface of the substrate layer. 4).
- the wound dressing or debridement tool according to any one of clauses 1 to 3 wherein the one or more substances are at least partially impregnated or coated on the first surface of the substrate layer in discrete units, wherein the discrete unit surface area for each unit differs. 5).
- the fabric material is a nonwoven fabric material consisting of gel forming fibres and/or non ⁇ gel forming fibres; preferably wherein the fabric material is a nonwoven fabric material consisting of gel ⁇ forming fibres and non ⁇ gel forming fibres; or wherein the fabric material is a nonwoven fabric material consisting of gel ⁇ forming fibres. 2).
- the wound dressing or debridement tool according to clauses 1 to 16 wherein the at least one substrate layer has a bulk density of about 40 – 80 kg/m 3 ).
- the wound dressing or debridement tool according to any one of clauses 1 to 19, wherein the o ne or more substances is selected from: a wound cleansing or debridement composition, a medicament, an adhesive, a deodorant, a chelating agent, a surfactant, an amphoteric surfactant, an anionic surfactant, a cationic surfactant, a thickening agent, an electrically conductive formulation, a thermoresponsive agent, an exothermic agent, an endothermic agent, or a combination thereof. ).
- the medicament comprises one or more agents selected from: antimicrobials, analgesics, coagulants, anti ⁇ inflammatories, or a combination thereof. ).
- the one or more substances comprises a wound cleansing or debridement composition; preferably wherein the composition comprises: (i). a chelating agent; (ii). an amphoteric surfactant; (iii). an anionic surfactant; and (iv). a thickening agent, wherein the thickening agent comprises at least one poly(meth)acrylic acid and/or salt thereof. ).
- the one or more substances comprises a non ⁇ antimicrobial composition
- said composition comprising (i) at least about 50 wt% of a carrier which is glycerol, triglycerol, or a combination thereof, (ii) a solvent which is one or more C 1 ⁇ 4 alcohol, and (iii) one or more excipients, wherein the weight ratio of (i) to (ii) in the composition is from about 2:1 to about 5:1. ).
- the wound dressing or debridement tool according to clauses 1 to 23, wherein the one or more substance is applied in the form of a solid, a gel, a wax, a liquid, a suspension, or an emulsion; preferably wherein the substance is applied in the form of a liquid. ).
- the wound dressing or debridement tool according to any one of clauses 1 to 25, wherein the w ound dressing or debridement tool is of a monolayer construction, or wherein the wound dressing or debridement tool is of a multi ⁇ layer construction; preferably wherein the multi ⁇ layer construction comprises one or more functional layers. ).
- the wound dressing or debridement tool according to clause 27, wherein at least one substrate layer is configured between two or more functional layers; preferably, wherein the one or more functional layers are selected from: an absorbent layer, a transmission layer, an adhesive layer, a support layer, a soluble medicated film layer, an odour ⁇ absorbing layer, a spreading layer, a keying layer, a protective layer, a packaging layer, an outer cover layer, a distribution layer, a superabsorbent layer or combinations thereof. ).
- the wound dressing or debridement tool according to any one of clauses 1 to 28, wherein at least one substrate layer is a wound or epidermis contacting layer. ).
- the one or more substances are applied to the first surface of the substrate layer by a printing process; preferably wherein the printing process is a screen printing process, a gravure printing process, a soft gravure printing process, a rotary pad printing process or a needle dosing process. 41).
- the printing process is a screen printing process, a gravure printing process, a soft gravure printing process, a rotary pad printing process or a needle dosing process. 41).
- a system for applying one or more substance(s) to one or more substrate layers of a wound dressing or debridement tool according to the method of clauses 39 and 40. 42).
- a method of applying one or more substance(s) to one or more substrate layers of an article comprising: ( a) providing at least one transfer means comprising an impression member and a transfer member, wherein the transfer member comprises one or more cells with outward facing apertures, and wherein the transfer member is provided on the exterior of the impression member; ( b) introducing the one or more substance(s) into the one or more cells of the transfer member; and (c) contacting the substrate layer with the transfer member as the substrate layer is conveyed a long a transport path in a machine direction, wherein force applied by the impression member to at least the one or more cells comprised within the transfer member causes the one or more substance(s) comprised within the one or more cells to transfer to the substrate layer. ).
- the transfer means consists of the i mpression member and the transfer member, preferably wherein the transfer member is in the form of a layer of the one or more cells.
- the method according to any one of clauses 1 to 4 wherein the transport path of the substrate layer in a machine direction comprises a vertical and/or horizontal configuration.
- the method according to any one of clauses 1 to 5 wherein the one or more substance(s) transferred to the substrate layer is at least partially impregnated within the substrate layer.
- the fabric material comprises gel ⁇ forming fibres, preferably chemically modified cellulosic fibres, and/or cellulosic fibres.
- the one or more substance(s) is selected from: one or more of a medicament, an adhesive, a deodorant, a chelating agent, a surfactant, an amphoteric surfactant, an anionic surfactant, a cationic surfactant, a thickening agent, an electrically conductive formulation, a thermoresponsive agent, an exothermic agent, an endothermic agent, or a combination thereof.
- the medicament comprises one or more agents s elected from: antimicrobials, analgesics, coagulants, anti ⁇ inflammatories or a combination thereof.
- the one or more substance(s) comprises a wound cleansing or debridement composition, preferably wherein the composition comprises: (i). a chelating agent; (ii). an amphoteric surfactant; (iii). an anionic surfactant; and (iv). a thickening agent, wherein the thickening agent comprises at least one poly(meth)acrylic acid and/or salt thereof. ).
- the one or more substance(s) comprises a non ⁇ antimicrobial composition, said composition comprising (i) at least about 50 wt% of a carrier which is glycerol, triglycerol, or a combination thereof, (ii) a solvent which is one or more C 1 ⁇ 4 alcohol, and (iii) one or more excipients, wherein the weight ratio of (i) to (ii) in the composition is from about 2:1 to about 5:1. ).
- the one or more substance(s) is applied in the form of a solid, a gel, a wax.
- a liquid, a suspension, or an emulsion preferably wherein the substance is applied in the form of a liquid.
- the one or more substrate layers are selected from: outer cover layer, an absorbent layer, a transmission layer, an adhesive layer, a distribution layer, a soluble medicated film layer, an odour ⁇ absorbing layer, a spreading layer, a keying layer, a superabsorbent layer or combinations thereof. ).
- the article is of a monolayer construction, or wherein the article is of a multi ⁇ layer construction, preferably wherein the multilayer construction comprises one or more functional layers; preferably, wherein the one o r more functional layers are selected from: outer cover layer, an absorbent layer, a transmission layer, an adhesive layer, a support layer, a distribution layer, a soluble medicated film layer, an odour ⁇ absorbing layer, a spreading layer, a keying layer, a superabsorbent layer or combinations thereof. ).
- At least one substrate layer is configured between t wo or more functional layers; preferably, wherein the one or more functional layers are selected from: outer cover layer, an absorbent layer, a transmission layer, an adhesive layer, a support layer, a distribution layer, a soluble medicated film layer, an odour ⁇ absorbing layer, a spreading layer, a keying layer, a superabsorbent layer or combinations thereof. ).
- a wound dressing or a debridement tool comprising at least one substrate layer, wherein the s ubstrate layer is at least partially impregnated or coated with one or more substance(s) in accordance with any one of clauses 1 to 35. ).
- a system for applying one or more substance(s) to one or more substrate layer(s) of an article as defined in any one of clauses 1 to 35 comprising: ( a) at least one transfer means comprising an impression member and a transfer member, wherein the transfer member comprises one or more cells with outward facing apertures, wherein the transfer member is provided on the exterior of the impression member, and wherein the one or more cells are configured to be reversibly compressible under force exerted by the impression member; (b) at least one reservoir comprising the substance; (c) a pump configured to draw the substance from the reservoir and introduce it into the one or more cells of the transfer member; (d) optionally a component configured to remove excess substance from the transfer member. ).
- a process for preparing an article as defined in any one of clauses 1 to 35 comprising, in order, the steps of: (a) conveying a substrate layer along a transport path in a machine direction toward at least o ne transfer means comprising an impression member and a transfer member, wherein the transfer member comprises one or more cells with outward facing apertures, wherein the transfer member is provided on the exterior of the impression member, and wherein the one or more cells are configured to be reversibly compressible under force exerted by the impression member; (b) contacting the substrate layer with the transfer member as the substrate layer is conveyed a long a transport path in a machine direction, wherein force applied by the impression member to at least the one or more cells comprised within the transfer member causes the one or more substance(s) comprised within the one or more cells to transfer to the substrate layer; (c) optionally adhering or affixing the substrate layer to one or more functional layers.
- the article is of a multilayer construction comprising: (a) the substrate layer comprising the one or more substance(s) configured as a wound or epidermis contacting layer; (b) at least one substrate layer comprising the one or more substance(s) adhered or affixed to one or more additional functional layers that are configured as a wound or epidermis c ontacting layer, preferably wherein the one or more additional functional layers are selected from the group consisting of: an absorbent layer, a transmission layer, an adhesive layer, a support layer, a soluble medicated film layer, an odour ⁇ absorbing layer, a spreading layer, a keying layer, a superabsorbent layer or combinations thereof.
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Manufacturing & Machinery (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Materials For Medical Uses (AREA)
Abstract
The invention relates generally to wound care, and more particularly to wound dressings or debridement tools having a defined substance surface coverage and/or substance deposition depth. The disclosure further relates to printing methods, and more particularly to a novel method of applying one or more substance(s) to substrate layers of an article, such as wound dressings or debridement tools.
Description
WOUND CARE TEXTILES FIELD [0001] The present disclosure relates generally to wound care, and more particularly to wound dressings or debridement tools having a defined substance surface coverage and/or substance deposition depth. The disclosure further relates to printing methods, and more particularly to a method of applying one or more substance(s) to substrate layers of an article. BACKGROUND [0002] Owing to an aging population and growing prevalence of vasculopathy, the incidence of chronic wounds is increasing worldwide. Chronic wounds are a major burden on healthcare systems and patient quality of life, often leading to loss of function and amputation. Although their treatment accounts for approximately 3% of total healthcare costs in developed countries, a 2018 cohort study found that fewer than 50% of chronic wounds managed by the UK National Health Service healed within a year. Moreover, chronic wounds recur in up to 60‐70% of patients. This poor prognosis underlines the need for new approaches to chronic wound care. [0003] Normal wound healing comprises four intricate and overlapping phases: haemostasis, inflammation, proliferation, and remodelling. After the formation of a thrombus, leukocytes infiltrate the wound and remove bacteria and debris, preparing the wound for healing. This enables the formation of new connective tissue and blood vessels, known as granulation tissue, and subsequent wound closure and re‐epithelialisation. A wound is classed as chronic if it fails to progress through this sequence within 4‐6 weeks. Wound chronicity is often attributed to diabetes and vascular diseases. The resulting nerve damage and poor perfusion to extremities alter the wound microenvironment and delay healing. Chronic wound healing stalls in the inflammatory phase due to an imbalance of cytokines, proteases, and their inhibitors. Prolonged inflammation leads to the accumulation of slough, a fibrinous substance composed of dead leukocytes and degraded proteins. [0004] Microbial infection occurs in almost all wounds and is a significant cause of chronicity. Bacteria adhere to necrotic tissue in the wound bed and form microcolonies that secrete extracellular polymeric substances (EPS). The bacteria become encased in an EPS matrix which eventually matures into a complex biofilm composed of proteins, polysaccharides, nucleic acids, metal ions, and lipids. Biofilm sequesters antimicrobials and inhibits the activation of phagocytes, providing resistance to both antimicrobials and the host immune system. Moreover, biofilm in the wound bed impedes the
1
migration and function of keratinocytes, leukocytes, and fibroblasts, preventing the normal inflammatory response and subsequent healing processes. The recalcitrant biofilm perpetuates an inflammatory cycle wherein tissue is degraded more quickly than it is produced, preventing the progression of healing. [0005] Biofilm is believed to exist in up to 80% of chronic wounds and is a direct cause of wound chronicity. Slough, and other non‐viable matter, delays the formation of granulation tissue and facilitates the development of biofilm. It is evident that for any wound to successfully heal, biofilm and necrotic tissue must be removed from the wound bed. Ideal wound management involves the reduction of microorganisms and necrotic tissue to levels that can be managed by the host immune system, without inducing damage to healthy tissues nor bacterial resistance. Standard wound care involves cleansing the wound to remove loosely attached debris and bacteria, followed by the removal of necrotic tissue (debridement), and finally dressing application. Dressings optimise the healing environment by balancing moisture levels, preventing infection, and removing debris. However, wounds should be irrigated between dressing changes to remove any debris and biofilm that may have sloughed off onto the dressing. With little clinical evidence supporting the use of more specialised cleansing materials, normal saline is often used to irrigate wounds due to its high biocompatibility. However, saline is non‐antimicrobial and is ineffective at removing biofilm from necrotic wounds. Broad‐spectrum antiseptics are frequently used to control wound infection but are often cytotoxic due to their lack of selectivity. Selective antibiotics may be more effective at preserving host tissue, but their repeated use catalyses antibiotic resistance. Moreover, owing to the sequestration properties of EPS, the single use of antimicrobials to combat wound infection has been largely unsuccessful. [0006] WO 2021/186188 A1 describes a wound dressing or debridement tool comprising an absorbent layer impregnated or coated with a composition comprising a chelating agent, an amphoteric surfactant, and an anionic surfactant. [0007] However, there remains a need for further improvements in wound dressings or debridement tools that are able to promote autolytic (spontaneous, biochemically‐mediated) debridement of non‐ viable tissue, while having physical modes of action against biofilms and the microorganisms comprised therein. In particular, there is a need for wound dressings or debridement tools that are simple, economical and safe to use while maintaining efficacy and suitability for use in wound dressings and debridement tools for the purposes discussed above. Moreover, there is also a need for wound dressings or debridement tools with good stability, e.g. during storage, prior to application on
2
a wound dressing or debridement tool to ensure good uniformity and consistency in manufactured articles, and during use, for example when saturated with wound exudate. [0008] Preparation of wound dressing or debridement tool typically requires printing of various substances on fabrics or other sheet‐based materials, which may be carried out in a substantially direct or indirect manner, by discharge or by resist independently of the type of process used. The direct printing method consists of applying a formulation directly onto the material and subsequently fixing said formulation onto the fibres of the material. Particularly, direct printing may be carried out by using conventional roller printing or flat screen printing procedures. [0009] Generally, with reference to roller printing methods (e.g. flexfographic, serigraphic and intaglio techniques), the method utilises equipment generally consists of a plurality of cylinders and/or rollers on which a number of engraved rollers may apply a particular formulation to an interceding material, such as a fabric material or other sheet‐based materials. [0010] In the case of the roller printing methods, such as a Gravure printing process or a Rotary Pad printing process, there are typically at least two rollers, one used for transporting a formulation (i.e. a printing roller) and the other acts as an impression member. Passing between the rollers is the substrate material to be printed on. The formulation is typically provided to the printing roller by passing through an underlying tray, where the printing roller takes up the formulation from the underlying tray, while a doctor blade eliminates any excess ink. This printing typology allows the application of substances on a material in a rapid and economical manner. [0011] This technology is often used for applying substances onto fabrics, such as woven or nonwoven fabrics, and sheet‐based materials, such as foams or plastic sheet materials. However, there are drawbacks to the previously described methods when the substance is to be applied in an accurate manner, particularly where precise volumes or doses of a substance are to be deposited on a substrate. For example, it is known that with nonwoven fabrics are uneven, porous, stretchable and easily creased materials. Due to the uneven surface structure of the substrate material, transfer of substances from a printing roller may lack uniformity and the substances may not completely transfer from the printing roller to the surface of the substrate material. However, for certain applications (e.g. medical devices) it advantageous to be able to accurately apply substances to a substrate material in a uniform manner. [0012] Accordingly, there is a need for printing methods that can accurately apply substances, such as those described above, to a substrate material in a precise and uniform manner. Such substrate
3
materials may have utility in a wide variety of applications, such as medical device articles. In particular, wound dressings, debridement tools, ostomy systems, compression articles or epidermal dressings. [0013] There is also a need for wound dressings and debridement tools comprising a substrate layer, that is at least partially impregnated or coated with a wound cleansing or debridement solution having physical modes of action against biofilms and the microorganisms comprised therein, while exhibiting a balance of efficacy and biocompatibility. [0014] The present disclosure seeks to address these needs with the various aspects and embodiments defined herein. SUMMARY [0015] In a first aspect, there is provided a wound dressing or a debridement tool comprising one or more substrate layers, wherein one or more substances are at least partially impregnated or coated on a first surface of at least one of the substrate layers, and wherein the one or more substances are at least partially impregnated or coated on about 1 % to about 20 % of the total surface area of the first surface of the substrate layer. [0016] In a second aspect, there is provided a wound dressing or a debridement tool comprises one or more substrate layers, wherein one or more substances are at least partially impregnated on a first surface of at least one of the substrate layers, and wherein the one or more substances are impregnated on the first surface of the substrate layer to a depth of from about 1% to about 50% of the total transverse cross‐section of the substrate layer. [0017] In a third aspect, there is provided a method of applying one or more substance(s) to one or more substrate layers of an article, wherein the method comprises: (a) providing at least one transfer means comprising an impression member and a transfer member, wherein the transfer member comprises one or more cells with outward facing apertures, and wherein the transfer member is provided on the exterior of the impression member; (b) introducing the one or more substance(s) into the one or more cells of the transfer member; and (c) contacting the substrate layer with the transfer member as the substrate layer is conveyed along a transport path in a machine direction, wherein force applied by the impression member to at least the one or more cells comprised within the transfer member causes the one or more substance(s) comprised within the one or more cells to transfer to the substrate layer.
4
[0018] In a further aspect, there is provided a wound dressing or a debridement tool comprising at least one substrate layer, wherein the substrate layer is at least partially impregnated or coated with one or more substance(s) as defined herein. [0019] In a further aspect, there is provided a method of applying one or more substance(s) to one or more substrate layers of a wound dressing or debridement tool as described herein, wherein the method comprises: (a) applying one or more substances to a first surface of at least one of the substrate layers; (b) optionally applying a compressed source gas via a gas feed to the first surface of the substrate layer; (c) optionally applying at least one drying means to the first surface of the substrate layer. [0020] In a further aspect, there is provided a system for applying one or more substance(s) to one or more substrate layers of a wound dressing or debridement tool according to the method defined herein. [0021] In a further aspect, the use of the wound dressing or debridement tool as defined herein is provided to prevent or minimise slough accumulation in a wound or to de‐slough a wound, the use comprising contacting said wound dressing or debridement tool with said wound or contacting said wound with said wound dressing or debridement tool, preferably wherein the wound is a chronic wound, acute wound, or burn. [0022] In a further aspect, there is provided a system for applying one or more substance(s) to one or more substrate layer(s) of an article as defined herein, wherein the system comprises: (a) at least one transfer means comprising an impression member and a transfer member, wherein the transfer member comprises one or more cells with outward facing apertures, wherein the transfer member is provided on the exterior of the impression member, and wherein the one or more cells are configured to be reversibly compressible under force exerted by the impression member; (b) at least one reservoir comprising the substance; (c) a pump configured to draw the substance from the reservoir and introduce it into the one or more cells of the transfer member; (d) optionally a component configured to remove excess substance from the transfer member. [0023] In a further aspect, there is provided a process for preparing an article as defined in herein, said process comprising, in order, the steps of:
5
(a) conveying a substrate layer along a transport path in a machine direction toward at least one transfer means comprising an impression member and a transfer member, wherein the transfer member comprises one or more cells with outward facing apertures, wherein the transfer member is provided on the exterior of the impression member, and wherein the one or more cells are configured to be reversibly compressible under force exerted by the impression member; (b) contacting the substrate layer with the transfer member as the substrate layer is conveyed along a transport path in a machine direction, wherein force applied by the impression member to at least the one or more cells comprised within the transfer member causes the one or more substance(s) comprised within the one or more cells to transfer to the substrate layer; (c) optionally adhering or affixing the substrate layer to one or more functional layers. [0024] These aspects and embodiments are set out in the appended independent and dependent claims. It will be appreciated that features of the dependent claims may be combined with each other and with features of the independent claims in combinations other than those explicitly set out in the claims. Furthermore, the approaches described herein are not restricted to specific embodiments such as those set out below, but include and contemplate any combinations of features presented herein. [0025] The foregoing and other objects, features, and advantages of the present disclosure will appear more fully hereinafter from a consideration of the detailed description that follows along with the accompanying drawings. It is to be expressly understood, however, that the drawings are for illustrative purposes and are not to be construed as defining the limits of the disclosure. BRIEF DESCRIPTION OF THE DRAWINGS Fig. 1: Representation of the equipment used in the art for screen printing. Fig. 2: Illustration of printing technique deposition mechanism. Fig. 3: Surface coverage printing pattern – 1mm and 0.50mm printing pattern. Fig. 4: Surface coverage printing pattern – Hexagonal (LH) and Circular Offset (RH). Fig. 5: Surface coverage printing pattern – Slotted Hole (LH) and Circular Hole (RH). Fig. 6: Surface coverage printing pattern – Parabolic distribution printing pattern.
6
Fig. 7: Open area pattern on a 120T (thread) screen. Black dots show the open area where ink will be printed onto a 10x10 cm AQUACEL® Extra dressing. Printed dots: 2.5mm diameter 4.908 mm2; Open Area: 961 mm2, equating to 9.61% surface area coverage. Fig. 8: Graphical relationship between the mass of ink added to a 10x10 cm dressing sample (per side) and the efficacy of samples on a simulated non‐viable matter model compared to an AQUACEL Extra control. Fig. 9: Graphical relationship between mass of excipients (g) per side of a 10x10 cm sample when printed with a high (55T), medium (2.8 g m‐2) and low (Nominal) concentration ink, and the efficacy of these samples on the simulated non‐viable matter model compared to an AQUACEL Extra control. Fig. 10: Efficacy of high (55T), medium (2.8 g m‐2) and low (Nominal) concentration formulations with 1 mm, 1.5 mm and 2 mm diameter dots on a simulated non‐viable matter model. Fig. 11: Comparative analysis of weight of ink transfer relative to blade setting Fig. 12: Comparative analysis of % area of ink transfer relative to blade setting Fig. 13: Comparative analysis of average weight of transferred formulation mass using maximum airblade setting and no airblade setting. Fig. 14: Comparative analysis of % area of ink transfer using maximum airblade setting and no airblade setting. Fig. 15: Comparative analysis of formulation deposition depth relative to substrate thickness. Fig. 16: Schematic illustration of a Gravure printing process. Fig. 17: Schematic illustration of a Rotary Pad printing process. Fig. 18: Schematic illustration of an exemplary printing method according to the present invention. Fig. 19: Illustrative example of a plurality of cells capable of reversibly collapsing under force. Fig. 20: Image of a 2mm printed dot pattern on a foam material using the printing method according to the present invention. Fig. 21: Image of a 2mm printed dot pattern on a nonwoven fabric material using the printing method according to the present invention.
7
Fig. 22: Image of a 2mm printed dot pattern on a woven material using the printing method according to the present invention. Fig. 23: Image of a 500µm dot pattern on a nonwoven fabric material using the printing method according to the present invention. Fig. 24: Image of a 250µm dot pattern on a nonwoven material using the printing method according to the present invention. Fig. 25: Image of a 250µm dot pattern on a polymer film material using the printing method according to the present invention. Fig. 26: Image of a 500µm dot pattern on a nonwoven fabric material using a rotary pad printing process and a high viscosity substance. Fig. 27: Image of a 500µm dot pattern on a nonwoven fabric material using a rotary pad printing process and a low viscosity substance. Fig. 28: Images of nonwoven fabric materials with a printed 500µm dot pattern using Formulation A applied by alternative printing techniques (cf. Examples 1‐1 to 5‐1). Fig. 29: Images of nonwoven fabric materials with a printed 500µm dot pattern using Formulation B applied by alternative printing techniques (cf. Examples 1‐2 to 5‐2). Fig. 30: Images of nonwoven fabric materials with a printed 500µm dot pattern using Formulation C applied by alternative printing techniques (cf. Examples 1‐3 to 5‐3). Fig. 31: Images of nonwoven fabric materials with a printed 500µm dot pattern using Formulation D applied by alternative printing techniques (cf. Examples 1‐4 to 5‐4). Fig. 32: Images of nonwoven fabric materials with a printed 500µm dot pattern using Formulation E applied by alternative printing techniques (cf. Examples 1‐5 to 5‐5). Fig. 33: Images of nonwoven fabric materials with a printed 500µm dot pattern using Formulation F applied by alternative printing techniques (cf. Examples 1‐6 to 5‐6). DETAILED DESCRIPTION [0026] While various exemplary embodiments are described or suggested herein, other exemplary embodiments utilizing a variety of methods and materials similar or equivalent to those described or
8
suggested herein are encompassed by the general inventive concepts. Those aspects and features of embodiments which are implemented conventionally may not be discussed or described in detail in the interests of brevity. It will thus be appreciated that aspects and features of apparatus and methods described herein which are not described in detail may be implemented in accordance with any conventional techniques for implementing such aspects and features. [0027] As used in this specification and the claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. Unless otherwise stated, the term "about" modifying the quantity of a component refers to variation in the numerical quantity that can occur, for example, through typical measuring and handling procedures used for making concentrates, mixtures or solutions in the real world; through inadvertent error in these procedures; through differences in the manufacture, source, or purity of the materials employed, or to carry out the methods; and the like. The term “about” also encompasses amounts that differ due to different equilibrium conditions for a composition or substance resulting from a particular initial mixture. Whether or not modified by the term "about", the claims include equivalents to the quantities. As used herein, the term “at least” includes the end value of the range that is specified. For example, “at least 10 wt%” includes the value 10 wt%. [0028] As used in this specification and the claims, “gel‐forming fibres” and “gelling fibres” may be used interchangeably. Similarly, references in this specification and the claims to “non‐gel forming fibres” and “non‐gelling fibres” can be used interchangeably. [0029] The ranges provided herein provide exemplary amounts of each of the components. Each of these ranges may be taken alone or combined with one or more other component ranges. [0030] As used herein, wt% means “weight percentage” as the basis for calculating a percentage. Unless indicated otherwise, all % values are calculated on a weight basis, and are provided with reference to the total weight of the product in which the substance is present. As used herein, w/w means “weight by weight” as the basis for calculating a percentage. Unless otherwise indicated, reference to "% by weight" (or “% by weight”) of a product, substance or composition reflects the total wet weight of the product or composition (i.e., including water). [0031] In various embodiments described herein, amounts may be described as an area density using the units g/m2. In such embodiments, the area density refers to the area of a substrate layer or an absorbent layer as further described herein and the weight of the specified component comprised in or on said substrate or absorbent layer. For example, in various embodiments the composition may be applied to a wound dressing or debridement tool as described herein with an area density of 30
9
g/m2 or 15 g/m2. An exemplary wound dressing may comprise a substrate and/or an absorbent layer of dimensions 10 x 10 cm, giving an area of 0.01 m2. Thus, for the example wherein the substrate or absorbent layer has an area of 0.01 m2, 0.3 g of a composition as described herein would be applied to the substrate layer and/or absorbent layer to obtain an area density of 30 g/m2. The composition may be applied to a single surface of the absorbent layer, for example in embodiments wherein the absorbent layer is comprised in a multi‐layer wound dressing. Alternatively, the composition may be applied to a first surface of the absorbent layer and to a second surface of the absorbent layer opposite to the first surface of the absorbent layer. In such embodiments wherein the composition is applied to a first and second surface of the absorbent layer, the composition may be applied to the wound dressing or debridement tool as described herein to contribute 15 g/m2 on each of the first and second surfaces, i.e. such that the total area density applied to the absorbent layer is 30 g/m2. In other words, the area densities recited herein refer to the total area density of composition applied to the absorbent layer, calculated on the basis of the area defined by the dimensions (width and length) of the absorbent layer and the total amount of the composition applied thereto, whether applied only to a single surface of the absorbent layer or applied to both a first surface and a second surface of the absorbent layer. Thus, for the example wherein the absorbent layer has an area of 0.01 m2 (10 x 10 cm), 1.5 g of a composition as described herein could be applied to the first surface of the absorbent layer and 1.5 g of the composition applied to the second surface of the absorbent layer to obtain a total area density of 30 g/m2. [0032] As used herein, “substantially free” means no more than trace amounts, i.e. the amount of the substance(s) concerned is negligible. In various embodiments, “substantially free” means no more than 1000 ppm, preferably no more than 100 ppm, more preferably no more than 10 ppm, even more preferably no more than 1 ppm of the substance(s) concerned. [0033] In all aspects of the present disclosure, the disclosure includes, where appropriate, all enantiomers and tautomers of the compounds disclosed herein. A person skilled in the art will recognise compounds that possess optical properties (one or more chiral carbon atoms) or tautomeric characteristics. The corresponding enantiomers and/or tautomers may be isolated/prepared by methods known in the art. [0034] Some of the compounds disclosed herein may exist as stereoisomers and/or geometric isomers – e.g. they may possess one or more asymmetric and/or geometric centres and so may exist in two or more stereoisomeric and/or geometric forms. The present disclosure contemplates the use of all the individual stereoisomers and geometric isomers of those compounds, and mixtures thereof. The terms used in the claims encompass these forms.
10
[0035] As used herein the expression "wound" may include an injury to living tissue and may be caused by a cut, blow, or other impact, abrasion, pressure, heat or chemical; typically, one in which the skin is cut or broken. A wound may often be described as chronic or acute. Acute wounds may occur as a result of surgery or trauma. Typically, when not too severe and where the victim is otherwise in good health, wounds progress through well‐defined stages of healing within a predicted timeframe. Chronic wounds begin as acute wounds. An acute wound can become a chronic wound when it does not follow the normal healing pathway resulting in a lengthened recovery. It is believed that the transition from acute to chronic wound can be due to an inadequate immune response for example: the patient being immuno‐compromised, the wound being insufficiently perfused or being highly contaminated. [0036] Chronic wounds may include for example: venous ulcers (such as those that occur in the legs due to venous insufficiency), which account for the majority of chronic wounds and mostly affect the elderly; diabetic ulcers (for example, foot or ankle ulcers); arterial ulcers (due to peripheral arterial disease); and pressure injuries due to immobility. [0037] 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. [0038] The term "slough" is known to the skilled person and may be defined as a layer or mass of dead tissue separated from surrounding living tissue, or tissue that is adhered to a wound but capable of being removed as in a wound, sore, or inflammation WOUND DRESSING OR DEBRIDEMENT TOOL [0039] Acute wounds occur as a result of surgery or trauma, typically when not too severe and where the subject is otherwise in good health. Wounds progress through well‐defined stages of healing. Chronic wounds begin as acute wounds. For example, an acute wound can become a chronic wound when it does not follow the normal healing pathway resulting in a lengthened recovery. It is believed that the transition from acute to chronic can be due to an inadequate immune response, for example the patient being immuno‐compromised, the wound being insufficiently perfused or being highly contaminated. Chronic wounds may include venous ulcers, diabetic ulcers, arterial ulcers, and pressure injuries due to immobility. Wounds may also include a deep tissue injury; this is an expression used to describe a unique form of pressure ulcers.
11
[0040] Wound dressings and debridement tools are articles suitable for placement in direct contact with a wound. A wound dressing may typically debride by autolysis. Autolytic debridement refers to the lysis or breakdown of necrotic debris and devitalised tissues from a wound through the body’s own mechanisms, such as moist environments and endogenous enzymes. In various embodiments, the wound dressing comprises at least one layer comprising a foam, fabric (preferably a nonwoven fabric), or technical substrate. For example, the substrate or absorbent layer may be a nonwoven or woven fibrous layer, a gel‐forming fibre, or gauze. Gauze may be made from a cellulose, such as cotton or viscose. In preferred embodiments the substrate layer and/or absorbent layer comprises one or more gel‐forming fibres. [0041] As described herein, the substances and compositions of the present disclosure are useful for the treatment of wounds, including initial treatment in first response settings, as well as in ongoing wound management such as in primary care settings. The substances and compositions described herein may be used in cleansing and/or irrigating a wound. The use of nonwoven fabrics in wound dressings or debridement tools is well known, with several products available on the market, such as the AQUACEL® Extra™ range of dressings manufactured and sold by Convatec Ltd and Convatec Inc. For optimum performance the fabric structure requires a flat surface to ensure a controlled dose of excipients can be applied to and delivered by the fabric surface, while the fabric should also maintain a high degree of wet and dry tensile strength, absorbency, and conformability. [0042] It is known in the art to use solvent flooding to manufacture wound dressings or debridement tools because it is efficacious in the delivery of excipients to the dressing. This process may involve saturating a layer of the wound dressings or debridement tools with an excipient‐containing solution, and removing excess solution. This technique requires a suitable solvent system that is able to dissolve all of the excipients to be delivered, without remaining on the dressing itself. Whilst the solvent system may comprise multiple components, for example a mixture of organic solvents or an aqueous:organic mixture, the integrity of the dressing must be maintained. Where gel‐forming fibres are employed, for example in an absorbent layer, the water content of the excipient‐containing solution may be minimised in order to avoid premature gelling of the fibres or reduction in absorbency of the absorbent layer. Consequently the solvent used in the flooding process is primarily organic, e.g. an alcohol, and this can limit its application for large‐scale manufacture both because of cost implications for infrastructure design and process controls, and safety implications surrounding the use of high volumes of volatile solvents. [0043] It would be desirable to manufacture substrate layers on a large scale with improved considerations for safety, feasibility and efficacy. Printing processes, such as Gravure, rotary pad and
12
screen printing techniques, are attractive for this purpose because a reduced volume of solvent can be used to apply one or more substances in a controlled fashion. For example, these techniques can apply substances, via a predesigned mesh or transfer cylinder, to provide wound dressings or debridement tools with a defined substance surface coverage and/or substance deposition depth. This is particularly advantageous where one or more substances are at least partially impregnated or coated on a substrate material surface in a discontinuous configuration. [0044] As discussed herein, the application of some substances to desirable substrate materials is often a complex process. For example, a substrate material having an irregular or uneven surface (e.g. nonwoven materials) may effect the precise and uniform application of substances to the substrate material surface, which in turn results in the uncontrolled dose of excipients to the end user. [0045] According to one embodiment of the present invention, the inventors found that one or more substances can be applied to a surface of a wound dressing or debridement tool substrate material in a discontinuous fashion without negatively impacting efficacy, such that the surface area of the substrate material is only partially coated or impregnated with the substance. In particular, a wound dressing or debridement tool is provided herein, where the wound dressing or debridement tool comprises one or more substrate layers, where one or more substances are at least partially impregnated or coated on a first surface of at least one of the substrate layers, where the one or more substances are at least partially impregnated or coated on about 0.1 % to about 75 % of the total surface area of the first surface of the substrate layer. [0046] According to another embodiment of the present invention, the inventors found that one or more substances can be applied to a surface of a wound dressing or debridement tool substrate material to a specific depth of the substrate material in order to provide optimal dissolution of the substance from the wound dressing or debridement tool and further improve the manufacturing efficiency of the wound dressing or debridement tool. In particular, a wound dressing or debridement tool is provided herein, where the wound dressing or debridement tool comprises one or more substrate layers, where one or more substances are at least partially impregnated on a first surface of at least one of the substrate layers, and where the one or more substances are impregnated on the first surface of the substrate layer to a depth of from about 0.1% to about 50% of the total transverse cross‐section of the substrate layer. [0047] The inventors envisaged that optimal substance coverage and substance deposition depth parameters in the substrate material can also be advantageously combined to provide a wound
13
dressing or debridement tool with the desired functional properties, depending on the intended application of the final product. [0048] The abovementioned wound dressings and debridement tools were also found to provide good wet and dry tensile strength, absorbency, and conformability. [0049] In various embodiments, the one or more substances are at least partially impregnated or coated in a discontinuous configuration. [0050] In various embodiments, the one or more substances are at least partially impregnated or coated on about 0.5 % to about 75 % of the total surface area of the first surface of the substrate layer. In various embodiments, the one or more substances are at least partially impregnated or coated on about 0.5 % to about 50 % of the total surface area of the first surface of the substrate layer. In various embodiments, the one or more substances are at least partially impregnated or coated on about 0.5 % to about 30 % of the total surface area of the first surface of the substrate layer. In various embodiments, the one or more substances are at least partially impregnated or coated on about 1 % to about 20 % of the total surface area of the first surface of the substrate layer. In various embodiments, the one or more substances are at least partially impregnated or coated on about 5 % to about 15 % of the total surface area of the first surface of the substrate layer. In various preferred embodiments, the one or more substances are at least partially impregnated or coated on about 8 % to about 12 % of the total surface area of the first surface of the substrate layer. [0051] In various embodiments, the one or more substances are impregnated on the first surface of the substrate layer to a depth of from about 0.5% to about 40% of the total transverse cross‐section of the substrate layer. In various embodiments, the one or more substances are impregnated on the first surface of the substrate layer to a depth of from about 1% to about 30% of the total transverse cross‐section of the substrate layer. In various embodiments, the one or more substances are impregnated on the first surface of the substrate layer to a depth of from about 5% to about 25% of the total transverse cross‐section of the substrate layer. In various embodiments, the one or more substances are impregnated on the first surface of the substrate layer to a depth of from about 10% to about 25% of the total transverse cross‐section of the substrate layer. In various preferred embodiments, the one or more substances are impregnated on the first surface of the substrate layer to a depth of from about 15% to about 20% of the total transverse cross‐section of the substrate layer. [0052] In some embodiments, the one or more substances are at least partially impregnated on about 0.5 % to about 75 % of the total surface area of the first surface of the substrate layer. In various embodiments, the one or more substances are at least partially impregnated on about 0.5 % to about
14
50 % of the total surface area of the first surface of the substrate layer. In various embodiments, the one or more substances are at least partially impregnated on about 0.5 % to about 30 % of the total surface area of the first surface of the substrate layer. In various embodiments, the one or more substances are at least partially impregnated on about 1 % to about 20 % of the total surface area of the first surface of the substrate layer. In various embodiments, the one or more substances are at least partially impregnated on about 5 % to about 15 % of the total surface area of the first surface of the substrate layer. In various preferred embodiments, the one or more substances are at least partially impregnated on about 8 % to about 12 % of the total surface area of the first surface of the substrate layer. [0053] In some embodiments, the one or more substances are at least partially impregnated or coated on the first surface of the substrate layer in discrete units, wherein the discrete unit surface area for each unit differs. [0054] In some embodiments, the one or more substances are at least partially impregnated on the first surface of the substrate layer in discrete units, wherein the discrete unit surface area for each unit differs. [0055] In some embodiments, the discrete unit surface area for each unit increases and decreases across an axis of the substrate layer surface in a parabolic distribution (see for example, Figure 6). [0056] In some embodiments, the one or more substances are at least partially impregnated or coated on the first surface of the substrate layer in discrete units, wherein the discrete unit surface area is equivalent for each unit. [0057] In some embodiments, the one or more substances are at least partially impregnated on the first surface of the substrate layer in discrete units, wherein the discrete unit surface area is equivalent for each unit. [0058] In various embodiments, the one or more substances are at least partially impregnated or coated on the first surface of the substrate layer in discrete units of from 0.08 mm2 to about 20.00 mm2. In various preferred embodiments, the one or more substances are at least partially impregnated or coated on the first surface of the substrate layer in discrete units of from 0.60 mm2 to about 1.75 mm2.
15
[0059] In various embodiments, the at least one substrate layer comprises a material selected from: fibres, fabrics or yarns, gels, foams, films, plastics, resins, rubber, collagen, decellularized tissue or a combination thereof. [0060] In various embodiments, the at least one substrate layers comprises a material selected from: fibres, fabrics or yarns, foams, films or a combination thereof. [0061] In various embodiments, the at least one substrate layer is a fabric material. In various preferred embodiments, the substrate layer is a nonwoven fabric material. [0062] In various embodiments, the fabric material is a nonwoven fabric material consisting of gel forming fibres and/or non‐gel forming fibres. In various preferred embodiments, the fabric material is a nonwoven fabric material consisting of gel‐forming fibres and non‐gel forming fibres; or the fabric material is a nonwoven fabric material consisting of gel‐forming fibres. [0063] In various embodiments, the at least one substrate layer is a foam material, preferably a polyurethane foam, a polypropylene foam, a polyester foam or a polyvinyl alcohol (PVA) foam. [0064] In various embodiments, the one or more substances are impregnated on the first surface of the substrate layer to a depth of from about 100µm to about 500 µm of the total transverse cross‐ section of the substrate layer. In various preferred embodiments, the one or more substances is impregnated on the first surface of the substrate layer to a depth of from about 200µm to about 400 µm of the total transverse cross‐section of the substrate layer. [0065] In various embodiments, the at least one substrate layer has a surface energy of about 45 to about 1000 mJ/m2. [0066] In various embodiments, the dissolution rate of the one or more substances is of from 10 to 90 % per day. [0067] In various embodiments, the one or more substances are impregnated on the first surface of the substrate layer to a depth of from about 1% to about 50% of the total transverse cross‐section of the substrate layer. In various preferred embodiments, the one or more substances are impregnated on the first surface of the substrate layer to a depth of from about 15% to about 20% of the total transverse cross‐section of the substrate layer. [0068] In various embodiments, the substrate layer(s) has a basis weight of about 150 – 200 gsm. In various preferred embodiments, the substrate layer(s) has a basis weight of about 160 – 185 gsm.
16
[0069] In various embodiments, the wound dressing or debridement tool has a basis weight of about 150 – 200 gsm. In various preferred embodiments, the wound dressing or debridement tool has a basis weight of about 160 – 185 gsm. [0070] In various embodiments, the substrate layer disclosed herein may have a thickness between about 0.5mm to about 20mm. In various embodiments, the substrate layer disclosed herein may have a thickness between about 1mm to about 10mm. In various embodiments, the substrate layer disclosed herein may have a thickness between about 1.5mm to about 7 mm. [0071] In various embodiments, the substrate layer(s) has a bulk density of about 25 – 100 kg/m3. In various embodiments, the substrate layer(s) has a bulk density of about 35 – 90 kg/m3. In various embodiments, the substrate layer(s) has a bulk density of about 40 – 80 kg/m3. [0072] In various embodiments, the wound dressing or debridement tool has a bulk density of about 25 – 100 kg/m3. In various embodiments, the wound dressing or debridement tool has a bulk density of about 35 – 90 kg/m3. In various embodiments, the wound dressing or debridement tool has a bulk density of about 40 – 80 kg/m3. [0073] In various embodiments, the substrate layer has a fluid absorbency of about 0.05g/cm2 or more. In various embodiments, the substrate layer has a fluid absorbency of about 0.10g/cm2 or more. In various embodiments, the substrate layer has a fluid absorbency of about 0.15g/cm2 or more. In various embodiments, the substrate layer has a fluid absorbency of about 0.20g/cm2 or more. In various embodiments, the substrate layer has a fluid absorbency of about 0.25g/cm2 or more. In various embodiments, the substrate layer has a fluid absorbency of about 0.30g/cm2 or more. In various embodiments, the substrate layer has a fluid absorbency of about 0.35g/cm2 or more. In various embodiments, the substrate layer has a fluid absorbency of about 0.40g/cm2 or more. In various embodiments, the substrate layer has a fluid absorbency of about 0.45g/cm2 or more. [0074] In various embodiments, the wound dressing or debridement tool has a fluid absorbency of about 0.05g/cm2 or more. In various embodiments, the wound dressing or debridement tool has a fluid absorbency of about 0.10g/cm2 or more. In various embodiments, the wound dressing or debridement tool has a fluid absorbency of about 0.15g/cm2 or more. In various embodiments, the wound dressing or debridement tool has a fluid absorbency of about 0.20g/cm2 or more. In various embodiments, the wound dressing or debridement tool has a fluid absorbency of about 0.25g/cm2 or more. In various embodiments, the wound dressing or debridement tool has a fluid absorbency of about 0.30g/cm2 or more. In various embodiments, the wound dressing or debridement tool has a fluid absorbency of about 0.35g/cm2 or more. In various embodiments, the wound dressing or
17
debridement tool has a fluid absorbency of about 0.40g/cm2 or more. In various embodiments, the wound dressing or debridement tool has a fluid absorbency of about 0.45g/cm2 or more. [0075] In various embodiments, the substrate layer has a fluid retention of at least about 45%. In various embodiments, the substrate layer has a fluid retention of at least about 55%. In various embodiments, the substrate layer has a fluid retention of at least about 65%. In various embodiments, the substrate layer has a fluid retention of at least about 75%. In various embodiments, the substrate layer has a fluid retention of at least about 85%. In various embodiments, the substrate layer has a fluid retention of at least about 90%. In various embodiments, the substrate layer has a fluid retention of at least about 95%. [0076] In various embodiments, the wound dressing or debridement tool has a fluid retention of at least about 45%. In various embodiments, the wound dressing or debridement tool has a fluid retention of at least about 55%. In various embodiments, the wound dressing or debridement tool has a fluid retention of at least about 65%. In various embodiments, the wound dressing or debridement tool has a fluid retention of at least about 75%. In various embodiments, the wound dressing or debridement tool has a fluid retention of at least about 85%. In various embodiments, the wound dressing or debridement tool has a fluid retention of at least about 90%. In various embodiments, the wound dressing or debridement tool has a fluid retention of at least about 95%. [0077] In various embodiments, the substrate layer has a lateral wicking distance of no more than about 40 mm in the machine direction and in the transverse direction. In various embodiments, the substrate layer has a lateral wicking distance of no more than about 30 mm in the machine direction and in the transverse direction. In various embodiments, the substrate layer has a lateral wicking distance of no more than about 25 mm in the machine direction and in the transverse direction. In various embodiments, the substrate layer has a lateral wicking distance of no more than about 20 mm in the machine direction and in the transverse direction. [0078] In various embodiments, the substrate layer has an absorption under compression of at least about 0.10 g/cm2. In various embodiments, the substrate layer has an absorption under compression of at least about 0.12 g/cm2. In various embodiments, the substrate layer has an absorption under compression of at least about 0.14 g/cm2. In various embodiments, the substrate layer has an absorption under compression of at least about 0.16 g/cm2. In various embodiments, the substrate layer has an absorption under compression of at least about 0.18 g/cm2. In various embodiments, the substrate layer has an absorption under compression of at least about 0.20 g/cm2. In various embodiments, the substrate layer has an absorption under compression of at least about 0.22 g/cm2.
18
In various embodiments, the substrate layer has an absorption under compression of at least about 0.24 g/cm2. In various embodiments, the substrate layer has an absorption under compression of at least about 0.26 g/cm2. [0079] In various embodiments, the substrate layer(s) has a dimensional shrinkage of no greater than about 25 % in the machine direction and in the transverse direction. In various embodiments, the substrate layer(s) has a dimensional shrinkage of no greater than about 20 % in the machine direction and in the transverse direction. In various embodiments, the substrate layer(s) has a dimensional shrinkage of no greater than about 15 % in the machine direction and in the transverse direction. In various embodiments, the substrate layer(s) has a dimensional shrinkage of no greater than about 10 % in the machine direction and in the transverse direction. [0080] In various embodiments, the substrate layer(s) has a wet tensile strength of at least about 1.0 N/cm. In various embodiments, the substrate layer(s) has a wet tensile strength of at least about 2.0 N/cm. In various embodiments, the substrate layer(s) has a wet tensile strength of at least about 3.0 N/cm. In various embodiments, the substrate layer(s) has a wet tensile strength of at least about 4.0 N/cm. In various embodiments, the substrate layer(s) has a wet tensile strength of at least about 5.0 N/cm. [0081] In various embodiments, the wound dressing or debridement tool has a wet tensile strength of at least about 1.0 N/cm. In various embodiments, the wound dressing or debridement tool has a wet tensile strength of at least about 2.0 N/cm. In various embodiments, the wound dressing or debridement tool has a wet tensile strength of at least about 3.0 N/cm. In various embodiments, the wound dressing or debridement tool has a wet tensile strength of at least about 4.0 N/cm. In various embodiments, the wound dressing or debridement tool has a wet tensile strength of at least about 5.0 N/cm. [0082] In various embodiments, the substrate layer(s) has a dry tensile strength of at least about 5.0 N/cm. In various embodiments, the substrate layer(s) has a dry tensile strength of at least about 9.0 N/cm. In various embodiments, the substrate layer(s) has a dry tensile strength of at least about 13.0 N/cm. In various embodiments, the substrate layer(s) has a dry tensile strength of at least about 17.0 N/cm. In various embodiments, the substrate layer(s) has a dry tensile strength of at least about 21.0 N/cm. [0083] In various embodiments, the substrate layer(s) is needle punched. In various embodiments, the substrate layer(s) has a needle punch density of about 25 to about 150 per cm2. In various
19
preferred embodiments, the substrate layer(s) has a needle punch density of about 30 to about 80 per cm2. [0084] In various embodiments, the substrate layer(s) has a needle punch depth of about 1mm to about 20mm. In various embodiments, the substrate layer(s) has a needle punch depth of about 5mm to about 20mm. In various embodiments, the substrate layer(s) has a needle punch depth of about 5mm to about 15mm. In various embodiments, the substrate layer(s) has a needle punch depth of about 5mm to about 10mm. [0085] In various embodiments, the wound dressing or debridement tool consists of one or more substrate layers. In various embodiments, the wound dressing or debridement tool consists of a plurality of substrate layers. In various embodiments, the wound dressing or debridement tool consists of one substrate layer. [0086] In a preferred embodiment, the wound dressing or debridement tool consists of the substrate layer. [0087] In various embodiments, the one or more substrate layers are selected from: an absorbent layer, a transmission layer, an adhesive layer, a soluble medicated film layer, an odour‐absorbing layer, a spreading layer, a keying layer, a distribution layer, a superabsorbent layer or combinations thereof. In various preferred embodiments, the one or more substrate layers is an absorbent layer. [0088] In various embodiments, the wound dressing or debridement tool is of a monolayer construction, or wherein the wound dressing or debridement tool is of a multi‐layer construction. In various embodiments, the multi‐layer construction comprises one or more functional layers. [0089] In various embodiments, the wound dressing or debridement tool is of a monolayer construction, i.e. the wound dressing or debridement tool consists of a single substrate layer. [0090] In various embodiments, the at least one substrate layer comprises a second surface opposite the first surface. [0091] In various embodiments, the wound dressing or debridement tool consists of one or more substrate layers and one or more functional layers selected from: an absorbent layer, a wound contacting, an outer cover layer, a transmission layer, an adhesive layer, a support layer, a distribution layer, a soluble medicated film layer, an odour‐absorbing layer, a spreading layer, a keying layer, a superabsorbent layer or combinations thereof; preferably wherein the one or more further functional
20
layers is selected from: a wound contacting layer, a transmission layer, an adhesive layer, a superabsorbent layer or combinations thereof. [0092] In a preferred embodiment, the wound dressing or debridement tool consists of the substrate layer, where the substrate layer consists of the nonwoven fabric. [0093] In a highly preferred embodiment, the wound dressing or debridement tool consists of the substrate layer, where the substrate layer consists of the nonwoven fabric and the nonwoven fabric consists of the gelling fibres and the non‐gelling fibres; preferably wherein the gelling fibres are present in an amount of from about 60 to about 95 wt% of the substrate layer and the non‐gelling fibres are present in an amount of from about 5 to about 40 wt% of the substrate layer. [0094] In some embodiments, a wound dressing or debridement tool is provided comprising a substrate layer, wherein the substrate layer comprises a nonwoven fabric, the nonwoven fabric comprising gelling fibres and non‐gelling fibres, wherein the gelling fibres are present in an amount of from about 60 to about 95 wt% of the substrate layer and the non‐gelling fibres are present in an amount of from about 5 to about 40 wt% of the substrate layer. [0095] In various embodiments, the gelling fibres are present in an amount of from about 65 to about 95 wt% of the substrate layer and the non‐gelling fibres are present in an amount of from about 5 to about 35 wt% of the substrate layer. In various embodiments, the gelling fibres are present in an amount of from about 70 to about 95 wt% of the substrate layer and the non‐gelling fibres are present in an amount of from about 5 to about 30 wt% of the substrate layer. In various embodiments, the gelling fibres are present in an amount of from about 75 to about 95 wt% of the substrate layer and the non‐gelling fibres are present in an amount of from about 5 to about 25 wt% of the substrate layer. In various embodiments, the gelling fibres are present in an amount of from about 80 to about 95 wt% of the substrate layer and the non‐gelling fibres are present in an amount of from about 5 to about 20 wt% of the substrate layer. In various embodiments, the gelling fibres are present in an amount of from about 85 to about 95 wt% of the substrate layer and the non‐gelling fibres are present in an amount of from about 5 to about 15 wt% of the substrate layer. In various embodiments, the gelling fibres are present in an amount of from about 90 to about 95 wt% of the substrate layer and the non‐gelling fibres are present in an amount of from about 5 to about 10 wt% of the substrate layer. In various embodiments, the gelling fibres are present in an amount of from about 65 to about 90 wt% of the substrate layer and the non‐gelling fibres are present in an amount of from about 10 to about 35 wt% of the substrate layer. In various embodiments, the gelling fibres are present in an amount of from about 70 to about 90 wt% of the substrate layer and the non‐gelling fibres are present
21
in an amount of from about 10 to about 30 wt% of the substrate layer. In various embodiments, the gelling fibres are present in an amount of from about 75 to about 90 wt% of the substrate layer and the non‐gelling fibres are present in an amount of from about 10 to about 25 wt% of the substrate layer. In various embodiments, the gelling fibres are present in an amount of from about 80 to about 90 wt% of the substrate layer and the non‐gelling fibres are present in an amount of from about 10 to about 20 wt% of the substrate layer. In various embodiments, the gelling fibres are present in an amount of from about 85 to about 90 wt% of the substrate layer and the non‐gelling fibres are present in an amount of from about 10 to about 15 wt% of the substrate layer. In various embodiments, the gelling fibres are present in an amount of from about 65 to about 85 wt% of the substrate layer and the non‐gelling fibres are present in an amount of from about 15 to about 35 wt% of the substrate layer. In various embodiments, the gelling fibres are present in an amount of from about 70 to about 85 wt% of the substrate layer and the non‐gelling fibres are present in an amount of from about 15 to about 30 wt% of the substrate layer. In various embodiments, the gelling fibres are present in an amount of from about 75 to about 85 wt% of the substrate layer and the non‐gelling fibres are present in an amount of from about 15 to about 25 wt% of the substrate layer. In various embodiments, the gelling fibres are present in an amount of from about 80 to about 85 wt% of the substrate layer and the non‐gelling fibres are present in an amount of from about 15 to about 20 wt% of the substrate layer. In various embodiments, the gelling fibres are present in an amount of from about 90 to about 85 wt% of the substrate layer and the non‐gelling fibres are present in an amount of from about 15 to about 10 wt% of the substrate layer. In various embodiments, the gelling fibres are present in an amount of from about 65 to about 80 wt% of the substrate layer and the non‐gelling fibres are present in an amount of from about 20 to about 35 wt% of the substrate layer. In various embodiments, the gelling fibres are present in an amount of from about 70 to about 80 wt% of the substrate layer and the non‐gelling fibres are present in an amount of from about 20 to about 30 wt% of the substrate layer. In various embodiments, the gelling fibres are present in an amount of from about 75 to about 80 wt% of the substrate layer and the non‐gelling fibres are present in an amount of from about 20 to about 25 wt% of the substrate layer. In various embodiments, the gelling fibres are present in an amount of from about 85 to about 80 wt% of the substrate layer and the non‐gelling fibres are present in an amount of from about 20 to about 15 wt% of the substrate layer. In various embodiments, the gelling fibres are present in an amount of from about 90 to about 80 wt% of the substrate layer and the non‐gelling fibres are present in an amount of from about 20 to about 10 wt% of the substrate layer. In various embodiments, the gelling fibres are present in an amount of from about 65 to about 75 wt% of the substrate layer and the non‐gelling fibres are present in an amount of from about 25 to about 35 wt% of the substrate layer. In various embodiments, the gelling fibres are present in an
22
amount of from about 70 to about 75 wt% of the substrate layer and the non‐gelling fibres are present in an amount of from about 25 to about 30 wt% of the substrate layer. In various embodiments, the gelling fibres are present in an amount of from about 80 to about 75 wt% of the substrate layer and the non‐gelling fibres are present in an amount of from about 25 to about 20 wt% of the substrate layer. In various embodiments, the gelling fibres are present in an amount of from about 85 to about 75 wt% of the substrate layer and the non‐gelling fibres are present in an amount of from about 25 to about 15 wt% of the substrate layer. In various embodiments, the gelling fibres are present in an amount of from about 90 to about 75 wt% of the substrate layer and the non‐gelling fibres are present in an amount of from about 25 to about 10 wt% of the substrate layer. [0096] By gelling fibres or gel forming fibres it is meant hygroscopic fibres that upon the uptake of wound exudate become moist slippery or gelatinous. The gel forming fibres can be of the type that retain their structural integrity on absorption of exudate or can be of the type that lose their fibrous form and become an amorphous or structureless gel. The gel forming fibres are typically sodium carboxymethylcellulose fibres, chemically modified cellulosic fibres, alkyl sulphonate modified cellulosic fibres, such as those described in WO2012/061225, pectin fibres, alginate fibres, chitosan fibres, hyaluronic acid fibres, or other polysaccharide fibres or fibres derived from gums, as well as non‐cellulose synthetic fibres such as poly(vinyl alcohol) and polyacrylate. [0097] The gelling fibres are typically chemically modified cellulosic fibres in the form of a fabric and in particular carboxymethylated cellulose fibres, as described in PCT WO00/01425. Sodium carboxymethylcellulose fibres typically have a degree of substitution of at least 0.05 carboxymethyl groups per glucose unit. The gelling fibres typically have an absorbency of at least 2 grams (or at least 8 grams, or at least 10 grams), 0.9% saline solution (Solution A) per gram of fibre (as measured by BS EN 13726‐1 (2002) "Test methods for primary wound dressings", section 3.2 "Free swell absorptive capacity"). The carboxymethylated cellulosic fabrics typically have a degree of substitution between 0.12 to 0.35 (as defined in WO00/01425), more typically a degree of substitution of between 0.20 and 0.30, such that the absorbency of a fabric produced from is increased when compared to the unmodified cellulose. Particular useful fabrics have an absorbency of from about 10 g/g to about 30 g/g of isotonic aqueous solution as measured by the method described in BS EN 13726‐1 (2002). [0098] Fabrics may consist solely of cellulosic fibre, but may contain a proportion of a textile fibre or gel forming fibre. This textile fibre may be for example a cellulose fibre of a known kind and may comprise continuous filament yarn and/or staple fibre.
23
[0099] In various embodiments, the gelling fibres are selected from: carboxymethylcellulose fibres and derivatives thereof, modified cellulosic fibres, alkyl sulphonate modified cellulosic fibres, pectin fibres, alginate fibres, chitosan fibres, hyaluronic acid fibres, fibres derived from gums, non‐cellulose synthetic fibres, superabsorbent fibres, such as polyacrylate fibres, and combinations thereof. [0100] In a preferred embodiment, the gelling fibres are carboxymethylcellulose fibres or derivatives thereof (e.g. HYDROCEL™). [0101] In various embodiments, the non‐gelling fibres are selected from: cellulosic fibres, modified cellulosic fibres, polyester fibres, polypropylene fibres, polyamide fibres, or combinations thereof. [0102] In a preferred embodiment, the non‐gelling fibres are cellulosic fibres, modified cellulosic fibres, or a combination thereof. Highly preferred non‐gelling fibres are lyocell fibres (e.g. LYOCELL™). [0103] In various embodiments, the gelling fibres and non‐gelling fibres are present in the nonwoven fabric at a weight ratio of from about 85:15 to about 65:35. In a various embodiments, the gelling fibres and non‐gelling fibres are present in the nonwoven fabric at a weight ratio of about 80:20 to about 70:30. In a preferred embodiment the gelling fibres and non‐gelling fibres are present in the nonwoven fabric at a weight ratio of about 75:25. METHODS & PROCESSES [0104] Uniform deposition of substances in substrate materials was challenging where a specific depth of deposition was required. The characteristics of the substance and substrate often dictate the depth of deposition, based upon gravitational and capillary forces. However, the inventors identified a method where substance deposition depth could be provided in a repeatable fashion while simultaneously improving the efficiency of the manufacturing process. [0105] According to the present invention, there is provided a method of applying one or more substance(s) to one or more substrate layers of a wound dressing or debridement tool, as disclosed above, wherein the method comprises: (a) applying one or more substances to a first surface of at least one of the substrate layers; (b) optionally applying at least one drying means to the first surface of the substrate layer. [0106] In a preferred embodiment of the invention, there is provided a method of applying one or more substance(s) to one or more substrate layers of a wound dressing or debridement tool, as disclosed above, wherein the method comprises: (a) applying one or more substances to a first surface of at least one of the substrate layers;
24
(b) applying a compressed source gas via a gas feed to the first surface of the substrate layer; (c) optionally applying at least one drying means to the first surface of the substrate layer. [0107] In various embodiments, the one or more substances are applied to the first surface of the substrate layer by a printing process; preferably wherein the printing process is a screen printing process, a gravure printing process, a soft gravure printing process, a rotary pad printing process or a needle dosing process. [0108] In various embodiments, according to step (b) of the preferred embodiment, the substrate layer is conveyed in a machine direction at a rate of about 0.01 to about 35.00 cm/sec. In various embodiments, according to step (b) of the preferred embodiment, the substrate layer is conveyed in a machine direction at a rate of about 0.05 to about 20 cm/sec. [0109] In various embodiments, the one or more substances are applied to the first surface of the substrate layer by a printing process; preferably wherein the printing process is a screen printing process, a gravure printing process, a soft gravure printing process, a rotary pad printing process or a needle dosing process. [0110] In various embodiments, the compressed gas feed is an air knife. Air knives (also know as air blades) are known in the art to be a system capable of producing a pressurized air plenum chamber with a continuous aperture through which pressurized air exits in a laminar (uniform) flow pattern. The exit air velocity creates an impact air velocity onto the surface of products that the air is directed toward. [0111] In various embodiments, the compressed gas feed outlet is positioned at a height of about 0.1cm to about 100cm above the first surface of the substrate layer. In various preferred embodiments, the compressed gas feed is positioned at a height of about 1cm to about 30cm above the first surface of the substrate layer. [0112] In various embodiments, the source gas is selected from: air, helium, nitrogen, oxygen, hydrogen, argon, nitrogen oxide or combinations thereof. [0113] In some embodiments, the source gas is a filtered source gas. [0114] In various embodiments, the pressure of the compressed gas feed is from greater than about 0 to about 150 psi. In various preferred embodiments, the pressure of the compressed gas feed is from about 40 to about 100 psi.
25
[0115] In various embodiments, the temperature of the compressed gas feed is from about 0 to about 100 oC. In various embodiments, the temperature of the compressed gas feed is from about 0 to about 50 oC. In various embodiments, the temperature of the compressed gas feed is from about 1 to about 40 oC. In various preferred embodiments, the temperature of the compressed gas feed is from about 5 to about 30 oC. [0116] In various embodiments, wherein at least one drying means is applied to the first surface of the substrate layer. Preferably wherein the at least one drying means is an air knife. [0117] In various other embodiments, a substance or composition described herein is comprised in a wound dressing or debridement tool as defined herein, wherein said wound dressing or debridement tool comprises a substrate layer at least partially impregnated or coated with said substance or composition. Various methods by which the substance or composition is at least partially impregnated or coated in or on the substrate layer are known in the art and discussed herein. [0118] Inclusion of the disclosed technology in a wound dressing or similar wound treatment device (for instance a debridement tool) can be achieved by addition to the material from which the dressing or device is constructed or by addition to the finished dressing/device. For example, where the substrate layer comprises fibres, the substance or composition may be added to the dope (the liquid from which the fibres are spun (extruded)). In other embodiments, the substance or composition may be co‐extruded in a hot melt process. The substance or composition may be washed into the fibre by a soaking process. The substance or composition may be coated onto the formed fibre by passing through a bath containing the technology in a liquid or solution form (where the solute may be removed by a drying process known in the art, such as by forced air or any other gas, particularly nitrogen if flammable solvents are involved, or by heat, or by heat and forced air) or as a molten liquid. The substance or composition may be sprayed onto the formed fibre in a liquid form or from a solution (where the solute may be removed by a drying process known in the art such as by forced air or any other gas, particularly nitrogen if flammable solvents are involved, or by heat, or by heat and forced air) or as a molten liquid in a hot‐melt inkjet process. The substance or composition may be added as a powder coating where adhesion could be encouraged by electrostatic effects or by increasing the adhesive tack properties of the receiving fibre (say by partial hydration using humidity or by pre‐ treating the fibre with a viscous liquid such as an alcohol (for example hexanol), a polyol (for example propan‐1,2‐diol or glycerol), a hydrophilic hydrocarbon (for example a polyethylene oxide) or by the order of addition of the substance or composition itself (for example a liquid surfactant such as liquid fatty acid or fatty acid salt or a liquid fatty acid that will form the salt in situ).
26
[0119] When the wound dressing or debridement tool is pre‐formed the technology may be added via similar washing, coating, spraying or powder coating. Additionally, the substance or composition may be added by suspending the substance or composition in a non‐solvent and passing this through the wound dressing/debridement tool such that the suspended technology is mechanically trapped (i.e. positively added by filtration). [0120] In further embodiments, the substance or composition may be added as an ink or pigment by a printing process, for example a screen‐printing process, where the addition can be closely controlled by use of the screen. The print could be a continuous, for example as achieved by flood‐coating, or, more preferably as a discontinuous coating (regular or random patterned) as it has less impact on porosity/breathability, flexibility, absorbency and ability to contour to the complex topography of the wound bed and both the macroscopic (physiology) and microscopic (cellular) levels. [0121] The substance or composition may be added as a separate layer, for example as a gel coating directly onto the wound dressing/debridement tool, for example by way of a knife‐ over‐roll or gravure coating technique. In further embodiments, the substance or composition may be cast as a film by a similar coating technique and then adhered to the wound device by tackifying the device or the film by, for example humidification, or by the addition of an adhesive. [0122] It is generally known that printing on fabrics or other sheet‐based materials may be carried out in a substantially direct or indirect manner, by discharge or by resist independently of the type of process used. The direct printing method consists of applying a formulation directly onto the material and subsequently fixing said formulation onto the fibres of the material. Particularly, direct printing may be carried out by using conventional roller printing or flat screen‐printing procedures. [0123] Generally, with reference to roller printing methods (e.g. flexographic, serigraphic and intaglio techniques), the method utilises equipment generally consists of a plurality of cylinders and/or rollers on which a number of engraved rollers may apply a particular formulation to an interceding material, such as a fabric material or other sheet‐based materials. [0124] In the case of the roller printing methods, such as a Gravure printing process or a Rotary Pad printing process, there are typically at least two rollers, one used for transporting a formulation (i.e. a printing roller) and the other acts as an impression member. Passing between the rollers is the substrate material to be printed on. The formulation is typically provided to the printing roller by passing through an underlying tray, where the printing roller takes up the formulation from the underlying tray, while a doctor blade eliminates any excess ink. This printing typology allows the application of substances on a material in a rapid and economical manner.
27
[0125] The aforementioned techniques are often used for applying substances onto fabrics, such as woven or nonwoven fabrics, and sheet‐based materials, such as foams or plastic sheet materials. As discussed above, the substance or compositions of the present disclosure are particularly suited for the above discussed processes, and in particular processes for producing discontinuous coatings such as regular or random patterns such as dot arrays. For example, the substance or compositions of the present disclosure are particularly suitable for screen‐printing. [0126] Further, the substance or compositions of the present disclosure are also specifically adapted for novel printing processes, such as the process disclosed herein. [0127] As described herein, it is known in the art to use solvent flooding to manufacture substrate layers for wound dressings or debridement tools because it is efficacious in the delivery of excipients to the dressing. However, due to potential cost implications for infrastructure design and process controls for using such a process, and indeed the associated safety implications surrounding the use of high volumes of volatile solvents, it would be desirable to manufacture substrate layers on a large scale with improved considerations for safety, feasibility and efficacy. Printing processes, such as Gravure, rotary pad and screen printing techniques, are attractive for this purpose because a reduced volume of solvent can be used to apply the excipients via a predesigned mesh or transfer cylinder. [0128] The process of screen printing involves pressing an ink or pigment (1) through a stencilled mesh (4) using a rubber blade or squeegee (2) (see Figure 1). The mesh (4) is stretched over a frame (5) and remains under tension in order to act as the ‘screen’. A design or pattern (3) may be created by making areas of the mesh (4) impermeable to the ink (1). This may be carried out using an emulsion as is known in the art. During use, the blade or squeegee is moved across the screen to fill the open mesh apertures with ink (excipients fully dissolved in a liquid) or pigment (particles suspended in a liquid carrier), and a reverse stroke causes the screen to touch the substrate momentarily along a line of contact. This causes the ink or pigment to wet the substrate and be pulled out of the mesh aperture as the screen springs back after the blade or squeegee has passed. However, application of substances using screen printing relies heavily upon both the process and the starting materials. In particular, the substances should be formulated into a liquid with specific viscosity and surface tension characteristics to allow reproducible printing. Thus, it is not always possible to use this technique, depending on the substance to be applied. [0129] In Gravure printing (as illustrated in Figure 16), a pattern is typically etched with cells of different depths on the surface of a metal cylinder, where the cells are recessed into the cylinder. This type of cylinder is often referred to as the Gravure cylinder (3). These cells hold a single substance that
28
can be transferred to the substrate material (2). The dimensions of the cells dictate the quantities of the substance applied to the substrate material. The Gravure cylinder typically sits partially immersed in a formulation container or tray (6), where it picks up the substance to fill its recessed cells on each rotation of the press. The substance fill the cells, i.e. the cells are loaded with a substance, and the non‐printing portions of the cylinder are wiped or scraped free of the formulation using a doctor blade (5). The substrate is then conveyed in a machine direction and pressed against the loaded Gravure cylinder on a rotary press using an impression roller (1). The pattern is transferred directly to the substrate surface by the Gravure cylinder, unlike in an offset printing method e.g. Rotary Pad printing, which uses an interim cylinder. [0130] Rotary pad printing (as illustrated in Figure 17) is similar to that of Gravure but, as mentioned above, this method involves an interim cylinder (4) positioned between the Gravure cylinder (3) and the impression roller (1). This interim cylinder (4) is a smooth uniform surface and is often formed from a soft flexible material, such as a rubber‐based material. The Gravure cylinder (3) has a plurality of recessed cells etched onto it, where said cells are capable of taking up a substance to fill the cells on each rotation of the press. A doctor blade (5) removes the excess substance from the Gravure cylinder (3) and, as the Gravure cylinder (3) rotates, the substance is transferred from the Gravure cylinder (3) to the interim cylinder (4) surface, which subsequently transfers the substance directly onto a substrate surface (2) when pressed against the impression roller (1). [0131] While Gravure and Rotary Pad printing techniques are well known for applying substances to substrate materials used in the medical device industry, problems have been observed with said techniques, particularly where the precise and uniform application of one or more substances is desirable. For example, during the transfer of substances from the Gravure cylinder to the substrate surface, either directly or indirectly via an interim cylinder (4), some substance is often retained in the recessed cells or transfers poorly, likely due to the certain characteristics of the substance itself, such as the surface tension of the substance and/or the surface energy of the cells (see examples provided in Figures 26 and 27). Similar problems are observed in other techniques used in the medical device industry, such as Flat Screen printing, Rotary Screen printing and Needle Dosing. This problem is particularly acute where the pattern to be printed is particularly fine, such as less than 0.75mm2. [0132] Accordingly, the present invention provides a solution, where a method of applying one or more substance(s) to one or more substrate layers of a wound dressing or debridement tool, as described herein, is provided, wherein the method comprises:
29
(a) providing at least one transfer means comprising an impression member and a transfer member, wherein the transfer member comprises one or more cells with outward facing apertures, and wherein the transfer member is provided on the exterior of the impression member; (b) introducing the one or more substance(s) into the one or more cells of the transfer member; and (c) contacting the substrate layer with the transfer member as the substrate layer is conveyed along a transport path in a machine direction, wherein force applied by the impression member to at least the one or more cells comprised within the transfer member causes the one or more substance(s) comprised within the one or more cells to transfer to the substrate layer. [0133] Figure 18 illustrates such an exemplary method. [0134] Figures 20‐25 illustrate the high quality results of printing substances on a variety of different substrate material, including foam, nonwoven fabrics, woven fabrics and polymer films. [0135] According to the present disclosure, the abovementioned method may be referred to as a “soft gravure printing” method or process. TRANSFER MEANS [0136] According to the present invention, the transfer means comprises of an impression member and a transfer member. [0137] As described herein, impression members are configured to apply a force to an opposing member or substrate, whereas the transfer member comprises one or more cells with outward facing apertures that are capable of being loaded with one or more substances, which can be transferred to a substrate material. The configuration of a transfer member provided on the exterior of the impression member results in a force being applied to at least the one or more of the cells comprised within the transfer member, causing the substance(s) comprised within the cells to transfer to the substrate layer. [0138] The one or more cells are constructed such that they can contain a substance described herein. The cell construction is compressible, preferably reversibly compressible, such that the boundary of each cell collapses when force is applied and reverts to it original configuration when force is removed. The action of the cell boundary forces all of the substance contained within the cell through the outward facing apertures and on to the substrate material, i.e. substantially no substance remains in the cell after step (c). This is advantageous because precise quantities of substance can be deposited on the substrate surface in a uniform manner.
30
[0139] The properties of the substrate upon which the substance is to be applied must also be considered carefully. For example, a substrate material with an irregular surface structure, i.e. an uneven surface, such as nonwoven fibres are notoriously difficult to apply precise and uniform amounts of a substance to using traditional printing techniques. [0140] The inventors found that by using a transfer member comprising collapsible cells, one or more substances could be forced from the cells, through the outward facing apertures, and on to the substrate surface. The results were found to be particularly good for nonwoven fabrics. Traditional techniques were found to produce a diffuse pattern when printed onto nonwoven fabrics, whereas the method of the invention produced a well resolved print pattern in a uniform manner. [0141] In various embodiments, the transfer means consists of an impression member and a transfer member. In various embodiments the transfer means consists of the impression member and the transfer member wherein the transfer member is in the form of a layer of the one or more cells. [0142] In various embodiments at least two transfer means are provided. In various embodiments at least two transfer means are provided, each comprising an impression member and a transfer member. In various embodiments at least two transfer means are provided, each comprising an impression member and a transfer member, wherein each of the transfer members comprise one or more cells with outward facing apertures and are provided on the exterior of the impression members. In various embodiments at least two transfer means are provided, each comprising an impression member and a transfer member, wherein each of the transfer members comprise one or more cells with outward facing apertures and are provided on the exterior of the impression members, and wherein the transfer means are positioned in proximity to each other such that pressure is formed on each transfer member by the corresponding impression members as the substrate layer is conveyed along a transport path in a machine direction. [0143] In various embodiments two transfer means are provided. In various embodiments two transfer means are provided, each comprising an impression member and a transfer member. In various embodiments two transfer means are provided, each comprising an impression member and a transfer member, wherein each of the transfer members comprise one or more cells with outward facing apertures and are provided on the exterior of the impression members. In various embodiments two transfer means are provided, each comprising an impression member and a transfer member, wherein each of the transfer members comprise one or more cells with outward facing apertures and are provided on the exterior of the impression members, and wherein the transfer means are positioned in proximity to each other such that pressure is formed on each transfer member by the
31
corresponding impression members as the substrate layer is conveyed along a transport path in a machine direction. [0144] Where two transfer means are provided, they can be provided in opposing positions and a substrate material can be fed between them in a machine direction. Such an embodiment permits the simultaneous printing on both sides of the substrate material. This can be advantageous where, for example, different concentration of substances or different types of substance are required on a single piece of substrate material. Alternatively, such a configuration can aid the production of wound dressings or debridement tools have a multilayer construction, thereby increasing efficiency and speed of the manufacturing process. [0145] In some embodiments the transfer means is a cylinder. In some embodiments the transfer means is stadium‐shaped. [0146] In various embodiments the transfer means comprises an impression member and a transfer member, wherein the transfer member is provided on the exterior of the impression member and wherein the transfer member partially surrounds the impression member in a longitudinal direction of the impression member. In various embodiments the transfer means comprises of impression member and a transfer member, wherein the transfer member completely encompasses the impression member in a longitudinal direction. TRANSFER MEMBER [0147] As described herein, the transfer member comprises one or more cells with outward facing apertures that are capable of being loaded with one or more substances, which can be transferred to a substrate material. Force applied by the by the impression member to the cells comprised within the transfer member causes the substance(s) contained within the cells to transfer to the substrate layer, for example when the force compresses the cells that are formed from an elastomeric material. [0148] In various embodiments, the one or more cells of the transfer member reversibly compress under force applied by the impression member to at least the one or more cells in step (c) of the above detailed method, so as to cause the one or more substance(s) comprised within the one or more cells to transfer to the substrate layer. [0149] For illustration, Figure 19 depicts an elastomeric product comprising cells that reversibly compress as a force is applied to them.
32
[0150] In various embodiments, the transfer member comprises an elastomeric material. In a preferred embodiment, the transfer member consists of an elastomeric material. [0151] In various embodiments, the transfer member comprises a silicone‐based material, an ethylene propylene diene monomer (EPDM) based material, a polypropylene material, a polyethylene terephthalate material, a thermoplastic polyurethane material or combinations thereof. In various embodiments, the transfer member comprises a silicone‐based material, an ethylene propylene diene monomer (EPDM) based material, or combinations thereof. In various embodiments, the transfer member comprises a silicone‐based material. In various embodiments, the transfer member consists of a silicone‐based material. In various embodiments, the transfer member comprises an ethylene propylene diene monomer (EPDM) based material. In various embodiments, the transfer member consists of an ethylene propylene diene monomer (EPDM) based material. In various embodiments, the transfer member comprises a silicone‐rubber foam material. In various embodiments, the transfer member consists of a silicone‐rubber foam material. [0152] As described herein, the transfer member has certain characteristics that ensure its suitability as a material for the transfer member(s) of the present invention, particularly for reversible compressibility of the one or more cells comprised within the transfer member(s). [0153] In some embodiments, the transfer member(s) have a Shore A hardness value of from about 5 to about 30. In some embodiments, the transfer member(s) have a Shore A hardness value of from about 5 to about 25. In some embodiments, the transfer member(s) have a Shore A hardness value of from about 5 to about 20. In some embodiments, the transfer member(s) have a Shore A hardness value of from about 7 to about 20. In some embodiments, the transfer member(s) have a Shore A hardness value of from about 7 to about 15. [0154] Shore A hardness values can be determined, for example, using an industry standard Durometer in accordance with ASTM D2240. [0155] In some embodiments, the transfer member(s) have a density of from about 100 to about 500 g/cm3. In some embodiments, the transfer member(s) have a density of from about 100 to about 400 g/cm3. In some embodiments, the transfer member(s) have a density of from about 150 to about 400 g/cm3. In some embodiments, the transfer member(s) have a density of from about 200 to about 300 g/cm3. [0156] In some embodiments, the transfer member(s) have a compressive stress 40% strain of from about 30 to about 150 KPa. In some embodiments, the transfer member(s) have a compressive stress
33
40% strain of from about 50 to about 90 KPa. In some embodiments, the transfer member(s) have a compressive stress 40% strain of from about 70 to about 110 KPa. [0157] In some embodiments, the transfer member(s) have a compression set value (22 hours @ 70oC) of about 20% or less. In some embodiments, the transfer member(s) has a compression set value (22 hours @ 70oC) of about 15% or less. In some embodiments, the transfer member(s) has a compression set value (22 hours @ 70oC) of about 12% or less. [0158] In some embodiments, the transfer member(s) have a tensile strength of about 0.5 N/mm2 or more. In some embodiments, the transfer member(s) have a tensile strength of about 0.6 N/mm2 or more. In some embodiments, the transfer member(s) have a tensile strength of about 0.7 N/mm2 or more. [0159] In some embodiments, the transfer member(s) have an elongation to failure of at least about 80%. In some embodiments, the transfer member(s) have an elongation to failure of at least about 100%. In some embodiments, the transfer member(s) have an elongation to failure of at least about 150%. [0160] In some embodiments, the transfer member(s) have: (a) a Shore A hardness value of from about 5 to about 30; (b) a density of from about 100 to about 500 g/cm3; (c) a compressive stress 40% strain of from about 30 to about 150 KPa; (d) a compression set value (22 hours @ 70oC) of about 20% or less; (e) a tensile strength of about 0.5 N/mm2 or more; (f) an elongation to failure of at least about 80%. [0161] A pattern or design can be provided in the transfer member(s), which will dictate the pattern or design that will be conveyed to the substrate material. In various embodiments, a pattern can be provided in the transfer member(s) by acid etching, laser etching, injection moulded or mechanical engraving. Preferably, a pattern can be provided in the transfer member(s) by laser etching or injection moulded. In various embodiments, a pattern can be provided in the transfer member(s) by 3D printing the transfer member(s). [0162] According to the present invention, there is also provided a process for preparing a wound dressing or debridement tool comprising a substrate layer, as described above, wherein the substrate layer comprises a nonwoven fabric; the process comprising the following steps:
34
(a) opening and carding the gelling fibres and non‐gelling fibres to provide a fibre web; (b) cross lapping and drafting the fibre web to provide a crossed fibre web; (c) needle punching the crossed fibre web. SUBSTANCES & COMPOSITIONS [0163] To cleanse a wound means to use fluid to remove loosely adherent debris and necrotic tissue from the wound surface. A wound cleanser may be an aid in debridement – removing deeply adherent, dead or contaminated tissue from a wound ‐ but a debridement solution is not a wound cleanser. Dakin’s solution, a buffered 0.5 percent solution of sodium or potassium hypochlorite, is for example a debridement agent rather than a cleansing one because it is injurious to tissues. A desirable wound cleanser should be biocompatible and physiologically compatible with the body tissue. Wound irrigation is the act of flushing a wound with a stream or flow of a solution across an open wound surface. A wound cleanser may also provide additional benefits such as moisturising, which may occur during irrigating or rinsing a wound with the cleanser. [0164] As described herein, the substances and compositions of the present disclosure disrupt and lift the loose components of wounds from the surface. Surprisingly the substances and compositions further disrupt one or more biofilms. The latter is advantageous because the presence of microbes in wounds is an additional and common impediment to the healing of wounds and can lead to clinical complications. [0165] As used herein, “microbe” means bacteria, protozoa, fungi, algae, amoeba, and slime molds. [0166] In various embodiments, the bacterial infection is associated with Staphylococcus aureus or Pseudomonas aeruginosa. [0167] It has surprisingly been found that substance according to the present disclosure are effective at disrupting biofilms while cleansing and/or irrigating wounds even in the absence of an antimicrobial agent. As used herein, “biofilm” means a syntrophic consortium of microorganisms in which cells stick to each other and optionally also to a surface. These adherent cells become embedded within a slimy extracellular matrix that is composed of extracellular polymeric substances (EPSs). [0168] Thus, in various embodiments, the wound comprises one or more biofilms, wherein “biofilm” is as defined herein. In various embodiments of the wound cleansing dressing for use as described herein, the wound comprises one or more biofilms and treating the wound comprises disrupting said
35
one or more biofilms. As used here, “disrupting” in the context of the one or more biofilms means loosening, softening, and detaching the biofilm from the wound bed. [0169] The substances of the present invention are advantageous for the treatment of all wounds. Wounds suitable for treatment may, for example, be acute, surgical, or traumatic wounds. Such wounds may be irrigated by the substances of the present invention to remove contamination and debris, and to clean the surrounding skin so that suitable dressings may be applied. Throughout the entire healing pathway, wounds may be cleansed e.g. between dressing changes, to remove excess exudates, debris, non‐viable tissues, and to reduce the surface/skin bioburden (e.g. bacteria, thereby reducing infection risk). The substance of the present invention may be used to cleanse a wound that appears to be on a healing pathway in order to prevent opportunistic pathogens from forming biofilm. Cleansing with the substances of the present invention is particularly advantageous after debridement. Wound cleansing may also be performed to assist appropriate inspection and diagnosis. Cleansing with the substances of the present invention is particularly advantageous for the treatment of long‐standing, non‐healing, so‐called chronic wounds. [0170] According to the present invention, the one or more substance(s) can be applied in the form of a solid, a gel, a wax, a liquid, a suspension, or an emulsion. In a preferred embodiment, the substance(s) are applied in the form of a liquid. [0171] A wide variety of substances are envisaged for the present invention, which are determined based upon, for example, application of the wound dressing or debridement tool, substrate material and printing pattern or design. In various embodiments, the one or more substance(s) are selected from: one or more of a wound cleansing or debridement composition, medicament, an adhesive, a deodorant, a chelating agent, a surfactant, an amphoteric surfactant, an anionic surfactant, a cationic surfactant, a thickening agent, an electrically conductive formulation, a thermoresponsive agent, an exothermic agent, an endothermic agent, or a combination thereof. [0172] In a preferred embodiment, the medicament comprises one or more agents selected from: antimicrobials, analgesics, coagulants, anti‐inflammatories or a combination thereof. [0173] In various embodiments, the one or more substance(s) comprises a wound cleansing or debridement composition. In various embodiments, the one or more substance(s) comprises a wound cleansing or debridement composition comprising a chelating agent, an amphoteric surfactant, and an anionic surfactant.
36
[0174] In a preferred embodiment, the one or more substance(s) comprises a wound cleansing or debridement composition, preferably wherein the composition comprises: i. a chelating agent; ii. an amphoteric surfactant; iii. an anionic surfactant; and iv. a thickening agent, wherein the thickening agent comprises at least one poly(meth)acrylic acid and/or salt thereof. [0175] In the present disclosure, the chelating agent may be selected from citrates, tartrates, tartramides, tartrimides, gluconates, lactates, glycolates, oxalates, phosphates, salts of ethylenediaminetetraacetic acid, and mixtures thereof. In some embodiments, the chelating agent may be selected from citrates, phosphates, oxalates, salts of ethylenediaminetetraacetic acid, and mixtures thereof. In various embodiments the salts are metal ion or ammonium salts. The metal ion of said salts is not limited. In various embodiments, metal ion salts are preferred and may be selected from sodium and/or potassium salts. In particularly preferred embodiments, the salts are sodium salts. [0176] In preferred embodiments the chelating agent comprises a salt of ethylenediaminetetraacetic acid. The ethylenediaminetetraacetate salt may be a mixture of di‐, tri‐, or tetra‐basic salts of ethylenediaminetetraacetate (EDTA). The EDTA salt may, for instance, be a di‐sodium salt of EDTA, or calcium di‐sodium salt of EDTA, or tetra‐sodium salt of EDTA. In various embodiments, the salt of EDTA is a mixture of salts of EDTA. It is believed that EDTA, when present, will have a form which is dependent on the pH of the wound site. In preferred embodiments, EDTA may be added to the wound cleansing or debridement composition as a tetra‐basic salt of EDTA such as tetrasodium EDTA. In some embodiments, EDTA is not in the form of the disodium salt. [0177] The citrate salt may similarly be a mono‐, di‐ or tri‐citrate salt. In various embodiments the citrate salt may be mono‐, di‐ or tri‐potassium citrate or mono‐, di‐ or tri‐sodium citrate. In preferred embodiments, the citrate salt is a tri‐citrate salt such as trisodium citrate. [0178] The tartrate may be a mono‐, or di‐tartrate salt. In various embodiments, the tartrate salt may be mono‐ or di‐potassium tartrate; or mono‐ or di‐sodium tartrate. In specific embodiments, the tartrate salt is a di‐tartrate salt such as disodium tartrate. [0179] The gluconate may be potassium gluconate or sodium gluconate. In specific embodiments, the gluconate salt is sodium gluconate. Similarly, the lactate may be potassium lactate or sodium lactate. In specific embodiments, the lactate salt is sodium lactate. The glycolate may be potassium glycolate or sodium glycolate. In specific embodiments, the glycolate salt is sodium glycolate.
37
[0180] The oxalate may be a mono‐, or di‐oxalate salt. In various embodiments, the oxalate salt may be mono‐ or di‐potassium oxalate; or mono‐ or di‐sodium oxalate. In specific embodiments, the oxalate salt is a di‐oxalate salt such as disodium oxalate. [0181] The phosphate salt may be an ortho‐phosphate, a pyrophosphate, a tripolyphosphate or a derivatised phosphate. The phosphate is typically in the form of a potassium or sodium salt. Examples include potassium phosphate dibasic, potassium pyrophosphate, tri‐sodium ascorbate phosphate, disodium phosphate and sodium tripolyphosphate. In preferred embodiments the phosphate salt is a di‐phosphate salt such as disodium phosphate. [0182] The chelating agent may be present in the substance in an amount of up to about 10 wt%, up to about 8 wt%, or up to about 6 wt% of the total weight of the substance. In various embodiments, the chelating agent may be present in the substance in an amount of at least about 0.5 wt%, at least about 1.0, or at least about 1.2 wt% of the total weight of the substance. [0183] In various embodiments, the amphoteric surfactant is selected from hydrocarbyl‐ amphoacetates, alkenyl‐amphoacetates, hydrocarbyl‐amphodiacetates, alkenyl‐amphodiacetates, hydrocarbylampho‐propionates, hydrocarbylampho‐diproprionates, hydrocarbylamphohydroxypropyl sultaines, and mixtures thereof. In various embodiments, the hydrocarbyl and alkenyl groups are C6 to C24, C8 to C24, or C10 to C20, hydrocarbyl or alkenyl groups. Typically, the amphoteric surfactant has a counter‐ion of an alkali metal such as sodium or potassium, or an ammonium ion. In preferred embodiments, the amphoteric surfactant has an alkali metal counter‐ion, and more preferably the counter‐ion is sodium. [0184] As used herein, the term “hydrocarbyl” includes a group such as alkyl, aryl, aralkyl, alkaryl, cycloalkyl or alkenyl, which may be linear or branched, and/or saturated or unsaturated. In one embodiment, the hydrocarbyl may be a linear or branched alkyl or alkenyl group. [0185] In various embodiments the amphoteric surfactant is a hydrocarbyl‐amphoacetate salt, preferably a fatty acid amphoacetate. The fatty acid or salt thereof may be a C6‐C24 fatty acid or salt thereof, or a mixture thereof. The fatty acid or salt thereof may be saturated or unsaturated. When unsaturated, the unsaturated fatty acid or salt thereof may be mono‐ or di‐unsaturated. The unsaturated fatty acid or salt thereof may comprise cis‐ or trans‐ double bonds or mixtures thereof. In further embodiments, the fatty acid or salt thereof is a C12‐C18 monounsaturated fatty acid or salt thereof. Examples of fatty acids include stearic acid, ricinoleic acid, oleic acid, eladic acid, petrolselinic acid, palmitic acid, erucic acid, behenic acid, lauric acid, myristic acid, or linoleic acid.
38
[0186] In preferred embodiments, the amphoteric surfactant comprises a cocoamphoacetate. The counter‐ion of the cocoamphoacetate is preferably sodium. Sodium cocoamphoacetate is commercially available, for example under the trade name Dehyton® MC (BASF) or Amphosol® 1C (Stepan®). Such commercial preparations are typically solutions of sodium cocoamphoacetate, typically containing from about 30 to about 40 wt% sodium cocoamphoacetate on an actives basis. [0187] In various embodiments, the metal ions of the salt of the chelating agent and the salt of the amphoteric surfactant are the same. Preferably, both the chelating agent and surfactant are sodium salts. [0188] The amphoteric surfactant may be present in the substance in an amount of up to about 15 wt%, up to about 10 wt% or up to about 5 wt% of the total weight of the substance. In various embodiments, the amphoteric surfactant may be present in the substance in an amount of at least about 1 wt% of the total weight of the substance. [0189] The anionic surfactant may include all forms of lipophilic oligomeric hydrocarbon and/or polyethoxylate with a negatively charged hydrophilic head group such as carboxylate, sulphate, sulphonate, sulphonated ester, sulphated ester, sulphated amide, carboxylated amide, or phosphate anionic head group. For example, including a fatty acid or fatty acid salt. The fatty acid may comprise 6 to 24 carbon atoms, such as 10 to 20 carbon atoms, preferably 12 to 18 carbon atoms. [0190] In various embodiments, the anionic surfactant comprises a fatty acid or salt thereof. The fatty acid may comprise 6 to 24 carbon atoms, such as 10 to 20 carbon atoms, preferably 12 to 18 carbon atoms. Examples of fatty acids include stearic acid, ricinoleic acid, oleic acid, eladic acid, petrolselinic acid, palmitic acid, erucic acid, behenic acid, lauric acid, myristic acid, or linoleic acid. [0191] In some embodiments, the anionic surfactant may be a fatty acid or salt thereof which is a C6‐ C24 fatty acid or salt thereof, or a mixture thereof. The salt may be an alkali metal or alkaline earth metal salt, preferably an alkali metal salt. In preferred embodiments, the alkali metal is sodium or potassium, more preferably sodium. The fatty acid or salt thereof may be saturated or unsaturated. When unsaturated, the unsaturated fatty acid or salt thereof may be mono‐ or di‐unsaturated. The unsaturated fatty acid or salt thereof may comprise cis‐ or trans‐ double bonds or mixtures thereof. In further embodiments, the fatty acid or salt thereof is a C12‐C18 monounsaturated fatty acid or salt thereof. [0192] In particularly preferred embodiments, the fatty acid or salt thereof is oleic acid or a salt thereof. The salt of oleic acid is not limited and may be a metal salt of oleic acid. In various
39
embodiments the salt of oleic acid may be sodium oleate. In various embodiments, the salt of oleic acid may be formed by adding oleic acid to the substance such that the metal ions, e.g. sodium ions, are provided by provided by the chelating agent, the thickening agent and/or the amphoteric surfactant. [0193] The amount of anionic surfactant in the substance is not necessarily limited. The anionic surfactant may, for example, be present in the substance in an amount of up to about 15 wt%, up to about 10 wt%, or up to about 8 wt% of the total weight of the substance. The anionic surfactant may be present in an amount of at least about 1 wt%, or at least about 1.5 wt% of the total weight of the substance. [0194] In various embodiments, the anionic surfactant is present in the substance in an amount of from about 1 wt% to about 15 wt%, preferably from about 1 wt% to about 10 wt%, more preferably from about 1.5 wt% to about 8 wt% of the total weight of the substance. [0195] According to the above description, poly(meth)acrylic acids may be homopolymers, copolymers, or interpolymers. For example, homopolymeric poly(meth)acrylic acids comprise a polymer backbone consisting of repeat units formed from (meth)acrylic acid. [0196] Poly(meth)acrylic acid copolymers comprise repeat units formed from (meth)acrylic acid and may comprise further repeat units derived from other monomers. Non‐limiting examples of such monomers include (meth)acrylate esters, (meth)acrylamides, olefins, maleic anhydrides, vinyl esters, vinyl ethers, and styrenics; as well as unsaturated carboxylic acids other than (meth)acrylic acid. For instance, a poly(meth)acrylic acid copolymer may comprise repeat units formed from (meth)acrylic acid and at least one alkyl acrylate. A non‐limiting example of a commonly used alkyl acrylate in such copolymers is C10‐C30 alkyl acrylate. [0197] In various embodiments the poly(meth)acrylic acid and/or salt thereof is an interpolymer. As used herein, the term “interpolymer” refers to a complex comprising at least two polymers. In such interpolymers, one or more of the constituent polymers may be a homopolymer or a copolymer. For example, at least one of the constituent polymers of the interpolymer may be a copolymer of acrylic acid and C10‐C30 alkyl acrylate. In various embodiments, and without wishing to be bound by theory, the complex between the at least two polymers arises due to non‐covalent interactions. For example one polymer may be entangled within the other and/or be associated via hydrogen bonding. In various embodiments the at least one poly(meth)acrylic acid and/or salt thereof is an interpolymer that comprises a block copolymer comprising polyethylene glycol and a fatty acid ester. In specific embodiments, the fatty acid ester is 12‐hydroxystearic acid.
40
[0198] In any of the embodiments of the at least one poly(meth)acrylic acid and/or salt thereof described above, the poly(meth)acrylic acid and/or salt thereof may be cross‐linked. Common cross‐ linking agents are known in the art. In particular, the at least one poly(meth)acrylic acid and/or salt thereof may be cross‐linked with an allyl ether cross‐linking agent. In specific embodiments, the allyl ether cross‐linking agent is selected from allyl sucrose and allyl pentaerythritol. Interpolymeric polyacrylic acids and/or salts thereof are described in e.g. US Patent Nos. 5,288,814 and 5,349,030, the contents of both being incorporated herein by reference. [0199] Examples of commercially available interpolymeric polyacrylic acids and/or salts thereof suitable for use in the present disclosure include Carbopol® ETD 2020 and Carbopol® Ultrez 10. [0200] The salts of the at least one poly(meth)acrylic acid are not limited. Poly(meth)acrylic acids are polyanionic polymers, i.e. the carboxylic acid side‐groups of the polymer chain can be deprotonated and thereby acquire negative charge. Accordingly, the at least one poly(meth)acrylic acid when deprotonated may be associated with any compatible cation, for example when supplied in salt form, or when formulated in the substance or composition as described herein such that cationic species are provided by other components present in the substance or composition. In various embodiments, the poly(meth)acrylic acid and/or salt thereof comprises a sodium salt of poly(meth)acrylic acid. In specific embodiments, counter‐ions such as sodium ions may be provided by the chelating agent, the amphoteric surfactant and/or the anionic surfactant. The skilled person will understand that the degree of deprotonation of the poly(meth)acrylic acid will depend on various factors including the pH of the substance or composition, and thus the poly(meth)acrylic acid may be present in the substance or composition of the present disclosure in varying proportions of free acid and (poly)anionic forms thereof. In various embodiments, the pH of the substance or composition is from about pH 4 to about pH 10, from about pH 5 to about pH8, or from about pH 5.5 to about pH 6.5. [0201] In various embodiments, the at least one poly(meth)acrylic acid and/or salt thereof is present in the substance of the present disclosure in an amount of at least about 0.1 wt%, at least about 0.2 wt%, or at least about 0.3 wt% of the total weight of the substance . [0202] In various embodiments, the at least one poly(meth)acrylic acid and/or salt thereof is present in the substance of the present disclosure in an amount of up to about 2 wt%, up to about 1.5 wt%, up to about 1 wt%, or up to about 0.5 wt% of the total weight of the substance . [0203] In various embodiments, the at least one poly(meth)acrylic acid and/or salt thereof is present in the substance of the present disclosure in an amount of from about 0.1 to about 2 wt%, from about 0.2 to about 1.5 wt%, or from about 0.3 to about 1 wt% of the total weight of the substance .
41
[0204] In a further preferred embodiment, the one or more substance(s) comprises a non‐ antimicrobial composition, said composition comprising (i) at least about 50 wt% of a carrier which is glycerol, triglycerol, or a combination thereof, (ii) a solvent which is one or more C1‐4 alcohol, and (iii) one or more excipients, wherein the weight ratio of (i) to (ii) in the composition is from about 2:1 to about 5:1. [0205] In some embodiments, (i) is glycerol or a combination of glycerol and triglycerol. The combination of glycerol and triglycerol may have a parts by weight ratio of about 99:1 to about 50:50 parts. This range may be combined with the above weight ratio ranges for (i):(ii) as well as the concentration ranges described herein. For example, the non‐antimicrobial composition may comprise (i) and (ii) at a weight ratio of from about 2.5:1 to about 4:1, wherein (i) is glycerol or a combination of glycerol and triglycerol, the combination having a parts by weight ratio of about 99:1 to about 50:50. [0206] In particularly preferred embodiments, (i) in the non‐antimicrobial composition is glycerol. [0207] The concentration of (i) glycerol, triglycerol, or combination thereof is not critical to the present disclosure. As will be appreciated from the scope of the appended claims and the Examples, it is the relative amount of (i) to (ii) the one or more C1‐4 alcohol which is important (from about 2:1 to about 5:1, preferably from about 2.5:1 to about 4:1, more preferably from about 13:4 to about 4:1), and the concentrations of (i) and (ii) will depend on the concentration of the one or more excipients. Should the skilled person require a lower limit for (i), (i) may be included in the non‐antimicrobial composition in an amount of at least about 50 wt% and preferably about 55 wt%. Should the skilled person require an upper limit for (i), (i) may be included in the non‐antimicrobial composition in an amount of no more than about 90 wt% and preferably no more than about 85 wt%. Combining these lower and upper limits provides a general range of at least about 50 wt% to no more than about 90 wt%, and a preferred range of at least about 55 wt% to no more than about 85 wt%. [0208] In some embodiments, the carrier (i) is glycerol or a combination of glycerol and triglycerol, wherein the combination has a parts by weight ratio of about 99:1 to about 50:50, and wherein (i) is present in the non‐antimicrobial composition in an amount of at least about 50 wt% to no more than about 90 wt%. Preferably (i) is glycerol, and glycerol is present in the non‐antimicrobial composition in an amount of at least about 50 wt% to no more than about 90 wt%. [0209] In some embodiments, (i) in the non‐antimicrobial composition is glycerol or a combination of glycerol and triglycerol, wherein the combination has a parts by weight ratio of about 99:1 to about 50:50, and wherein (i) is present in the non‐antimicrobial composition in an amount of at least about
42
55 wt% to no more than about 85 wt%. Preferably (i) is glycerol, and glycerol is present in the non‐ antimicrobial composition in an amount of at least about 55 wt% to no more than about 85 wt%. [0210] The one or more C1‐4 alcohol is included in the non‐antimicrobial composition to assist the glycerol, triglycerol, or combination thereof, in the solubilisation of the one or more excipients. As the alcohol is volatile, it can be evaporated off the substrate layer after printing. In some embodiments, the one or more C1‐4 alcohol is selected from methanol, ethanol and propanol, or isomers and mixtures thereof, preferably wherein the one or more C1‐4 alcohol comprises ethanol. In the examples, industrial denatured alcohol is employed but the present disclosure is not limited to this specific form of the one or more C1‐4 alcohol. [0211] In some embodiments, (i) in the non‐antimicrobial composition is glycerol or a combination of glycerol and triglycerol, wherein the combination has a parts by weight ratio of about 99:1 to about 50:50; wherein (i) is present in the non‐antimicrobial composition in an amount of at least about 50 wt% to no more than about 90 wt%; and wherein (ii) the one or more C1‐4 alcohol is selected from methanol, ethanol and propanol, or isomers and mixtures thereof. Preferably (i) is glycerol, and glycerol is present in the non‐antimicrobial composition in an amount of at least about 50 wt% to no more than about 90 wt%. Particularly preferably, (i) is glycerol, present in the non‐antimicrobial composition in an amount of at least about 50 wt% to no more than about 90 wt% and the one or more C1‐4 alcohol comprises ethanol. [0212] In some embodiments, (i) in the non‐antimicrobial composition is glycerol or a combination of glycerol and triglycerol, wherein the combination has a parts by weight ratio of about 99:1 to about 50:50; wherein (i) is present in the non‐antimicrobial composition in an amount of at least about 55 wt% to no more than about 85 wt%; and wherein the one or more C1‐4 alcohol comprises ethanol. Preferably (i) is glycerol, and glycerol is present in the non‐antimicrobial composition in an amount of at least about 55 wt% to no more than about 85 wt%. Particularly preferably, (i) is glycerol, present in the non‐antimicrobial composition in an amount of at least about 55 wt% to no more than about 85 wt% and the one or more C1‐4 alcohol comprises ethanol. [0213] In any of the above embodiments, the weight ratio of (i) to (ii) in the non‐antimicrobial composition may be from about 2.5:1 to about 4:1, preferably from about 13:4 to about 4:1. [0214] In some embodiments, it may be preferable to avoid use of an non‐antimicrobial agent, for example to avoid the risk of resistance to said non‐antimicrobial agent, and/or due to intolerance to the non‐antimicrobial agent in the subject whose wound is to be treated. Wound cleansers that do
43
not contain non‐antimicrobial agents may also be preferable in certain applications because they may not be classed as medicaments. [0215] Thus, in various embodiments the substances of the present disclosure are non‐antimicrobial. For instance, in various embodiments the substances of the present disclosure do not comprise an non‐antimicrobial agent. The non‐antimicrobial agent is not limited and includes silver compounds, hypochlorous acid, polyhexamethylene biguanide (also known as polyhexanide biguanide), chlorhexidine and salts thereof. [0216] The generally accepted criterion for an non‐antimicrobial cleanser solution is a 3‐log10 reduction in microbial cell number in a given contact time period. Thus, in various embodiments, the non‐antimicrobial wound cleansing compositions described herein cause less than about a 3‐log10 reduction in the number of microbial cells in the wound when contacted with the wound for about 10 minutes. Preferably, the non‐antimicrobial wound cleansing compositions described herein cause less than about a 2‐log10 reduction in the number of microbial cells in the wound when contacted with the wound for about 10 minutes. More preferably, the non‐antimicrobial wound cleansing compositions described herein cause less than about a 1‐log10 reduction in the number of microbial cells in the wound when contacted with the wound for about 10 minutes. [0217] In various embodiments, the substances may be thickened with a thickening agent. Exemplary thickening agents include gums, polysaccharides such as starch, agar, carboxymethylcellulose, hydroxyethylcellulose, gelatin, pectin, chitosan, alginate, clay, synthetic thickeners such as polyethylene glycols, poloxamers (as defined herein above), polyvinyl alcohol/acetate, polyvinylpyrrolidone, polyacrylates, silicates/silica, carbomers. Any of the preceding forms may alternatively be prepared extemporaneously, e.g. by a clinician, healthcare practitioner, or pharmacist. In various embodiments, the substances may be supplied as a concentrate for dilution, e.g. prior to application in a care setting, such as in a bath or bucket for application. [0218] In various embodiments, the substances of the present invention do not contain further components other than those already described above. In such embodiments, the substances are preferably supplied as a sterile solution, e.g. wherein such solutions are prepared from sterilised components in a sterile environment, or wherein the final solution is sterilised by methods commonly known in the art. In alternative embodiments, the substances of the present invention may comprise one or more additional components selected from preservatives, anti‐oxidants, osmotic adjusters and surfactants.
44
[0219] Suitable preservatives are known in the art, such as polyhexamethylene biguanide (PHMB). Preservatives may advantageously have a mild bacteriostatic effect in the wound. Anti‐oxidants are also well known and a person skilled in the art of the present invention will be able to select suitable anti‐oxidants. Anti‐oxidants may advantageously aid preservation and reduce the prevalence of reactive oxygen species in the wound environment that are typically elevated in chronically inflamed wounds and associated with retarded healing. [0220] Osmotic adjusters may be included in the solutions of the present invention to adjust the tonicity (ionic strength) of said substances. For example, pain can be minimised by the use of isotonic substances (i.e. having an osmolality similar to plasma). Plasma osmolality typically falls within 0.285 to 0.300 Osmol/kg. Alternatively, hypotonic (i.e. having an osmolality less than plasma) substances may be advantageous to increase surfactancy potential. Conversely, hypertonic (i.e. having an osmolality greater than plasma) solutions may confer bactericidal effects that may be advantageous in various applications. The skilled person will be able to select suitable osmotic adjusters and obtain a desired tonicity as a matter of routine. [0221] In various embodiments, the wound cleansing composition is an isotonic or hypertonic solution. In various embodiments, one or more surfactants in addition to those described above may be included, e.g. as “secondary surfactants” to boost the primary surfactant as described above. Such secondary surfactants may be any of the surfactants described hereinabove, but do not include cationic surfactants. The wound cleansing composition may have a surface tension of less than about 35 mN/m to facilitate loosening and cleansing. [0222] In various embodiments, one substance is applied to the substrate layer. [0223] In various embodiments, multiple substances are applied to the substrate layer. [0224] In various embodiments, the one or more substance(s) are applied to a single surface of the substrate layer. [0225] In various embodiments, different substances are applied to different surfaces of the substrate layer. [0226] In various embodiments, a combination of substances are applied to a single surface of the substrate layer. [0227] In various embodiments, a combination of substances are applied to multiple surfaces of the substrate layer.
45
[0228] In various embodiments, two or more substance(s) are applied to the first surface of the at least one substrate layer. [0229] In various embodiments, a combination of substance(s) are applied to the first surface of the at least one substrate layer. [0230] In various embodiments, a combination of substance(s) are applied to the first surface and a second surface of the at least one substrate layer. [0231] In various embodiments, the at least one substrate layer comprises a second surface opposite the first surface and the second surface comprises the same substance(s) impregnated at the same depth as the first surface. [0232] In preferred embodiments where two or more substances are applied to one or more surfaces of the substrate material, the two or more substances may produce, for example, a physical, physiological or physiochemical response between the two substances when applied to a wound site that is in essence activated or initiated by contact with a wound. For example, activation of endothermic excipients or initiation of electrochemical substances. In essence, the two or more substances provide a synergistic effect when applied to a user. Exemplary applications of the substances in this regard can be seen in Figure 4, where (A) and (B) designate different substances deposited on the substrate surface, although this is not limiting on the potential scope for these applications. [0233] In various embodiments, the mass of substance comprised in the at least one substrate layer is of from about 0.10 to about 50.00 g/m2 per surface; preferably wherein the mass of substance comprised in the at least one substrate layer is of from about 0.5 to about 20.00 g/m2 per surface. [0234] In various embodiments, the wound dressing or debridement tool is of a multi‐layer construction. In various embodiments, the wound dressing or debridement tool is of a multi‐layer construction wherein the multilayer construction further comprises one or more functional layers, as described above. [0235] In various embodiments, the wound dressing or debridement tool comprises an outer cover layer, a support layer, a superabsorbent layer, a wound contacting layer and a transmission layer. [0236] In various embodiments, the wound dressing or debridement tool comprises an outer cover layer, a support layer, a superabsorbent layer, and a wound contacting layer.
46
[0237] In various embodiments, the wound dressing or debridement tool comprises an outer cover layer and a wound contacting layer. [0238] In some embodiments, the one or more substance(s) transferred to the substrate layer is at least partially impregnated within the substrate layer. [0239] In some embodiments, the one or more substance(s) transferred to the substrate layer is coated on or at least partially impregnated within the substrate layer. In some embodiments, the one or more substance(s) transferred to the substrate layer is at least partially impregnated within the substrate layer. In some embodiments, the one or more substance(s) transferred to the substrate layer is coated on the substrate layer. SYSTEMS, PROCESSES AND USES [0240] As described herein, the wound dressings or debridement tools of the present disclosure are useful for the treatment of wounds, including initial treatment in first response settings, as well as in ongoing wound management such as in primary care settings. The wound dressing or debridement tool described herein may be used in cleansing and/or irrigating a wound. [0241] According to the present invention, the use of the wound dressing or debridement tool as disclosed herein may prevent or minimise slough accumulation in a wound or to de‐slough a wound, the use comprising contacting said wound dressing or debridement tool with said wound or contacting said wound with said wound dressing or debridement tool, preferably wherein the wound is a chronic wound, acute wound, or burn. [0242] In some embodiments the wound is a chronic wound. In some embodiments the wound is an acute wound. In some embodiments the wound is a burn. [0243] In further embodiments, there is provided a system for applying one or more substance(s) to one or more substrate layers of a wound dressing or debridement tool as described herein. [0244] According to the present invention, the inventors were able to identify further advantages associated with the method of the invention in terms of the system parameters and the process of manufacture. [0245] The disclosure provided above is relevant to the following disclosures relating to parameters and the process of manufacture.
47
[0246] There is provided a system for applying one or more substance(s) to one or more substrate layer(s) of an article, as disclosed herein, wherein the system comprises: (a) at least one transfer means comprising an impression member and a transfer member, wherein the transfer member comprises one or more cells with outward facing apertures, wherein the transfer member is provided on the exterior of the impression member, and wherein the one or more cells are configured to be reversibly compressible under force exerted by the impression member; (b) at least one reservoir comprising the substance; (c) a pump configured to draw the substance from the reservoir and introduce it into the one or more cells of the transfer member; (d) optionally a component configured to remove excess substance from the transfer member. [0247] As previously discussed, traditional rotary‐based printing techniques typically take up fluid from a formulation tray or container (see Figs. 16 and 17; feature 6), where excess formulation can be removed using a doctor blade (5). Given substances applied to medical articles typically require a high degree of sanitation, these processes are suboptimal on the basis that the substances are typically exposed to air and other possible contaminants prior to application. [0248] The inventors found with the present method and associated system, the formulation could be pumped from a closed reservoir directly into the one or more cells of the transfer member, with little risk of the substance being exposed to air or other possible contaminants for significant periods of time, as is typically the case with Gravure and rotary pad printing. The inventors also found that this system resulted in significant reductions in wasted substance and a significantly simpler process of changing the substance type. A further advantage is that multiple substance can be applied to a single transfer means/transfer member using multiple reservoirs and pumps. This is particularly advantageous, given that Gravure and rotary pad printing typically require multiple cylinders to apply multiple formulations to a single substrate material. Thus, efficiency is improved. [0249] A process for preparing an article as disclosed herein is provided, where said process comprises, in order, the steps of: (a) conveying a substrate layer along a transport path in a machine direction toward at least one transfer means comprising an impression member and a transfer member, wherein the transfer member comprises one or more cells with outward facing apertures, wherein the transfer member is provided on the exterior of the impression member, and wherein the one or more cells are configured to be reversibly compressible under force exerted by the impression member;
48
(b) contacting the substrate layer with the transfer member as the substrate layer is conveyed along a transport path in a machine direction, wherein force applied by the impression member to at least the one or more cells comprised within the transfer member causes the one or more substance(s) comprised within the one or more cells to transfer to the substrate layer; [0250] In a preferred embodiment, the process for preparing an article comprises the preparation of an article that is of a multilayer construction comprising: (a) the substrate layer comprising the one or more substance(s) configured as a wound or epidermis contacting layer; (b) at least one substrate layer comprising the one or more substance(s) adhered or affixed to one or more additional functional layers that are configured as a wound or epidermis contacting layer, preferably wherein the one or more additional functional layers are selected from the group consisting of: an absorbent layer, a transmission layer, an adhesive layer, a support layer, a soluble medicated film layer, an odour‐absorbing layer, a spreading layer, a keying layer, a superabsorbent layer or combinations thereof. [0251] Having generally described this disclosure, a further understanding can be obtained by reference to certain specific examples illustrated below which are provided for purposes of illustration only and are not intended to be all inclusive or limiting unless otherwise specified. EXAMPLES [0252] According to the present invention, the following methods can be used to determine key characterising features and parameters of the wound dressings and debridement tools described herein: [0253] [Base Weight] Base weight can be calculated using the following formulae:
49
[0254] [Bulk Density] Bulk density can be calculated using the following formula:
[0255] [Fluid Absorbency] Fluid absorbency can be determined in accordance with BS EN 13726‐1:2002; Test methods for primary wound dressings – Part 1: Aspects of absorbency, Section 3.2. [0256] [Fluid Retention] Fluid retention can be calculated using the following formulae:
A1 = Area of the dressing sample (cm2) W1 = Dressing sample mass (g)
W3 = Dressing sample re‐weighed mass (g) For fluid retention, the hydrated sample is placed onto a perforated metal sheet and a compression load (a weight equivalent to 40 mmHg) is applied to the sample for 1 minute. Any unbound liquid is allowed to drain, the sample is then re‐weighed (W3). [0257] [Lateral Wicking Distance]
50
Lateral wicking distance can be determined in accordance with ISO 9073‐6:2000 ‘Textiles – Test methods for nonwovens – Part 6: Absorption’. [0258] [Absorption Under Compression] This in‐vitro test method for determining ‘absorption under compression’ was carried out based upon standard Pharmacopoeia method (BP 1993, Volume II, Appendices A222, Appendix XX, T. Water Retention Capacity). The method has been developed further to differentiate a dressing’s ability to retain and lock away fluid when compression is applied. Based on the measurements taken in this test, the GSM can be calculated for each sample. The area [A1] of the dressing sample is 25cm2. This area is used to calculate the weight required to exert 40mmHg of compression over the dressing pad. The test sample is weighed [W1] and placed onto a perforated plate within absorption container. A compression load (a weight equivalent to 40 mmHg as commonly applied with a high compression bandage therapy) is applied evenly over the surface of the test sample. Warmed hydrating fluid (Solution A at 37°C ±2°C) is added to the container at a volume such that the perforated plate is covered. Samples are then incubated for 24 hours at 20°C(±2°C). After incubation, the hydrating fluid is drained off prior to removing the weights. Each sample is removed from the solution and the sample is weighed again [W2]. Absorption under compression can subsequently be determined using the following formula:
[0259] [Dimensional Shrinkage] This in‐vitro test method for determining ‘dimensional shrinkage’ was carried out based upon BS ISO 1817:2015 ‘Rubber Vulcanized or Thermoplastic‐Determination of the Effect of Liquids’, although the method has been developed further. This in‐vitro test method was carried out by measuring the dry dimensions [L1, W1] and area [A1], hydrating each sample with an excess of Solution A (ref: BS EN 13726‐1:2002 Test methods for primary wound dressings – Part 1: Aspects of absorbency, Section 3.2.2.3) until fully hydrated, then measuring the wet dimensions [L2, W2] and area [A2] and calculating the percentage shrinkage. All samples cut using a standard 5x5cm cutting die. Accordingly, dimensional shrinkage (in the machine direction) can be calculated using the following formula:
51
The same formula can be used to determine dimensional shrinkage in the transverse direction by replacing the [L1] and [L2] values with [W1] and [W2]. [0260] [Wet Tensile Strength] Wet tensile strength can be determined in accordance with the test method provided in ISO 9073‐ 3:1989; Textiles – Test method for nonwovens – Part 3: Determination of tensile strength and elongation. [0261] [Dry tensile strength] Wet tensile strength can be determined in accordance with the test method provided in ISO 9073‐ 3:1989; Textiles – Test method for nonwovens – Part 3: Determination of tensile strength and elongation. [0262] [Lap Draft] Lap Draft is defined as:
Draft can be expressed as a ratio or percentage increase factor. [0263] [Needle Punch Density] Needle Punch density is defined as:
Where:
52
EXAMPLE 1 Ink Formulations [0264] Materials and Methods (a) Cetyl alcohol and oleic acid (Priolene 6907 and Super Refined™ Oleic Acid NF) were received as samples from CRODA Europe Ltd. (b) Sodium cocoamphoactetate (Dehyton MC) was supplied as a sample from BASF. (c) Tetrasodium EDTA, glycerol and industrial denatured alcohol (IDA) (containing 96% ethanol) were obtained from a commercial source. (d) AQUACEL® EXTRA dressings are commercially available from ConvaTec Ltd. [0265] Three formulations Table 1 Concentration in Ink (% w/w) Component Nominal 55T 2.8 g/m2 Oleic acid 4.6054 7.0487 9.2999 Sodium Cocoamphoacetate 3.6345 5.5627 7.3393 Tetrasodium EDTA 1.3284 2.0332 2.6826 Glycerol 69.6324 65.7236 62.1222 IDA 20.7993 19.6317 18.5560 [0266] The order of addition was controlled for the above formulations. The glycerol was mixed with the solvent (IDA) followed by the addition of oleic acid. Sodium cocoamphoacetate and EDTA were then added followed by sonication, if required. [0267] Table 2 Ink Compound Concentration in Ink (% w/w) (w/w) 55T Oleic Acid 7.0487
53
Sodium Cocoamphoacetate 5.5627 Tetrasodium EDTA 2.0332 2.8 g m‐2 Oleic Acid 4.4537 Sodium Cocoamphoacetate 3.5148 Tetrasodium EDTA 1.2847 Nominal Oleic Acid 2.7310 Sodium Cocoamphoacetate 2.1552 Tetrasodium EDTA 0.8023 Screen Printing Specification [0268] To prepare the screen‐printed dressings, the screen was clamped into place on a screen‐ printing rig and a 2.6 kg weight was added on top of the squeegee to provide an appropriate pressure. Samples were printed with a Hunt the Moon 55T thread count screen having a 1mm diameter dot pattern. A 10x10 cm AQUACEL® Extra dressing was placed onto the loading tray, which is moved under the screen with a bottom switch. Approximately 5 ml of ink formulations were poured onto the screen between the squeegee and open pattern. An upper switch moved the squeegee across the screen, pushing ink through the mesh. The mass deposited equated to 0.15 g per 10 x 10 cm dressing (15 g/m2). Samples were left to dry for 24 hours, 2x2 cm squares were then cut from the 10x10 cm printed samples and tested using the simulated non‐viable matter model described below (cf Efficacy Testing). Efficacy Testing [0269] The abovementioned formulations wre tested for efficacy in a simulated biofilm/non‐viable material test model. This model measures the ability of the test formulations to disrupt and loosen an artificial substance designed to mimic biofilm and slough. The key components included in the simulated biofilm/non‐viable material wound matrix are set out below in Table 3. Table 3 Materials % w/w Deionised water 44.338 Sodium propylparaben 0.112 Gelatin type A 0.5 Sodium alginate 1.75 Hydrolysed collagen 1 Hydrolysed keratin 20% solution 1 Pooled Human plasma 3 Microcrystalline cellulose 0.3 Xanthan gum pre‐mix 25.2 Deactivated yeast slurry 20
54
Crystal violet 0.26% w/w solution 2.5 Sodium hydroxide 10% solution 0.3 [0270] The proteins, polysaccharides, and water mimic the hydrated EPS matrix found in biofilm, and the deactivated yeast represents the cellular debris present in inflammatory wounds. Crystal violet was incorporated into the substrate to enable the quantification of efficacy. [0271] To prepare the simulated biofilm/non‐viable matrix for testing, 100 ml of liquid substrate was warmed to room temperature and spread across a cellulose acetate sheet to a wet thickness of 1.5 mm. The substrate film was soaked in 1.5% w/w calcium chloride solution for 18 hours. This enabled calcium ions to penetrate and bind to the alginate polymers in the substrate, causing gelation. This mimicked the ionic bridging between divalent cations and EPS polymers in biofilm. The substrate gel was removed from the calcium chloride and rinsed with deionised water. [0272] To prepare the dressings for testing, the formulations detailed in Table 1 were prepared at their corresponding concentrations on a %w/w basis. A screen was clamped into place on a screen‐ printing rig and a 2.6 kg weight was added on top of the squeegee to provide an appropriate pressure (corresponding to 15 g/m2). A 10x10 cm AQUACEL® Extra dressing (commercially available from ConvaTec) was then placed onto the loading tray, which is moved under the screen with a bottom switch. Approximately 5 ml of ink formulation was poured onto the screen between the squeegee and open pattern. An upper switch moved the squeegee across the screen, pushing ink through the mesh. [0273] Once prepared, the printed dressings were hydrated with 1 ml Test Solution A according to BS EN 13726‐1:2002. Test Solution A is an artificial exudate. Finally, the dressings with Test Solution A were placed onto the substrate prepared above and incubated at 37˚C for 18 hours. [0274] “Biofilm” disruption was characterised by the change in colour of the dressings resulting from absorption of the stained material. This was quantified by extraction of the crystal violet stain from the dressings. Dressings were removed from the substrate, added to 2 ml of 33% acetic acid and the crystal violet stain extracted for 30 minutes on a roller mixer. The absorbance of each solution was read at 595 nm. Results [0275] The data is presented in Figures 8 and 9.
55
[0276] Figure 8 illustrates the relationship between the mass of AQUACEL Clean excipients (g) per side of a 10x10 cm sample when different surface areas are covered and the efficacy of these samples on the simulated non‐viable matter model compared to an AQUACEL Extra control. [0277] Figure 9 illustrates the relationship between the mass of formulation excipients (g) per side of a 10x10 cm sample when printed with a high (55T), medium (2.8 g/m2) and low (Nominal) concentration ink, and the efficacy of these samples on the simulated non‐viable matter model compared to an AQUACEL Extra control. [0278] It can be seen that a quadratic relationship (R2 = 0.86) exists between the mass of excipients added and efficacy on the simulated non‐viable matter model. Efficacy increases with the mass of excipients until approximately 0.014g per side of a 10x10cm dressing (or 2.8 g/m2 when printed on both sides), where the data levels off, with the start of a potential decrease. Based upon this data, the optimum ink area coverage is therefore 10%. Increasing the area to 20% does not increase efficacy compared to 10% coverage (P = 0.870), but does have an increased drying time and wastage/cost of materials. There is also a large observable decrease in mass of ink added and efficacy between 10% and 8% coverage (P = 0.014). [0279] There was no statistically significant difference in efficacy between formulation samples printed with 55T medium ink and 2.8 g/m2 ink (P = 1.000), despite the difference in concentration. This demonstrates how efficacy plateaus after 2.8 g/m2 of excipients (when both sides are printed) is reached. There was also no significant difference between the higher concentration ink and the nominal ink (P = 0.207). However, it is lower, and when the P‐values between the two higher concentrations and the highest and lowest concentration are compared, it can be justified that the 2.8 g/m2 concentration ink should be used over the nominal concentration. EXAMPLE 2 [0280] Prototypes printed with glycerol‐based inks were found to take up to three days to “dry”. The ink deposits do not truly dry, they remain liquid because glycerol is a non‐volatile humectant. A better definition is that ink stops visibly transferring onto any other surface it encounters. This can be understood as the migration of the liquid residue into the voids within the dressing fabric as opposed to remaining on the surface of the fabric as initially deposited. Changing the diameter of the printed dots in the pattern will increase the relative surface area of ink and will more closely match the size of the voids within the fabric. Therefore, it is hypothesised that decreasing the diameter of the dots without having to decrease the open area (area covered by ink) may decrease the drying time.
56
[0281] Three screens were made using 55T mesh and 1 mm, 1.5 mm and 2 mm diameter dot patterns covering approximately 10% of the sample area. 10x10 cm AQUACEL® Extra samples were then printed using these screens and the medium concentration ink from Table 4, see Figure 10. [0282] Samples were left to dry for 18 hours. The 1 mm dot samples were completely dry and did not transfer ink onto an inert surface. As the dot size increased, the ‘wetter’ the samples still felt, and the more ink was transferred when gently pressed onto a solid surface. This shows that decreasing the diameter of the dots printed onto dressings does decrease drying time. [0283] These samples were then tested on the simulated non‐viable matter model, Figure 10 shows that the dot size does not affect the efficacy of AQUACEL® Clean prototypes when the area covered remains the same. However, the variability of efficacy results did reduce with a reduction in dot diameter. EXAMPLE 3 [0284] A substance is applied to the surface of the dressing fabric using a screen‐printing process (see Figure 11). Following printing, the volatile solvent present in the substance requires removal by heat before the dressing can be processed further, e.g., slitting and packaging. Removing the volatile solvent increases the viscosity on the remaining ink and reduces its mobility. An air knife using air at ambient temperature was trialled with the aim of reducing the proportion of ink on the surface of the dressing, by forcing it further into the voids within the fabric, before the heated solvent‐evaporation process. It was envisaged that this process would result in lower subsequent losses of the substance from the substrate material due to transfer onto contact surfaces in downstream processing equipment and onto final packaging. [0285] Printed dressings were produced, and the amount of ink transferred onto contacting surface was measured either by weight or by using a coloured ink where the amount transferred was quantified by imaging software. Weights were used facilitate transfer of the ink to the paper and to mimic conditions the printed dressing may see during processing, rewinding, storage etc. [0286] A pilot plant was prepared where the following settings could be manipulated: compressed air pressure (0‐90psi), height of the air knife above the dressing (4cm – 15cm) and speed of the dressing moving below the air knife (20‐100, 0.08‐1.87cm/sec). A range of air knife settings were used and assessed during the development of the test method. [0287] The experimental method involved the following qualitative and quantitative steps:
57
(a) Print dressing (weigh dressing pre and post printing) (b) Apply air knife to printed substance site (c) Place dressing print side down onto paper (pre‐weighed) (d) Add a known force for a set time (e) Remove the force and dressing from the paper (f) Reweigh the paper and analyse the paper for weight change and % area covered by the ink. [0288] Transfer onto Bristol paper with coloured ink ‐ Visualisation with ImageJ software [0289] Bristol paper (Exacompta 13306E; 210x297 A4) proved to be a high‐quality white paper with a homogenous texture and produced good quality transfers: [0290] Dressings (AQUACEL® Extra™) were printed with a methylene blue ink mixture (1mg/g) and subjected to different air knife settings before transferring the ink to Bristol paper using a 300g Perspex sheet weight for 30 seconds. The air knife settings are provided below: (a) Max air knife = 90psi air pressure, height above the dressing = 4cm, speed setting = 0.08 cm/sec (b) Medium air knife = 50psi air pressure, height above the dressing = 9cm, speed setting = 0.19 cm/sec (c) Min air knife = 10psi air pressure, height above the dressing = 15cm, speed setting = 1.87 cm/sec [0291] The mass differential of the Bristol paper before and after ink transfer was assessed, as was the transferred ink % area. The ink transfer samples on Bristol paper were photographed using a digital camera (Canon EOSM50) in the Just Normlicht Basic Color Viewing cabinet (Asset ID 1307) on the daylight setting. The Photographs were analysed using ImageJ software for percentage area and total area. The ImageJ software requires the following steps to capture the image and quantify the coverage of the transferred ink: (a) Step 1 Capture image (b) Step 2 Maximise view of image (c) Step 3 Define maximum test area that is free from aberrations (d) Step 4 Improve image quality (e) Step 5 Select optimum colour channel (f) Step 6 Set threshold (g) Step 6 Analyse
58
When comparing photographs within the same experiment the same settings were used e.g. threshold values, so as provide comparable data. [0292] Up to 10mg of ink was transferred with and without the air knife. Weight change of the Bristol paper was found to be higher when the minimum air knife setting and where no air knife was used, relative to the use of the maximum and medium settings, as was transferred ink % area (see Figures 12 and 13). [0293] Additional experiments were run using the same protocol, where either no air knife or maximum air knife settings were used to represent the extremes of the deposition process. 10 replicates were used for each setting to increase confidence in the data. Weight change of the Bristol paper was found to be higher when no air knife was used relative to the use of the maximum settings, as was transferred ink % area (see Figures 14 and 15). [0294] An analysis of the resulting depth of ink deposition from each of the air knife settings produced the results tabulated below (see also Figure 15). Average Ink Average Dressing Depth (mm) Width (mm) % Depth No air knife 0.331286 2.495 13.27798 Min air knife 0.324333 2.265 14.31935 Med air knife 0.4255 2.476333 17.18266 Max air knife 0.4388 2.45 17.9102 [0295] Using fabric scissors a 1‐2mm wide section is cut from the dressing along the printed section approximately 3‐4cm in length. This section of textile is then mounted onto a petri dish by placing the edge of the section onto the petri dish so the edge is perpendicular to the petri dish, the ends of the section are then taped to secure the textile in place. The sample is then viewed under a microscope (Keyence Microscope; Model: VHX‐6000; Lens = VH‐Z00R/W/T) using the transmitted light and brought into focus at 50x magnification by adjusting the microscope stage and brightness. Once in focus the printed section is identified, and the microscope is manually calibrated using a ruler. Once calibrated the thickness of the textile is measured using the plane measurement function, followed by the depth of the ink using the one‐click measurement function with the perpendicular and parallel functions. The depth of the ink is measured from the top surface of the textile to the bottom of the ink deposit, and the width of the printed ink is measured from one edge of the ink deposit to the other edge of the ink deposit. The ink depth and textile width are measured in millimetres.
59
[0296] According to these results, a deposition depth of 13‐15 % of the total transverse cross‐section of the substrate layer (using either the medium or maximum air knife settings) would result in less ink transfer from the dressing material. EXAMPLE 4 [0297] Comparative studies involving Formulations A‐F, as summarised in Table 5, where the formulations were prepared and evaluated for their transfer performance on the surface of a carboxymethylcellulose based wound dressing (AQUACEL® Extra™; Convatec Ltd) using alternative printing techniques. A red dye was added to visualise the shapes of the dots produced by the various processes. [0298] Table 5 Formulation A No thickening agent, 20 wt% denatured ethanol, 3.5 wt% added water Thickened with 4 wt% PEG 6000, comprises denatured ethanol and added B water C Thickened with Carbopol® Ultrez 10; no denatured alcohol, no added water D Thickened with Carbopol® Ultrez 10; no denatured alcohol, no added water, Na4EDTA pre‐mixed in the amphoteric surfactant E Thickened with Carbopol® Ultrez 10; viscosity increased by reducing amount of glycerol to 50 wt%; no denatured alcohol, no added water Thickened with Carbopol® Ultrez 10; oleic acid to amphoteric surfactant F ratio reduced1 to 1.5:1; no denatured alcohol, no added water [0299] The assessed printing techniques include the method of the invention (Examples 1‐1 to 1‐6), Flat Screen printing (Examples 2‐1 to 2‐6), Gravure printing (Examples 3‐1 to 3‐6), Rotary Pad printing (Examples 4‐1 to 4‐6) and Needle Dosing (Examples 5‐1 to 5‐6). [0300] Process Methodology [0301] The method of the invention used a system as depicted in Figure 18, comprising two cylindrical impression members completely encompassed with a laser etched 3mm thick silicone rubber foam sheet (RS Components; RS PRO White Rubber Sponge Sheet, 1m x 600mm x 3mm). [0302] The substances were prepared using the components set out in Table 6. [0303] Table 6 Ingredient Source Sodium Cocoamphoacetate Amphosol 1C (Stepan Company, US) Tetrasodium EDTA Sigma Aldrich
60
Oleic Acid Sigma Aldrich Glycerol Sigma Aldrich Poly(meth)acrylic Acid Carbopol® Ultrez 10 (Lubrizol Corp) Polyethylene Glycol Sigma Aldrich Industrial denatured alcohol ‐ Deionised water ‐ [0304] Formulation A Ingredient Concentration in Ink (% w/w) Sodium Cocoamphoacetate 4.54 Tetrasodium EDTA 1.27 Oleic Acid 4.62 Polyethylene Glycol 4.00 Deionised water 3.50 Glycerol 63.19 Industrial denatured alcohol 18.88 TOTAL 100 [0305] Substance Preparation: The glycerol was mixed with the solvent (alcohol) followed by the anionic surfactant (sodium oleate/oleic acid), and the solution sonicated. All remaining components were combined and sonicated if necessary [0306] Table 7: 1‐1 2‐1 3‐1 4‐1 5‐1 Printability EXCELLENT EXCELLENT GOOD GOOD GOOD VERY Print Consistency EXCELLENT EXCELLENT FAIR FAIR GOOD VERY Resolution Tolerance EXCELLENT GOOD POOR POOR GOOD VERY Coat Weight Range EXCELLENT EXCELLENT GOOD POOR GOOD VERY Depth/Placement GOOD GOOD FAIR GOOD FAIR Speed EXCELLENT GOOD EXCELLENT EXCELLENT FAIR [0307] Formulation B Ingredient Concentration in Ink (% w/w) Sodium Cocoamphoacetate 4.54 Tetrasodium EDTA 1.27 Oleic Acid 4.62 Deionised water 3.50 Glycerol 66.27 Industrial denatured alcohol 19.80
61
TOTAL 100 [0308] Substance Preparation: The glycerol was mixed with the solvent (alcohol) followed by the anionic surfactant (sodium oleate/oleic acid), and the solution sonicated. All remaining components were combined and sonicated if necessary [0309] Table 8: 1‐2 2‐2 3‐2 4‐2 5‐2 Printability EXCELLENT EXCELLENT GOOD GOOD GOOD VERY Print Consistency EXCELLENT EXCELLENT FAIR FAIR GOOD VERY Resolution Tolerance EXCELLENT GOOD POOR POOR GOOD VERY Coat Weight Range EXCELLENT EXCELLENT GOOD POOR GOOD VERY Depth/Placement GOOD GOOD FAIR GOOD POOR Speed EXCELLENT GOOD EXCELLENT EXCELLENT FAIR [0310] Formulation C Ingredient Concentration in Ink (% w/w) Sodium Cocoamphoacetate 20.93 Tetrasodium EDTA 6.20 Oleic Acid 22.87 Glycerin 49.50 Poly(meth)acrylic Acid 0.5 TOTAL 100 [0311] Substance Preparation: In a baker fitted with propeller shaft and an electrical motor, Sodium Cocoamphoacetate was added to Na4EDTA and mixed. The remaining components were added and mixed. [0312] Table 9: 1‐3 2‐3 3‐3 4‐3 5‐3 Printability EXCELLENT EXCELLENT GOOD GOOD FAIR Print Consistency EXCELLENT EXCELLENT FAIR FAIR GOOD VERY Resolution Tolerance EXCELLENT GOOD POOR POOR GOOD VERY Coat Weight Range EXCELLENT EXCELLENT GOOD POOR GOOD
62
VERY Depth/Placement GOOD GOOD FAIR GOOD POOR Speed EXCELLENT GOOD EXCELLENT EXCELLENT FAIR [0313] Formulation D Ingredient Concentration in Ink (% w/w) Sodium Cocoamphoacetate 20.93 Tetrasodium EDTA 6.20 Oleic Acid 22.87 Glycerin 49.50 Poly(meth)acrylic Acid 0.5 TOTAL 100 [0314] Substance Preparation: A 1L thick wall glass beaker along with the propeller blade shaft is weighed and recorded tare weight of the beaker + shaft. Added 463.25 g of Glycerol and attached the shaft to the Electrox motor's Chuck and arrest the mixing shaft tightly and the beaker sitting on a hot plate, arrested using a chain bracket. Turned on the mixer and generate a vortex. Slowly added 3.00g of preweighed Carbopol Ultrez 10 towards the vortex, so the powder gets dispersed quickly in the glycerol. Continued stirring for 15 min and turned on the hot plate to reach temperature to 75°C. Mixed for an additional 30 min. Added 9.48g of Oleic Acid, and 5.55g of Na4EDTA. Turned off heating, cooled to 60°C and added 18.73g of Amphosol 1C and mixed for another 60 min. Stopped mixing and reweighed the total weight and ensure that the formula weight is 500g (there was no loss of weight from evaporation). [0315] Table 10: 1‐4 2‐4 3‐4 4‐4 5‐4 Printability EXCELLENT EXCELLENT GOOD FAIR GOOD VERY Print Consistency EXCELLENT EXCELLENT FAIR FAIR GOOD VERY Resolution Tolerance EXCELLENT GOOD POOR POOR GOOD VERY Coat Weight Range EXCELLENT EXCELLENT GOOD POOR GOOD VERY Depth/Placement GOOD GOOD FAIR GOOD FAIR Speed EXCELLENT GOOD EXCELLENT EXCELLENT FAIR [0316] Formulation E Ingredient Concentration in Ink (% w/w) Sodium Cocoamphoacetate 3.75 Tetrasodium EDTA 1.11
63
Oleic Acid 4.09 Glycerin 90.55 Poly(meth)acrylic Acid 0.50 TOTAL 100 [0317] Substance Preparation: [0318] A 600mL thick‐walled glass beaker on a hot plate equipped with a propeller blade shaft connected to an electrical motor was used for blending this SOAP formulation. Weighed in 452.75g of Glycerol in the beaker and turned on the mixer. Dispersed 2.5g of Carbopol Ultrez 10. While stirring, turned on the hot plate and raised the liquid temperature to 60°C and mixed for an additional 15 min. Turned off heating and added 20.47g of Oleic Acid, 5.55g of Na4EDTA and 18.75g of Amphosol 1C. Continued mixing for an additional 30 min and transferred the contents to a 16 Oz glass jar. [0319] Table 11: 1‐5 2‐5 3‐5 4‐5 5‐5 Printability EXCELLENT EXCELLENT GOOD FAIR GOOD VERY Print Consistancy EXCELLENT EXCELLENT FAIR FAIR GOOD VERY Resolution Tolerance EXCELLENT GOOD POOR POOR GOOD VERY Coat Weight Range EXCELLENT EXCELLENT GOOD POOR GOOD VERY Depth/Placement GOOD GOOD FAIR GOOD FAIR Speed EXCELLENT GOOD EXCELLENT EXCELLENT FAIR [0320] Formulation F Ingredient Concentration in Ink (% w/w) Sodium Cocoamphoacetate 3.75 Tetrasodium EDTA 1.11 Oleic Acid 4.09 Glycerin 90.55 Poly(meth)acrylic Acid 0.50 TOTAL 100 [0321] Substance Preparation: [0322] A 600mL thick‐walled glass beaker on a hot plate equipped with a propeller blade shaft connected to an electrical motor was used for blending this SOAP formulation. Weighed in 452.75g of Glycerol in the beaker and turned on the mixer. Dispersed 2.5g of Carbopol Ultrez 10. While stirring, turned on the hot plate and raised the liquid temperature to 60°C and mixed for an additional 15 min. Separately, a 500 mL jar equipped with a single rectangular blade shaft connected to an electrical
64
motor is used to formulate a Na4EDTA/Sodium Cocoamphoacetate premix. 154.3g of Amphosol 1C (Sodium Cocoamphoacetate, Stepan) was placed in the glass jar and turned on the mixer. Added 45.7g of Na4EDTA and continued mixing and raised the temperature to 54°C. After 30 min, QS the lost wt. with deionised water and mixed for an additional 10 min before removing the shaft and closing the jar. Turned off heating and added 20.47g of Oleic Acid, 5.55g of Na4EDTA and 18.75g of Amphosol 1C. Continued mixing for an additional 30 min and transferred the contents to a 16 Oz glass jar. [0323] Table 12: 1‐6 2‐6 3‐6 4‐6 5‐6 Printability EXCELLENT EXCELLENT GOOD FAIR GOOD VERY Print Consistancy EXCELLENT EXCELLENT FAIR FAIR GOOD VERY Resolution Tolerance EXCELLENT GOOD POOR POOR GOOD VERY Coat Weight Range EXCELLENT EXCELLENT GOOD POOR GOOD VERY Depth/Placement GOOD GOOD FAIR GOOD FAIR Speed EXCELLENT GOOD EXCELLENT EXCELLENT FAIR [0324] The results of the printing tests are illustrated in Figures 28, 29, 30, 31, 32 and 33. The inventive method was found to possess many advantages over comparable techniques known in the art, including superior printability, print consistency, resolution tolerance, coat weight range, depth/placement and speed. [0325] Figure 18 Component List (2) Substrate (7) Reservoir (8) Pump (9) Transfer Member (10) Cells with outward facing aperture (11) Impression Member (12) Transfer Means (13) Channel Feeder (14) Squeegee Blade (15) Formulation impregnated and/or coated on substrate [0326] The invention will be described in further detail in the following numbered embodiments.
65
FIRST SET OF NUMBERED CLAUSES 1). A wound dressing or debridement tool, wherein the dressing or tool comprises one or more substrate layers, wherein one or more substances are at least partially impregnated on a first surface of at least one of the substrate layers, and wherein the one or more substances are impregnated on the first surface of the substrate layer to a depth of from about 1% to about 50% of the total transverse cross‐section of the substrate layer. 2). The wound dressing or debridement tool according to clause 1, wherein the one or more substances are impregnated on the first surface of the substrate layer to a depth of from about 5% to about 30% of the total transverse cross‐section of the substrate layer; preferably wherein the one or more substances are impregnated on the first surface of the substrate layer to a depth of from about 15% to about 20% of the total transverse cross‐section of the substrate layer. 3). The wound dressing or debridement tool according to any one of clauses 1 and 2, wherein the one or more substances are impregnated in a discontinuous configuration. 4). The wound dressing or debridement tool according to any one of clauses 1 to 3, wherein the at least one substrate layer comprises a material selected from: fibres, fabrics or yarns, gels, foams, films, plastics, resins, rubber, collagen, decellularized tissue or a combination thereof. 5). The wound dressing or debridement tool according to clause 4, wherein the at least one substrate layer comprises a material selected from: fibres, fabrics or yarns, foams, films or a combination thereof. 6). The wound dressing or debridement tool according to any one of clauses 1 to 5, wherein the at least one substrate layer is a fabric material, preferably a nonwoven fabric material. 7). The wound dressing or debridement tool according to clause 6, wherein the fabric material is a nonwoven fabric material consisting of gel forming fibres and/or non‐gel forming fibres; preferably wherein the fabric material is a nonwoven fabric material consisting of gel‐forming fibres and non‐gel forming fibres; or wherein the fabric material is a nonwoven fabric material consisting of gel‐forming fibres.
66
). The wound dressing or debridement tool according to any one of clauses 1 to 5, wherein the at least one substrate layer is a foam material, preferably a polyurethane foam, a polypropylene foam, a polyester foam or a polyvinyl alcohol (PVA) foam. ). The wound dressing or debridement tool according to any one of clauses 1 to 8, wherein the at least one substrate layer has a basis weight of about 50 – 400 gsm, preferably wherein the at least one substrate layer has a basis weight of about 150 – 200 gsm. 0). The wound dressing or debridement tool according to any one of clauses 1 to 9, wherein the at least one substrate layer has a thickness of about 0.5 – 20.0 mm; preferably wherein the at least one substrate layer has a thickness of about 1.0 – 10.0 mm. 1). The wound dressing or debridement tool according to any one of clauses 1 to 10, wherein the one or more substances are impregnated on the first surface of the substrate layer to a depth of from about 100µm to about 500 µm of the total transverse cross‐section of the substrate layer; preferably wherein the one or more substances is impregnated on the first surface of the substrate layer to a depth of from about 200µm to about 400 µm of the total transverse cross‐ section of the substrate layer. 2). The wound dressing or debridement tool according to any one of clauses 1 to 11, wherein the at least one substrate layer has a bulk density of about 40 – 80 kg/m3. 3). The wound dressing or debridement tool according to clauses 1 to 12, wherein the at least one substrate layer has a fluid absorbency of about 0.15g/cm2 or more. 4). The wound dressing or debridement tool according to any one of clauses 1 to 13, wherein the one or more substances are impregnated on about 1 % to about 20 % of the total surface area of the first surface of the substrate layer; preferably wherein the one or more substances are impregnated on about 5 % to about 15 % of the total surface area of the first surface of the substrate layer. 5). The wound dressing or debridement tool according to any one of clauses 1 to 14, wherein the one or more substances are at least partially impregnated on the first surface of the substrate layer in discrete units, wherein the discrete unit surface area for each unit differs.
). The wound dressing or debridement tool according to clause 15, wherein the discrete unit surface area for each unit increases and decreases across an axis of the substrate layer surface in a parabolic distribution. ). The wound dressing or debridement tool according to any one of clauses 1 to 14, wherein the one or more substances are at least partially impregnated on the first surface of the substrate layer in discrete units, wherein the discrete unit surface area is equivalent for each unit. ). The wound dressing or debridement tool according to clauses 1 to 17, wherein the dissolution rate of the one or more substances is of from 10 to 90 % per day. ). The wound dressing or debridement tool according to any one of clauses 1 to 18, wherein the one or more substances is selected from: a wound cleansing or debridement composition, a medicament, an adhesive, a deodorant, a chelating agent, a surfactant, an amphoteric surfactant, an anionic surfactant, a cationic surfactant, a thickening agent, an electrically conductive formulation, a thermoresponsive agent, an exothermic agent, an endothermic agent, or a combination thereof. ). The wound dressing or debridement tool according to clause 19, wherein the medicament comprises one or more agents selected from: antimicrobials, analgesics, coagulants, anti‐ inflammatories or a combination thereof. ). The wound dressing or debridement tool according to any one of clauses 1 to 20, wherein the one or more substances comprises a wound cleansing or debridement composition; preferably wherein the composition comprises: (i). a chelating agent; (ii). an amphoteric surfactant; (iii). an anionic surfactant; and (iv). a thickening agent, wherein the thickening agent comprises at least one poly(meth)acrylic acid and/or salt thereof. ). The wound dressing or debridement tool according to clauses 1 to 21, wherein the one or more substances comprises a non‐antimicrobial composition, said composition comprising (i) at least
about 50 wt% of a carrier which is glycerol, triglycerol, or a combination thereof, (ii) a solvent which is one or more C1‐4 alcohol, and (iii) one or more excipients, wherein the weight ratio of (i) to (ii) in the composition is from about 2:1 to about 5:1. ). The wound dressing or debridement tool according to clauses 1 to 22, wherein the one or more substance is applied in the form of a solid, a gel, a wax, a liquid, a suspension, or an emulsion; preferably wherein the substance is applied in the form of a liquid. ). The wound dressing or debridement tool according to any one of clauses 1 to 23, wherein the one or more substrate layers are selected from: an absorbent layer, a transmission layer, an adhesive layer, a soluble medicated film layer, an odour‐absorbing layer, a spreading layer, a keying layer, a distribution layer, a superabsorbent layer or combinations thereof; preferably wherein the one or more substrate layers is an absorbent layer. ). The wound dressing or debridement tool according to any one of clauses 1 to 24, wherein the wound dressing or debridement tool is of a monolayer construction, or wherein the wound dressing or debridement tool is of a multi‐layer construction; preferably wherein the multi‐layer construction comprises one or more functional layers. ). The wound dressing or debridement tool according to any one of clauses 1 to 24, wherein the wound dressing or debridement tool is of a monolayer construction. ). The wound dressing or debridement tool according to clause 25, wherein at least one substrate layer is configured between two or more functional layers; preferably, wherein the one or more functional layers are selected from: an absorbent layer, a transmission layer, an adhesive layer, a support layer, a soluble medicated film layer, an odour‐absorbing layer, a spreading layer, a keying layer, a protective layer, a packaging layer, an outer cover layer, a distribution layer, a superabsorbent layer or combinations thereof. ). The wound dressing or debridement tool according to any one of clauses 1 to 27, wherein at least one substrate layer is a wound or epidermis contacting layer. ). The wound dressing or debridement tool according to any one of clauses 1 to 28, wherein multiple substance(s) are applied to the at least one substrate layer.
). The wound dressing or debridement tool according to any one of clauses 1 to 29, wherein two or more substance(s) are applied to the first surface of the at least one substrate layer. ). The wound dressing or debridement tool according to any one of clauses 1 to 30, wherein a combination of substance(s) are applied to the first surface of the at least one substrate layer. ). The wound dressing or debridement tool according to any one of clauses 1 to 31, wherein a combination of substance(s) are applied to the first surface and a second surface of the at least one substrate layer. ). The wound dressing or debridement tool according to any one of clauses 1 to 28, wherein one substance is applied to the at least one substrate layer. ). The wound dressing or debridement tool according to any one of clauses 1 to 33, wherein the at least one substrate layer comprises a second surface opposite the first surface, preferably wherein the second surface opposite the first surface comprises the same substance(s) impregnated at the same depth as the first surface. ). The wound dressing or debridement tool according to any one of clauses 1 to 34, wherein different substances are applied to the first surface and a second surface of the at least one substrate layer. ). The wound dressing or debridement tool according to clauses 1 to 35, wherein the mass of substance comprised in the at least one substrate layer is of from about 0.10 to about 50.00 g/m2 per surface; preferably wherein the mass of substance comprised in the at least one substrate layer is of from about 0.5 to about 20.00 g/m2 per surface. ). A method of applying one or more substance(s) to one or more substrate layers of a wound dressing or debridement tool according to any one of clauses 1 to 36, wherein the method comprises: (a) applying one or more substances to a first surface of at least one of the substrate layers; (b) applying a compressed source gas via a gas feed to the first surface of the substrate layer; (c) optionally applying at least one drying means to the first surface of the substrate layer.
). The method according to clause 37, wherein according to step (b) the substrate layer is conveyed in a machine direction at a rate of about 0.01 to about 35.00 cm/sec; preferably according to step (b) the substrate layer is conveyed in a machine direction at a rate of about 0.05 to about 20 cm/sec. ). The method according to any one of clauses 37 and 38, wherein the one or more substances are applied to the first surface of the substrate layer by a printing process; preferably wherein the printing process is a screen printing process, a gravure printing process, a soft gravure printing process, a rotary pad printing process or a needle dosing process. ). The method according to any one of clauses 37 to 39, wherein the compressed gas feed is an air knife. ). The method according to any one of clauses 37 to 40 wherein the compressed gas feed outlet is positioned at a height of about 0.1cm to about 100cm above the first surface of the substrate layer; preferably wherein the compressed gas feed is positioned at a height of about 1cm to about 30cm above the first surface of the substrate layer. ). The method according to any one of clauses 37 to 41, wherein the source gas is selected from: air, helium, nitrogen, oxygen, hydrogen, argon, nitrogen oxide or combinations thereof. ). The method according to any one of clauses 37 to 42, wherein the source gas is a filtered source gas. ). The method according to any one of clauses 37 to 43, wherein the pressure of the compressed gas feed is from greater than about 0 to about 150 psi; preferably wherein the pressure of the compressed gas feed is from about 40 to about 100 psi. ). The method according to any one of clauses 37 to 44, wherein the temperature of the compressed gas feed is from about 0 to about 100 oC; preferably wherein the temperature of the compressed gas feed is from about 5 to about 30 oC.
46). A system for applying one or more substance(s) to one or more substrate layers of a wound dressing or debridement tool according to the method of clauses 37 to 45. 47). Use of the wound dressing or debridement tool according to any one of clauses 1 to 36 to prevent or minimise slough accumulation in a wound or to de‐slough a wound, the use comprising contacting said wound dressing or debridement tool with said wound or contacting said wound with said wound dressing or debridement tool, preferably wherein the wound is a chronic wound, acute wound, or burn. SECOND SET OF NUMBERED CLAUSES 1). A wound dressing or debridement tool, wherein the dressing or tool comprises one or more substrate layers, wherein one or more substances are at least partially impregnated or coated on a first surface of at least one of the substrate layers, and wherein the one or more substances are at least partially impregnated or coated on about 1 % to about 20 % of the total surface area of the first surface of the substrate layer. 2). The wound dressing or debridement tool according to clause 1, wherein the one or more substances are at least partially impregnated or coated in a discontinuous configuration. 3). The wound dressing or debridement tool according to any one of clauses 1 or 2, wherein the one or more substances are at least partially impregnated or coated on about 5 % to about 15 % of the total surface area of the first surface of the substrate layer; preferably wherein the one or more substances are at least partially impregnated or coated on about 8 % to about 12 % of the total surface area of the first surface of the substrate layer. 4). The wound dressing or debridement tool according to any one of clauses 1 to 3, wherein the one or more substances are at least partially impregnated or coated on the first surface of the substrate layer in discrete units, wherein the discrete unit surface area for each unit differs. 5). The wound dressing or debridement tool according to clause 4, wherein the discrete unit surface area for each unit increases and decreases across an axis of the substrate layer surface in a parabolic distribution.
72
). The wound dressing or debridement tool according to any one of clauses 1 to 3, wherein the one or more substances are at least partially impregnated or coated on the first surface of the substrate layer in discrete units, wherein the discrete unit surface area is equivalent for each unit. ). The wound dressing or debridement tool according to any one of clauses 1 to 6, wherein the one or more substances are at least partially impregnated or coated on the first surface of the substrate layer in discrete units of from 0.08 mm2 to about 20.00 mm2; preferably wherein the one or more substances are at least partially impregnated or coated on the first surface of the substrate layer in discrete units of from 0.60 mm2 to about 1.75 mm2. ). The wound dressing or debridement tool according to any one of clauses 1 to 7, wherein the at least one substrate layer comprises a material selected from: fibres, fabrics or yarns, gels, foams, films, plastics, resins, rubber, collagen, decellularized tissue or a combination thereof. ). The wound dressing or debridement tool according to clause 8, wherein the at least one substrate layers comprises a material selected from: fibres, fabrics or yarns, foams, films or a combination thereof. 0). The wound dressing or debridement tool according to any one of clauses 1 to 9, wherein the at least one substrate layer is a fabric material, preferably a nonwoven fabric material. 1). The wound dressing or debridement tool according to clause 10, wherein the fabric material is a nonwoven fabric material consisting of gel forming fibres and/or non‐gel forming fibres; preferably wherein the fabric material is a nonwoven fabric material consisting of gel‐forming fibres and non‐gel forming fibres; or wherein the fabric material is a nonwoven fabric material consisting of gel‐forming fibres. 2). The wound dressing or debridement tool according to any one of clauses 1 to 9, wherein the at least one substrate layer is a foam material, preferably a polyurethane foam, a polypropylene foam, a polyester foam or a polyvinyl alcohol (PVA) foam.
). The wound dressing or debridement tool according to clauses 1 to 12, wherein the at least one substrate layer has a basis weight of about 50 – 400 gsm, preferably wherein the at least one substrate layer has a basis weight of about 150 – 200 gsm. ). The wound dressing or debridement tool according to clauses 1 to 13, wherein the at least one substrate layer has a thickness of about 0.5 – 20.0 mm; preferably wherein the at least one substrate layer has a thickness of about 1.0 – 10.0 mm. ). The wound dressing or debridement tool according to clauses 1 to 14, wherein the at least one substrate layer has a surface energy of about 45 to about 1000 mJ/m2. ). The wound dressing or debridement tool according to clauses 1 to 15, wherein the one or more substances are impregnated on the first surface of the substrate layer to a depth of from about 1% to about 50% of the total transverse cross‐section of the substrate layer; preferably wherein the one or more substances are impregnated on the first surface of the substrate layer to a depth of from about 15% to about 20% of the total transverse cross‐section of the substrate layer. ). The wound dressing or debridement tool according to clauses 1 to 16, wherein the at least one substrate layer has a bulk density of about 40 – 80 kg/m3 ). The wound dressing or debridement tool according to clauses 1 to 17, wherein the at least one substrate layer has a fluid absorbency of about 0.15g/cm2 or more. ). The wound dressing or debridement tool according to clauses 1 to 18, wherein the dissolution rate of the one or more substances is of from 10 to 90 % per day. ). The wound dressing or debridement tool according to any one of clauses 1 to 19, wherein the one or more substances is selected from: a wound cleansing or debridement composition, a medicament, an adhesive, a deodorant, a chelating agent, a surfactant, an amphoteric surfactant, an anionic surfactant, a cationic surfactant, a thickening agent, an electrically conductive formulation, a thermoresponsive agent, an exothermic agent, an endothermic agent, or a combination thereof.
). The wound dressing or debridement tool according to clause 20, wherein the medicament comprises one or more agents selected from: antimicrobials, analgesics, coagulants, anti‐ inflammatories, or a combination thereof. ). The wound dressing or debridement tool according to clauses 1 to 21, wherein the one or more substances comprises a wound cleansing or debridement composition; preferably wherein the composition comprises: (i). a chelating agent; (ii). an amphoteric surfactant; (iii). an anionic surfactant; and (iv). a thickening agent, wherein the thickening agent comprises at least one poly(meth)acrylic acid and/or salt thereof. ). The wound dressing or debridement tool according to clauses 1 to 22, wherein the one or more substances comprises a non‐antimicrobial composition, said composition comprising (i) at least about 50 wt% of a carrier which is glycerol, triglycerol, or a combination thereof, (ii) a solvent which is one or more C1‐4 alcohol, and (iii) one or more excipients, wherein the weight ratio of (i) to (ii) in the composition is from about 2:1 to about 5:1. ). The wound dressing or debridement tool according to clauses 1 to 23, wherein the one or more substance is applied in the form of a solid, a gel, a wax, a liquid, a suspension, or an emulsion; preferably wherein the substance is applied in the form of a liquid. ). The wound dressing or debridement tool according to any one of clauses 1 to 24, wherein the one or more substrate layers are selected from: an absorbent layer, a transmission layer, an adhesive layer, a soluble medicated film layer, an odour‐absorbing layer, a spreading layer, a keying layer, a distribution layer, a superabsorbent layer or combinations thereof; preferably wherein the one or more substrate layers is an absorbent layer. ). The wound dressing or debridement tool according to any one of clauses 1 to 25, wherein the wound dressing or debridement tool is of a monolayer construction, or wherein the wound dressing or debridement tool is of a multi‐layer construction; preferably wherein the multi‐layer construction comprises one or more functional layers.
). The wound dressing or debridement tool according to any one of clauses 1 to 26, wherein the wound dressing or debridement tool is of a monolayer construction. ). The wound dressing or debridement tool according to clause 27, wherein at least one substrate layer is configured between two or more functional layers; preferably, wherein the one or more functional layers are selected from: an absorbent layer, a transmission layer, an adhesive layer, a support layer, a soluble medicated film layer, an odour‐absorbing layer, a spreading layer, a keying layer, a protective layer, a packaging layer, an outer cover layer, a distribution layer, a superabsorbent layer or combinations thereof. ). The wound dressing or debridement tool according to any one of clauses 1 to 28, wherein at least one substrate layer is a wound or epidermis contacting layer. ). The wound dressing or debridement tool according to any one of clauses 1 to 29, wherein multiple substances are applied to the at least one substrate layer. ). The wound dressing or debridement tool according to any one of clauses 1 to 30, wherein two or more substance(s) are applied to the first surface of the at least one substrate layer. ). The wound dressing or debridement tool according to any one of clauses 1 to 31, wherein a combination of substances are applied to the first surface of the at least one substrate layer. ). The wound dressing or debridement tool according to any one of clauses 1 to 29, wherein one substance is applied to the at least one substrate layer. ). The wound dressing or debridement tool according to any one of clauses 1 to 33, wherein the at least one substrate layer comprises a second surface opposite the first surface. ). The wound dressing or debridement tool according to any one of clauses 1 to 34, wherein the second surface opposite the first surface comprises the same substance(s) impregnated at the same depth as the first surface.
36). The wound dressing or debridement tool according to any one of clauses 1 to 35, wherein a combination of substances are applied to the first surface and a second surface of the at least one substrate layer. 37). The wound dressing or debridement tool according to any one of clauses 1 to 34, wherein different substances are applied to the first surface and a second surface of the at least one substrate layer. 38). The wound dressing or debridement tool according to clauses 1 to 37, wherein the mass of substance comprised in the at least one substrate layer is of from about 0.10 to about 50.00 g/m2 per surface; preferably wherein the mass of substance comprised in the at least one substrate layer is of from about 0.5 to about 20.00 g/m2 per surface. 39). A method of applying one or more substance(s) to one or more substrate layers of a wound dressing or debridement tool according to any one of clauses 1 to 38, wherein the method comprises: (a) applying one or more substances to a first surface of at least one of the substrate layers; (b) optionally applying at least one drying means to the first surface of the substrate layer. 40). The method according to clause 39, wherein the one or more substances are applied to the first surface of the substrate layer by a printing process; preferably wherein the printing process is a screen printing process, a gravure printing process, a soft gravure printing process, a rotary pad printing process or a needle dosing process. 41). A system for applying one or more substance(s) to one or more substrate layers of a wound dressing or debridement tool according to the method of clauses 39 and 40. 42). Use of the wound dressing or debridement tool according to any one of clauses 1 to 38 to prevent or minimise slough accumulation in a wound or to de‐slough a wound, the use comprising contacting said wound dressing or debridement tool with said wound or contacting said wound with said wound dressing or debridement tool, preferably wherein the wound is a chronic wound, acute wound, or burn. THIRD SET OF NUMBERED CLAUSES
77
). A method of applying one or more substance(s) to one or more substrate layers of an article, wherein the method comprises: (a) providing at least one transfer means comprising an impression member and a transfer member, wherein the transfer member comprises one or more cells with outward facing apertures, and wherein the transfer member is provided on the exterior of the impression member; (b) introducing the one or more substance(s) into the one or more cells of the transfer member; and (c) contacting the substrate layer with the transfer member as the substrate layer is conveyed along a transport path in a machine direction, wherein force applied by the impression member to at least the one or more cells comprised within the transfer member causes the one or more substance(s) comprised within the one or more cells to transfer to the substrate layer. ). The method according to clause 1, wherein the one or more cells of the transfer member reversibly compress under force applied by the impression member to at least the one or more cells in step (c) so as to cause the one or more substance(s) comprised within the one or more cells to transfer to the substrate layer. ). The method according to any one of clauses 1 or 2, wherein at least two transfer means are provided, each comprising an impression member and a transfer member, wherein each of the transfer members comprise one or more cells with outward facing apertures and are provided on the exterior of the impression members, and wherein the transfer means are positioned in proximity to each other such that pressure is formed on each transfer member by the corresponding impression members as the substrate layer is conveyed along a transport path in a machine direction. ). The method according to any one of clauses 1 to 3, wherein the transfer means consists of the impression member and the transfer member, preferably wherein the transfer member is in the form of a layer of the one or more cells. ). The method according to any one of clauses 1 to 4, wherein the transport path of the substrate layer in a machine direction comprises a vertical and/or horizontal configuration.
). The method according to any one of clauses 1 to 5, wherein the one or more substance(s) transferred to the substrate layer is at least partially impregnated within the substrate layer. ). The method according to any one of clauses 1 to 6, wherein the transfer member(s) comprises an elastomeric material; preferably wherein the transfer member(s) consists of an elastomeric material. ). The method according to any one of clauses 1 to 7, wherein the transfer member(s) have a Shore A hardness value of from about 5 to about 30. ). The method according to any one of clauses 1 to 8, wherein the transfer member(s) has a density of from about 100 to about 500 g/cm3. 0). The method according to any one of clauses 1 to 9, wherein the transfer member(s) have a compressive stress 40% strain of from about 30 to about 150 KPa. 1). The method according to any one of clauses 1 to 10, wherein the transfer member(s) has a compression set value (22 hours @ 70oC) of about 20% or less. 2). The method according to any one of clauses 1 to 11, wherein the transfer member(s) has a tensile strength of about 0.5 N/mm2 or more. 3). The method according to any one of clauses 1 to 12, wherein the transfer member(s) has an elongation to failure of at least about 80%. 4). The method according to any one of clauses 1 to 13, wherein at least one of the substrate layers comprises a material selected from : fibres, fabrics or yarns, gels, foams, films, plastics, resins, rubber, or a combination thereof. 5). The method according to clause 14, wherein at least one of the substrate layers comprises a material selected from the group consisting of: fibres, fabrics or yarns, foams, films or a combination thereof.
). The method according to any one of clauses 1 to 15, wherein at least one of the substrate layers is a fabric material, preferably a nonwoven fabric material. ). The method according to clause 16, wherein the fabric material comprises gel‐forming fibres, preferably chemically modified cellulosic fibres, and/or cellulosic fibres. ). The method according to any one of clauses 1 to 17, wherein at least one of the substrate layers is a foam material, preferably a polyurethane foam, a polypropylene foam, a polyester foam or a polyvinyl alcohol (PVA) foam. ). The method according to any one of clauses 1 to 18, wherein the one or more substance(s) is selected from: one or more of a medicament, an adhesive, a deodorant, a chelating agent, a surfactant, an amphoteric surfactant, an anionic surfactant, a cationic surfactant, a thickening agent, an electrically conductive formulation, a thermoresponsive agent, an exothermic agent, an endothermic agent, or a combination thereof. ). The method according to clause 19, wherein the medicament comprises one or more agents selected from: antimicrobials, analgesics, coagulants, anti‐inflammatories or a combination thereof. ). The method according to any one of clauses 1 to 20, wherein the one or more substance(s) comprises a wound cleansing or debridement composition, preferably wherein the composition comprises: (i). a chelating agent; (ii). an amphoteric surfactant; (iii). an anionic surfactant; and (iv). a thickening agent, wherein the thickening agent comprises at least one poly(meth)acrylic acid and/or salt thereof. ). The method according to any one of clauses 1 to 20, wherein the one or more substance(s) comprises a non‐antimicrobial composition, said composition comprising (i) at least about 50 wt% of a carrier which is glycerol, triglycerol, or a combination thereof, (ii) a solvent which is one or more C1‐4 alcohol, and (iii) one or more excipients, wherein the weight ratio of (i) to (ii) in the composition is from about 2:1 to about 5:1.
). The method according to any one of clauses 1 to 22, wherein the one or more substance(s) is applied in the form of a solid, a gel, a wax. a liquid, a suspension, or an emulsion; preferably wherein the substance is applied in the form of a liquid. ). The method according to any one of clauses 1 to 23, wherein the article is a medical article. ). The method according to clause 24, wherein the medical article is selected from the group consisting of: a wound dressing, a debridement tool, an ostomy system, a compression article, an epidermal dressing; preferably wherein the medical article is a wound dressing or a debridement tool. ). The method according to any one of clauses 1 to 25, wherein the one or more substrate layers are selected from: outer cover layer, an absorbent layer, a transmission layer, an adhesive layer, a distribution layer, a soluble medicated film layer, an odour‐absorbing layer, a spreading layer, a keying layer, a superabsorbent layer or combinations thereof. ). The method according to any one of clauses 1 to 26, wherein the article is of a monolayer construction, or wherein the article is of a multi‐layer construction, preferably wherein the multilayer construction comprises one or more functional layers; preferably, wherein the one or more functional layers are selected from: outer cover layer, an absorbent layer, a transmission layer, an adhesive layer, a support layer, a distribution layer, a soluble medicated film layer, an odour‐absorbing layer, a spreading layer, a keying layer, a superabsorbent layer or combinations thereof. ). The method according to clause 27, wherein at least one substrate layer is configured between two or more functional layers; preferably, wherein the one or more functional layers are selected from: outer cover layer, an absorbent layer, a transmission layer, an adhesive layer, a support layer, a distribution layer, a soluble medicated film layer, an odour‐absorbing layer, a spreading layer, a keying layer, a superabsorbent layer or combinations thereof. ). The method according to any one of clauses 1 to 28, wherein at least one substrate layer is a wound or epidermis contacting layer.
). The method according to any one of clauses 1 to 29, wherein one substance is applied to a substrate layer. ). The method according to any one of clauses 1 to 30, wherein multiple substances are applied to a substrate layer. ). The method according to any one of clauses 1 to 30, wherein the one or more substance(s) are applied to a single surface of a substrate layer. ). The method according to any one of clauses 1 to 30, wherein different substances are applied to different surfaces of a substrate layer. ). The method according to any one of clauses 1 to 30, wherein a combination of substances are applied to a single surface of a substrate layer. ). The method according to any one of clauses 1 to 30, wherein a combination of substances are applied to multiple surfaces of a substrate layer. ). A wound dressing or a debridement tool comprising at least one substrate layer, wherein the substrate layer is at least partially impregnated or coated with one or more substance(s) in accordance with any one of clauses 1 to 35. ). Use of the wound dressing or debridement tool according to clause 36 to prevent or minimise slough accumulation in a wound or to de‐slough a wound, the use comprising contacting said wound dressing or debridement tool with said wound or contacting said wound with said wound dressing or debridement tool, preferably wherein the wound is a chronic wound, acute wound, or burn. ). A system for applying one or more substance(s) to one or more substrate layer(s) of an article as defined in any one of clauses 1 to 35, wherein the system comprises: (a) at least one transfer means comprising an impression member and a transfer member, wherein the transfer member comprises one or more cells with outward facing apertures, wherein the transfer member is provided on the exterior of the impression member, and
wherein the one or more cells are configured to be reversibly compressible under force exerted by the impression member; (b) at least one reservoir comprising the substance; (c) a pump configured to draw the substance from the reservoir and introduce it into the one or more cells of the transfer member; (d) optionally a component configured to remove excess substance from the transfer member. ). A process for preparing an article as defined in any one of clauses 1 to 35, said process comprising, in order, the steps of: (a) conveying a substrate layer along a transport path in a machine direction toward at least one transfer means comprising an impression member and a transfer member, wherein the transfer member comprises one or more cells with outward facing apertures, wherein the transfer member is provided on the exterior of the impression member, and wherein the one or more cells are configured to be reversibly compressible under force exerted by the impression member; (b) contacting the substrate layer with the transfer member as the substrate layer is conveyed along a transport path in a machine direction, wherein force applied by the impression member to at least the one or more cells comprised within the transfer member causes the one or more substance(s) comprised within the one or more cells to transfer to the substrate layer; (c) optionally adhering or affixing the substrate layer to one or more functional layers. ). The process according to clause 39, wherein the article is of a multilayer construction comprising: (a) the substrate layer comprising the one or more substance(s) configured as a wound or epidermis contacting layer; (b) at least one substrate layer comprising the one or more substance(s) adhered or affixed to one or more additional functional layers that are configured as a wound or epidermis contacting layer, preferably wherein the one or more additional functional layers are selected from the group consisting of: an absorbent layer, a transmission layer, an adhesive layer, a support layer, a soluble medicated film layer, an odour‐absorbing layer, a spreading layer, a keying layer, a superabsorbent layer or combinations thereof.
[0327] The various embodiments described herein are presented only to assist in understanding and teaching the claimed features. These embodiments are provided as a representative sample of embodiments only, and are not exhaustive and/or exclusive. It is to be understood that advantages, embodiments, examples, functions, features, structures, and/or other aspects described herein are not to be considered limitations on the scope of the invention as defined by the claims or limitations on equivalents to the claims, and that other embodiments may be utilised and modifications may be made without departing from the scope of the claimed invention. Various embodiments of the invention may suitably comprise, consist of, or consist essentially of, appropriate combinations of the disclosed elements, components, features, parts, steps, means, etc., other than those specifically described herein. In addition, this disclosure may include other inventions not presently claimed, but which may be claimed in future.
84
Claims
CLAIMS 1). A wound dressing or debridement tool, wherein the dressing or tool comprises one or more substrate layers, wherein one or more substances are at least partially impregnated or coated on a first surface of at least one of the substrate layers, and wherein the one or more substances are at least partially impregnated or coated on about 1 % to about 20 % of the total surface area of the first surface of the substrate layer. 2). A wound dressing or debridement tool, wherein the dressing or tool comprises one or more substrate layers, wherein one or more substances are at least partially impregnated on a first surface of at least one of the substrate layers, and wherein the one or more substances are impregnated on the first surface of the substrate layer to a depth of from about 1% to about 50% of the total transverse cross‐section of the substrate layer. 3). The wound dressing or debridement tool according to claim 1 or claim 2, wherein the one or more substances are impregnated or coated in a discontinuous configuration. 4). The wound dressing or debridement tool according to any one of claims 1 to 3, wherein the at least one substrate layer is a fabric material, preferably a nonwoven fabric material, more preferably a nonwoven fabric material consisting of gel forming fibres and/or non‐gel forming fibres; or wherein the at least one substrate layer is a foam material, preferably a polyurethane foam, a polypropylene foam, a polyester foam or a polyvinyl alcohol (PVA) foam. 5). The wound dressing or debridement tool according to any one of claims 1 to 4, wherein the at least one substrate layer has a basis weight of about 50 – 400 gsm, preferably wherein the at least one substrate layer has a basis weight of about 150 – 200 gsm. 6). The wound dressing or debridement tool according to any one of claims 1 to 5, wherein the at least one substrate layer has a thickness of about 0.5 – 20.0 mm; preferably wherein the at least one substrate layer has a thickness of about 1.0 – 10.0 mm. 7). The wound dressing or debridement tool according to any one of claims 1 to 6, wherein the one or more substances are impregnated on the first surface of the substrate layer to a depth of from about 100µm to about 500 µm of the total transverse cross‐section of the substrate layer; preferably wherein the one or more substances is impregnated on the first surface of the
85
substrate layer to a depth of from about 200µm to about 400 µm of the total transverse cross‐ section of the substrate layer. ). The wound dressing or debridement tool according to any one of claims 1 to 7 wherein the one or more substances are impregnated on the first surface of the substrate layer to a depth of from about 5% to about 30% of the total transverse cross‐section of the substrate layer; preferably wherein the one or more substances are impregnated on the first surface of the substrate layer to a depth of from about 15% to about 20% of the total transverse cross‐section of the substrate layer. ). The wound dressing or debridement tool according to any one of claims 1 to 8, wherein the one or more substances are impregnated or coated on about 1 % to about 20 % of the total surface area of the first surface of the substrate layer, preferably wherein the one or more substances are at least partially impregnated or coated on about 5 % to about 15 % of the total surface area of the first surface of the substrate layer; more preferably wherein the one or more substances are at least partially impregnated or coated on about 8 % to about 12 % of the total surface area of the first surface of the substrate layer. 0). The wound dressing or debridement tool according to any one of claims 1 to 9, wherein the one or more substances are at least partially impregnated or coated on the first surface of the substrate layer in discrete units, wherein the discrete unit surface area for each unit differs, preferably wherein the discrete unit surface area for each unit increases and decreases across an axis of the substrate layer surface in a parabolic distribution, or wherein the discrete unit surface area is equivalent for each unit. 1). The wound dressing or debridement tool according to any one of claims 1 to 10, wherein the one or more substances comprises a wound cleansing or debridement composition; preferably wherein the composition comprises: (i). a chelating agent; (ii). an amphoteric surfactant; (iii). an anionic surfactant; and (iv). a thickening agent, wherein the thickening agent comprises at least one poly(meth)acrylic acid and/or salt thereof.
). The wound dressing or debridement tool according to claims 1 to 11, wherein the one or more substances comprises a non‐antimicrobial composition, said composition comprising (i) at least about 50 wt% of a carrier which is glycerol, triglycerol, or a combination thereof, (ii) a solvent which is one or more C1‐4 alcohol, and (iii) one or more excipients, wherein the weight ratio of (i) to (ii) in the composition is from about 2:1 to about 5:1. ). The wound dressing or debridement tool according to any one of claims 1 to 12, wherein the one or more substrate layers is an absorbent layer. ). The wound dressing or debridement tool according to any one of claims 1 to 13, wherein the at least one substrate layer comprises a second surface opposite the first surface, wherein the second surface opposite the first surface comprises the same substance(s) impregnated at the same depth as the first surface. ). A method of applying one or more substance(s) to one or more substrate layers of a wound dressing or debridement tool according to any one of claims 1 to 14, wherein the method comprises: (a) applying one or more substances to a first surface of at least one of the substrate layers; (b) optionally applying at least one drying means to the first surface of the substrate layer; or wherein the method comprises: (a) applying one or more substances to a first surface of at least one of the substrate layers; (b) applying a compressed source gas via a gas feed to the first surface of the substrate layer; (c) optionally applying at least one drying means to the first surface of the substrate layer. ). The method according to claim 15, wherein according to step (b) the substrate layer is conveyed in a machine direction at a rate of about 0.01 to about 35.00 cm/sec; preferably according to step (b) the substrate layer is conveyed in a machine direction at a rate of about 0.05 to about 20 cm/sec. ). The method according to claim 15 or claim 16, wherein the one or more substances are applied to the first surface of the substrate layer by a printing process; preferably wherein the printing process is a screen printing process, a gravure printing process, a soft gravure printing process, a rotary pad printing process or a needle dosing process.
). The method according to any one of claims 15 to 17 wherein a compressed gas feed outlet is positioned at a height of about 0.1cm to about 100cm above the first surface of the substrate layer; preferably wherein the compressed gas feed outlet is positioned at a height of about 1cm to about 30cm above the first surface of the substrate layer. ). The method according to any one of claims 15 to 18, wherein the pressure of the compressed gas feed is from greater than about 0 to about 150 psi; preferably wherein the pressure of the compressed gas feed is from about 40 to about 100 psi; and/or wherein the temperature of the compressed gas feed is from about 0 to about 100 oC; preferably wherein the temperature of the compressed gas feed is from about 5 to about 30 oC. ). A system for applying one or more substance(s) to one or more substrate layers of a wound dressing or debridement tool according to the method according to any one of claims 15 to 19. ). A method of applying one or more substance(s) to one or more substrate layers of an article, such as a wound dressing or debridement tool, wherein the method comprises: (c) providing at least one transfer means comprising an impression member and a transfer member, wherein the transfer member comprises one or more cells with outward facing apertures, and wherein the transfer member is provided on the exterior of the impression member; (d) introducing the one or more substance(s) into the one or more cells of the transfer member; and (e) contacting the substrate layer with the transfer member as the substrate layer is conveyed along a transport path in a machine direction, wherein force applied by the impression member to at least the one or more cells comprised within the transfer member causes the one or more substance(s) comprised within the one or more cells to transfer to the substrate layer. ). The method according to claim 21, wherein the one or more cells of the transfer member reversibly compress under force applied by the impression member to at least the one or more cells in step (c) so as to cause the one or more substance(s) comprised within the one or more cells to transfer to the substrate layer.
). The method according to any one of claims 21 or 22, wherein at least two transfer means are provided, each comprising an impression member and a transfer member, wherein each of the transfer members comprise one or more cells with outward facing apertures and are provided on the exterior of the impression members, and wherein the transfer means are positioned in proximity to each other such that pressure is formed on each transfer member by the corresponding impression members as the substrate layer is conveyed along a transport path in a machine direction. ). The method according to any one of claims 21 to 23, wherein the one or more substance(s) transferred to the substrate layer is at least partially impregnated within the substrate layer. ). The method according to any one of claims 21 to 24, wherein the transfer member(s) comprises an elastomeric material; preferably wherein the transfer member(s) consists of an elastomeric material. ). The method according to any one of claims 21 to 25, wherein at least one of the substrate layers is a fabric material, preferably a nonwoven fabric material, more preferably wherein the fabric material comprises gel‐forming fibres, and/or wherein at least one of the substrate layers is a foam material, preferably a polyurethane foam, a polypropylene foam, a polyester foam or a polyvinyl alcohol (PVA) foam. ). A wound dressing or a debridement tool comprising at least one substrate layer, wherein the substrate layer is at least partially impregnated or coated with one or more substance(s) in accordance with any one of claims 21 to 26, preferably wherein the wound dressing or a debridement tool is according to any one of claims 1 to 14. ). Use of the wound dressing or debridement tool according to any one of claims 1 to 14 or 27 to prevent or minimise slough accumulation in a wound or to de‐slough a wound, the use comprising contacting said wound dressing or debridement tool with said wound or contacting said wound with said wound dressing or debridement tool, preferably wherein the wound is a chronic wound, acute wound, or burn. ). A system for applying one or more substance(s) to one or more substrate layer(s) of an article according to the method defined in any one of claims 21 to 28, wherein the system comprises:
(a) at least one transfer means comprising an impression member and a transfer member, wherein the transfer member comprises one or more cells with outward facing apertures, wherein the transfer member is provided on the exterior of the impression member, and wherein the one or more cells are configured to be reversibly compressible under force exerted by the impression member; (b) at least one reservoir comprising the substance; (c) a pump configured to draw the substance from the reservoir and introduce it into the one or more cells of the transfer member; (d) optionally a component configured to remove excess substance from the transfer member. ). A process for preparing an article as defined in any one of claims 21 to 27, said process comprising, in order, the steps of: (a) conveying a substrate layer along a transport path in a machine direction toward at least one transfer means comprising an impression member and a transfer member, wherein the transfer member comprises one or more cells with outward facing apertures, wherein the transfer member is provided on the exterior of the impression member, and wherein the one or more cells are configured to be reversibly compressible under force exerted by the impression member; (b) contacting the substrate layer with the transfer member as the substrate layer is conveyed along a transport path in a machine direction, wherein force applied by the impression member to at least the one or more cells comprised within the transfer member causes the one or more substance(s) comprised within the one or more cells to transfer to the substrate layer; (c) optionally adhering or affixing the substrate layer to one or more functional layers.
Applications Claiming Priority (6)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| GBGB2405224.3A GB202405224D0 (en) | 2024-04-12 | 2024-04-12 | Wound care textiles |
| GB2405226.8 | 2024-04-12 | ||
| GB2405228.4 | 2024-04-12 | ||
| GBGB2405228.4A GB202405228D0 (en) | 2024-04-12 | 2024-04-12 | Printing method |
| GB2405224.3 | 2024-04-12 | ||
| GBGB2405226.8A GB202405226D0 (en) | 2024-04-12 | 2024-04-12 | Wound care textiles |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| WO2025215375A1 true WO2025215375A1 (en) | 2025-10-16 |
Family
ID=95554821
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/GB2025/050780 Pending WO2025215375A1 (en) | 2024-04-12 | 2025-04-11 | Wound care textiles |
Country Status (1)
| Country | Link |
|---|---|
| WO (1) | WO2025215375A1 (en) |
Citations (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB1140083A (en) * | 1965-01-08 | 1969-01-15 | Scott Paper Co | Printing method |
| US3879257A (en) * | 1973-04-30 | 1975-04-22 | Scott Paper Co | Absorbent unitary laminate-like fibrous webs and method for producing them |
| US5288814A (en) | 1992-08-26 | 1994-02-22 | The B. F. Goodrich Company | Easy to disperse polycarboxylic acid thickeners |
| WO2000001425A1 (en) | 1998-07-01 | 2000-01-13 | Acordis Speciality Fibres Limited | Wound dressings and materials suitable for use therein |
| WO2009047564A2 (en) * | 2007-10-09 | 2009-04-16 | Brightwake Limited | Wound dressing |
| WO2012061225A2 (en) | 2010-11-01 | 2012-05-10 | Becton, Dickinson And Company | Gardnerella vaginalis assay |
| US20170157966A1 (en) * | 2013-11-27 | 2017-06-08 | Merck Patent Gmbh | Rotary printing method |
| US20210290815A1 (en) * | 2020-03-20 | 2021-09-23 | Convatec Limited | Debridement Composition |
| WO2021186188A1 (en) | 2020-03-20 | 2021-09-23 | Convatec Limited | Debridement composition |
-
2025
- 2025-04-11 WO PCT/GB2025/050780 patent/WO2025215375A1/en active Pending
Patent Citations (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB1140083A (en) * | 1965-01-08 | 1969-01-15 | Scott Paper Co | Printing method |
| US3879257A (en) * | 1973-04-30 | 1975-04-22 | Scott Paper Co | Absorbent unitary laminate-like fibrous webs and method for producing them |
| US5288814A (en) | 1992-08-26 | 1994-02-22 | The B. F. Goodrich Company | Easy to disperse polycarboxylic acid thickeners |
| US5349030A (en) | 1992-08-26 | 1994-09-20 | The B. F. Goodrich Company | Easy to disperse polycarboxylic acid thickeners |
| WO2000001425A1 (en) | 1998-07-01 | 2000-01-13 | Acordis Speciality Fibres Limited | Wound dressings and materials suitable for use therein |
| WO2009047564A2 (en) * | 2007-10-09 | 2009-04-16 | Brightwake Limited | Wound dressing |
| WO2012061225A2 (en) | 2010-11-01 | 2012-05-10 | Becton, Dickinson And Company | Gardnerella vaginalis assay |
| US20170157966A1 (en) * | 2013-11-27 | 2017-06-08 | Merck Patent Gmbh | Rotary printing method |
| US20210290815A1 (en) * | 2020-03-20 | 2021-09-23 | Convatec Limited | Debridement Composition |
| WO2021186188A1 (en) | 2020-03-20 | 2021-09-23 | Convatec Limited | Debridement composition |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| JP4949587B2 (en) | Foam-on-film medical article | |
| EP0714310B1 (en) | A non-fibrous porous material, a wound dressing comprising such a material as well as a method of making the material | |
| EP3672655B1 (en) | Biomaterial and methods of making and using said biomaterial | |
| JP4860872B2 (en) | Foam / film composite medical article | |
| AU2009265996B2 (en) | Wound dressing | |
| US12290425B2 (en) | Lint free crosslinked chitosan-PVA sponge as an absorbent wound dressing and method of preparation thereof | |
| US11246957B2 (en) | Systems and methods for making hydrophilic foams | |
| JP3954646B2 (en) | Alginate fiber, its production and use | |
| EP2774629B1 (en) | Absorbent materials | |
| RU149063U1 (en) | ANTI-MICROBIAL ACTION BAND FOR HEALING | |
| WO2016007776A1 (en) | Honey-based foam compositions | |
| CN102905657B (en) | Wound dressing | |
| JP2022523780A (en) | Antibacterial dressings, dressing components, and methods | |
| US20060211972A1 (en) | Wound dressing | |
| HU225557B1 (en) | Absorbent wound dressing containing a hydrogel layer | |
| WO2021186188A1 (en) | Debridement composition | |
| EP4121129A1 (en) | Debridement composition | |
| US20070020318A1 (en) | Hydrocolloid materials for use in wound healing | |
| EP1401362A2 (en) | A wound dressing | |
| WO2025215375A1 (en) | Wound care textiles | |
| WO2025215378A1 (en) | Nonwoven textile composition | |
| WO2025215374A1 (en) | Nonwoven textile composition | |
| WO2025215376A1 (en) | Debridement composition | |
| WO2025215377A1 (en) | Vehicle for non-antimicrobial composition | |
| RU2719444C9 (en) | Wound dressing system |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| 121 | Ep: the epo has been informed by wipo that ep was designated in this application |
Ref document number: 25721582 Country of ref document: EP Kind code of ref document: A1 |