Wound Closure Devices

Abstract

The present invention relates to a wound closure device for closing a wound and a method for manufacturing the same.The present invention also relates to the use of the wound closure device for closing a wound and a kit-of-parts for closing a wound.

Description

[Technical field]

[0001] The present invention relates to a wound closure device for closing a wound and a method for manufacturing the same.The present invention also relates to the use of the wound closure device for closing a wound and a kit-of-parts for closing a wound. [Background technology]

[0002] Wound closure devices (e.g., wound closure systems) are well-known alternatives to conventional stapling and suturing techniques that are frequently utilized in wound closure procedures. One of the major problems associated with conventional stapling and suturing techniques relates to the need to puncture the skin as part of the wound closure procedure. This can cause patient discomfort and tissue trauma, as well as a series of other adverse effects, such as further bleeding, scarring, tissue irritation, increased risk of infection, and longer healing times.

[0003] Wound closure devices, such as wound closure strips, have been developed to overcome the problems associated with stapling and suturing techniques. These wound closure devices are generally formed from a flexible material strip with an adhesive, typically a pressure sensitive adhesive (PSA), applied to its wound-facing surface. In use, the adhesive on the wound-facing surface of the strip acts to gently secure the strip to the skin surrounding the wound and holds the wound firmly in a sealed position as the wound is pulled closed. The strip generally remains adhered to the surface of the skin and is aligned with the wound during the entire healing process. The strip is often porous to allow for fluid flow through the strip to aid in the healing process. An additional adhesive (e.g., a polymerizable adhesive composition used with a suitable initiator) can be applied on top of the strip to secure the wound strip in place and prevent it from migrating during its application and the wound healing process. This additional adhesive can also form a protective barrier over the wound, thus facilitating the healing process. Such wound closure strips are quick to apply and avoid the need to pierce the skin during the wound closure procedure. These devices also result in less tissue trauma, improved cosmetic appearance, and less discomfort for the patient.

[0004] Despite their advantages, wound closure strips such as those described above can be difficult for users to handle during use. This is because the user must manually position and apply the strip to the skin surrounding the wound, which generally involves gripping the edge area of ​​the strip using their fingers and thumbs. This often leads to the user inadvertently touching the adhesive disposed on the wound-facing surface of the strip (e.g., the underside), which then becomes contaminated and rubs off the adhesive from the wound-facing surface during use. This can compromise the sterility of the wound environment and the bond strength of the wound closure strip to the wound. Furthermore, application of such strips generally requires a high level of dexterity from the operator, especially when smaller sized wounds and closure strips are utilized.

[0005] Recently, modified wound closure strips have been developed to overcome the above handling problems. One particular example includes incorporating multiple sections of a release liner into the adhesive disposed on the wound-facing surface of the wound closure strip. In such an example, the wound closure strip includes a section of the release liner that is normally removed to expose the adhesive on the wound-facing surface of the strip, but also includes another section of the release liner that is not removed from the wound-facing surface of the strip until the end of the wound closure procedure. The portion of the release liner that remains adhered to the wound-facing surface of the strip can be used to control and position the strip during use. Referring to US Patent Application Publication No. 2018 / 0085260, a wound closure device is described having a first section of a release liner and a second section of a release liner applied to an adhesive layer on the wound-facing surface of the strip prior to use. The first section of the release liner is removed to expose a portion of the wound-facing surface of the wound closure strip. The exposed portion allows the wound closure strip to be placed on the wound and used to secure the wound in a closed position. The user achieves this by using the second section of the release liner as a handle, allowing the user to grip the second section of the release liner using their thumb and fingers on the top and bottom surfaces of the wound closure strip. Once the wound closure strip is in place and the wound is secured closed, the second section of the release liner can be removed from the bottom surface of the strip to expose the remaining portion of the adhesive on the wound-facing side of the strip. This can then be pressed down onto the surface of the skin to fully secure the strip to the wound.

[0006] However, solutions such as those described in US Patent Application Publication No. 2018 / 0085260 have their own drawbacks. For example, when using a device with multiple sections of release liner disposed on the adhesive of the wound-facing side of the strip, it can be difficult to remove the section of the release liner that serves as a handle portion at the end of the procedure. This is because a large percentage of the closure strip is already adhered to the surface of the skin at the wound site at the time of removing the remaining portion of the release liner from the underside of the strip. This makes it difficult for the user to manipulate his or her fingers and thumb under the strip to grip and peel off the remaining release liner. It is therefore common for users to inadvertently touch the adhesive layer disposed on the wound-facing side of the strip, causing abrasion and contamination. Indeed, in most cases, users tend to actually bend the wound closure strip outward from the surface of the skin to make it easier to grip and remove the remaining liner. This can inadvertently change the position of the wound closure strip, compromising the degree to which the strip is aligned with and secured to the wound.

[0007] It is an object of the present invention to obviate or mitigate one or more of the above disadvantages. Summary of the Invention

[0008] The inventors have developed a wound closure device for closing a wound. Generally speaking, the inventors have established a wound closure device having a wound closure layer (e.g., a wound closure strip) that is easily handled when applied to a wound and, unlike many known wound closure devices, prevents a user from intentionally or inadvertently gripping or contacting an adhesive located on the wound-facing surface of the device during use.

[0009] In a first aspect of the present invention, there is provided a wound closure device comprising: (i) a wound closure layer including a wound facing surface, a non-wound facing surface opposite the wound facing surface of the wound closure layer, and one or more open areas extending through the wound closure layer from the wound facing surface to the non-wound facing surface of the wound closure layer; and (ii) an adhesive disposed on the wound facing surface of the wound closure layer, the adhesive penetrating one or more of the open areas to the extent that, in use, a base layer disposed adjacent the non-wound facing surface of the wound closure layer contacts the adhesive that penetrates one or more of the open areas.

[0010] The wound closure device of the present invention includes an adhesive (e.g., wound closure strip) disposed on the wound-facing surface of the wound closure layer, the adhesive passing through one or more of the open areas of the wound closure layer. The adhesive located on the wound-facing surface of the wound closure layer allows the wound closure layer to adhere to the skin surrounding the wound. The adhesive also advantageously passes through one or more of the open areas formed in the wound closure layer (e.g., seeps through the open areas formed in the wound closure layer) to the extent that, during use, a backing layer (e.g., a release liner, etc.) disposed adjacent to the non-wound-facing surface of the wound closure layer in contact with the adhesive passes through one or more of the open areas. This causes the non-wound closure layer of the adhesive to bond to the backing layer and hold the backing layer adjacent to the non-wound-facing surface of the wound closure layer. By including a "weep out" adhesive disposed on the wound-facing surface of the wound closure layer but which passes through the open area to the non-wound-facing surface, the wound closure device of the present invention has (i) a wound-facing side capable of firmly adhering the skin surrounding the wound, and (ii) a non-wound-facing side which has the advantage of being adhesive. Thus, the non-wound-facing side of the device can be used with a backing layer (e.g., a release liner, etc.) designed to readily facilitate convenient handling of the wound closure device during use and to reduce the likelihood of a user touching and contaminating the adhesive on the wound-facing side of the wound closure device during use.

[0011] Generally speaking, the adhesive passing through one or more of the open areas of the wound closure layer of the present invention can contact and adhere to a release liner designed to provide a handle by which the user can grip or grasp the device without having to touch the adhesive or the wound-facing side of the wound closure layer. As seen in the exemplary devices shown in Figures 5-13 described herein, the user is only required to handle the adhesive and the release liner adhered to the non-wound-facing side of the wound closure layer to manipulate and control the position of the device during the wound closure procedure. Once applied to the wound and secured, the release liner can be easily removed without having to contact the wound-facing side (i.e., underside) of the wound closure layer or adhesive. This requires less skill and dexterity from the user compared to that required to operate the known devices described above. It will also be appreciated that the "weep out" adhesive eliminates the need to separately apply additional adhesive to the non-wound-facing side of the wound closure layer when it is highly desirable. This results in a more efficient and economical manufacturing method in making the wound closure device of the present invention.

[0012] In a second aspect of the present invention, there is provided a method of manufacturing a wound closure device comprising: (i) providing a wound closure layer including a wound facing surface, a non-wound facing surface opposite the wound facing surface, and one or more open areas extending through the wound closure layer from the wound facing surface to the non-wound facing surface of the wound closure layer; and (ii) disposing adhesive on the wound facing surface of the wound closure layer to such an extent that, in use, a base layer disposed adjacent to the non-wound facing surface of the wound closure layer contacts the adhesive passing through the one or more of the open areas.

[0013] In a third aspect of the present invention, there is provided a wound closure device obtained or obtainable according to the method of the second aspect of the present invention or any embodiment thereof.

[0014] In a fourth aspect of the invention there is provided the use of a wound closure device according to the first aspect of the invention or any embodiment thereof or the third aspect of the invention or any embodiment thereof in a method of closing a wound.

[0015] In a fifth aspect of the present invention there is provided a kit-of-parts for closing a wound comprising a wound closure device according to the first aspect of the present invention or any embodiment thereof or the third aspect of the present invention or any embodiment thereof and an applicator comprising a wound closure adhesive.

[0016] In an embodiment of the first or second aspect of the invention, the backing layer is positioned adjacent the non-wound facing surface of the wound closure layer and in contact with the adhesive passing through one or more of the open areas.

[0017] In an embodiment of the first or second aspect of the invention, the adhesive passes through one or more of the open areas but does not protrude from the non-wound facing surface of the wound closure layer. In another embodiment of the first or second aspect of the invention, the adhesive passes through one or more of the open areas and protrudes from the non-wound facing surface of the wound closure layer but does not cover the non-wound facing surface of the wound closure layer. In an embodiment, the adhesive is on the wound facing surface of the wound closure layer and, in use, a substrate layer disposed adjacent the non-wound facing surface of the wound closure layer passes through one or more of the open areas to an extent that it comes into contact with the adhesive passing through one or more of the open areas, and the substrate layer contacts the non-wound facing surface of the wound closure layer. In an embodiment, the adhesive is on the wound facing surface of the wound closure layer and, in use, a substrate layer disposed adjacent the non-wound facing surface of the wound closure layer passes through one or more of the open areas to an extent that it comes into contact with the adhesive passing through one or more of the open areas, and the substrate layer does not contact the non-wound facing surface of the wound closure layer.

[0018] It will be appreciated that if the adhesive passes through one or more open areas and protrudes from the non-wound facing surface of the wound closure layer, the adhesive will not spill from the one or more open areas onto the non-wound facing surface of the wound closure layer. In this embodiment, the adhesive may contact the base layer, which does not contact the non-wound facing surface of the wound closure layer. In some examples, the adhesive may only extend partially along one or more open areas, but pass through to such an extent that the adhesive will later contact the substrate in use. This may occur, for example, when the base layer extends (e.g., sags or is pressed down) partially along one or more open areas from the non-wound facing surface of the wound closure layer toward the wound facing surface of the wound closure layer until contact is made with the adhesive. It will also be appreciated that the adhesive may only extend along one or more open areas to a point where it is flush with the non-wound facing surface of the wound closure layer. wound closure layer

[0019] The wound closure device of the present invention includes a wound closure layer. The wound closure layer has a wound-facing surface and a non-wound-facing surface opposite the wound-facing surface of the wound closure layer. During use, the wound-facing surface of the wound closure layer is located closest to and proximal to the wound opening, and the non-wound-facing surface is located furthest from and distal to the wound opening. This is apparent from Figures 1-13 described herein.

[0020] The wound closure layer of the present invention comprises one or more open areas passing through the wound closure layer from the wound facing side to the non-wound facing side of the wound closure layer. In the context of the present invention, the open areas are appropriately shaped and dimensioned to allow the passage or extension of adhesive from the wound facing side to the non-wound facing side of the wound closure layer. It will be understood that the open areas can take the form of open cells in a foam, holes / openings in a perforated film, open areas in a mesh material, etc.

[0021] The wound closure layer may be formed from any material that has suitable performance characteristics for use in wound closure procedures and is capable of closing a wound. For example, the wound closure layer should be resistant to tearing throughout the wound closure procedure, particularly during application to and removal from the wound. It will be appreciated that the wound closure layer may also be sufficiently flexible and / or elastic to conform to the contours of a given wound and accommodate movements (e.g., bending or rotation) of the wound during use. The wound closure layer is preferably a biocompatible material suitable for use with tissue during wound closure procedures. The material is preferably recognized or deemed safe for wound closure applications.

[0022] In an embodiment of the first or second aspect of the present invention, the wound closure layer is a perforated film, a mesh, a foam (e.g., an open-cell foam), a woven fabric, a nonwoven fabric, or any combination thereof.The wound closure layer may be a mesh or a perforated film, and preferably, the wound closure layer is a mesh.In a further embodiment, the mesh is a mesh fabric, and typically the mesh fabric is a woven mesh fabric.

[0023] In a further embodiment of the first or second aspect of the invention, the wound closure layer is formed from a suitable polymer. Typically, the polymer may be selected from the group consisting of polyester, polyolefin, polyamide, polyethylene, polypropylene, ethylene propylene and ethylene butylene copolymers, polyurethane, polystyrene, polyvinyl chloride, polylactic acid, polyglycolic acid, polycaprolactone or any combination thereof.

[0024] The wound closure layer may be a mesh, typically a woven mesh fabric. The mesh or woven mesh fabric may be made of any suitable polymer, preferably the mesh or woven mesh fabric is made of polyester, polyolefin or polyamide. In some embodiments, the wound closure layer is a polyester woven mesh fabric.

[0025] In some embodiments of the first or second aspect of the invention, the wound closure layer has a density of about 5 grams / m 2 ~50g / m 2 , about 10 g / m 2 ~50g / m 2 , about 15 g / m 2 ~50g / m 2 , about 20 g / m 2 ~50g / m 2 , about 25 g / m 2 ~50g / m 2 , about 30 g / m 2 ~50g / m 2 , about 35 g / m 2 ~50g / m 2 , about 40 g / m 2 ~50g / m 2 or about 45 grams / m 2 ~50g / m 2 In another embodiment, the wound closure layer has a weight of about 5 grams / m 2 ~45g / m 2 , about 5 g / m 2 ~40g / m 2 , about 5 g / m 2 ~35g / m 2 , about 5 g / m 2 ~30g / m 2 , about 5 g / m 2 ~25g / m 2 , about 5 g / m 2 ~20g / m 2 , about 5 g / m 2 ~15g / m 2 or about 5 grams / m 2 ~10g / m 2 The wound closure layer has a weight of about 10 grams / m 2 ~45g / m 2 or the wound closure layer may have a weight of about 15 grams / m 2 ~40g / m 2 Typically, the wound closure layer has a weight of about 5 grams / m 2 ~30g / m 2 , preferably about 10 grams / m 2~20g / m 2 The wound closure layer has a weight of about 15 grams / m 2 The weight of the sintered body may be 1.0 kg.

[0026] In an embodiment of the first or second aspect of the present invention, the wound closure layer has an open area percentage (%) of about 10 to about 95. In further embodiments, the wound closure layer has an open area percentage (%) of about 20 to about 95, about 30 to about 95, about 30 to about 95, about 40 to about 95, about 50 to about 95, about 60 to about 95, about 70 to about 95 or about 80 to about 95, about 10 to about 80, about 10 to about 70, about 10 to about 60, about 10 to about 50, about 10 to about 40, about 10 to about 30, about 10 to about 20, about 20 to about 80, about 30 to about 70 or about 40 to about 60. In other embodiments, the wound closure layer has an open area percentage (%) of about 50 to about 95, typically about 70 to about 80. The wound closure layer preferably has an open area percentage (%) of about 80. It will be understood that the open area percentage (%) may reflect how much of the wound closure layer is occupied by the open area. The open area percentage may be varied to control the amount of adhesive that can extend (weep) through the wound closure layer.

[0027] According to the first aspect, the second aspect or an embodiment thereof, the one or more open areas through the wound closure layer from the wound facing surface to the non-wound facing surface of the wound closure layer are less than about 0.5 mm. 2 ~about 5mm 2 As used herein, "area of ​​hole" refers to the area occupied by one of the "one or more open areas" formed within the wound closure layer of the present invention. In other embodiments, the one or more open areas passing through the wound closure layer from the wound-facing surface to the non-wound-facing surface of the wound closure layer may have a hole area of ​​about 0.5 mm. 2 ~about 5mm 2 , about 0.1mm 2 ~about 5mm 2 , about 2 mm 2 ~about 5mm 2 , about 3mm 2 ~about 5mm 2 , about 4mm 2 ~about 5mm2 , about 0.5mm 2 ~about 4mm 2 , about 0.5mm 2 ~about 3mm 2 , about 0.5mm 2 ~ approx. 2 mm 2 or about 0.5 mm 2 ~about 1mm 2 Preferably, the one or more open areas passing through the wound closure layer from the wound facing surface to the non-wound facing surface of the wound closure layer are less than about 0.5 mm 2 ~about 2.5mm 2 , or about 1 mm 2 ~ approx. 2 mm 2 , or about 1.5 mm 2 The hole area may be 0.01 mm or less. glue

[0028] According to the first or second aspect or embodiments thereof, the adhesive may be an adhesive layer including a wound-facing surface and a non-wound-facing surface opposite the wound-facing surface of the adhesive layer, and the backing layer disposed adjacent to the non-wound-facing surface of the wound closure layer contacts the non-wound-facing surface of the adhesive layer. The adhesive may be disposed as a continuous or discontinuous layer on the wound-facing surface of the wound closure layer. In some embodiments, the adhesive may fully or completely cover the wound-facing surface of the wound closure layer. In other embodiments, the adhesive may partially cover the wound-facing surface of the wound closure layer.

[0029] In an embodiment in which the adhesive partially covers the wound-facing surface of the wound closure layer, the coverage (%) of the adhesive on the wound-facing surface of the wound closure layer is about 20% to about 80%, about 30% to about 80%, about 40% to about 80%, about 50% to about 80%, about 60% to about 80%, about 70% to about 80%, about 20% to about 70%, about 20% to about 60%, about 20% to about 50%, about 20% to about 40% or about 20% to about 30%. In an embodiment, the coverage (%) of the adhesive on the wound-facing surface of the wound closure layer is about 20% to about 50%, about 30% to about 40%, about 35% to about 45% or about 35% to about 40%. The coverage of the adhesive on the wound-facing surface may be about 35% or 37.5%.

[0030] In some embodiments, the adhesive layer may form a pattern of stripes or a pattern of dots on the wound-facing surface of the wound closure layer. When the adhesive layer forms a pattern of stripes, the stripes may be separated by gaps of about 2 mm to about 10 mm, preferably, the stripes may be separated by gaps of about 3 mm and about 5 mm.

[0031] In embodiments of the first and second aspects of the invention, the non-wound facing surface of the adhesive layer has a peel adhesion value that is less than the peel adhesion value of the wound facing surface of the adhesive layer. Without being bound by theory, in such embodiments, the wound facing surface of the adhesive layer may have a surface exposed area that is greater than the exposed surface area of ​​the non-wound facing surface of the adhesive layer. This causes the non-wound facing surface of the adhesive layer to have a peel adhesion value that is less than the peel adhesion value of the wound facing surface of the adhesive layer.

[0032] In some embodiments, the peel adhesion value of the non-wound facing surface of the adhesive layer is from about 0.1 N / 25 mm to about 5.0 N / 25 mm, from about 0.1 N / 25 mm to about 4.0 N / 25 mm, from about 0.1 N / 25 mm to about 3.0 N / 25 mm, from about 0.5 N / 25 mm to about 5.0 N / 25 mm, from about 1.0 N / 25 mm to about 5.0 N / 25 mm, from about 2.0 N / 25 mm to about 5.0 N / 25 mm, from about 3.0 N / 25 mm to about 5.0 N / 25 mm, or from about 4.0 N / 25 mm to about 5.0 N / 25 mm. In other embodiments, the peel adhesion value of the non-wound facing surface of the adhesive layer is from about 0.1 N / 25 mm to about 2.0 N / 25 mm, from about 0.2 N / 25 mm to about 2.0 N / 25 mm, from about 0.4 N / 25 mm to about 2.0 N / 25 mm, from about 0.6 N / 25 mm to about 2.0 N / 25 mm, from about 0.8 N / 25 mm to about 2.0 N / 25 mm, from about 1.0 N / 25 mm to about 2.0 N / 25 mm, from about 1.2 N / 25 mm to about 2.0 N / 25 mm, from about 1.4 N / 25 mm to about 2.0 N / 25 mm, from about 1.6 N / 25 mm to about 2.0 N / 25 mm, from about 1.8 N / 25 mm to about 2.0 N / 25 mm mm, about 0.1N / 25mm to about 1.8N / 25mm, about 0.1N / 25mm to about 1.6N / 25mm, about 0.1N / 25mm to about 1.4N / 25mm, about 0.1N / 25mm to about 1.6N / 25mm, about 0.1N / 25mm to about 1.4N / 25mm, about 0.1N / 25mm ~1.2N / 25mm, 0.1N / 25mm~1.0N / 25mm, 0.1N / 25mm~0.8N / 25mm, 0.1N / 25mm~0.6N / 25mm, 0.1N / 25mm~0.4N / 25mm or 0.1N / 25mm~0.2N / 25mm. In a further embodiment, the peel adhesion value of the non-wound facing surface of the adhesive layer is between about 0.5 N / 25 mm and about 1.0 N / 25 mm. In a preferred embodiment, the peel adhesion value of the non-wound facing surface of the adhesive layer is between about 0.8 N / 25 mm and about 1.0 N / 25 mm. The peel adhesion value of the non-wound facing surface of the adhesive layer may be about 0.9 or about 0.89.

[0033] In embodiments, the peel adhesion value of the wound-facing surface of the adhesive layer is about 2.5 N / 25 mm to about 10 N / 25 mm, about 4 N / 25 mm to about 10 N / 25 mm, about 6 N / 25 mm to about 10 N / 25 mm, about 8 N / 25 mm to about 10 N / 25 mm, about 2.5 N / 25 mm to about 8 N / 25 mm, about 2.5 N / 25 mm to about 6 N / 25 mm, or about 2.5 N / 25 mm to about 4 N / 25 mm. In other embodiments, the peel adhesion value of the wound-facing surface of the adhesive layer is about 4 N / 25 mm to about 8 N / 25 mm, or about 4 N / 25 mm to about 6 N / 25 mm. In further embodiments, the peel adhesion value of the wound-facing surface of the adhesive layer is about 2.5 N / 25 mm to about 5.0 N / 25 mm, or about 4 N / 25 mm to about 5.0 N / 25 mm. The peel adhesion value of the wound-facing surface of the adhesive layer may be about 4.5 or about 4.29.

[0034] In an embodiment, the adhesive has a thickness of about 5 grams / m 2 ~ approx. 100g / m 2 , about 10 g / m 2 ~ approx. 100g / m 2 , about 20 g / m 2 ~ approx. 100g / m 2 , about 30 g / m 2 ~ approx. 100g / m 2 , about 40 g / m 2 ~ approx. 100g / m 2 , about 50 g / m 2 ~ approx. 100g / m 2 , about 60 g / m 2 ~ approx. 100g / m 2 , about 70 g / m 2 ~ approx. 100g / m 2 , about 80 g / m 2 ~ approx. 100g / m 2 , about 90 g / m 2 ~ approx. 100g / m 2 , about 10 g / m 2 ~ approx. 90g / m 2 , about 10 g / m 2 ~ approx. 80g / m 2 , about 10 g / m 2 ~ approx. 70g / m 2 , about 10 g / m2 ~ approx. 60g / m 2 , about 10 g / m 2 ~ approx. 50 grams / m 2 , about 10 g / m 2 ~ approx. 40 grams / m 2 , about 10 g / m 2 ~ approx. 30 grams / m 2 Approximately 10 grams / m 2 ~ approx. 20 grams / m 2 , about 20 g / m 2 ~ approx. 90g / m 2 , about 30 g / m 2 ~ approx. 80g / m 2 , about 40 g / m 2 ~ approx. 70g / m 2 or about 50 grams / m 2 ~ approx. 60g / m 2 In some embodiments, the adhesive is applied at a coat weight of about 10 grams / m 2 ~ approx. 30 grams / m 2 The coat weight of the adhesive is approximately 10 g / m 2 ~ approx. 20 grams / m 2 or the adhesive has a coat weight of about 30 grams / m 2 ~ approx. 50 grams / m 2 Preferably, the adhesive has a coat weight of about 20 grams / m 2 , about 30 g / m 2 or about 40 grams / m 2 In some examples, the adhesive is applied at a coat weight of about 35 grams / m 2 The adhesive is preferably applied at a coat weight of about 20 grams / m 2 The composition may be laid down at a coat weight of 1000 mg / g.

[0035] According to the first and second aspects of the present invention or embodiments thereof, the adhesive may be any suitable adhesive having sufficient tack to adhere to the wound-facing surface of the wound closure layer and to the surface of a suitable release liner. The adhesive may be any suitable adhesive having sufficient tack to provide acceptable adhesion to the skin during use. In some embodiments, the adhesive comprises a pressure-sensitive adhesive. In some embodiments, the adhesive comprises an acrylic pressure-sensitive adhesive or a silicone pressure-sensitive adhesive or a mixture thereof. In some embodiments, the adhesive comprises an acrylic pressure-sensitive adhesive. It will be appreciated that the acrylic pressure-sensitive adhesive may comprise a polymer formed from the polymerization of at least one alkyl acrylate monomer or methacrylate, an unsaturated carboxylic acid, and optionally a vinyl lactam. Examples of suitable alkyl acrylate or methacrylate esters include, but are not limited to, butyl acrylate, ethyl acrylate, 2-ethylhexyl acrylate, isooctyl acrylate, isononyl acrylate, isodecyl acrylate, methyl acrylate, methylbutyl acrylate, 4-methyl-2-pentyl acrylate, sec-butyl acrylate, ethyl methacrylate, isodecyl methacrylate, methyl methacrylate, and the like, and mixtures thereof. Examples of suitable ethylenically unsaturated carboxylic acids include, but are not limited to, acrylic acid, methacrylic acid, fumaric acid, itaconic acid, and the like, and mixtures thereof. Release Liner

[0036] According to the first and second aspects of the invention or embodiments thereof, the backing layer is a first release liner and there is a second release liner in contact with the wound facing surface of the adhesive layer.

[0037] It will be appreciated that the first release liner may be any suitable backing or release material used to contact the non-wound facing surface of the adhesive layer and cover the non-wound facing surface of the wound closure layer when placed adjacent to the wound closure layer. The first release liner has a wound facing surface and a non-wound facing surface opposite the wound facing surface. The first release liner may be, for example, paper, plastic, etc. In some embodiments, the first release liner is a polyethylene release liner.

[0038] In some embodiments, the first release liner is clear or transparent, allowing a user to see through it in use to position and align the mesh adhesive layer with the wound, as shown in FIG.

[0039] In embodiments, when the first release liner is adhered to the non-wound facing surface of the adhesive layer, the first release liner forms a border area around the wound closure layer and the adhesive layer. During use, this border area functions as a handle portion that avoids the need for the user to touch the wound facing side of the adhesive layer (i.e., the lower adhesive) during use (see FIG. 7 and border area 14). In some embodiments, the first release liner can form at least one handle portion that is disposed around the wound closure layer and the adhesive layer such that when the first release liner is adhered to the non-wound facing surface of the adhesive layer, the handle portion prevents the user from touching the wound facing surface of the adhesive layer during use. For example, the handle portion can be in the form of at least one tab or flap that can be gripped on the wound facing surface and / or the non-wound facing surface during use.

[0040] The second release liner may be any suitable backing or release material used to contact and cover the wound-facing surface of the adhesive layer when placed adjacent to the wound-facing adhesive layer. The second release liner has a wound-facing surface and a non-wound-facing surface opposite the wound-facing surface. The second release liner may be, for example, paper, plastic, etc. In some embodiments, the second release liner is a glassine release liner, a clay-coated release liner, a PE-coated release liner. Preferably, the second release liner is a glassine release liner.

[0041] According to the first and second aspects of the present invention or embodiments thereof, the peel adhesion force (or peel force) required to remove the first release liner from the non-wound facing surface of the adhesive layer is greater than the peel adhesion force (or peel force) required to remove the second release liner from the wound facing surface of the adhesive layer. In such embodiments, the user can remove the second release liner from the wound facing surface of the adhesive layer while ensuring that the non-wound facing surface (exuding surface) of the adhesive layer remains in contact and adhered to the wound facing surface of the first release liner during the wound closure procedure. This is evident from Figures 5 to 7 described herein.

[0042] In embodiments, the peel adhesion force required to remove the first release liner from the non-wound facing surface of the adhesive layer is about 0.5 N / 40 mm to about 10 N / 40 mm, about 0.5 N / 40 mm to about 5 N / 40 mm, about 0.5 N / 40 mm to about 2 N / 40 mm, or about 0.5 N / 40 mm to about 1 N / 40 mm. In embodiments, the peel adhesion force required to remove the first release liner from the non-wound facing surface of the adhesive layer is about 0.5 N / 40 mm to about 3 N / 40 mm, 1 N / 40 mm to about 3 N / 40 mm, or 2 N / 40 mm to about 3 N / 40 mm. In some embodiments, the peel adhesion force required to remove the first release liner from the non-wound facing surface of the adhesive layer is about 2 N / 40 mm to about 2.5 N / 40 mm.

[0043] In some embodiments, the peel adhesion force required to remove the second release liner from the wound-facing surface of the adhesive layer is about 0.05 N / 40 mm to about 5 N / 40 mm, about 0.05 N / 40 mm to about 2 N / 40 mm, about 0.05 N / 40 mm to about 1 N / 40 mm, about 0.05 N / 40 mm to about 0.5 N / 40 mm, about 0.05 N / 40 mm to about 0.2 N / 40 mm. In embodiments, the peel adhesion force required to remove the second release liner from the wound-facing surface of the adhesive layer is about 0.1 N / 40 mm to about 0.2 N / 40 mm, or about 0.15 N / 40 mm.

[0044] According to some embodiments of the first or second aspect of the present invention, the peel adhesion force required to remove the first release liner from the non-wound facing surface of the adhesive layer is about 0.5 N / 40 mm to about 3 N / 40 mm, about 1 N / 40 mm to about 3 N / 40 mm, or about 2 N / 40 mm to about 3 N / 40 mm, and the peel adhesion force required to remove the second release liner from the wound facing surface of the adhesive layer is about 0.05 N / 40 mm to about 0.5 N / 40 mm, or about 0.05 N / 40 mm to about 0.2 N / 40 mm. In other embodiments, the peel adhesion force required to remove the first release liner from the non-wound facing surface of the adhesive layer is from about 2 N / 40 mm to about 2.5 N / 40 mm and the peel adhesion force required to remove the second release liner from the wound facing surface of the adhesive layer is from about 0.1 N / 40 mm to about 0.2 N / 40 mm or about 0.15 N / 40 mm.

[0045] It will be appreciated that in embodiments in which the non-wound facing surface of the adhesive layer has a peel adhesion value less than that of the wound facing surface of the adhesive layer, the material properties of the first and second release liners can be selected to ensure that the peel adhesion force required to remove the first release liner from the non-wound facing surface of the adhesive layer is greater than the peel adhesion force required to remove the second release liner from the wound facing surface of the adhesive layer. For example, if the non-wound facing surface of the adhesive layer has a peel adhesion value less than that of the wound facing surface of the adhesive layer, the second release liner may include a coating on its non-wound facing surface that reduces its adhesive strength to the wound facing surface of the adhesive layer to such an extent that, in use, the peel adhesion force required to remove the first release liner from the non-wound facing surface of the adhesive layer is greater than the peel adhesion force required to remove the second release liner from the wound facing surface of the adhesive layer. In some embodiments, the second release liner may include a silicone coating on its non-wound facing surface. In some embodiments, the first release liner may include a silicone coating on its wound-facing surface and the second release liner may include a silicone coating on its non-wound-facing surface, such that the relative amounts of silicone coatings ensure that the peel adhesion force required to remove the first release liner from the non-wound-facing surface of the adhesive layer during use is greater than the peel adhesion force required to remove the second release liner from the wound-facing surface of the adhesive layer. In such embodiments, the second release liner may include a silicone coating on its non-wound-facing surface having a greater coat weight than the silicone coating on the wound-facing surface of the first release liner. In these embodiments, the silicone coating on the non-wound-facing surface of the second release liner has a coat weight of about 0.1 grams / m 2 ~ approx. 5 grams / m 2 Preferably, the silicone coating on the non-wound facing side of the second release liner has a coat weight of about 0.1 grams / m 2 ~ approx. 2 grams / m 2In other embodiments, the percentage surface area of ​​the non-wound facing surface of the second release liner is covered by a coating of silicone as compared to the percentage surface area of ​​the wound facing surface of the first release liner that is covered by a coating of silicone.

[0046] According to the first and second aspects of the invention or embodiments thereof, the first release liner includes a tab configured such that, during use, the first release liner is removed from the non-wound facing surface of the adhesive layer by pulling the tab. In such embodiments, the tab is disposed on the non-wound facing surface of the first release liner. The tab may be operable to be pulled from a central location of the first release liner toward a longitudinal edge of the first release liner. In some embodiments, the first release liner includes a line of weakness (e.g., a perforation line) such that when the tab is pulled away from the non-wound facing surface of the adhesive layer during removal, the first release liner tears or breaks along the line of weakness. In other embodiments, the first release liner includes a complete line of break (e.g., a complete cut line). In such embodiments, the complete break allows the user to stretch the wound closure layer when applying the device to a wound. The complete break allows bending and / or tensioning of the wound closure layer while the first release liner is still attached.

[0047] In embodiments according to the first and second aspects of the present invention, the second release liner includes a cut (or perforation) formed diagonally below a middle portion of the second release liner. This creates two separate halves for the second release liner. In operation, a user bends the wound closure device to deform the second release liner outward and the first release liner inward. This separates or splits the halves of the second release liner along the cut, allowing a user to grasp and remove the liner by a peeling action.

[0048] A second aspect of the invention relates to a method of manufacturing a wound closure device comprising: (i) providing a wound closure layer including a wound facing surface, a non-wound facing surface opposite the wound facing surface, and one or more open areas extending through the wound closure layer from the wound facing surface to the non-wound facing surface of the wound closure layer; and (ii) disposing an adhesive on the wound facing surface of the wound closure layer through one or more of the open areas such that, in use, a backing layer disposed adjacent the non-wound facing surface of the wound closure layer contacts the adhesive that passes through the one or more of the open areas.

[0049] In an embodiment of the second aspect of the invention, the placing includes compressing the wound closure layer and adhesive together with a suitable compressive pressure to cause the adhesive to pass through one or more of the open areas to the extent that, in use, a backing layer disposed adjacent to the non-wound facing surface of the wound closure layer contacts the adhesive passing through one or more of the open areas. In a preferred embodiment, compressing the wound closure layer and adhesive together causes the adhesive to pass through one or more of the open areas but not protrude from the non-wound facing surface of the wound closure layer. In some embodiments, compressing the wound closure layer and adhesive together causes the adhesive to extend through one or more of the open areas and protrude from the non-wound facing surface of the wound closure layer but does not cover the non-wound facing surface of the wound closure layer. It will be appreciated that the compression conditions (e.g., pressure and time) required to force the adhesive through one or more of the open areas to the extent that, in use, the backing layer positioned adjacent to the non-wound facing surface of the wound closure layer contacts the adhesive passing through one or more of the open areas will vary depending on the properties of the material of the wound closure layer and the adhesive used.

[0050] In some embodiments of the second aspect of the invention, the compression is performed using any suitable means for compressing the wound closure layer and adhesive together. For example, the compression may be performed using a nip point roller to compress the wound closure layer and adhesive together.

[0051] In some embodiments of the second aspect of the present invention, the compression is performed at a pressure of about 20 Psi to about 40 Psi, about 25 Psi to about 40 Psi, about 30 Psi to about 40 Psi, about 30 Psi to about 40 Psi, about 20 Psi to about 35 Psi, about 20 Psi to about 30 Psi, or about 20 Psi to about 25 Psi. In preferred embodiments, the compression is performed at a pressure of about 25 Psi to about 35 Psi, or about 30 Psi.

[0052] In certain embodiments of the second aspect of the invention, the placing step is preceded by the following steps: (i) providing a carrier layer including a wound-facing surface and a non-wound-facing surface opposite the wound-facing surface of the carrier layer, and (ii) applying an adhesive-solvent mixture to the non-wound-facing surface of the carrier layer and removing the solvent to form an adhesive. It will be appreciated that the carrier layer may be a sacrificial carrier layer (e.g., a sacrificial paper liner) that is removed from the wound-facing surface of the adhesive and replaced with a second release liner as described herein prior to use.

[0053] In some embodiments, removing the solvent comprises drying to form the adhesive at a temperature of about 50° C. to about 150° C. It will be appreciated that the drying temperature may vary depending on the properties of the adhesive-solvent mixture used.

[0054] In an embodiment of the second aspect of the invention, a first release liner (ie, backing layer) as described herein is applied to the non-wound facing surface of the adhesive.

[0055] According to the first and second aspects of the present invention or embodiments thereof, the wound closure device may include one or more auxiliary layers. Such auxiliary layers may include a further release liner forming a packaging system for the wound closure device.

[0056] According to a second aspect of the invention or an embodiment thereof, the adhesive is an adhesive layer including a wound facing surface and a non-wound facing surface opposite the wound facing surface of the adhesive layer, the non-wound facing surface of the carrier layer being in contact with the wound facing surface of the adhesive layer, and disposing the adhesive includes contacting the wound facing surface of the wound closure layer with the non-wound facing surface of the adhesive layer. In such an embodiment, the adhesive has a viscosity of about 20 grams / m 2 , about 30 g / m 2 or about 40 grams / m 2 In some examples, the adhesive is applied at a coat weight of about 35 grams / m 2 The adhesive is preferably applied at a coat weight of about 20 grams / m 2 The composition may be laid down at a coat weight of 1000 mg / g.

[0057] A fourth aspect of the invention relates to the use of a wound closure device according to the first aspect of the invention or any embodiment thereof or the third aspect of the invention or any embodiment thereof in a method of closing a wound.

[0058] In an embodiment of the fourth aspect of the invention, the method includes removing the second release liner from the wound-facing side of the adhesive. The first release liner (preferably at the handle or border area) is then grasped by the user to place and align the device over the wound. In an embodiment, the wound-facing side of the adhesive is then applied to the skin surrounding the wound, and the first release liner is used to control and manipulate the device during application to close the open wound (e.g., approximate the wound). In such an embodiment, the first release liner is removed from the non-wound-facing side of the adhesive once the wound is closed.

[0059] A fifth aspect of the present invention relates to a kit-of-parts for closing a wound comprising a wound closure device according to the first aspect of the present invention or any embodiment thereof or the third aspect of the present invention or any embodiment thereof and an applicator comprising a wound closure adhesive. In such an embodiment, the wound closure adhesive may be a polymerizable adhesive composition and optionally an accelerator and / or initiator. In certain embodiments, the polymerizable adhesive composition is different from the adhesive adhered to the wound closure layer.

[0060] In an embodiment of the fifth aspect of the invention, the kit further comprises additional components. Different components or groups of components are sterilized in separate containers before packaging the components or groups of components in the kit, and the kit can then be sterilized.

[0061] In some embodiments of the first and second aspects of the invention, the wound closure device comprises a wound closure layer including a wound-facing surface, a non-wound facing surface opposite the wound facing surface of the wound closure layer, and one or more open areas extending through the wound closure layer from the wound facing surface to the non-wound facing surface of the wound closure layer; and an adhesive disposed on the wound-facing surface of the wound closure layer, the adhesive including an adhesive that penetrates one or more of the open areas to the extent that, in use, a backing layer disposed adjacent the non-wound facing surface of the wound closure layer contacts the adhesive that penetrates one or more of the open areas, a material layer is disposed adjacent to the non-wound facing surface of the wound closure layer and contacts the adhesive that passes through one or more of the open areas, and (i) the adhesive passes through the one or more open areas but does not protrude beyond the non-wound facing surface of the wound closure layer, or (ii) the adhesive passes through the one or more open areas and protrudes beyond the non-wound facing surface of the wound closure layer but does not cover the non-wound facing surface of the wound closure layer, the adhesive being an adhesive layer including a wound facing surface and a non-wound facing surface opposite the wound facing surface of the adhesive layer, and a base layer disposed adjacent to the non-wound facing surface of the wound closure layer and contacts the non-wound facing surface of the adhesive layer; the non-wound facing surface of the adhesive layer has a peel adhesion value that is less than the peel adhesion value of the wound facing surface of the adhesive layer, optionally the peel adhesion value of the non-wound facing surface of the adhesive layer is from about 0.5 N / 25 mm to about 1.0 N / 25 mm and the peel adhesion value of the wound facing surface of the adhesive layer is from about 2.5 N / 25 mm to about 5.0 N / 25 mm; the wound closure layer has a weight of from about 10 grams / m2 to 20 grams / m2; and the wound closure layer is formed from a polymer selected from the group consisting of polyesters, polyolefins, and polyamides, and the wound closure layer has a peel adhesion value of from about 70 to about 9 5, the wound closure layer is a woven mesh fabric, the adhesive has a coat weight of about 10 grams / m2 to about 30 grams / m2, and the adhesive comprises a pressure sensitive adhesive, preferably an acrylic pressure sensitive adhesive; optionally, the backing layer is a first release liner and there is a second release liner in contact with the wound facing surface of the adhesive layer; and optionally, the peel adhesion value required to remove the first release liner from the non-wound facing surface of the adhesive layer is greater than the peel adhesion value required to remove the second release liner from the wound facing surface of the adhesive layer. [Brief description of the drawings]

[0062] The invention will now be described with reference to the following non-limiting examples and figures. [Figure 1] 1A is a side or cross-sectional view of a wound closure device according to an embodiment of the present invention that does not have a release liner. [Diagram 2] 2 is a side or cross-sectional view of a wound closure device according to an embodiment of the present invention showing a release liner. [Diagram 3] A side or cross-sectional view of a wound closure device according to an embodiment of the present invention, wherein a release liner is adhered to the non-wound facing surface of an adhesive and positioned adjacent to the non-wound facing surface of a wound closure layer (e.g., a mesh). [Figure 4] FIG. 2 is a perspective view of a wound closure device according to an embodiment of the present invention, with the wound closure layer and release liner shown in exploded form. [Diagram 5] 2 is a top view of a wound closure device according to an embodiment of the present invention shown with a first half of a release liner removed from the wound-facing surface of the adhesive and wound closure layer. FIG. [Figure 6] 2 is a top view of a wound closure device according to an embodiment of the present invention shown with the second half of the release liner removed from the wound-facing surface of the adhesive and wound closure layer. FIG. [Figure 7] 1 is a perspective view of a wound closure device according to an embodiment of the present invention, the device being positioned and aligned over a wound opening. FIG. [Figure 8] 1 is a perspective view of a wound closure device according to an embodiment of the present invention, where the wound closure device is applied to an area of ​​skin surrounding a wound opening. [Figure 9] 1 is a perspective view of a wound closure device according to an embodiment of the present invention, in which the wound closure device is used to close a wound opening. [Figure 10] FIG. 2 is a perspective view of a wound closure device according to an embodiment of the present invention, where the wound closure device is completely applied to an area of ​​skin surrounding a wound. [Figure 11]FIG. 2 is a perspective view of a wound closure device according to an embodiment of the present invention showing a user gripping the tab prior to removing the release liner from the non-wound facing surface of the adhesive and wound closure layer. [Figure 12] FIG. 2 is a perspective view of a wound closure device according to an embodiment of the present invention with a release liner removed from the non-wound facing surface of the adhesive and wound closure layer. [Figure 13] 13 is a perspective view of a wound closure device according to an embodiment of the present invention, showing a user applying additional adhesive to the closed wound using an applicator device. Detailed Description of the Invention

[0063] 1, there is shown a wound closure device 1 for closing a wound (not shown) according to a preferred embodiment of the present invention. As described herein, the wound closure device 1 may vary in size and shape depending on the nature and dimensions of the wound to which the device is being applied. It will be appreciated that the materials used to make the wound closure device 1 may also vary depending on the particular requirements of the wound to which the device is being applied.

[0064] As shown in FIG. 1, wound closure device 1 includes wound closure layer 2 and adhesive 3. Wound closure layer 2 has a wound facing surface 4 on which adhesive is disposed and a non-wound facing surface 5. Wound closure layer 2 is a woven mesh material including filaments 6 forming a mesh material. The woven mesh material includes open areas (or pores) 7 extending from wound facing surface 4 to the non-wound facing surface 5 of mesh wound closure layer 2. As shown in FIGS. 1-3, in cross-sectional schematic form, adhesive 3 is disposed on and adhered to wound facing surface 4 of mesh wound closure layer 2, but also forms an adhesive layer extending through open areas 7 of mesh wound closure layer 2. Adhesive layer 3 has a wound facing surface 8 and a non-wound facing surface 9 as shown. It will be appreciated that the extension of adhesive from the wound facing surface of the wound closure layer to the non-wound facing surface of the wound closure layer may, in some cases, be referred to as "weeping." 1-3, the adhesive layer 3 shown does not protrude from or extend beyond the non-wound facing surface 5 of the mesh wound closure layer 2. It will be appreciated that in some embodiments, the adhesive layer 3 may protrude or extend beyond the non-wound facing surface 5 of the mesh wound closure layer 2 without covering the non-wound facing surface 5 of the mesh wound closure layer 2.

[0065] Prior to use, the wound closure device 1 includes a first release liner 10 adhered in contact with the non-wound facing surface 9 of the adhesive layer 3, as shown in FIG. 2. The first release liner 10 is adhered to the non-wound facing surface 9 of the adhesive layer 3 via its wound facing surface 16 (see also FIG. 4). The first release liner 10 is thus held adjacent to the non-wound facing surface 5 of the mesh wound closure layer 2. The second release liner 11 is also adhered in contact with the wound facing surface 8 of the adhesive layer 3. The second release liner 1 is adhered to the wound facing surface 8 of the adhesive layer 3 via its non-wound facing surface 17 (see also FIG. 4). The adhesive layer 3 passes through the open area 7 of the mesh wound closure layer 2 so as to contact the wound facing surface 16 of the first release liner 10 and hold the first release liner 10 in a position adjacent to the non-wound facing surface 9 of the adhesive layer 3.

[0066] For the avoidance of doubt, the mesh wound closure layer 2 and the "weep out" adhesive layer 3 are shown together in Figures 4-13 and, where appropriate, labeled "2+3." It will be understood that, as referred to herein, "mesh-adhesive layer" and / or "2+3" refer to the combination of the mesh wound closure layer 2 and adhesive layer 3. The arrangement of the mesh adhesive layers labeled 2+3 in Figures 4-13 corresponds to that shown in Figures 1-3.

[0067] FIG. 4 shows an exploded perspective view of the wound closure device 1 prior to use. As seen in FIG. 4, the mesh adhesive layer 2+3 and the first and second release liners 10 and 11 are rounded rectangular. In FIG. 4, the first and second release liners 10 and 11 are sized to form a border around the mesh adhesive layer 2+3 with the mesh adhesive layer 2+3 disposed as an island in the center of the release liner. This will be explained in more detail with reference to FIGS. 5-13 below. The first release liner 10 has a wound facing surface 16 and a non-wound facing surface 15, and the second release liner 11 has a wound facing surface 18 and a non-wound facing surface 17 (also shown in FIG. 2).

[0068] In operation, the user removes the release liner 11 by a peeling action as shown in FIG. 5. As can be seen, the user holds the wound closure device 1 in one hand, typically between thumb and index finger, and pulls the first half of the release liner 11a apart with the other hand. As shown in FIG. 4, the release liner 11 can include a cut (or perforation) 12 formed diagonally below the middle portion of the release liner 11. This forms two separate halves (11a and 11b) of the release liner 11. When the user bends the wound closure device 1 along axis 13 (see dashed line in FIG. 4), the separate halves (11a and 11b) of the second release liner 11 are separated along the cut 12 by deforming the second release liner 11 outward and deforming the first release liner 10 inward. This causes the inner edges of the two halves 11a, 11b of the release liner 11 to lift up along the cut 12, so that the user can easily grab the liner 11a before removal. The user can then remove the remaining half 11b of the release liner 11 in a similar manner to fully expose the wound-facing surface 8 of the adhesive layer 3, as shown in Figure 6. As shown in Figure 6, the user can grip the border region 14 of the first release liner 10 to avoid contacting the wound-facing surface 8 of the adhesive layer 3.

[0069] When the second release liner 11 is removed from the wound facing surface 8 of the adhesive layer 3, it is observed that the mesh adhesive layer 2+3 remains fixed to the first release liner 10. That is, the non-wound facing surface 9 of the adhesive layer 3 remains adhered to the wound facing surface 16 of the first release liner 10. This is possible because the peel adhesion force required to separate the non-wound facing surface 9 of the adhesive layer 3 from the wound facing surface 16 of the first release liner 10 is greater than the peel adhesion force required to separate the wound facing surface 8 of the adhesive layer 3 from the non-wound facing surface 17 of the second release liner 11. As shown by the tests described herein, the relative peel adhesion value of the wound facing surface 8 of the adhesive layer 3 may be greater than the peel adhesion value of the non-wound facing surface 9 of the adhesive layer 3, but it is possible to control the peel adhesion force required to separate the first and second release liners by carefully selecting the respective release liner properties. Now, by appropriately selecting the properties of the release liners, it can be ensured that the peel adhesion force required to separate the non-wound facing surface 9 of the adhesive layer 3 from the wound facing surface 16 of the first release liner 10 is greater than the peel adhesion force required to separate the wound facing surface 8 of the adhesive layer 3 from the non-wound facing surface 17 of the second release liner 11. One way to achieve this is to use a second release liner 11 that includes a coating on its non-wound facing surface 17 that reduces the adhesive strength to the wound facing surface 8 of the adhesive layer 3 (e.g. a coating of silicone). In some examples, the coat weight of this coating can play an important role in controlling the peel adhesion force required to separate the wound facing surface 8 of the adhesive layer 3 from the non-wound facing surface 17 of the second release liner 11.

[0070] Once the second release liner 11 has been removed to fully expose the wound facing surface 8 of the adhesive layer 3, the user can grasp the border region 14 of the first release liner 10. As shown in Figure 7, the user's hands and fingers do not contact the wound facing surface 8 of the adhesive layer 3, but instead remain in the border region 14 of the first release liner 10. Figure 3 shows a cross-sectional view of the wound closure device 1 with the second release liner 11 removed before the device is applied to a wound.

[0071] Between FIG. 6 and FIG. 7, the user inverts the device so that the user's thumb is placed inside the boundary region 14 but on the non-wound facing surface 15 of the first release liner 10, and the user's index finger is placed inside the boundary region 14 but on the wound facing surface 16 of the first release liner 10, as shown in FIG. 7. At this stage, the wound closure device is ready to be applied to the wound opening 19, as shown in FIG. 7. The user can carefully place the mesh adhesive layer 2+3 over the wound opening 19 without having to touch any part of the mesh adhesive layer 2+3. In a preferred embodiment, the first release liner 10 is sufficiently transparent or clear to allow the user to see the mesh adhesive layer 2+3 and the wound opening 19 through the liner 10 during use, and to precisely align the mesh adhesive layer 2+3 with the wound opening 19. After the user has the device in the desired position, the user carefully applies a portion of the mesh adhesive layer 2+3 to an area of ​​skin located on one side of the wound opening 19. The user then adheres the mesh adhesive layer 2+3 to the skin by applying pressure to the non-wound facing surface 15 of the first release liner 10, as shown in Figures 8 and 9. Pressure is applied by the user to the non-wound facing surface 15 of the first release liner 10 in the area 20 shown in Figure 8. It will be understood that this area may vary in size and shape depending on the nature, size and shape of both the wound opening 19 and the wound closure device 1 itself. Upon applying pressure to the non-wound facing surface 15 of the first release liner 10, the wound facing surface 8 of the adhesive layer 3 adheres to the surface of the skin. This secures the mesh adhesive layer 2+3 to the area of ​​the skin located to one side of the wound opening 19. The mesh adhesive layer 2+3 remains untouched by the user.

[0072] Once the device is secured to the skin located on one side of the wound opening 19, as shown in Figures 8 and 9, the user grasps and pulls the border region 14 of the liner 10 for the skin adhered to the mesh adhesive layers 2+3 towards the area of ​​the skin located on the other width of the wound opening 19. This action is shown in Figure 9, with the user's pulling direction indicated by the arrow. Once the wound is approximated (i.e. closed), the user then applies the remaining portion of the exposed mesh adhesive layers 2+3 to the skin by applying pressure to the non-wound facing surface 15 of the first release liner 10, as shown in Figure 10. This secures the wound 19 in its closed position. As mentioned above, and with reference to Figures 1-10, the user can quickly and conveniently handle the wound closure device 1 of the present invention without having to touch any portion of the mesh adhesive layers 2+3. This is greatly facilitated by the liner 10 being advantageously adhered to the non-wound facing surface 9 of the adhesive layer 3. Liner 10 serves as a convenient handle and support structure for mesh adhesive layer 2+3, allowing manipulation of the device during the wound closure procedure without the need to touch or come into contact with the wound-facing surface 8 of adhesive layer 3.

[0073] After being secured in the desired position on the wound to be closed, the user removes the first release liner 10, as shown in Figures 11 and 12. In some embodiments, this is accomplished using a tab 21. Here, the user holds the wound closure device 1 in place with one hand while moving the tab 21 away from the non-wound facing surface 15 of the first release liner 10 (see the straight arrow in Figure 11). The user pulls the tab 21 in a direction starting from a central location of the liner 10 toward the longitudinal edge of the first release liner 10 (as shown by the curved arrow in Figure 11). This causes the first release liner 10 to tear along the lines of weakness 22 (e.g., perforation or cut lines) shown in Figures 4 and 12 as the user peels the first release liner 10 away from the mesh adhesive layer 2+3. The first release liner 10 is pulled away and removed from the non-wound facing surfaces 5, 9 of the mesh adhesive layer 2+3 in the direction shown by the arrow in Figure 12.

[0074] When the first release liner 10 is removed from the non-wound facing surface 9 of the adhesive layer 3, it can be seen that the mesh adhesive layer 2+3 remains secured to the skin surrounding the wound. That is, the wound facing surface 8 of the adhesive layer 3 remains adhered to the skin surrounding the wound while the first release liner 10 is removed. This is possible because the peel adhesion force required to separate the wound facing surface 8 of the adhesive layer 3 from the skin surrounding the wound is greater than the peel adhesion force required to separate the non-wound facing surface 9 of the adhesive layer 3 from the wound facing surface 16 of the first release liner 10.

[0075] Further adhesive 23 (eg, polymerizable adhesive+initiator / accelerator) can then be applied to the mesh adhesive layer 2+3 using a suitable applicator device 24, as shown in FIG. 2. Fabrication of Wound Closure Device

[0076] The wound closure device of the present invention may be suitably manufactured according to the following exemplary method. 1. Solvent-based acrylic pressure-sensitive adhesive (purchased from Raleigh Coatings, product ID: RM 0004) was applied at 35 g / m 2 The adhesive was applied to a sacrificial paper release liner at a coat weight of 30 g / m2 on 50 μm PET. The adhesive contains a mixture of heptane, isopropanol, ethyl acetate, toluene and pentanedione. The adhesive was applied at a coat weight of 30 g / m2 on 50 μm PET. 2 When tested at 36 N / 25 mm, it has the following properties: (i) peel adhesion of 36 N / 25 mm; (ii) peel adhesion of 16 N / 25 mm 2 and (iii) a 0.2 hour shear test. The adhesive also has a solids content of 49% to 53% and a viscosity of 1750 to 3500 mPas. 2. The sacrificial paper release liner with the layer of pressure sensitive adhesive disposed thereon was then passed through an oven to remove the solvent by evaporation. The oven contains three zones through which the sacrificial paper liner and adhesive pass. Zone 1 is set at a temperature of 50°C, Zone 2 is set at a temperature of 100°C, and Zone 3 is set at a temperature of 112°C. 3. A soft netted woven mesh (i.e., wound closure layer) purchased from Heathcoat Fabrics was then placed on top of the pressure sensitive adhesive (i.e., the surface opposite the adhesive layer surface in contact with the sacrificial paper release liner) to form a mesh adhesive laminate (i.e., mesh adhesive layer). The material properties and characteristics of the woven mesh are shown in Table 1 below. [Table 1] 4. The mesh adhesive laminate was then passed through a nip point with a compression pressure of 30 Psi. 5. The laminate was then rolled into logs and slit into smaller width logs. 6. The sacrificial paper release liner was then removed and replaced with a glassine based paper release liner (Supplier: Laufenberg - Product name: KS 900 white, 51B / 51B8). The liner was formed split diagonally down the center (as shown in Figures 4 to 6). The paper release liner was purchased from Laufenberg GmbH. The paper release liner had a viscosity of 92 grams / m 2 and a caliper of 80 μm. It will be appreciated that the paper release liner is adhered to the wound facing side of the adhesive layer and the mesh is adhered to the non-wound facing side of the adhesive layer. 7. A transparent polyethylene release liner (substrate OPET film) (supplier: Laufenberg - product name: PETP 36 transparent, 51B16) is then applied to the non-wound facing side of the mesh adhesive laminate to form an exemplary wound closure device of the present invention. The transparent polyethylene release liner has a viscosity of 48-56 grams / m 2 and a caliper of 34 to 40 μm.

[0077] Suitable release liners, mesh and adhesives can be purchased or made using conventional methods. Experimental Testing Measuring peel adhesion values ​​of wound closure devices

[0078] The peel adhesion data of wound closure devices according to the present invention was measured according to the methods described below. The wound closure device samples subjected to these tests were prepared using the methods described above in the section entitled "Preparation of Wound Closure Devices."

[0079] To measure the peel adhesion values ​​of the wound facing side of the adhesive layer and the non-wound facing side of the adhesive layer, the release liner was removed to provide a wound closure device in the form of a mesh-adhesive layer (as shown in Figure 1). It will be understood that the wound facing side of the adhesive layer on which the following tests were performed corresponds to wound facing side 8, as described above with reference to Figures 1-13. The non-wound facing side of the adhesive layer (i.e. the weeping side), on which the following tests were performed corresponds to non-wound facing side 9, as described above with reference to Figures 1-13.

[0080] A sample of the mesh adhesive layer was cut to 25 mm x 150 mm using a cutting press and die. The stainless steel plate was cleaned with isopropyl alcohol or acetone. The side of the mesh adhesive layer to be tested was then glued to the stainless steel plate. A 1 kg roller was passed over the top of the mesh adhesive layer to ensure that the sample was fixed. The stainless steel plate was then mounted on a suitable tensiometer test rig. The cross section of the mesh adhesive layer was fixed at a 90 degree angle to the upper jaw of the tensiometer. The upper jaw was raised and the mesh adhesive layer was peeled off the stainless steel plate at a rate of 5 mm / s. The maximum and average force applied to remove the mesh adhesive layer was measured by the tensiometer. Ten separate measurements were made on both the wound facing and non-wound facing sides of the mesh adhesive layer. The average values ​​for both sides of the mesh adhesive layer are shown in Table 2. [Table 2]

[0081] As shown in the experimental test data in Table 2, the wound facing side of the adhesive layer forming portion of the wound closure device (corresponding to wound facing side 8 in Figures 1-13) has a greater average peel adhesion value of 4.29 N / 25 mm compared to the non-wound facing side or exuding side of the adhesive layer forming portion of the wound closure device (corresponding to non-wound facing side 9 in Figures 1-13), which is 0.89 N / 25 mm. In use, this difference in peel adhesion values ​​between the wound facing side and the exuding side beneficially allows the mesh adhesive layer (corresponding to mesh adhesive layer 2+3 in Figures 1-13) to remain adhered to the skin surrounding the wound while removing the liner adhered to the exuding side. Measurement of peel adhesion values ​​for removing a paper release liner (i.e., a second release liner) from the wound-facing surface of an adhesive layer forming part of a wound closure device of the present invention.

[0082] The wound closure device samples on which the following tests were performed were prepared using the methods described above in the "Preparation of Wound Closure Device" section. It will be understood that the wound facing surface of the adhesive layer on which the following tests were performed corresponds to wound facing surface 8 as described above with reference to Figures 1-13. The paper release liner on which the following tests were performed corresponds to second release liner 11 as described above with reference to Figures 1-13. The clear polyester release liner on which the following tests were performed corresponds to second release liner 10 as described above with reference to Figures 1-13.

[0083] Samples of the wound closure device were cut to 70 mm x 125 mm (the width of the mesh adhesive layer located between the liners was 40 mm) using a cutting press and die. The paper release liner was clamped to the lower jaw of the tensiometer using the uncut 70 mm side. The clear polyester liner was then clamped at a 180 degree angle to the upper jaw of the tensiometer using the same 70 mm side. The jaws were moved in opposite directions at a rate of 5 mm / s to pull the liner in opposite directions. Maximum and average peel adhesion values ​​were measured by the tensiometer. For the test to be valid, the mesh adhesive layer had to remain adhered to the clear polyester liner with the paper release liner removed. The measurements were repeated on 56 samples. The data are shown in Table 3 below. Measurement of peel adhesion values ​​for removing a clear polyester release liner (i.e., the first release liner) from the non-wound facing surface of an adhesive layer (i.e., the exuding side) forming part of a wound closure device of the present invention.

[0084] Peel adhesion data for removal of the clear polyester release liner was obtained using the method described below starting with samples obtained after removing the paper release liner as described in the test above.

[0085] The stainless steel plate was cleaned with isopropyl alcohol or acetone. The sample, with the clear polyester release liner still in place, was glued to the stainless steel plate using the surface previously attached to the paper liner (i.e., the wound-facing side of the adhesive layer). The stainless steel piece was sized so that once the sample was glued to the steel, there was an additional 10 mm of steel around the mesh in each direction. A 1 kg roller was passed over the top of the clear polyester liner three times to ensure the sample was firmly fixed to the steel plate. The stainless steel plate was then mounted on a tensiometer test rig. A piece of the clear polyester liner was clamped at a 90 degree angle to the top jaw of the tensiometer using the 70 mm side of the sample. The top jaw was moved up and the clear polyester liner was peeled away from the adhesive layer and the non-wound-facing side of the stainless steel plate at a rate of 5 mm / s. The force applied to remove the clear polyester liner was measured with the tensiometer. The measurements were repeated on 56 samples. The data are shown in Table 3. [Table 3]

[0086] As shown in the experimental test data in Table 3, the peel adhesion force for removing the paper release liner (i.e., the second release liner) from the wound-facing surface of the adhesive layer forming part of the wound closure device of the present invention is 0.14 N / 40 mm. The peel adhesion force for removing the clear polyester release liner (i.e., the first release liner) from the non-wound-facing surface of the adhesive layer (i.e., the weeping side) forming part of the wound closure device of the present invention is 2.21 N / 40 mm. In use, the difference in peel adhesion force required to remove the paper release liner and the clear polyester release liner usefully allows the paper release liner to be removed from the wound-facing surface of the adhesive before the clear polyester release liner is removed from the non-wound-facing surface of the adhesive layer.

[0087] It will be understood that many modifications to the wound closure devices and uses described above can be made without departing from the spirit and scope of the invention, e.g., as defined in the appended claims. Furthermore, any one or more of the above-described embodiments can be combined with one or more features of other embodiments, and all such combinations are contemplated within the present disclosure.

[0088] Optional and / or preferred features may be used in other combinations than those explicitly described herein, and optional and / or preferred features described in connection with one aspect of the invention may also be present in other aspects of the invention, where appropriate.

[0089] The described and illustrated embodiments should be considered exemplary and not limiting in nature, with the understanding that only preferred embodiments have been shown and described, and that all changes and modifications that fall within the scope of the invention as defined in the claims are desired to be protected. The use of words such as "preferred," "preferably," "suitable," or "more preferred" herein indicates that the feature so described may be desirable, but may nevertheless not be necessary, and it is to be understood that embodiments lacking such features are considered to be within the scope of the invention as defined in the appended claims. When, in the context of a claim, words such as "a," "an," or "at least one" are used before a feature, it is intended that there is no intention to limit the claim to only one of such features, unless the claim specifically states to the contrary.

[0090] The present disclosure also provides the following aspects / embodiments, which are listed as numbered clauses below. Clause 1. A wound closure device comprising: a wound closure layer including a wound-facing surface, a non-wound-facing surface opposite the wound-facing surface of the wound closure layer, and one or more open areas extending through the wound closure layer from the wound-facing surface to the non-wound-facing surface of the wound closure layer; and A wound closure device comprising an adhesive disposed on a wound-facing surface of a wound closure layer, the adhesive penetrating one or more of the open areas to the extent that, in use, a base layer disposed adjacent to a non-wound-facing surface of the wound closure layer contacts the adhesive penetrating one or more of the open areas. Clause 2. The wound closure device of clause 1, wherein the backing layer is positioned adjacent to the non-wound facing surface of the wound closure layer and in contact with the adhesive passing through one or more of the open areas. Clause 3(i) the adhesive passes through one or more open areas but does not protrude beyond the non-wound facing surface of the wound closure layer; or (ii) the adhesive passes through the one or more open areas and protrudes beyond the non-wound-facing surface of the wound closure layer, but does not cover the non-wound-facing surface of the wound closure layer; 3. The wound closure device according to clause 1 or 2. Clause 4. A wound closure device as described in clauses 1 to 3, wherein the adhesive is an adhesive layer including a wound facing surface and a non-wound facing surface opposite the wound facing surface of the adhesive layer, and wherein the backing layer positioned adjacent to the non-wound facing surface of the wound closure layer contacts the non-wound facing surface of the adhesive layer. Clause 5. The wound closure device of clause 4, wherein the non-wound facing surface of the adhesive layer has a peel adhesion value that is less than a peel adhesion value of the wound facing surface of the adhesive layer. Clause 6. The wound closure device of clause 4 or 5, wherein the peel adhesion value of the non-wound facing surface of the adhesive layer is from about 0.1 N to about 2.0 N / 25 mm, preferably from about 0.5 N / 25 mm to about 1.0 N / 25 mm. Clause 7. The wound closure device according to any one of clauses 4 to 6, wherein the peel adhesion value of the wound facing surface of the adhesive layer is from about 2.5 N / 25 mm to about 10 N / 25 mm, preferably from about 2.5 N / 25 mm to about 5.0 N / 25 mm. Clause 8. The wound closure layer has a density of about 5 grams / m 2 ~30g / m 2 , preferably about 10 grams / m 2~20g / m 2 8. The wound closure device of any one of clauses 1 to 7, having a weight of Clause 9. The wound closure device of any one of clauses 1-8, wherein the wound closure layer is formed from a polymer, optionally wherein the polymer is selected from the group consisting of polyesters, polyolefins, and polyamides. Clause 10. The wound closure device of any one of clauses 1-9, wherein the wound closure layer has an open area percentage (%) of about 50 to about 95, preferably about 70 to about 95. Clause 11. The wound closure device of any one of clauses 1-10, wherein the wound closure layer is a mesh or a perforated film, preferably the wound closure layer is a mesh. Clause 12. The wound closure device of clause 11, wherein the mesh is a mesh fabric, and optionally the mesh fabric is a woven mesh fabric. Article 13 The adhesive shall have a density of approximately 5 g / m 2 ~ approx. 100g / m 2 Preferably, the adhesive is applied at a coat weight of about 10 grams / m 2 ~ approx. 30 grams / m 2 13. The wound closure device of any one of clauses 1-12, having a coat weight of Clause 14. The wound closure device of any one of clauses 1-13, wherein the adhesive comprises a pressure sensitive adhesive, preferably the adhesive comprises an acrylic or silicone pressure sensitive adhesive or a mixture thereof. Clause 15 A wound closure device described in any one of clauses 4 to 14, wherein the base layer is a first release liner and there is a second release liner in contact with the wound facing surface of the adhesive layer, and optionally the peel adhesion value required to remove the first release liner from the non-wound facing surface of the adhesive layer is greater than the peel adhesion value required to remove the second release liner from the wound facing surface of the adhesive layer. Clause 16. A method of manufacturing a wound closure device, comprising: providing a wound closure layer including a wound facing surface, a non-wound facing surface opposite the wound facing surface, and one or more open areas extending through the wound closure layer from the wound facing surface to the non-wound facing surface of the wound closure layer; A method of manufacturing comprising disposing an adhesive on the wound-facing surface of the wound closure layer, passing through one or more of the open areas, to an extent that, in use, a backing layer disposed adjacent to the non-wound-facing surface of the wound closure layer contacts the adhesive passing through one or more of the open areas. Clause 17. The method of claim 16, wherein the positioning comprises compressing the wound closure layer and the adhesive together at a pressure of about 20 Psi to about 40 Psi. Clause 18 Prior to the step of placing, the following steps: providing a carrier layer including a wound facing surface and a non-wound facing surface opposite the wound facing surface of the carrier layer; applying an adhesive-solvent mixture to the non-wound facing surface of the carrier layer and removing the solvent to form an adhesive, optionally wherein removing the solvent includes drying at about 50° C. to about 150° C. to form the adhesive. 18. The method of claim 16 or 17, wherein Clause 19: The adhesive is an adhesive layer including a wound facing surface and a non-wound facing surface opposite the wound facing surface of the adhesive layer, the non-wound facing surface of the carrier layer being in contact with the wound facing surface of the adhesive layer, and disposing the adhesive comprises: contacting the wound-facing surface of the wound closure layer with the non-wound-facing surface of the adhesive layer; 19. The method of claim 18, comprising: Clause 20. A wound closure device obtained or obtainable according to the method of any one of clauses 16 to 19. Clause 21. Use of the wound closure device of any one of clauses 1 to 15 or 20 in a method of closing a wound. Clause 22 A kit-of-parts for closing a wound, comprising: The wound closure device according to any one of clauses 1 to 15 or 20, and A kit-of-parts comprising an applicator containing a wound closure adhesive.

Claims

1. 1. A wound closure device comprising: a wound closure layer including a wound-facing surface, a non-wound-facing surface of the wound closure layer opposite the wound-facing surface, and one or more open areas extending through the wound closure layer from the wound-facing surface to the non-wound-facing surface of the wound closure layer; and A wound closure device comprising an adhesive disposed on the wound facing surface of the wound closure layer, the adhesive passing through one or more of the open areas to the extent that, in use, a base layer disposed adjacent to the non-wound facing surface of the wound closure layer contacts the adhesive passing through one or more of the open areas.

2. The wound closure device of claim 1 , wherein the backing layer is positioned adjacent the non-wound facing surface of the wound closure layer and in contact with the adhesive passing through one or more of the open areas.

3. (i) the adhesive passes through the one or more open areas but does not protrude beyond the non-wound facing surface of the wound closure layer; or (ii) the adhesive passes through the one or more open areas and protrudes from, but does not cover, the non-wound facing surface of the wound closure layer; The wound closure device of claim 1 or 2.

4. 2. The wound closure device of claim 1, wherein the adhesive is an adhesive layer including a wound facing surface and a non-wound facing surface opposite the wound facing surface of the adhesive layer, and wherein the backing layer positioned adjacent to the non-wound facing surface of the wound closure layer contacts the non-wound facing surface of the adhesive layer.

5. The wound closure device of claim 4 , wherein the non-wound facing surface of the adhesive layer has a peel adhesion value that is less than a peel adhesion value of a wound facing surface of the adhesive layer.

6. The wound closure device of claim 4 or 5, wherein the peel adhesion value of the non-wound facing surface of the adhesive layer is from 0.1 N to 2.0 N / 25 mm.

7. The wound closure device of claim 4, wherein the peel adhesion value of the wound facing surface of the adhesive layer is between 2.5 N / 25 mm and 10 N / 25 mm.

8. The wound closure layer has a thickness of 5 grams / m ２ The wound closure device of claim 1 having a weight of up to 30 grams / m 2 .

9. The wound closure device of claim 1 , wherein the wound closure layer is formed from a polymer, optionally wherein the polymer is selected from the group consisting of polyesters, polyolefins, and polyamides.

10. The wound closure device of claim 1, wherein the wound closure layer has a percentage open area of ​​from 50 to 95%.

11. The wound closure device of claim 1 , wherein the wound closure layer is a mesh or a perforated film.

12. The wound closure device of claim 11 , wherein the mesh is a mesh fabric, optionally wherein the mesh fabric is a woven mesh fabric.

13. The adhesive has a viscosity of 5 grams / m ２ ~100g / m ２ The wound closure device of claim 1 , wherein the wound closure device is applied at a coat weight of

14. The wound closure device of claim 1 , wherein the adhesive comprises a pressure sensitive adhesive.

15. 5. The wound closure device of claim 4, wherein the base layer is a first release liner and there is a second release liner in contact with the wound facing surface of the adhesive layer, and optionally the peel adhesion value required to remove the first release liner from the non-wound facing surface of the adhesive layer is greater than the peel adhesion value required to remove the second release liner from the wound facing surface of the adhesive layer.

16. 1. A method of manufacturing a wound closure device, comprising: providing a wound closure layer including a wound facing surface, a non-wound facing surface opposite the wound facing surface, and one or more open areas extending through the wound closure layer from the wound facing surface to the non-wound facing surface of the wound closure layer; A method of manufacturing comprising disposing an adhesive on the wound-facing surface of the wound closure layer, passing through one or more of the open areas, to an extent that, in use, a base layer disposed adjacent to the non-wound-facing surface of the wound closure layer contacts the adhesive passing through one or more of the open areas.

17. The method of claim 16, wherein said placing comprises compressing said wound closure layer and said adhesive together at a pressure of between 20 Psi and 40 Psi.

18. Prior to the step of placing, the following steps: providing a carrier layer including a wound facing surface and a non-wound facing surface opposite the wound facing surface of the carrier layer; applying an adhesive-solvent mixture to the non-wound facing surface of the carrier layer and removing the solvent to form the adhesive, optionally removing the solvent includes drying at 50°C to 150°C to form the adhesive. The method according to claim 16 or 17, wherein the following is carried out:

19. The adhesive is an adhesive layer including a wound facing surface and a non-wound facing surface opposite the wound facing surface of the adhesive layer, the non-wound facing surface of the carrier layer being in contact with the wound facing surface of the adhesive layer, and disposing the adhesive comprises: contacting the wound-facing surface of the wound closure layer with the non-wound-facing surface of the adhesive layer. The method of claim 18, comprising:

20. 17. A wound closure device obtained or obtainable according to the method of claim 16.

21. 13. Use of the wound closure device of claim 1 in a method for closing a wound.

22. 1. A kit-of-parts for closing a wound, comprising: The wound closure device of claim 1 , and A kit of parts including an applicator containing a wound closure adhesive.

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