Thin film dressing with perforations and slits

Abstract

Thin film dressing with perforations and slits. The invention relates to a thin film dressing (1a) comprising: - a first thin and flexible film; - a layer of a first thin and flexible film (5) in contact with the first thin and flexible film; - a detachable protective layer (6) positioned on the layer of the first adhesive; - a layer of a second adhesive (3) in contact with the first thin and flexible film; and - a second thin and flexible film (2) in contact with the layer of the second adhesive (3). The assembly (14) consisting of the layer of the first adhesive (5), the first thin and flexible film, and the layer of the second adhesive (3) has perforations (8) and slits (7) extending through the entire thickness of said assembly (14). Figure 1

Description

Title of the invention: Thin film dressing with perforations and slits

[0001] The present invention relates to a thin film dressing provided with perforations and slits.

[0002] In the field of flexible and thin dressings, known as "thin film dressings", which are generally used as a protective layer on wounds (particularly burn wounds), it is common for these dressings to include at least one layer made of a thin and flexible film of polymer or copolymer (for example, a polyurethane film) and which has the following advantageous properties: - due to its thinness and flexibility, an extensibility in all directions which makes the dressing conformable and therefore adaptable to the anatomical part (namely patch of skin or nail) on which it is applied and in particular at the level of a joint; - High permeability to water vapor and impermeability to liquids (such as water, solvents, and bodily fluids) which also prevents bacterial contamination, all of which promotes healing in a moist environment. This is the "barrier effect" of the dressing.

[0003] These thin film dressings can also be used to fix catheters, measuring probes or portable electronic devices.

[0004] In the context of the present invention, the term "anatomical part" means either a patch of skin or a fingernail. The following description will more frequently refer to the skin, but this does not limit the scope of the invention to the application of the dressing to the skin. The scope of the invention therefore also extends to the application of the dressing to a fingernail.

[0005] In the context of the present invention, a "thin, flexible polymer or copolymer film" means a polymer or copolymer-based film that can be easily flexed, folded, and curved without breaking or deteriorating. This film has such flexibility that it can conform appropriately to the curvature of the anatomical part to which the dressing is applied, particularly at a joint. Its thickness can be between 2 µm and 2000 µm, preferably between 5 µm and 500 µm, more preferably between 10 µm and 200 µm, even more preferably between 10 µm and 70 µm, and most preferably between 10 µm and 30 µm. A polymer or copolymer, one side of which is coated with an adhesive layer (for example, an acrylic-based adhesive or silicone gel layer). A removable protective layer (for example, a polyester layer coated with a thin layer of silicone or fluorosilicone) typically covers the side of the adhesive layer that is not in contact with the thin, flexible polymer or copolymer film layer.

[0007] In addition, for some of these thin film dressings, multiple perforations may be present in the thin, flexible polymer or copolymer film layer to improve its breathability, or in other words, to improve its permeability to water vapor.

[0008] However, these thin film dressings, even perforated ones, are not always optimal for user comfort. Indeed, these thin film dressings are not always perfectly conformable to certain anatomical areas, such as the elbows. Furthermore, this conformability can be reduced when the area on which the dressing has been applied is moved. The thin film dressing then tends to detach from the skin.

[0009] Furthermore, this conformability of the dressing can be reduced during physical exertion (e.g., muscular) that generates perspiration. Indeed, if the sweat emanating from the pores of the area of ​​skin covered by the dressing is not wicked away, this will contribute to the dressing detaching.

[0010] Finally, if the dressing is not perfectly conformable to the skin, folds, also called "tunnels", may form on the said dressing, particularly during movements of its user (possibly causing the evacuation of sweat), extending from one end of the dressing to its central part and causing the rupture of the bacterial barrier that the dressing is supposed to guarantee.

[0011] The inventors of the present invention sought to overcome these known problems of lack of conformability of thin film dressings and the disadvantages detailed above that this can cause, by developing a new thin film dressing: - perfectly conformable, regardless of the anatomical part involved and the movements (possibly accompanied by perspiration) of its user - exhibiting a barrier effect as defined above (namely high permeability to water vapor and impermeability to liquids) which is excellent, - not involving the risk of the formation of folds (in other words "tunnels") as detailed above and which cause the breakdown of the bacterial barrier.

[0012] The present invention thus relates to a thin-film dressing comprising at least: - a first thin and flexible film of polymer or copolymer having a first face and a second side; - a layer of a first adhesive, one of whose two faces is in contact with the first face of the first thin and flexible polymer or copolymer film; - a detachable protective layer positioned on the face of the first adhesive layer that is opposite to the one that is in contact with the first face of the first thin and flexible polymer or copolymer film; The said dressing is characterized by the following: It also includes: - a layer of a second adhesive, one of whose two faces is in contact with the second face of the first thin and flexible polymer or copolymer film, - a 2nd thin and flexible polymer or copolymer film having a 1st face and a 2nd face, the 1st face of this 2nd thin and flexible polymer or copolymer film being in contact with the face of the layer of the 2nd adhesive which is opposite to that in contact with the 2nd face of the 1st thin and flexible polymer or copolymer film; the assembly consisting of the layer of 1st adhesive, the 1st thin and flexible polymer or copolymer film and the layer of 2nd adhesive has perforations and slits which extend throughout the thickness of said assembly.

[0013] Thus, the dressing according to the invention has the following advantages: - the completely original combination of slits and perforations in the assembly formed by the first adhesive layer, the first thin and flexible polymer or copolymer film and the second adhesive layer not only improves its breathability (in other words, its permeability to water vapor) thanks to said perforations but also its conformability thanks to said slits, Furthermore, the combination of said perforated and slotted assembly with a second thin and flexible polymer or copolymer film guarantees an excellent barrier effect as defined above. Indeed, the second thin and flexible polymer or copolymer film, by virtue of its intrinsic properties, guarantees this barrier effect. - thanks to its excellent conformability, during the user's movements (possibly accompanied by perspiration), the absence of the formation of folds (or in other words, "tunnels") as defined above on the said dressing, which are the cause of a breach in the bacterial barrier. In other words, the bacterial barrier is maintained with the dressing according to the invention, regardless of the anatomical part to which the dressing is applied and the movements (possibly accompanied by perspiration) of its user.

[0014] In other words, the originality of the dressing according to the invention lies in the association of two thin and flexible films of polymer or copolymer, the first of which is perforated and slit throughout its thickness to allow excellent breathability and conformability, and the second guaranteeing a barrier effect as defined above.

[0015] It should be noted that good breathability of the dressing is very advantageous because it prevents an accumulation of sweat under the dressing which generates discomfort for the patient and detachment of the dressing.

[0016] The thin-film dressing according to the invention is particularly suitable as a protective layer on wounds (especially wounds of severe burns). It can also be perfectly used to secure catheters, measuring probes, or portable electronic devices.

[0017] The surface area of ​​the dressing can be between 5 cm2 and 800 cm2, preferably between 16 cm2 and 450 cm2.

[0018] The dressing can have any shape. It may, in particular, be square, rectangular, round, or oval. For example, the dressing may be square with a side length between 25 mm and 300 mm, preferably between 40 mm and 200 mm. In one embodiment of the invention, the side of the square measures 100 mm. For example, the dressing may be rectangular with a width between 10 mm and 200 mm, preferably between 30 mm and 150 mm, and a length between 50 mm and 400 mm, preferably between 60 mm and 300 mm. In one embodiment of the invention, the width measures 100 mm and the length measures 300 mm.

[0019] The 1st and 2nd thin and flexible polymer or copolymer films have the technical characteristics that have been described in the introduction to the presentation of the invention.

[0020] The thickness of these 1st and 2nd thin and flexible polymer or copolymer films can be between 2 pm and 2000 pm, preferably between 5 pm and 500 pm, more preferably between 10 pm and 200 pm, even more preferably between 10 pm and 70 pm.

[0021] More specifically, the thickness of the first thin, flexible polymer or copolymer film can be between 15 µm and 150 µm, preferably between 30 µm and 100 µm. The thickness of the second thin, flexible polymer or copolymer film can be between 5 µm and 50 µm, preferably between 10 µm and 30 µm.

[0022] Advantageously, the thickness of the first thin, flexible polymer or copolymer film is greater than that of the second thin, flexible polymer or copolymer film. For example, the ratio of the thickness of the first thin, flexible polymer or copolymer film to the thickness of the second thin, flexible polymer or copolymer film can be between 1.5 and 10, preferably between 3 and 6.

[0023] The first and second thin, flexible polymer or copolymer films are chosen to conform to the surface of the anatomical part to which the dressing according to the invention is fixed, and in particular at the joints, even when this surface is in motion. These films thus exhibit a certain resistance silence to continue conforming to the surface of the anatomical part during flexion and extension movements.

[0024] The 1st and 2nd thin and flexible polymer or copolymer films can, for example, be chosen from polyurethane, polyester, polyamide, polyether, polyvinyl chloride, polyvinylidene chloride, polyvinyl alcohols, polyvinyl acetate, polystyrene, polyolefins (such as polyethylene and polypropylene), polyvinyl fluoride, silicone elastomers, or from polyether-polyester, polyester-polyurethane, polyether-polyurethane, polyether-polyamide copolymer films, as well as triblock or diblock copolymer films of styrene and olefin (for example styrene / butadiene) and block polyether amide films.

[0025] The 1st and 2nd thin and flexible polymer or copolymer films can be made of identical or different materials (for example chosen from those described above).

[0026] Examples of thin, flexible polymer or copolymer film that are suitable within the scope of the present invention are described in US patents 5,088,483 and 5,160,315.

[0027] Preferably, the first and second thin, flexible polymer or copolymer films are transparent or translucent, or slightly colored while retaining a certain degree of transparency. This facilitates the application of the dressing to the anatomical part (namely, a patch of skin or nail).

[0028] The first and second thin, flexible polymer or copolymer films are permeable to water vapor. The water vapor permeability of the thin, flexible film with a thickness of 20 µm is advantageously greater than 200 g / m² / 24 hours, more preferably greater than 1000 g / m² / 24 hours, and even more preferably greater than 5000 g / m² / 24 hours. For example, it may be between 100 and 50,000 g / m² / 24 hours, preferably between 1000 and 40,000 g / m² / 24 hours, and more preferably between 5,000 and 30,000 g / m² / 24 hours.

[0029] The first and second thin, flexible polymer or copolymer films can be obtained from a polyurethane solution marketed by ICAP-SIRA Spa under the trade names "ICAFLEX BR447 MATT 10" and "ICAFLEX BR447 MATT 3 / 25". After drying, the film thus obtained is a polyurethane film.

[0030] Preferably, the first and second thin, flexible polymer or copolymer films are polyurethane films. Indeed, they have the advantage of being breathable and allowing water vapor to escape from the skin.

[0031] The first adhesive layer is made of an adhesive material that can be used on the body. It is advantageously hypoallergenic.

[0032] Preferably, the first adhesive layer has high water vapor permeability.

[0033] In addition, the first adhesive layer has high adhesion to the anatomical part to which the dressing according to the invention is fixed, and in particular where appropriate to secure the placement of a catheter.

[0034] The first adhesive layer may be a pressure-sensitive adhesive. More specifically, the first adhesive layer may be a pressure-sensitive adhesive based on acrylic, polyurethane, silicone, natural rubber, ethylene-vinyl acetate copolymer, or poly(styrene-isoprene-styrene) block copolymers.

[0035] Examples of pressure-sensitive adhesives are described in patents EP 0 035 399 Bl, EP 0 051 935 Bl, US 3,389,827, US 4,112,213, US 4,310,509, US 4,323,557 and US 4,737,410.

[0036] The first adhesive layer may also be a layer of an acrylic-based pressure-sensitive adhesive marketed by the company ASHLAND under the trade names AROSET 1920-Z-52 or AROSET 1910-TH-52.

[0037] The first adhesive layer may also be a layer of a rubber-based pressure-sensitive adhesive marketed by HB FULLER under the trade name SwiftCol 9063.

[0038] In other embodiments of the invention, the first adhesive layer can be a gel chosen from silicone gel, polyurethane gel and hydrogels.

[0039] Preferably, the first adhesive layer comprises silicone gel, which provides excellent adhesion properties to the skin of the dressing according to the invention during application. Furthermore, the silicone gel has the advantage of making dressing removal atraumatic. Finally, if parts of the first adhesive layer become stuck together, because it is silicone gel, they can be easily separated without risk of damaging the very thin, flexible first film of polymer or copolymer.

[0040] Silicone gel is a cross-linked silicone compound. It provides high adhesion to the skin and low release force upon detachment. Preferably, the adhesive strength of silicone gel is between 0.5 N / cm and 4 N / cm. The silicone gel exhibits such cohesion that it leaves no residue on the skin upon removal of the dressing while remaining bonded to the first thin, flexible polymer or copolymer film to which it is attached.

[0041] Silicone gel can be manufactured from silicone precursors that crosslink after contact following a hydrosilylation or condensation reaction. Silicone gel can be obtained from a mixture of a poly-di-organosiloxane resin and a catalyst, for example in a weight ratio of these The aforementioned compounds in 1:1, 3:1, or 10:1 ratios, the mixture of poly-di-organosiloxane and catalyst being subjected to crosslinking. An example of a silicone gel is described in US patent 4,991,574.

[0042] For example, silicone gel is chosen from the following products: - the WACKER company, which are called SILPURAN, series 2120, - the ELKEM company of the SILBIONE 4717 series, - the company NUSIL which are called CEREPLAST MED 634.

[0043] The process of crosslinking silicone gel is perfectly within the capabilities of a person skilled in the art.

[0044] The thickness of the first adhesive layer can be between 5 pm and 500 pm, preferably between 10 pm and 250 pm.

[0045] The surface mass of the first adhesive layer can be between 5 g / m² and 500 g / m², preferably between 10 g / m² and 300 g / m². Acrylic-based pressure-sensitive adhesives have lower surface masses (i.e., less than 50 g / m²) than silicone gels, which are greater than 100 g / m².

[0046] The first adhesive layer may further comprise at least one compound selected from among the antimicrobial agents. This has the advantage of promoting healing, and when a catheter is placed under the dressing, of controlling infection in this potentially infectious area.

[0047] The second adhesive layer can be made of an adhesive material based on acrylic, silicone, polyurethane, natural rubber, hydrogel, ethylene-vinyl acetate copolymer, or poly(styrene-isoprene-styrene) block copolymers. Preferably, the second adhesive layer is an acrylic adhesive layer.

[0048] The thickness of the 2nd adhesive layer can be between 5 pm and 100 pm, preferably between 10 pm and 50 pm.

[0049] As explained above, the dressing according to the invention has the originality of comprising an assembly consisting of the 1st adhesive layer, the 1st thin and flexible film and the 2nd adhesive layer which has perforations and slits extending throughout its thickness.

[0050] The technical characteristics of these perforations and slots are now described in more detail.

[0051] The perforation openness rate can be between 10% and 60%, preferably between 20% and 40%. "Perforation openness rate" means the percentage of the total perforation area relative to the area the assembly would have in the absence of perforations. If the openness rate is too high, problems with detachment of the dressing according to the invention may occur.

[0052] The perforations can have all sorts of different geometric shapes, for example, circular, square, rectangular, triangular, oval. Preferably, the perforations are circular. Indeed, circular perforations can be easily incorporated during the manufacture of the dressing according to the invention. In this embodiment of the invention, the diameter of the perforations can be between 0.5 mm and 10 mm, preferably between 2 mm and 5 mm.

[0053] The perforations may have identical or different shapes.

[0054] More generally, whatever the geometric shape of the perforations, the surface The size of each perforation can be between 0.2 mm² and 80 mm², preferably between 1.5 mm² and 20 mm². These surface intervals are particularly suitable for providing good conformability to the dressing and avoiding any problems of untimely detachment.

[0055] The perforations may have identical or different surfaces.

[0056] In embodiments of the invention, the perforations may be arranged so that they are all aligned with each other or arranged in a staggered pattern.

[0057] In other embodiments of the invention, the perforations are not all aligned with each other or they are not all staggered.

[0058] The perforations can be arranged randomly (i.e., for example, without following any alignment) on the assembly consisting of the 1st adhesive layer, the 1st thin and flexible polymer or copolymer film and the 2nd adhesive layer.

[0059] The arrangement of the perforations may be homogeneous or heterogeneous on said assembly.

[0060] In other words, in embodiments of the invention, the surface of said assembly may include areas with varying density of perforations.

[0061] In embodiments of the invention, the distribution of perforations may not be uniform over the surface of said assembly.

[0062] In embodiments of the invention, said assembly may include one or more zones in which the perforations may be aligned with each other or staggered or arranged in a completely random manner.

[0063] The arrangement of perforations on said assembly can be diverse and varied.

[0064] The slits may have a length between 0.5 mm and 20 mm, preferably between 1 mm and 10 mm. These slit length ranges are particularly suitable for providing excellent conformability to the dressing.

[0065] The width of the slots is less than 2 mm, preferably less than 1 mm. Advantageously, the width of the slots is as small as possible. Thus, preferably, no material of the assembly consisting of the first adhesive layer, the first thin and flexible film of polymer or copolymer and the 2nd adhesive layer is not removed during the formation of slits throughout the thickness of said assembly during the manufacture of the dressing according to the invention.

[0066] The slots may have identical or different characteristics (for example length and width).

[0067] In embodiments of the invention, the slits connect at least two adjacent perforations, more preferably at least four adjacent perforations. Indeed, when the slits connect at least two adjacent perforations, preferably between two and four adjacent perforations, this improves the conformability of the dressing.

[0068] Advantageously, the total length of the slits per unit area of ​​said assembly consisting of the first adhesive layer, the first thin and flexible polymer or copolymer film, and the second adhesive layer can be between 1 mm / cm² and 30 mm / cm², preferably between 2 mm / cm² and 15 mm / cm². These intervals are particularly suitable for good conformability of the dressing according to the invention.

[0069] The arrangement of the slits can be homogeneous or heterogeneous over the whole consisting of the 1st adhesive layer, the 1st thin and flexible polymer or copolymer film and the 2nd adhesive layer.

[0070] In other words, in embodiments of the invention, the surface of said assembly may include areas with varying densities of slots.

[0071] In embodiments of the invention, the distribution of the slots may not be uniform over the surface of said assembly.

[0072] The arrangement of the slots on said assembly can be diverse and varied.

[0073] Of course, within the scope of the present invention, a wide variety of perforation and slit characteristics and arrangements can be implemented. In other words, the dressing according to the invention can have very diverse configurations with regard to the perforations and slits, which provide it with excellent conformability and prevent unwanted detachment.

[0074] In one embodiment of the invention, the dressing further comprises a compress which is attached: - on the side of the first adhesive layer that is opposite to the side that is in contact with the first side of the first thin and flexible polymer or copolymer film Or - on the face of the 2nd adhesive layer that is opposite to the one that is in contact with the 2nd face of the 1st thin and flexible polymer or copolymer film.

[0075] In the embodiment of the invention in which the pad is fixed to the first adhesive layer, said pad may partially cover this first adhesive layer so that the dressing according to the invention can be fixed to the body (to (knowing a patch of skin or nail) thanks to said first layer of adhesive.

[0076] In the embodiment of the invention in which the compress is fixed on the 2nd adhesive layer, the wound exudates can pass through the perforations of said assembly consisting of the 1st adhesive layer, the 1st thin and flexible polymer or copolymer film and the 2nd adhesive layer so as to reach the compress.

[0077] Preferably, the pad is fixed to the center of said face of the 1st adhesive layer or of said face of the 2nd adhesive layer.

[0078] The surface area of ​​the compress can be between 1 cm2 and 480 cm2, preferably between 4 cm2 and 250 cm2.

[0079] The compress can have all sorts of different shapes. It can be square, rectangular, round, or oval. For example, the compress can be square with sides between 10 mm and 150 mm, preferably between 20 mm and 80 mm. In one embodiment of the invention, the side of the square measures 50 mm. For example, the compress can be rectangular with a width between 5 mm and 200 mm, preferably between 20 mm and 100 mm, and a length between 20 mm and 300 mm, preferably between 30 mm and 250 mm. In one embodiment of the invention, the width measures 50 mm and the length measures 250 mm.

[0080] The thickness of the compress can be between 0.5 mm and 10 mm, preferably between 1.5 mm and 5 mm.

[0081] The compress is made of at least one absorbent material.

[0082] The absorbent material can be chosen from: - polyurethane foams, and more preferably aliphatic polyurethane foams,

[0083] - non-woven fabrics such as viscose non-woven fabrics or non-woven fabrics based on a polyester blend and viscose (for example, a mixture comprising by weight 70% to 80% viscose and 20% to 30% polyester), or non-wovens containing cellulose, - cotton materials, - cellulose materials.

[0084] The choice of absorbent material is perfectly within the reach of a person skilled in the art.

[0085] Aliphatic polyurethane foam has the advantage of being an ab foam A flexible, open-cell absorbent material that provides an excellent retention level of approximately 65%. It also exhibits absorption capacities of more than 15 times its weight. Its thickness can vary from 1.5 to 5 mm. Furthermore, it has the advantage of being resistant to beta and gamma ray irradiation. This is particularly suitable when the dressing according to the invention is sterilizable; which implies that all its components must be sterilizable.

[0086] The compress may further comprise at least one compound selected from among the antimicrobial agents.

[0087] In a preferred embodiment of the invention, the side of the pad opposite the side in contact with the first adhesive layer (in other words, the side of the pad intended to be in contact with the anatomical part) is partially covered with a layer of a third adhesive. For example, between 20% and 80%, preferably 50%, of the surface of this side of the pad is covered with a layer of the third adhesive. This third adhesive layer is thus perforated and may, for example, have a grid pattern.

[0088] This third adhesive layer improves the adhesion of the compress to the anatomical part (skin or nail). Furthermore, its perforations allow wound exudate to pass through, thus ensuring proper healing.

[0089] The third adhesive layer may be a silicone gel layer, an acrylic-based adhesive, a silicone-based adhesive, a polyurethane-based adhesive, a natural rubber-based adhesive, a hydrogel-based adhesive, an ethylene-vinyl acetate copolymer adhesive, or a poly(styrene-isoprene-styrene) block copolymer. Preferably, it is a silicone gel layer.

[0090] In a preferred embodiment of the invention, 50% of the face of the pad that is not in contact with the first adhesive layer is covered by a layer of silicone gel having the shape of a grid.

[0091] Preferably, the dressing according to the invention is sterilizable. This means that all its components are sterilizable. This sterilization property is essential if the dressing according to the invention is intended to be applied to acute, chronic, and exudative wounds. These wounds are often found in weakened individuals (for example, burn victims or people at the end of life). Sterilization of the dressing is therefore essential to avoid any risk of contamination.

[0092] The material of the removable protective layer can be chosen from the following materials: - a polyester film coated with a layer of fluorosilicone or silicone; - a polyolefin film such as polyethylene, polypropylene or polyethylene terephthalate; - a metal sheet; - a paper coated with a layer of silicone, fluorosilicone or covered with a layer of polyolefin (for example polypropylene or polyethylene or other equivalent polyolefin).

[0093] For example, it may be a polyethylene film which is smooth or embossed and / or debossed.

[0094] The material of the detachable protective layer is advantageously a film of Polyethylene is preferred because this polymer inherently adheres poorly to adhesive layers, particularly silicone gel. Ideally, the film is an embossed and / or debossed polyethylene film to reduce the contact area with the first adhesive layer, thus facilitating its easy removal from the first adhesive layer during dressing application. RKW's diamond-point embossed polyethylene films, 55 µm and 65 µm, are preferred.

[0095] The thickness of the detachable protective layer can be between 30 µm and 150 µm. In one embodiment of the invention, this thickness is 60 µm.

[0096] The surface mass of the detachable protective layer can be between 25 g / m2 and 120 g / m2. Preferably, it is 50 g / m2.

[0097] In one embodiment of the invention, the detachable protective layer comprises two overlapping parts in the middle region of the dressing, so as to allow the user to remove them without touching the first adhesive layer with their fingers, thus without causing it to lose its adhesive power.

[0098] In one embodiment of the invention, the detachable protective layer may include at least one gripping tab to allow it to be detached from the first adhesive layer without touching said first adhesive layer and contaminating it.

[0099] The gripping tab may be an integral part of the detachable protective layer or may have been attached to it, for example with an adhesive or other means of attachment.

[0100] In preferred embodiments of the dressing according to the invention, the first and second thin, flexible films are made of polyurethane, the first adhesive layer is a silicone gel layer, and the second adhesive layer is an acrylic layer. The dressing then offers the following advantages: - it is perfectly conformable and breathable thanks to the slits and perforations as explained above; - it guarantees an excellent barrier against bacteria as explained above; - Thanks to the silicone gel, once the removable protective layer has been taken off, if any parts of the first adhesive layer become stuck together, they can be easily peeled back without risk of damaging the very thin, flexible first and second polyurethane films. Furthermore, it is repositionable and its removal is atraumatic.

[0101] In this preferred embodiment, said dressing may further comprise a pad, for example a pad as described above, and preferably made of aliphatic polyurethane foam. The pad is fixed to the face of the first adhesive layer that is opposite to the face that is in contact with the first face of the first thin, flexible polyurethane film or to the face of the second adhesive layer that is opposite to that which is in contact with the 2nd side of the 1st thin and flexible film of polymer or copolymer.

[0102] The invention also relates to a method for manufacturing the dressing as described above. The manufacturing method comprises at least the following steps: a) the 1st side of the 1st thin and flexible polymer or copolymer film is covered with the 1st adhesive layer and the 2nd side of the 1st thin and flexible polymer or copolymer film is covered with the 2nd adhesive layer; b) a first support layer is applied to the face of the first adhesive layer that is opposite to the face that is in contact with the first face of the first thin, flexible polymer or copolymer film; c) a 2nd layer of support is applied to the face of the layer of the 2nd adhesive which is opposite to that which is in contact with the 2nd face of the 1st thin and flexible film of polymer or copolymer; d) perforations are made throughout the thickness of an assembly consisting of the 1st support layer, the 1st adhesive layer, the 1st thin and flexible polymer or copolymer film, the 2nd adhesive layer and the 2nd support layer; e) slits are made throughout the thickness of an assembly consisting of the 1st adhesive layer, the 1st thin and flexible polymer or copolymer film, the 2nd adhesive layer and the 2nd support layer; f) the 2nd layer of support is removed; g) the 2nd thin and flexible polymer or copolymer film is applied over the 2nd adhesive layer; h) the first support layer is removed; i) the removable protective layer is applied over the first adhesive layer so as to obtain said dressing.

[0103] The resulting dressing can be cut to the desired dimensions.

[0104] The technical characteristics of the 1st thin and flexible polymer film or co polymer and the 1st and 2nd adhesive layers of step a) have been described above.

[0105] The thickness of the first support layer in step b) can be between 30 µm and 150 µm. In one embodiment of the invention, this thickness is 60 µm.

[0106] The material of the first support layer may be selected from the following materials: polyethylene, polyurethane, polyester, polyamide, polyether, polyvinyl chloride, polyvinylidene chloride, polyvinyl alcohols, polyvinyl acetate, polystyrene, polyolefins, polyvinyl fluoride, polyether-polyester copolymer, polyester-polyurethane, polyether-polyurethane, polyether-polyamide, triblock or diblock copolymer films of styrene and olefin, and polyether block amides. Preferably, it is a polyethylene layer. Advantageously, this support may be coated with a silicone- or fluorosilicone-based anti-adhesive coating.

[0107] The thickness of the 2nd support layer in step c) can be between 30 µm and 150 µm. In one embodiment of the invention, this thickness is 60 µm.

[0108] The material of the second support layer may be selected from the following materials: polyethylene, polyurethane, polyester, polyamide, polyether, polyvinyl chloride, polyvinylidene chloride, polyvinyl alcohols, polyvinyl acetate, polystyrene, polyolefins, polyvinyl fluoride, polyether-polyester copolymer, polyester-polyurethane, polyether-polyurethane, polyether-polyamide, triblock or diblock copolymer films of styrene and olefin, polyether block amides. Preferably, it is a polyethylene terephthalate layer. Advantageously, this support may be coated with a silicone or fluorosilicone-based anti-adhesive coating.

[0109] The 1st and 2nd support layers which are applied respectively in steps b) and c) allow the 1st and 2nd adhesive layers respectively to be protected for the following steps of the manufacturing process of the dressing according to the invention.

[0110] In step e), the first support layer covering the first adhesive layer is not slit and was therefore only perforated in step d). The absence of slits in the first support layer gives a certain rigidity to the assembly consisting of the first support layer, the first adhesive layer, the first thin and flexible polymer or copolymer film and the second adhesive layer, in particular when the second support layer will be removed in step f) so that the second thin and flexible polymer or copolymer film can then be applied to the second adhesive layer in step g).

[0111] At step i), the detachable protective layer has the technical characteristics that have been described above.

[0112] When the dressing according to the invention further comprises a compress as described above, its manufacturing process includes an additional step consisting, after step h) and before step i), of applying the compress: - on the side of the first adhesive layer that is opposite to the side that is in contact with the first side of the first thin and flexible polymer or copolymer film Or - on the face of the 2nd adhesive layer that is opposite to the one that is in contact with the 2nd face of the 1st thin and flexible polymer or copolymer film.

[0113] The compress is a compress as described above.

[0114] In the embodiment of the invention in which the pad is applied to the first adhesive layer, in step i), the detachable protective layer thus covers the pad and the portion of the first adhesive layer which is not covered by said pad.

[0115] The invention will be better understood with the aid of the detailed description set forth below with reference to the accompanying drawing showing, by way of non-linear example mitatifs, three embodiments of thin film dressings according to the invention, as well as test samples of thin and flexible polyurethane film which were used for experiments.

[0116] [Fig-1] The [Fig. 1] is a perspective and exploded view of a thin film dressing according to a 1st embodiment of the invention.

[0117] [Fig.2] The [Fig.2] is a top view of the assembly consisting of the 2nd adhesive layer, the 1st thin and flexible polymer or copolymer film and the 1st adhesive layer of the dressing shown in the [Fig.1].

[0118] [Fig.3] The [Fig.3] is a cross-sectional view along axis III-III of the [Fig.2] of the assembly consisting of the layer of the 2nd adhesive, the 1st thin and flexible film of polymer or copolymer and the layer of the 1st adhesive of the dressing shown in the [Fig.1].

[0119] [Fig.4a] The [Fig.4a] is a perspective and exploded view of a thin film dressing according to a 2nd embodiment of the invention.

[0120] [Fig.4b] Fig.4b is a perspective and exploded view of a thin film dressing according to a 3rd embodiment of the invention.

[0121] [Fig.5a] The [Fig.5a] is a top view of a first test sample of a first thin and flexible polyurethane film.

[0122] [Fig.5bl] The [Fig.5bl] is a top view of a 2nd test sample of 1st thin and flexible polyurethane film.

[0123] [Fig.5b2] [Fig.5b2] is a top view of a 3rd test sample of 1st film thin and flexible polyurethane.

[0124] [Fig.5b3] [Fig.5b3] is a top view of a 4th test sample of 1st film thin and flexible polyurethane.

[0125] [Fig.5c] The [Fig.5c] is a top view of a 5th test sample of 1st thin and flexible polyurethane film.

[0126] [Fig.5d] The [Fig.5d] is a top view of a 6th test sample of 1st thin and flexible polyurethane film.

[0127] [Fig.5el] The [Fig.5el] is a top view of a 7th test sample of 1st thin and flexible polyurethane film.

[0128] [Fig.5e2] [Fig.5e2] is a top view of an 8th test sample of 1st film thin and flexible polyurethane.

[0129] [Fig.5fl] The [Fig.5fl] is a top view of a 9th test sample of 1st thin and flexible polyurethane film.

[0130] [Fig.5f2] [Fig.5f2] is a top view of a 10th test sample of 1st film thin and flexible polyurethane.

[0131] [Fig.5f3] [Fig.5f3] is a top view of a first test sample of the first film thin and flexible polyurethane.

[0132] [Fig.5f4] [Fig.5f4] is a top view of a 12th test sample of 1st film thin and flexible polyurethane.

[0133] [Fig.5g] The [Fig.5g] is a top view of a 13th test sample of 1st thin and flexible polyurethane film.

[0134] [Fig.5h] The [Fig.5h] is a top view of a 14th test sample of 1st thin and flexible polyurethane film.

[0135] [Fig.5i] The [Fig.5i] is a top view of a 15th test sample of 1st thin and flexible polyurethane film.

[0136] [Fig.5j] The [Fig.5j] is a top view of a 16th test sample of 1st thin and flexible polyurethane film.

[0137] [Fig.5k] The [Fig.5k] is a top view of a 17th test sample of 1st thin and flexible polyurethane film.

[0138] [Fig.51] The [Fig.51] is a top view of an 18th test sample of 1st thin and flexible polyurethane film.

[0139] [Fig.5m] The [Fig.5m] is a top view of a 19th test sample of 1st thin and flexible polyurethane film.

[0140] [Fig.5n] The [Fig.5n] is a top view of a 20th test sample of 1st thin and flexible polyurethane film.

[0141] [Fig.5o] The [Fig.5o] is a top view of a 21st test sample of 1st thin and flexible polyurethane film.

[0142] [Fig.5p] The [Fig.5p] is a top view of a 22nd test sample of 1st thin and flexible polyurethane film.

[0143] [Fig.5q] The [Fig.5q] is a top view of a 23rd test sample of 1st thin and flexible polyurethane film.

[0144] Figure 1 shows a perspective and exploded view of a thin film dressing according to a first embodiment of the invention.

[0145] The dressing has a square shape of 150 mm on each side.

[0146] The dressing comprises a first thin and flexible polyurethane film 4 (visible in [Fig.3]) which has a first face 10 and a second face 11. The thickness of this first thin and flexible polyurethane film 4 is 60 µm.

[0147] The dressing further comprises a layer of a 1st adhesive 5 which is a layer of silicone gel and one of whose two faces is in contact with the 1st face 10 of the 1st thin and flexible polyurethane film 4. The thickness of the layer of 1st adhesive 5 is 150 µm.

[0148] A detachable protective layer 6 consisting of a polyethylene film is positioned on the face of the layer of the 1st adhesive 5 which is opposite to that which is in contact with the 1st face 10 of the 1st thin and flexible polyurethane film 4. The thickness of the detachable protective layer 6 is 50 pm.

[0149] The dressing further comprises a layer of a second adhesive 3 consisting of a layer of an acrylic adhesive, one of whose two faces is in contact with the 2nd face 11 of the 1st thin and flexible polyurethane film 4. The thickness of the 2nd adhesive layer 3 is 20 µm.

[0150] The dressing further comprises a second thin and flexible polyurethane film 2, which has a first face 12 and a second face 13. The first face 12 of this second thin, flexible polyurethane film 2 is in contact with the face of the layer of the second adhesive 3 that is opposite to the face in contact with the second face 11 of the first thin, flexible polyurethane film 4. The thickness of the second thin, flexible polyurethane film 2 is 15 µm.

[0151] The assembly 14, consisting of the layer of the first adhesive 5, the first thin, flexible polyurethane film 4, and the layer of the second adhesive 3, has perforations 8 and slots 7 that extend through the entire thickness of said assembly 14.

[0152] Figure 2 is a top view of said assembly 14. In Figure 2, the circular perforations 8a, 8b, 8c, 8d, and 8e, as well as the slot 7', are referenced. These perforations 8a, 8b, 8c, 8d, and 8e, and the slot 7', are visible in Figure 3 described below. The slot 7' extends longitudinally between perforations 8b and 8c in a direction parallel to axis III-III.

[0153] Fig. 3 is a cross-sectional view along axis III-III of Fig. 2 of the assembly 14 which consists of the layer of the 2nd adhesive 3, the 1st thin and flexible polyurethane film 4 and the layer of the 1st adhesive 5.

[0154] Fig. 4a is a perspective and exploded view of a thin film dressing 1b according to a second embodiment of the invention.

[0155] Dressing 1b differs from dressing 1a only in that it further comprises a 2 mm thick polyurethane foam pad 9. The pad 9 is positioned centrally on the first adhesive layer 5 of dressing 1b.

[0156] Fig. 4b is a perspective and exploded view of a thin film dressing according to a third embodiment of the invention.

[0157] Dressing le differs from dressing la only in that it further comprises a 2 mm thick polyurethane foam pad 9. Pad 9 is positioned centrally on the second adhesive layer 3 of dressing le.

[0158] The present invention is now illustrated by means of the description of the following experiments which were carried out by implementing different tests according to the protocols as detailed below.

[0159] First, the extensibility was determined on 23 test samples of thin, flexible polyurethane films of square shape (150 mm on each side) and thickness 60 µm, all of which had perforations and slits except for the 1st test sample "5a", said perforations and slits having been made in the thickness of said test samples.

[0160] The arrangement of perforations and slits for each of these 23 test samples is represented respectively on figures 5a, 5bi, 5b2, 5b3, 5c, 5d, 5eb 5e2, 5fi 5f2, 5f3, 5f4, 5g, 5h, 5i, 5j, 5k, 51, 5m, 5n, 5o, 5p and 5q.

[0161] The test sample “5a” shown in [Fig. 5a] had circular perforations 85 with a diameter of 2.60 mm arranged in a staggered pattern such that the distance between the centers of two consecutive perforations 85 in the same row of perforations 85 extending in a direction parallel to axis B was 4.11 mm, and the distance between the centers of two consecutive perforations 85 in the same row of perforations 85 extending in a direction parallel to axis A was 8.60 mm. This test sample “5a” was slit-free and had an openness rate of 30%. This test sample “5a” was therefore a comparative test.

[0162] The following test samples described below are all test samples according to the invention.

[0163] The test sample “5bi” shown in [Fig. 5bl] comprised circular perforations 85, 2.60 mm in diameter, arranged in rows of perforations 85 extending parallel to axis A, such that the distance between the centers of two consecutive perforations 85 in the same row was 4.11 mm, and said rows of perforations 85 were spaced 4.11 mm apart. This test sample “5b 1” further comprised slots 75b, 4.11 mm long, arranged between each row of perforations 85 extending parallel to axis A, as shown in [Fig. 5bl]. This test sample “5b 1” had an openness rate of 31.4%.

[0164] The test sample “5b2” shown in [Fig. 5b2] was identical to the test sample “5bl” shown in [Fig. 5bl] except that it also included slits 75a with a length of 2.4 mm, which were perpendicular to the slits 75b and arranged as shown in [Fig. 5b2]. This test sample “5b2” had an openness rate of 31.4%.

[0165] The test sample “5b3” shown in [Fig. 5b3] was identical to the test sample “5bl” shown in [Fig. 5bl] except that it also included slits 75a with a length of 2.4 mm, which were perpendicular to the slits 75b and arranged as shown in [Fig. 5b3]. This test sample “5b3” had an openness rate of 31.4%.

[0166] The test sample “5c” shown in [Fig. 5c] comprised circular perforations 85 with a diameter of 2.60 mm arranged in rows of perforations 85 extending in a direction parallel to axis A, such that the distance between the centers of two consecutive perforations 85 in the same row was 4.11 mm and said rows of perforations 85 were spaced 4.11 mm apart. This test sample “5c” further comprised slots 75c, each 1.5 mm long, which connected two consecutive perforations 85 in the same row of perforations 85 extending in a direction parallel to axis A, as shown in [Fig. 5c]. This test sample “5C” had an openness rate of 31.4%.

[0167] The test sample “5d” shown in [Fig. 5d] was identical to the test sample shown “5C” in [Fig. 5c] except that it had slits 75c, each 1.5 mm long, connecting three consecutive perforations 85 in the same row of perforations 85 extending in a direction parallel to axis A, as shown in [Fig. 5d]. This test sample “5d” had an openness rate of 31.4%.

[0168] The test sample “5ei” shown in [Fig. 5el] was identical to the test sample “5a” shown in [Fig. 5a] with respect to the perforations 85 and their arrangement. This test sample “5el” further comprised first slots 75ea, 2 mm long, and second slots 75eb, 2 mm long, arranged as shown in [Fig. 5el]. This test sample “5el” had an openness rate of 30%.

[0169] The test sample “5e2” shown in [Fig. 5e2] was identical to that of [Fig. 5el] with respect to the perforations 85 and their arrangement. This test sample “5e2” further comprised first slots 75ea, 2 mm long, and second slots 75eb, 2 mm long, arranged as shown in [Fig. 5e2]. Thus, some of the slots 75ea and 75eb were spaced further apart than the slots of the test sample “5el” shown in [Fig. 5el]. This test sample “5e2” had an openness rate of 30%.

[0170] The test sample “5fi” shown in [Fig. 5fl] was identical to that of [Fig. 5a] with respect to the perforations 85 and their arrangement. This test sample “5fl” further comprised first slots 75ea, 2 mm long, and second slots 75eb, 2 mm long, arranged as shown in [Fig. 5fl]. The slots 75ea and 75eb formed a “chevron” pattern over four consecutive columns of perforations 85, extending in a direction parallel to axis B. This test sample “5fl” had an openness rate of 30%.

[0171] The test sample “5f2” shown in [Fig. 5f2] was identical to that of [Fig. 5fl] except that the slits 75ea and 75eb, which formed a “chevron” pattern extending in a direction parallel to axis B over 4 consecutive columns of perforations 85, were spaced further apart than the slits of the test sample “5fl” in [Fig. 5fl]. This test sample “5f2” had an openness rate of 30%.

[0172] The test sample “5f3” shown in [Fig.5f3] was identical to that of [Fig.5f2] except that the slits 75ea and 75eb formed on 4 columns The consecutive perforations of 85, forming a "chevron" pattern extending in a direction parallel to axis B, were more widely spaced than the slits of test sample "5f2" in [Fig. 5f2]. This test sample "5f3" had an openness rate of 30%.

[0173] The test sample “5f4” shown in [Fig. 5f4] was identical to that of [Fig. 5f3] except that the slots 75ea and 75eb, which formed a “chevron” pattern extending in a direction parallel to axis B over 4 consecutive columns of perforations 85, were spaced further apart than in the test sample “5f3” of [Fig. 5f3]. This test sample “5f4” had an openness rate of 30%.

[0174] The test sample “5g” shown in [Fig. 5g] was identical to that of [Fig. 5a] with respect to the perforations 85 and their arrangement. This test sample “5g” further comprised first slots 75ea and second slots 75eb, each 2 mm long, which connected four consecutive perforations 85 and were arranged as shown in [Fig. 5g]. This test sample “5g” had an openness rate of 30%.

[0175] The test sample “5h” shown in [Fig. 5h] had circular perforations 85h with a diameter of 10 mm arranged in a staggered pattern such that the distance between the centers of two consecutive perforations 85h on the same row of perforations 85h extending in a direction parallel to axis B was 1.2 mm and the distance between the centers of two consecutive perforations 85h on the same row of perforations 85h extending in a direction parallel to axis A was 20 mm. This sample “5h” also had first slits 75ha with a length of 2 mm and second slits 75hb with a length of 2 mm which were arranged as shown in [Fig. 5h]. The 75ha and 75hb slits formed on 4 consecutive columns of 85h perforations a "chevron" pattern extending in a direction parallel to axis B. This "5h" test sample had an opening rate of 62.9%.

[0176] The test sample “5i” shown in [Fig. 5i] was identical to that of [Fig. 5a] with respect to the perforations 85 and their arrangement. This test sample “5i” further comprised first slots 75ia and second slots 75ib arranged as shown in [Fig. 5i]. This test sample “5i” had an openness rate of 30%.

[0177] The test sample “5j” shown in [Fig. 5j] was identical to that of [Fig. 5a] with respect to the perforations 85 and their arrangement. This test sample “5j” further comprised 1st slots 75ia, 2nd slots 75ib, 3rd slots 75iia and 4th slots 75iib which were arranged as shown in [Fig. 5j]. This test sample “5j” had an openness rate of 30%.

[0178] The test sample “5k” shown in [Fig. 5k] was identical to that of [Fig. 5a] with respect to the perforations 85 and their arrangement. This test sample “5k” also had slots 75k arranged as shown in [Fig. 5k]. This test sample “5k” had an openness rate of 30%.

[0179] The test sample “51” shown in [Fig. 51] was identical to that of [Fig. 5a] with respect to the perforations 85 and their arrangement. This test sample “51” further comprised 1st slots 75ea, 2nd slots 75eb, 3rd slots 75k, and 4th slots 75ib, which were arranged as shown in [Fig. 51]. This test sample “51” had an openness rate of 30%.

[0180] The test sample “5m” shown in [Fig. 5m] was identical to that of [Fig. 5a] with respect to the perforations 85 and their arrangement. This test sample “5m” further comprised 1st slots 75ea, 2nd slots 75eb, 3rd slots 75ma, and 4th slots 75mb, which were arranged as shown in [Fig. 5m]. This test sample “5m” had an openness rate of 30%.

[0181] The test sample “5n” shown in [Fig. 5n] was identical to that of [Fig. 5a] with respect to the perforations 85 and their arrangement. This test sample “5m” further comprised first slots 75ea and second slots 75n arranged as shown in [Fig. 5n]. This test sample “5n” had an openness rate of 30%.

[0182] The test sample “5o” shown in [Fig. 5o] was identical to that of [Fig. 5a] with respect to the perforations 85 and their arrangement. This test sample “5o” further comprised 1st slots 75ea, 2nd slots 75eb, and 3rd slots 75n, which were arranged as shown in [Fig. 5o]. This test sample “5o” had an openness rate of 30%.

[0183] The test sample “5p” shown in [Fig. 5m] was identical to that of [Fig. 5a] with respect to the perforations 85 and their arrangement. This test sample “5p” further comprised 1st slots 75ea, 2nd slots 75eb, 3rd slots 75n and 4th slots 75p which were arranged as shown in [Fig. 5p]. This test sample “5p” had an openness rate of 30%.

[0184] The test sample “5q” shown in [Fig. 5q] was identical to that of [Fig. 5a] with respect to the perforations 85 and their arrangement. This test sample “5q” further comprised 1st slots 75ea, 2nd slots 75eb, 3rd slots 75ma, 4th slots 75mb, 5th slots 75qa, and 6th slots 75qb, which were arranged as shown in [Fig. 5q]. This test sample “5m” had an openness rate of 30%.

[0185] The extensibility of the 23 test samples was measured as follows.

[0186] Each test sample was cut in 3 different ways to obtain: - a "first cut test sample" with a width of 25 mm along axis B and a length of 150 mm along axis A; - a "2nd cut test sample" with a width of 25 mm along axis A and a length of 150 mm along axis B; - a "3rd cut test sample" with a width of 25 mm forming an angle of 45° with axis B and a length of 150 mm forming an angle of 45° with axis A.

[0187] The extensibility measurement was carried out according to standard EN 13726-4. Extensibility is the maximum force, expressed in N / cm, required to stretch by 20%: - said "1st test sample cut" along a direction parallel to axis A (hereinafter referred to as "extensibility at 0°"); - said "2nd test sample cut" along a direction perpendicular to axis A (hereinafter referred to as "extensibility at 90°"); - said "3rd test sample cut" along a direction forming an angle of 45° with axis A (hereinafter referred to as "extensibility at 45°").

[0188] Thus, a test sample is all the more conformable the lower the extensibility is in the 3 directions mentioned above.

[0189] Next, the ease of application of different dressings according to the invention and of a comparative dressing was determined.

[0190] More specifically, 23 types of square dressings, each 100 mm on a side, were manufactured such that each of the 23 types of dressings incorporated one of the 23 test samples of the thin, flexible polyurethane films described above. The first side of each of these 23 test samples of the thin, flexible polyurethane films was coated with a first adhesive layer consisting of silicone gel, 150 µm thick, and the second side was coated with a second adhesive layer consisting of an acrylic adhesive layer, 20 µm thick. This acrylic layer was itself coated with a second thin, flexible polyurethane film, 15 µm thick. The silicone gel layer was covered with a removable protective layer of polyethylene terephthalate.

[0191] The assembly consisting of the first adhesive layer, the first thin, flexible polyurethane film, and the second adhesive layer had perforations and slots extending through the entire thickness of the assembly. The characteristics and arrangement of these perforations and slots have been described above for the 23 test samples.

[0192] The dressings tested during this experiment differed from each other only with regard to the distribution of perforations and slits (where applicable, the absence of slits for the 1st test sample) in the assembly consisting of the 1st thin and flexible polyurethane film and the 1st and 2nd adhesive layers. The The comparative dressing was that obtained from the test sample "5a" described above. All other dressings in this experiment were dressings according to the invention.

[0193] The ease of application of these tested dressings was determined as follows: after removing the detachable protective layer, three samples of each tested dressing were applied to the wrist of 5 users. Application was evaluated by ratings from 0 to 4 given by the users. A rating of "0" corresponded to very difficult application of the tested dressing. A rating of "4" corresponded to very easy application of the tested dressing. For each tested dressing, an average of the ratings was calculated.

[0194] Next, the percentages of dressing detachment of the dressings according to the invention and of a comparative dressing were determined. These were dressings tested similar to those used for the ease-of-application experiments, except that these dressings also included a square pad, 50 mm on each side and 2 mm thick, made of polyurethane foam. This pad was centered on the side of the first adhesive layer opposite the side in contact with the first side of the thin, flexible polyurethane film. The comparative dressing was the dressing obtained from test sample "5a," and the other dressings were dressings according to the invention.

[0195] The percentage of detachment of these tested dressings was determined as follows: after removing the removable protective layer, two samples of each tested dressing were applied to the right and left biceps of five users. After 12 hours of application, the percentage of detached surface area of ​​the two applied dressings was measured, and an average of these two percentages was calculated. It was also noted whether the detachment resulted in a breach of the bacterial barrier, i.e., whether the detachment extended from the edge of the dressing to the pad.

[0196] Table 1 below summarizes all the results obtained from: - the extensibility at 0°, 45° and 90° for the various cut test samples mentioned above; - the ease of application of the 23 dressings described above for this experiment; - the percentage of detachment of the 23 dressings described above for this experiment.

[0197] [Tables] Test Sample / Dressing including test sample Extensibility (N / cm) Ease of application % of detachment 0° 45° 90° 5a 1.5 1.4 1.8 1.2 29 5bi 1.4 0.9 0.8 2.7 10 5b2 0.9 0.8 0.8 2.2 15 5bs 0.9 1 0.9 2.1 22 5c 1.5 0.3 0.8 2.9 11 5d 1.6 0.2 0.5 2.7 7 5ei 0.7 0.5 0.05 3.8 5e2 0.9 0.6 0.2 3.1 5fi 1 0.2 0.9 3.3 10 5f2 1.2 0.9 0.9 .2?5 14 5f3 1.3 1 0.9 2.1 20 5E 1.5 1.1 1.1 1.8 24 5g 1 0.1 0.5 3.2 12 5h 0.4 0.3 0.3 2.9 60 5i 0 0 0 3.6 3 5d 0 0 0 3.7 2 5k 0.8 0 0 3.4 8 51 0.4 0 0 3.3 5 5m 0.3 0.5 0 3.1 7 5n 0.7 0.4 0 3.5 5 5o 0.4 0.5 0 3 4 5p 0.3 0 0 3.9 2 Sq 0.1 0.4 0.1 3.8 3

[0198] By comparing the results of the comparative test sample "5a" with those of the other test samples according to the invention, it is noted that the slits have a very positive effect on: - conformability (the extensibility of the test sample "5a" is lower in all 3 directions than that of the test samples according to the invention), - the ease of applying the dressing (the score of 1.2 for test sample "5a" is the lowest score), - the percentage of dressing detachment. The percentage of detachment of 29% of the test sample "5a" is high compared to the percentages of detachment of the dressings according to the invention, with the exception of that of the test sample "5h", which we will discuss in more detail below.

[0199] Comparing the results of test samples "5c" and "5d", a positive effect is observed when the slits are longer. Test sample "5d" is more conformable than test sample "5c". Indeed, its extensibility values ​​at 45° and 90° are lower than those of test sample "5c". Furthermore, its delamination rate is much lower (7% versus 11%).

[0200] Comparing the results of test samples “5ei” and “5e2”, it was observed that increasing the density of the slits had a positive effect on conformability, ease of application, and the percentage of dressing detachment. Indeed, test sample “5ei” exhibited lower extensibility values ​​in all three directions (namely 0°, 45°, and 90°), indicating better conformability, a higher score for ease of application, and a lower percentage of detachment (namely 5% versus 8%) than test sample “5e2”.

[0201] The same findings regarding the effect of slit density were made by comparing the results of test samples "5fi" and "5f4". Indeed, it was also observed for these test samples that increasing slit density had a positive effect on conformability, ease of application, and the percentage of dressing detachment. Among these four test samples, test sample "5fi" exhibited the lowest extensibility values ​​in all three directions (namely 0°, 45°, and 90°), indicating the best conformability, the highest score for ease of application, and the lowest percentage of detachment (namely 10% versus 14%, 20%, and 24%).

[0202] By comparing the results of the test samples "5g" and "5f2", which differ in the length of their slits, the positive effect of increasing the slit length on conformability, ease of application, and dressing detachment percentage is observed. Indeed, the "5g" test sample exhibits: - lower extensibility values ​​in all 3 directions than those of the test sample "5f2", thus demonstrating better conformability of the test sample "5g", - a better rating for ease of dressing application (3.2 versus 2.5), - a lower percentage of dressing detachment (12% versus 14%).

[0203] By comparing the results of the test samples "5h" and "5f2", which differ in the size of their perforations, the effect of this size on the percentage of dressing detachment is observed. Indeed, the test sample "5h" has perforations of a much larger diameter than those of the other samples. drilling of the test sample "5f2" shows a detachment percentage of 60% which is much higher than that of the test sample "5f2" (14%).

[0204] Among all the dressings according to the invention tested, the dressing in test sample "5j" exhibits excellent conformability, very good ease of application (with a score of 3.7), and a very low detachment rate of 2%. The dressing according to the invention in test sample "5p" also shows excellent results with very good conformability, excellent ease of application (with a score of 3.9), and a very low detachment rate of 2%. This demonstrates that the characteristics of the slits and perforations in these test samples "5j" and "5p," as well as their arrangement, are particularly suitable for making the dressing according to the invention highly conformable, easy to apply, and without risk of detachment.

[0205] Finally, taking into account the diversity of the characteristics of the slits and perforations, as well as the diversity of their arrangement which were implemented with these 22 test samples according to the invention, it is noted with these results that the dressing according to the invention has the advantage of having a conformability, ease of application and percentage of detachment which can be modulated to best meet the needs of its user.

[0206] The breathability (in other words, the water vapor permeability) of the dressings of the test samples "5a" and "5ei" implemented for the experiment to determine ease of application was determined by carrying out tests according to the standard NF EN 13726 - 2, and this in a straight cup (the tested dressing was in contact with water vapor) and in an inverted cup (the tested dressing was in contact with liquid).

[0207] The aim was to compare the breathability of a dressing according to the invention (namely the dressing comprising the test sample "5ei") with that of the comparator dressing (namely the dressing comprising the test sample "5a"). As a reminder, the test sample "5ei" was identical to the test sample "5a" with regard to the perforations 85 and their arrangement, and it also included first slits 75ea of ​​a length of 2 mm and second slits 75eb of a length of 2 mm.

[0208] In addition, the breathability with elongation of these dressings was determined according to the standard NF EN 13726 - 2, and this only in a straight cup (the tested dressing was in contact with water vapor) by stretching the dressing by 20% in the directions 0° and 90° as defined above for the experimentation of the measurement of extensibility.

[0209] Implementing this breathability with elongation experiment is interesting because it is representative of situations involving muscular exertion (for example, during sports activities) in which the dressing is more deformed (compared to at rest) and the body produces perspiration. Therefore, the higher the breathability with elongation of the dressing, the better its ability to wick away perspiration from the pores of the area of ​​skin covered by the dressing. during situations requiring effort from the user.

[0210] Table 2 below summarizes the breathability and breathability with elongation results for the two dressings mentioned above. The results are expressed in g / m² / 24h. This involves determining the quantity of water (in g) that evaporates from one m² of the tested dressing in 24 hours. The higher this quantity, the better the breathability of the tested dressing.

[0211] [Tables2] Dressing including test sample Breathability - inverted cup Breathability - upright cup (g / m2 / 24hj Breathability with 20% elongation - upright cup Jg / mWh) 5a 9025 1660 2074 5ei 12540 1941 2488

[0212] In view of the results detailed in Table 2 above, it can be seen that the breathability (with or without elongation) of the dressing according to the invention is better than that of the comparator dressing. The presence of slits also improves the breathability of the dressing according to the invention.

Claims

Demands

1. Thin film dressing (la,lb,lc) comprising at least: - a first thin and flexible polymer or copolymer film (4) having a first face (10) and a second face (11); - a layer of a first adhesive (5) one of whose two faces is in contact with the first face (10) of the first thin and flexible polymer or copolymer film (4); - a detachable protective layer (6) positioned on the face of the layer of the first adhesive (5) which is opposite to that which is in contact with the first face (10) of the first thin and flexible polymer or copolymer film (4);characterized in that: said dressing (la,lb,lc) further comprises: - a layer of a 2nd adhesive (3) one of the two faces of which is in contact with the 2nd face (11) of the 1st thin and flexible film of polymer or copolymer (4), - a 2nd thin and flexible film of polymer or copolymer (2) having a 1st face (12) and a 2nd face (13), the 1st face (12) of this 2nd thin and flexible film of polymer or copolymer (2) being in contact with the face of the layer of the 2nd adhesive (3) which is opposite to that in contact with the 2nd face (11) of the 1st thin and flexible film of polymer or copolymer (4); the assembly (14) consisting of the 1st adhesive layer (5), the 1st thin and flexible polymer or copolymer film (4) and the 2nd adhesive layer (3) has perforations (8,8a,8b,8c,8d,8e,85,85h) and slots (7,7,75b,75a,75C,75ea,75eb,75ha,75hb,75ia,75ib,75iia,75iib,75k,751a,751b,75ma,75mb,75n,75p,75qa,75qb) which extend throughout the thickness of said assembly (14).

2. Thin film dressing (la,lb,lc) according to claim 1, characterized in that the thickness of the 1st thin and flexible polymer or copolymer film (4) is between 15 pm and 150 pm, preferably between 30 pm and 100 pm and the thickness of the 2nd thin and flexible polymer or copolymer film (2) is between 5 pm and 50 pm, preferably between 10 pm and 30 pm.

3. Thin film dressing (la,lb,lc) according to claim 1 or 2, characterized in that the 1st and 2nd thin and flexible polymer or copolymer films (4,2) are selected from polyurethane films, polyester, polyamide, polyether, polyvinyl chloride, polyvinylidene chloride, polyvinyl alcohols, polyvinyl acetate, polystyrene, polyolefins (such as polyethylene and polypropylene), polyvinyl fluoride, silicone elastomers, polyether-polyester copolymer films, polyester-polyurethane, polyether-polyurethane, polyether-polyamide, styrene and olefin triblock or diblock copolymer films (e.g. styrene / butadiene) and block polyether amide films.

4. Thin film dressing (la,lb,lc) according to any one of the preceding claims, characterized in that the first adhesive layer (5) is a pressure-sensitive adhesive based on acrylic, polyurethane, silicone, natural rubber, ethylene vinyl acetate copolymer or poly(styrene-isoprene-styrene) type block copolymer or a gel selected from silicone gel, polyurethane gel and hydrogels.

5. Thin film dressing (la,lb,lc) according to any one of the preceding claims, characterized in that the 2nd adhesive layer (3) is made of an adhesive material based on acrylic, silicone, polyurethane, natural rubber, hydrogel, ethylene vinyl acetate copolymer or poly block copolymer (styrene-isoprene-styrene).

6. Thin film dressing (la,lb,lc) according to any one of the preceding claims, characterized in that the opening ratio of the perforations (8,8a,8b,8c,8d,8e,85,85h) is between 10% and 60%, preferably between 20% and 40%, said opening ratio being the percentage of the total surface area of ​​the perforations (8,8a,8b,8c,8d,8e,85,85h) expressed in relation to the surface area that said assembly (14) would have in the absence of the perforations (8,8a,8b,8c,8d,8e,85,85h).

7. Thin film dressing (la,lb,lc) according to any one of the preceding claims, characterized in that the surface area of ​​each perforation (8,8a,8b,8c,8d,8e,85,85h) is between 0.2 mm2 and 80 mm2, preferably between 1.5 mm2 and 20 mm2.

8. Thin film dressing (la,lb,lc) according to any one of the preceding claims, characterized in that the slits (7,7',75b,75a,75C,75ea,75eb,75ha,75hb,75ia,75ib,75üa,75üb,75k,751a,751b,75ma,75mb,75n,75p,75qa,75qb) have a length between 0.5 mm and 20 mm, preferably between 1 mm and 10 mm.

9. Thin film dressing (la,lb,lc) according to any one of the claims previous indications, characterized in that the total length of the slots (7,7',7 5b,7 5a,7 5c,7 5ea,7 5eb,7 5ha,7 5hb,7 5ia,7 5ib,7 5iia,7 5iib,7 5k,7 51a,7 51b,7 sma,7 smb,7 5n,7 5p,75qa,75qb) per unit area of ​​said assembly (14) is between 1 mm / cm2 and 30 mm / cm2, preferably between 2 mm / cm2 and 15 mm / cm2.

10. Thin film dressing (la,lb,lc) according to any one of the preceding claims, characterized in that the 1st and 2nd thin, flexible polymer or copolymer films (4,2) are polyurethane, the 1st adhesive layer (5) is a silicone gel layer and the 2nd adhesive layer (3) is an acrylic layer.

11. Thin film dressing (lb,lc) according to any one of the preceding claims, characterized in that it further comprises a pad (9) which is fixed: - on the face of the 1st adhesive layer (5) which is opposite to that which is in contact with the 1st face (10) of the 1st thin and flexible polymer or copolymer film (4) or - on the face of the 2nd adhesive layer (3) which is opposite to that which is in contact with the 2nd face (11) of the 1st thin and flexible polymer or copolymer film (4).

12. A method for manufacturing a dressing (la) according to any one of claims 1 to 10, characterized in that it comprises at least the following steps: a) the first face (10) of the first thin, flexible polymer or copolymer film (4) is covered with the layer of first adhesive (5) and the second face (11) of the first thin, flexible polymer or copolymer film (4) is covered with the layer of second adhesive (3); b) a first support layer is applied to the face of the layer of first adhesive (5) which is opposite to that which is in contact with the first face (10) of the first thin, flexible polymer or copolymer film (4); c) a 2nd support layer is applied to the face of the layer of the 2nd adhesive (3) which is opposite to that which is in contact with the 2nd face (11) of the 1st thin and flexible film of polymer or copolymer (4);d) perforations (8,8a,8b,8c,8d,8e,85,85h) are made throughout the thickness of an assembly consisting of the first support layer, the first adhesive layer (5), the first thin and flexible polymer or copolymer film (4), the second adhesive layer (3) and the second support layer; e) slots (7,7,75b,75a,75C,75ea,75eb,75ha,75hb,75ia,75ib,75ba,75bb,75k,75ia,751b,75ma,75mb,75n,75p,75qa,75qb) are made throughout the thickness of a; assembly consisting of the 1st adhesive layer (5), the 1st thin and flexible polymer or copolymer film (4), the 2nd adhesive layer (3) and the 2nd support layer; f) the 2nd layer of support is removed; (g) the 2nd thin and flexible polymer or copolymer film (2) is applied to the 2nd adhesive layer (3); h) the first support layer is removed; (i) the detachable protective layer (6) is applied over the first adhesive layer (5) so as to obtain said dressing (la).

13. A method of manufacturing according to claim 12 a thin film dressing (lb,lc) according to claim 11, characterized in that it comprises an additional step consisting, at the end of step h) and before step i), of applying the compress (9): - on the face of the first adhesive layer (5) which is opposite to that which is in contact with the first face (10) of the first thin and flexible polymer or copolymer film (4) Or - on the face of the 2nd adhesive layer (3) which is opposite to that which is in contact with the 2nd face (11) of the 1st thin and flexible film of polymer or copolymer (4).

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