Method of making polydiorganosiloxane adhesive with a mask and articles

Abstract

Methods of making an adhesive article are described, the method comprising: a) providing a mask between a layer of a polydiorganosiloxane composition and a source of radiant energy, wherein the mask comprises one or more openings that expose a portion of the layer of the polydiorganosiloxane composition and covers a portion of the layer of the polydiorganosiloxane composition; b) crosslinking the layer of the polydiorganosiloxane composition with the radiation such that the portion of the layer of the polydiorganosiloxane composition exposed through the one or more openings of the mask has greater crosslinking than the portion covered by the mask. In some embodiments, the mask is a mask substrate that is permanently bonded to the layer of polydiorganosiloxane after crosslinking. In other embodiments, the mask is a release liner mask that is removable from the layer of polydiorganosiloxane after crosslinking. In yet other embodiments, the mask is a non-contact machining mask. Also described are adhesive articles such as medical articles, including medical tapes, bandages, and wound dressings; and methods of use.

Description

Summary of the Invention

[0001] A method of manufacturing an adhesive article, the method comprising: a) providing a mask between a layer of a polydiorganosiloxane composition and a radiation energy source, wherein the mask includes one or more openings exposing a portion of the layer of the polydiorganosiloxane composition and covering a portion of the layer of the polydiorganosiloxane composition; b) crosslinking the layer of the polydiorganosiloxane composition with radiation such that the portions of the layer of the polydiorganosiloxane composition exposed through the one or more openings of the mask have greater crosslinking than the portions covered by the mask. In some embodiments, the mask is a mask substrate permanently bonded to the layer of polydiorganosiloxane after crosslinking. In other embodiments, the mask is a release liner mask removable from the layer of polydiorganosiloxane after crosslinking. In still other embodiments, the mask is a non-contact processing mask.

[0002] It also describes adhesive products, such as medical products, including medical tapes, bandages, and wound dressings.

[0003] In one embodiment, the adhesive article comprises a layer of a crosslinked polydiorganosiloxane composition having two main surfaces, the first main surface comprising a pressure-sensitive adhesive, and the second main surface bonded to a mask substrate comprising at least one opening exposing a film backing of the crosslinked polydiorganosiloxane composition.

[0004] In another embodiment, the adhesive article comprises a layer of a crosslinked polydiorganosiloxane composition having two main surfaces, the first main surface comprising a pressure-sensitive adhesive, and the second main surface being bonded to a mask substrate; wherein the first main surface comprises a portion covered by the mask substrate and a portion exposed through an opening in the mask substrate, and the exposed portion comprises a larger crosslinking than the covered portion.

[0005] In another embodiment, the adhesive article comprises a layer of a crosslinked polydiorganosiloxane composition having two main surfaces, the first main surface comprising a pressure-sensitive adhesive and the second main surface comprising a film backing, wherein the first main surface comprises a first portion comprising a larger crosslinking than the adjacent portion. Attached Figure Description

[0006] Figure 1A It is a top plan view of the specific mask; Figure 1B It is a top plan view of the cross-linked assembly including the mask substrate and layers; Figure 2 It is a schematic side view of the specific method; Figure 3 This is a schematic side view of a specific article comprising a crosslinked layer of a polydiorganosiloxane composition disposed between a mask and a release liner substrate; Figure 4A and Figure 4B It is a top plan view of other specific artifacts (such as wound dressings) that include the mask base frame; Figure 5 It is a top plan view of the specific mask; Figure 6 This is a schematic side view of a specific article comprising a crosslinked layer of a polydiorganosiloxane composition disposed between a release liner and a mask substrate, the mask substrate further comprising a carrier substrate; Figure 7 It is by Figure 5 A top plan view of the product fabricated using a mask; Figure 8 It is a top plan view suitable for providing an exemplary mask for enhancing the system; Figure 9A It is a top plan view of the article including the mask base frame and the reinforcement system; Figure 9B yes Figure 9A The position of the dotted line Figure 9A A schematic side view of the product; Figure 10 It is a top plan view of the article including the mask base frame, the reinforcement system, and the opening suitable for inserting the tube; Figure 11 This is a top plan view of a specific article, which includes a mask base frame with a reinforcement system and an absorbent pad disposed between a release liner and a crosslinked layer of a polydiorganosiloxane composition; Figure 12 This is a schematic diagram of another article, which includes a mask substrate, a reinforcement system, a crosslinked layer of a polydiorganosiloxane composition, an absorbent pad, and a release liner; Figure 13 It includes Figure 11 Enhanced system Figure 12 Top plan view of the product; Figure 14 This is a schematic diagram of another specific article (e.g., a surgical drape) that includes a mask substrate with openings, a cross-linked layer of a polydiorganosiloxane composition, and a release liner.

[0007] Manufacturing method

[0008] refer to Figure 2A schematic side view of a specific method for manufacturing an adhesive article, the method typically comprising providing a layer 220 of a polydiorganosiloxane composition between a mask 201 and a radiation energy source 275. In a typical embodiment, the mask is a mask substrate permanently bonded to the polydiorganosiloxane layer after crosslinking. In other embodiments, the mask is a release liner mask that can be removed from the polydiorganosiloxane layer after crosslinking. In yet another embodiment, the mask is a non-contact processing mask, such as a metal mask. Non-contact processing masks are sufficiently close to the polydiorganosiloxane layer during crosslinking, but typically do not contact the polydiorganosiloxane.

[0009] In a typical embodiment, a layer of the polydiorganosiloxane composition (e.g., uncrosslinked or partially crosslinked) is applied to a substrate 240 (such as a release liner as described above) using any suitable dispenser 250 (such as an extruder). The layer of the polydiorganosiloxane composition includes a first primary surface 221 adjacent to the substrate. In some embodiments, a mask substrate or release liner mask 201 contacts the opposite surface 223 of the layer 220 of the polydiorganosiloxane composition.

[0010] Figure 1 is a top plan view of an exemplary mask 101, which includes one or more openings 110 through the mask thickness. The method also includes exposing the opposite second primary surface 223 of the polydiorganosiloxane composition layer to radiation, thereby crosslinking the polydiorganosiloxane composition layer. Typically, the chamber is inert (e.g., the oxygen-containing chamber air is replaced with an inert gas, such as nitrogen), and the sample is crosslinked by the electron beam. During crosslinking, the portions of the polydiorganosiloxane composition layer present within one or more openings of the mask are exposed to a greater dose of radiation energy and therefore have greater crosslinking than the portions covered by the mask.

[0011] Figure 3This is a schematic side view of a layer 320 of a polydiorganosiloxane composition disposed between a mask substrate or release liner mask 301 and a release liner substrate 340. Layer 320 of the polydiorganosiloxane composition includes a first primary surface 321 adjacent to the release liner substrate 340 and an opposite second primary surface 323 partially covered by the mask. The primary surfaces are substantially parallel to each other, and the thickness of one or more layers is orthogonal to the primary surfaces. The mask substrate 301 is absent at the location of the mask substrate opening 310. During crosslinking, the portion 325 of the layer of the polydiorganosiloxane composition exposed through one or more openings 310 of the mask is exposed to a greater dose of radiation energy than the portion covered by the mask. Therefore, the portion 325 of the layer of the polydiorganosiloxane composition exposed through one or more openings 310 of the mask has higher crosslinking and lower tackiness than the adjacent portions 324, 325 of the polydiorganosiloxane layer covered by the mask substrate 301 during crosslinking. Conversely, the portion of the polydiorganosiloxane composition layer covered by the mask substrate 301 is exposed to a lower dose of radiation energy than the portion 325 of the polydiorganosiloxane composition layer exposed through one or more openings 310 of the mask.

[0012] In some embodiments, due to differences in radiation energy dose exposure, the same polydiorganosiloxane composition can be used to manufacture both the wound contact surface (i.e., surface 323 of exposed portion 325) and the adjacent skin contact pressure-sensitive adhesive surface (i.e., surface 321 of portions 324, 326). In other embodiments, the polydiorganosiloxane composition may comprise two or more layers of different polydiorganosiloxane compositions, as will be discussed later relative to... Figure 9B As described. Therefore, the wound contact surface, the adjacent skin contact pressure-sensitive adhesive surface, and the opposite membrane backing surface comprise a cross-linked polydiorganosiloxane composition. In this embodiment, the medical article may be without a separate membrane backing, such as a polyurethane membrane backing, particularly at the second surface opposite the wound contact surface.

[0013] When the mask is a mask substrate 301 that contacts an uncrosslinked or partially crosslinked polydiorganosiloxane layer before crosslinking, the mask substrate 301 is typically permanently bonded to layer 320 of the polydiorganosiloxane composition, except at the locations of openings in the mask substrate 301.

[0014] In a typical implementation, the base (240, 340, 640) is a non-opening (e.g., continuous) release liner. During use, the release liner 340 is removed from the article and applied to the patient such that the surface 323 of the exposed portion 325 comes into contact with the wound, and the surfaces 321 of the portions 324 and 326 covered by the masking base 301 adhere to the skin around the wound. In some implementations, the mask is a release liner mask.

[0015] Various release liner types are known and commercially available. Release liner types may include a polyester terephthalate support film and a release coating. Other support films used for the release coating include polyolefins (e.g., polyethylene, polypropylene) and paper. In some embodiments, the release coating may be a fluorosilicone material. Release coatings free of silicone and / or fluorinated materials have also been described for use with polydiorganosiloxane adhesives.

[0016] Release liners are typically characterized as having light, medium, or heavy peel strength based on the peel force required to remove the pressure-sensitive adhesive from the adhesive article. This can be measured according to EN ISO 29862, Annex B (Self-adhesive tapes – Peel adhesion measured from a surface at a 90° angle) using an SP-2100 peel tester from IMass, Inc., equipped with a 10 lbf force sensor and a peel rate of 30 cm / min. When heavy peel strength is required, the peel force required to remove the pressure-sensitive adhesive from the adhesive article from the release liner can be at least 40 g / in (2.54 nm) or greater. When light peel strength is required, the peel force required to remove the pressure-sensitive adhesive from the adhesive article from the release liner can be less than 10 g / in or 5 g / in (2.54 nm). When medium peel strength is required, the peel force required to remove the pressure-sensitive adhesive from the adhesive article from the release liner can be greater than 10 g / in and less than 40 g / in (2.54 nm).

[0017] Various release liner products are commercially available, including release liner products purchased under the trade name "SILFLU" from Siliconature Spa (Godega di Sant'Urbano, Italy); and release liner products purchased under the trade name Cerapeel. ™ The stripping liner was purchased from Toray; the POLYSILK was from Loparex International BV (Apeldoorn, The Netherlands). ™ Silicone release liner; from 3M Company (StPaul, MN), St. Paul, Minnesota, USA. ™ Scotchpak ™ 9741 stripper gasket; and perfluorinated stripper chemicals as disclosed in US 4,472,480.

[0018] In some embodiments, a thicker layer of the same polydiorganosiloxane composition is crosslinked from one side, thereby providing a crosslinking gradient. However, in other embodiments, layers of the polydiorganosiloxane composition may be exposed to more than one instance of radiation or (e.g., radiation of different intensities) from both sides. The polydiorganosiloxane composition, thickness, and crosslinking conditions are selected such that a first primary surface (e.g., 321) adjacent to (e.g., a release liner) of the substrate is a pressure-sensitive adhesive, and the opposite second primary surface (i.e., closer to the radiation energy source) 323 and exposed portions 325 form a film backing. In some embodiments, covered portions 324 and 326 may form a film backing together with the mask substrate.

[0019] In another embodiment, the polydiorganosiloxane layer can be formed by coating more than one layer of the same polydiorganosiloxane composition. For example, a first layer can be applied to a release liner substrate, a porous substrate can be applied to the first layer, and a second layer can be applied to the porous substrate, as described in commonly filed U.S. Application No. 63 / 595859, which is incorporated herein by reference.

[0020] In another embodiment, the polydiorganosiloxane composition may comprise more than one layer of different polydiorganosiloxane compositions. Figure 9B This is a cross-sectional view of a specific article comprising a first layer 920B of a polydiorganosiloxane composition (e.g., applied to a release liner substrate) and a second layer 920A of a different polydiorganosiloxane composition (e.g., applied to the first layer). In one embodiment, the polydiorganosiloxane composition of the second layer 920A contains little or no (e.g., silicate) tackifying resin compared to the polydiorganosiloxane composition of the first layer 920B. In another embodiment, the polydiorganosiloxane composition of the first layer 920B contains additives, such as antimicrobial agents (e.g., silver materials) or pharmaceuticals, while the polydiorganosiloxane composition of the second layer 920A contains little or no such additives. In yet another embodiment, the polydiorganosiloxane composition of the first layer 920B may contain additives, such as antimicrobial agents or pharmaceuticals, and tackifying resins; however, the second layer 920A may not contain such additives and tackifying resins. Various other combinations of different polydiorganosiloxane compositions will be apparent to those skilled in the art.

[0021] The total thickness of the polydiorganosiloxane layer is typically at least 250 micrometers. The thickness of the polydiorganosiloxane layer is typically no greater than 1000 micrometers, 900 micrometers, 800 micrometers, or 700 micrometers. In some embodiments, the thickness is no greater than 650 micrometers, 600 micrometers, 550 micrometers, 500 micrometers, 450 micrometers, 400 micrometers, 350 micrometers, 300 micrometers, or 250 micrometers. However, when the polydiorganosiloxane layer comprises multiple layers, a single layer may have a thickness of less than 250 micrometers.

[0022] In typical embodiments, the polydiorganosiloxane composition is crosslinked by exposure to electron beam radiation. In some embodiments, the coating can be crosslinked by exposure to gamma radiation. In some embodiments, a combination of electron beam crosslinking and gamma-ray crosslinking can be used. For example, in some embodiments, the coating can be partially crosslinked by exposure to electron beam radiation. Subsequently, the coating can be further crosslinked by gamma radiation. Commercially available electron beam generating equipment is available, such as the CB-300 electron beam generating device (available from Energy Sciences, Inc. (Wilmington, MA) of the United States), also described in US 8,541,481. Commercially available gamma radiation equipment includes equipment commonly used for gamma radiation sterilization of products intended for medical applications.

[0023] In some embodiments, the polydiorganosiloxane material is exposed to electron beam radiation having a voltage of at least 200 kV, 250 kV, or 300 kV. The voltage of the electron beam radiation is typically no greater than 500 kV, 450 kV, 400 kV, 350 kV, or 300 kV. The total dose of the (electron beam) radiation is typically at least 8 MRad, 9 MRad, 10 MRad, 11 MRad, 12 MRad, 13 MRad, 14 MRad, or 15 MRad. In some embodiments, the total dose of the (electron beam) radiation is typically no greater than 25 MRad or 20 MRad. The intensity and total exposure are based on the electron beam generating device and the exposure time. It should be understood that in this invention, the first primary surface and the opposite second primary surface of the polydiorganosiloxane layer receive different doses of (electron beam) radiation.

[0024] Mask substrate and product

[0025] Masks include mask substrates, stripper masks, or non-contact processing masks with one or more openings. Figure 1A This is a top plan view of an exemplary mask (e.g., a substrate or release liner mask) 105 including one or more openings 110. In the top plan view, the total surface area of ​​the openings may be at least 25%, 30%, 35%, 40%, 45%, 50%, or greater of the total surface area of ​​the mask. In the top plan view, the surface area of ​​a single opening is typically at least 1 square centimeter, 2 square centimeters, 3 square centimeters, 4 square centimeters, or 5 square centimeters. The total surface area of ​​one or more openings may range up to 10 square centimeters, 15 square centimeters, or 20 square centimeters or greater. The size of the openings in the mask is the same as the size of the crosslinked layer exposed through the openings in the mask substrate of the polydiorganosiloxane composition.

[0026] Figure 1B This is a top plan view of a crosslinked assembly including a mask (e.g., substrate 105). The crosslinked layer of the polydiorganosiloxane composition 120 is exposed through openings in the mask. The crosslinked layer of the polydiorganosiloxane composition 120 is also present beneath the mask substrate 105 and is permanently bonded to the mask substrate 105 in some embodiments (as shown in the schematic side view). In some embodiments, the mask includes a plurality of openings, each of which is a single (e.g., medical) article 115 formed by cutting the crosslinked assembly of the layers in a lateral direction at a location 121 between the openings. The crosslinked layer of the polydiorganosiloxane composition 120 exposed through the openings in the mask substrate can be characterized as a membrane backing layer (i.e., at the opposite surface) or a wound contact layer (i.e., at the first main surface near the release liner substrate). The crosslinked layer of the polydiorganosiloxane composition 120 exposed through the openings in the mask substrate is transparent or translucent, allowing observation of the wound through such a layer.

[0027] Masking substrates are typically made of natural or synthetic organic materials that allow electron beams and / or gamma radiation to pass through. Masking substrates can be made from a variety of (e.g., thermoplastic) organic polymer materials, such as polyesters, polyurethanes, polyamides (e.g., nylon), polyimides, and polyolefins.

[0028] The masking substrate is typically a soft, flexible, conformal, non-irritating, and non-allergenic material. In some embodiments, the masking substrate is a moisture-permeable membrane, or a porous substrate including perforated membranes, or a fibrous web including woven fabrics, nonwovens, knitted webs, and loosely woven fabrics.

[0029] Suitable moisture-permeable membranes may include (e.g., thermoplastic) polyurethanes, such as those available under the trade names PELLETHANE or ESTANE from Lubrizol, Brecksville, Ohio; elastomeric polyesters, such as those available under the trade name HYTREL from El. duPont deNemours & Co., Wilmington, Del.; and polyether ester block amides, such as those available under the trade name PEBAX from Elf Altochem North America, Philadelphia, Pa. Other available membranes are those described in U.S. Patent Nos. 4,499,896 (Heinecke), 4,598,004 (Heinecke), and 5,849,325 (Heinecke et al.). However, since the mask substrate does not come into contact with the wound, a variety of other substrates may be suitable, such as (meth)acrylate membranes and polyolefins. Typically, the mask substrate has higher tensile strength and lower elongation than the crosslinked layer of the polydiorganosiloxane composition, and therefore provides reinforcement and improves web processing. In some embodiments, the mask substrate material has a maximum tensile strength of at least 20 MPa, 30 MPa, or 40 MPa, and typically no greater than 60 MPa, 50 MPa, or 40 MPa (ASTM D 412). In some embodiments, the mask substrate material has a maximum elongation of at least 100%, 200%, 300%, 400%, or 500%, and typically no greater than 1000%, 750%, or 500% (ASTM D 412). In some embodiments, the thickness of the mask substrate film is at least 25 micrometers, 50 micrometers, or 75 micrometers. In some embodiments, the thickness of the mask substrate film is no greater than 200 micrometers, 150 micrometers, or 100 micrometers. In some embodiments, a thicker mask substrate film may preferably form a frame portion with a smaller width.

[0030] The fiber mask substrate can be made from the same natural and synthetic organic materials as described above. The fiber web can also be made from a variety of organic fibers, such as cotton, wool, hemp, and flax. Fiber webs come in many forms, including, for example, woven webs, nonwoven webs, knitted fabrics, loose fabrics, and mesh.

[0031] The fiber mask substrate may have a density of at least 15 g / m². 2 20g / m 2 25g / m 2 30g / m 2 35g / m 240g / m 2 45g / m 2 Or 50g / m 2 The basis weight. Fiber mask substrates typically have a basis weight of no more than 200 g / m². 2 150g / m 2 Or 100g / m 2 The basis weight. The thickness of the fiber mask substrate is typically at least 0.05 mm (50 micrometers), 0.10 mm (100 micrometers), or 0.15 mm (150 micrometers). In some embodiments, the thickness of the fiber mask substrate is no greater than 0.5 mm (500 micrometers), 0.4 mm, 0.3 mm, or 0.2 mm. The number of strands in the fiber mask substrate is typically at least 5 strands / inch, 10 strands / inch, 15 strands / inch, 20 strands / inch, or 25 strands / inch (2.54 cm). In some embodiments, the number of strands in the fiber mask substrate is no greater than 100 strands / inch, 150 strands / inch, 100 strands / inch, 75 strands / inch, or 50 strands / inch (2.54 cm).

[0032] Masks can have a variety of designs. In some embodiments, a mask includes one or more openings having the same (e.g., repeating) geometry, such as polygons (e.g., triangles, squares, rectangles, etc.), ovals, ellipses, hexagons, etc. The geometric openings typically include rounded corners. It should be understood that medical articles including wound dressings can be available in a variety of sizes and shapes, depending on the medical article. Exemplary medical articles include medical tapes, bandages, wound dressings, IV site dressings, pressure bandages, surgical drapes, prostheses, ostomy or ostomy bags, oral patches, or transdermal patches. In some embodiments, a cross-linked layer of a polydiorganosiloxane composition can also be used in other articles, including dentures and wigs.

[0033] Figure 4A and Figure 4B This is a top plan view of other articles (e.g., wound dressings) including a mask (e.g., substrate) frame 405 substantially surrounding a single opening comprising a crosslinked polydiorganosiloxane layer 420. In some embodiments, the mask (e.g., substrate) frame has a width “w” of 1 cm, ranging up to 5 cm, 10 cm, 15 cm, or 20 cm. In the top plan view, the width is typically the minimum dimension of the mask (e.g., substrate) frame. In some embodiments, the mask used during manufacturing has a wider frame width, which is cut to a smaller width after crosslinking of the polydiorganosiloxane composition. Figure 4A In the process, the frame of the product is cut across its width. This facilitates the removal of the underlying peel liner. Figure 4B In the middle, a portion of the frame has been removed to provide a space 460 suitable for inserting an intravenous (IV) tube.

[0034] Figure 5 This is a top plan view of another specific mask 501, which includes a plurality of first main openings 510 and second small (e.g., circular) openings 560. The first main openings are adapted to contact the central wound area of ​​a single medical article, and the second small openings are adapted to insert an intravenous (IV) catheter. In some embodiments, in the top plan view, the surface area of ​​the main openings is at least 5, 10, 15, or 20 times that of the small openings.

[0035] Figure 6 This is a schematic side view of layer 620 of the polydiorganosiloxane composition disposed between mask substrate 601 and release liner substrate 640. In this embodiment, mask substrate 501 (e.g., polyurethane) may also include carrier substrate 615 (e.g., paper) to facilitate web processing of the highly conformable polyurethane film. Mask substrate 601 and carrier substrate 615 include one or more openings 610. The carrier substrate may be removed after the polydiorganosiloxane composition has been crosslinked or when using the article of manufacture.

[0036] Figure 7 It is by Figure 5 A top plan view of an article (e.g., a wound dressing) prepared using a mask. The article includes a mask base frame 705 surrounding a main opening 710. A cross-linked polydisiloxane layer 720 is exposed through the main opening 710. A second (e.g., circular) minor opening 760 is adapted for insertion of an IV tube. In some embodiments, the cross-linked polydisiloxane layer 720 is exposed through the minor opening 760. In another embodiment, the minor opening 760 may not be present in the mask, and instead all layers are cut through after the polydisiloxane layer has been cross-linked.

[0037] Figure 8 This is a top plan view of another specific mask, which includes a system for forming reinforcement (i.e., relative to...). Figure 9A Multiple openings 810 of the same reinforcement system.

[0038] Figure 9A It is by Figure 8 A top plan view of an article (e.g., a wound dressing) prepared using a mask. The article includes a mask (e.g., a substrate) frame 905 surrounding an opening. A crosslinked polydiorganosiloxane layer 920 is exposed through the opening. Portions of masks 971, 972, and 973 extend from one side of mask (e.g., substrate) frame 905A to the opposite side of mask (e.g., substrate) frame 905B, thereby forming a reinforcing system for the crosslinked polydiorganosiloxane layer 920. A portion of frame 905 and crosslinked polydiorganosiloxane layer 920 has been removed to provide a gap 960 suitable for insertion of an intravenous (IV) catheter.

[0039] Figure 9B yes Figure 9A The position of the dotted line Figure 9A A schematic side view of the article. In this embodiment, the crosslinked layer 920 of the polydiorganosiloxane comprises two different polydiorganosiloxane compositions 920A and 920B as previously described, disposed between a mask (e.g., a substrate) and a release liner substrate (below a first main surface 921, not shown). The mask includes a mask (e.g., a substrate) frame 905 and a mask (e.g., a substrate) reinforcing element 973. During crosslinking, surface 923 (i.e., surface C) of layer 920B is exposed to the maximum dose of radiation energy because it is exposed by the opening of the mask and is closest to the radiation energy source. The first main surface 921 of layer 920B comprises two adjacent pressure-sensitive adhesive surfaces A and B. Surface A has different adhesive properties than surface B, such as lower tack, lower elongation, and higher tensile strength, and surface B is covered by the mask (e.g., a substrate) 905 or 973 during crosslinking.

[0040] Figure 10 This is a top plan view of article 1000, which includes a mask base frame 1005; a reinforcement system including mask base reinforcement elements 1071, 1072 and 1073 extending from one side of the mask base frame 1005A to the opposite side of the mask base frame 1005A; and a gap 1060, which is at least in the mask base and generally in all layers suitable for inserting a tube.

[0041] Figure 11 This is a top plan view of article 1100, which includes a mask (e.g., substrate) frame 1105; a reinforcement system including mask (e.g., substrate) reinforcement elements 1071, 1072, and 1073 extending from one side of mask (e.g., substrate) frame 1105A to the opposite side of mask (e.g., substrate) frame 1105B; and an absorbent pad 1080 disposed between a release liner substrate and a crosslinked layer 1120 of polydiorganosiloxane. When the crosslinked layer 1120 of polydiorganosiloxane is transparent, the absorbent pad 1080 underneath is visible through the crosslinked layer 1020 of polydiorganosiloxane.

[0042] Figure 12 It describes US 7,294,752. Figure 2 The middle section shows an exploded schematic diagram of the layers of another specific article of manufacture. In one embodiment, the article of manufacture includes a layer 1220 of a polydiorganosiloxane composition disposed between a mask substrate 1201 and a release liner substrate 1240. The mask substrate 1201 is not present at the location of the opening in the mask substrate. As previously stated relative to... Figure 3As illustrated in Figure 9, during crosslinking, the portion of the polydiorganosiloxane composition layer exposed through one or more openings in the mask is exposed to a greater dose of radiation energy than the portion covered by the mask substrate. Therefore, the portion of the polydiorganosiloxane composition layer exposed through one or more openings in the mask has higher crosslinking and lower tackiness than the adjacent portion of the polydiorganosiloxane layer covered by the mask substrate during crosslinking, as previously described. In some embodiments, the article of manufacture further includes a reinforcing system 1270 between the mask substrate and the crosslinked layer of the polydiorganosiloxane composition layer, rather than a reinforcing system integrated with the openings in the mask substrate. Such a reinforcing system can be made using various techniques, such as those described in US 7,294,752 and WO2020 / 245721; which are incorporated herein by reference.

[0043] Figure 13 It includes Figure 11 A top plan view of another specific product of the reinforcing system, which is integrated into Figure 12 The article is located within the main opening of the mask substrate. This embodiment may optionally also include a second reinforcement system 1270 between the mask substrate and the crosslinked layer of the polydiorganosiloxane composition, such as... Figure 12 What is depicted.

[0044] Figure 14 This is an exploded schematic diagram depicting a layer of another specific article suitable for use as a surgical drape or cover for a negative pressure treatment system as described in US2017 / 0079846; incorporated herein by reference. The article includes a layer 1420 of a polydiorganosiloxane composition disposed between a mask (e.g., a substrate) 1401 (including a plurality of openings 1410) and a release liner substrate 1440. The portions of the crosslinked layer of the polydiorganosiloxane composition exposed through the openings in the mask substrate have greater crosslinking and generally lower tack than adjacent portions covered by the mask substrate. The crosslinked layer of the polydiorganosiloxane composition can be characterized as a sealing adhesive. The article may optionally also contain an adhesive (e.g., acrylic) as described in US2017 / 0079846.

[0045] Polydiorganosiloxane Composition

[0046] Silicone gel materials have been used in medical therapies to promote scar tissue healing. Slightly cross-linked silicone gels are soft, tacky, and elastic materials with low to moderate adhesive strength compared to traditional tackifying silicone PSA. Silicone gels are generally softer than silicone PSA, resulting in less discomfort when adhering to and removing from the skin. This combination of relatively low adhesive strength and moderate tack makes silicone gels suitable for gentle adhesive applications on the skin.

[0047] Crosslinked siloxane networks can be formed from functional or non-functional organosilicon materials. When the siloxane network is formed from a functional organosilicon material, the functional groups can react or, in other words, cure, which can also be characterized as crosslinking. Due to the very low glass transition temperature (Tg) and modulus of polysiloxane networks, these gel adhesives exhibit excellent wetting properties.

[0048] Organosilicon materials are polydiorganosiloxanes, i.e., materials comprising a polysiloxane backbone. In some embodiments, nonfunctionalized organosilicon materials can be linear materials described by the following formula, which exemplifies a siloxane backbone having aliphatic and / or aromatic substituents:

[0049] R1, R2, R3, and R4 are independently selected from the group consisting of alkyl and aryl groups, each R5 is an alkyl group, and n and m are integers, with at least one of m or n being non-zero. In some embodiments, one or more of the alkyl or aryl groups may contain a halogen substituent, such as fluorine. For example, in some embodiments, one or more alkyl groups may be -CH2CH2C4F9.

[0050] In some embodiments, R5 is a methyl group, i.e., the nonfunctionalized polydiorganosiloxane material is end-capped with a trimethylsiloxy group. In some embodiments, R1 and R2 are alkyl groups, and n is zero, i.e., the material is poly(dialkylsiloxane). In some embodiments, the alkyl group is a methyl group, i.e., poly(dimethylsiloxane) (“PDMS”). In some embodiments, R1 is an alkyl group, R2 is an aryl group, and n is zero, i.e., the material is poly(alkylarylsiloxane). In some embodiments, R1 is a methyl group, and R2 is a phenyl group, i.e., the material is poly(methylphenylsiloxane). In some embodiments, R1 and R2 are alkyl groups, and R3 and R4 are aryl groups, i.e., the material is poly(dialkyldiarylsiloxane). In some embodiments, R1 and R2 are methyl groups, and R3 and R4 are phenyl groups, i.e., the material is poly(dimethyldiphenylsiloxane).

[0051] In some embodiments, the nonfunctionalized polydiorganosiloxane material may be branched. For example, one or more of the R1, R2, R3 and / or R4 groups may be linear or branched siloxanes having alkyl or aryl (including haloalkyl or aryl) substituents and a terminal R5 group.

[0052] As used herein, a “nonfunctional group” is an alkyl or aryl group consisting of carbon, hydrogen, and, in some embodiments, a halogen (e.g., fluorine) atom. As used herein, a “nonfunctionalized polydiorganosiloxane material” is a polydiorganosiloxane material in which the R1, R2, R3, R4, and R5 groups are nonfunctional groups.

[0053] Typically, functionalized organosilicon systems include specific reactive groups (e.g., hydrogen, hydroxyl, vinyl, allyl, or acrylic groups) attached to the polysiloxane backbone of the starting material. As used herein, a “functionalized polydiorganosiloxane material” is a material in which at least one of the R groups of Formula 2 is a functional group.

[0054]

[0055] In some embodiments, the functionalized polydiorganosiloxane material comprises at least two R-groups that are functional groups. Typically, the R-groups of Formula 2 can be selected independently. In some embodiments, at least one functional group, such as a hydride group, hydroxyl group, alkoxy group, vinyl group, epoxy group, and acrylate group. When the polydiorganosiloxane is a non-functionalized polydiorganosiloxane, the polydiorganosiloxane does not contain functional groups.

[0056] In addition to the functional R group, the R group can be a non-functional group, such as an alkyl or aryl group, including haloalkyl (e.g., fluorinated) and aryl groups. In some embodiments, the functionalized polydiorganosiloxane material may be branched. For example, one or more R groups may be linear or branched siloxanes having functional and / or non-functional substituents.

[0057] Polydiorganosiloxanes (such as polydimethylsiloxane PDMS) can be oils, fluids, gums, elastomers, or resins, such as brittle solid resins. Materials with lower molecular weights and lower viscosity are referred to as fluids or oils, while materials with higher molecular weights and higher viscosity are referred to as gums; however, there is no clear distinction between these terms. Silicone oils are commercially available (e.g., from Wacker) and have a viscosity of 0.65 mPa at 25°C. s to 1,000,000 mPa In typical embodiments, a high-viscosity (e.g., nonfunctional) liquid polydiorganosiloxane is preferred. In some embodiments, the liquid polydiorganosiloxane has a viscosity of at least 25,000 mPa at 25°C. s, 50,000 mPa s, 100,000 mPa s, 250,000 mPa s, 500,000 mPa s, 750,000 mPa s or 1,000,000 mPa Higher viscosity (which also indicates a higher molecular weight) may be preferred. When using polydiorganosiloxane adhesives, the viscosity at 25°C can be greater than 1,000,000 mPa. s.

[0058] Skin-friendly adhesives are prepared by optionally combining one or more polydiorganosiloxane materials (e.g., silicone oils or fluids) with a suitable tackifying resin, coating the resulting combination, and crosslinking it using radiation (typically an electron beam (E-beam) or gamma radiation). Typically, any known additives that can be used in the adhesive formulation may also be included.

[0059] In some embodiments, silicate tackifying resins may be used. In some exemplary adhesive compositions, a variety of silicate tackifying resins may be used to achieve the desired properties.

[0060] Suitable silicate tackifying resins include those composed of the following structural units: M (i.e., monovalent R'3SiO) 1 / 2 Unit), D (i.e., divalent R'2SiO), 2 / 2 Unit), T (i.e., trivalent R'SiO), 3 / 2 Unit) and Q (i.e., quaternary SiO) 4 / 2 (units) and combinations thereof. Typical exemplary silicate resins include MQ silicate tackifying resin, MQD silicate tackifying resin, and MQT silicate tackifying resin. These silicate tackifying resins typically have a number average molecular weight in the range of 100 gm / mol to 50,000 gm / mol, for example, 500 gm / mol to 15,000 gm / mol, and typically the R' group is a methyl group.

[0061] MQ silicate tackifying resin is a copolymer resin in which each M unit is bonded to a Q unit, and each Q unit is bonded to at least one other Q unit. Some Q units are bonded only to other Q units. However, some Q units are bonded to hydroxyl radicals, producing HOSiO 3 / 2 Unit (i.e., "T") OH (Unit), thereby obtaining the content of some silicon-bonded hydroxyl groups in the silicate tackifying resin.

[0062] Based on the weight of the silicate tackifying resin, the amount of silicon-bonded hydroxyl groups (i.e., silanols) on the MQ resin can be reduced to no more than 1.5 wt%, no more than 1.2 wt%, no more than 1.0 wt%, or no more than 0.8 wt%. This can be achieved, for example, by reacting hexamethyldisilazane with the silicate tackifying resin. This reaction can be catalyzed, for example, with trifluoroacetic acid. Alternatively, trimethylchlorosilane or trimethylsilylacetamide can be reacted with the silicate tackifying resin, in which case a catalyst is not necessary.

[0063] MQD silicone tackifying resin is a terpolymer having M, Q, and D units. In some embodiments, some methyl R' groups of the D unit can be replaced by vinyl (CH2=CH-) groups (“D…”). Vi (Unit) replacement. MQT silicate tackifying resin is a terpolymer having M, Q and T units.

[0064] Suitable silicate tackifying resins are commercially available from sources such as Dow Corning (e.g., DC 2-7066), Momentive Performance Materials (e.g., SR545 and SR1000), and Wacker Chemie AG (e.g., BELSIL TMS-803).

[0065] In some embodiments, the layer of the polydiorganosiloxane composition comprises at least 5%, 6%, 7%, 8%, 9%, or 10% by weight of a (e.g., silicate) tackifying resin. In some embodiments, the amount of (e.g., silicate) tackifying resin is no more than 20%, 25%, or 10% by weight.

[0066] In some embodiments, the polydiorganosiloxane composition may include any of a variety of known fillers (e.g., siliceous fillers, such as pyrolytic silica) and additives, including but not limited to pigments, additives for improving adhesion, additives for improving moisture permeability, antimicrobial agents (e.g., silver materials), pharmaceuticals, cosmetics, natural extracts, silicone waxes, silicone polyethers, hydrophilic polymers, and rheology modifiers. Hydrophilic additives for improving adhesion (particularly to wet surfaces) include polymers such as poly(ethylene oxide) polymers, poly(propylene oxide) polymers, and copolymers of poly(ethylene oxide and propylene oxide), acrylic polymers, hydroxyethyl cellulose polymers, carboxyethyl cellulose, silicone polyether copolymers, such as copolymers of poly(ethylene oxide) and polydiorganosiloxane, and copolymers of poly(propylene oxide) and polydiorganosiloxane, as well as blends thereof. The polydiorganosiloxane composition may contain various combinations of additives.

[0067] In some embodiments, the polydiorganosiloxane composition comprises up to 10%, 15%, 20%, 25%, or 30% by weight of filler and / or additives in the total polydiorganosiloxane composition. In other embodiments, the polydiorganosiloxane composition comprises less than 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, or 1% by weight of filler and / or additives.

[0068] Polysiloxane materials, tackifying resins (if present), and any optional additives can be combined using any of a variety of known methods prior to coating and crosslinking. For example, in some embodiments, the various components can be pre-blended using common equipment such as mixers, blenders, mills, extruders, etc.

[0069] In some embodiments, the material can be dissolved in a solvent, coated, and dried prior to crosslinking. In some embodiments, a solvent-free compounding and coating process can be used. In some embodiments, solvent-free coating can be performed at approximately room temperature. For example, in some embodiments, the material may have a kinematic viscosity of no more than 100,000 centistokes (cSt), such as no more than 50,000 cSt. However, in some embodiments, a hot-melt coating process such as extrusion can be used, for example, to reduce the viscosity of higher molecular weight materials to a value more suitable for coating. Various components can be added together in various combinations or individually through one or more separate ports of an extruder, blended (e.g., melt-mixed) within the extruder, and extruded to form a hot-melt coated composition.

[0070] Physical properties of cross-linked polydiorganosiloxane compositions

[0071] In some embodiments, the tackiness of the portion of the pressure-sensitive adhesive on the first main surface exposed through the opening in the mask substrate is at least 5 g / L, 10 g / L, 15 g / L, 20 g / L, 25 g / L, 30 g / L, 40 g / L, 45 g / L, 50 g / L, 55 g / L, 60 g / L, 65 g / L, 70 g / L, 75 g / L, or 80 g / L. The portion of the pressure-sensitive adhesive on the first main surface covered by the mask substrate typically has greater tackiness than the portion exposed through the opening in the mask substrate. The difference in tackiness can be at least 25 g / L, 50 g / L, 75 g / L, 100 g / L, 150 g / L, or greater.

[0072] In some embodiments, the tack of the portion of the pressure-sensitive adhesive on the first main surface covered by the mask substrate is at least 50 g / L, 55 g / L, 60 g / L, 65 g / L, 70 g / L, 75 g / L, or 80 g / L. In some embodiments, the tack of the portion of the pressure-sensitive adhesive on the first main surface covered by the mask substrate is not greater than 300 g / L, 250 g / L, 200 g / L, or 150 g / L. In some embodiments, the tack of the portion of the pressure-sensitive adhesive on the first main surface covered by the mask substrate is not greater than 120 g / L, 110 g / L, or 100 g / L.

[0073] In some implementations, the adhesiveness of the membrane backing surface of the second primary surface (e.g., the surface in contact with the wound) is less than 50 g, 45 g, 40 g, 35 g, 30 g, 25 g, 20 g, 15 g, or 10 g.

[0074] In some embodiments, the crosslinked polydiorganosiloxane layer has a tensile modulus of at least 0.10 N / inch, 0.15 N / inch, or 0.2 N / inch (2.54 cm). In some embodiments, the crosslinked polydiorganosiloxane layer has a tensile modulus of no more than 0.4 N / inch, 0.3 N / inch, or 0.2 N / inch. In some embodiments, the crosslinked polydiorganosiloxane layer has a maximum tensile strength of at least 1 N / inch, 1.5 N / inch, 2 N / inch, or 2.5 N / inch (2.54 cm). In some embodiments, the crosslinked polydiorganosiloxane layer has a maximum tensile strength of no more than 4 N / inch, 4.5 N / inch, 3 N / inch, 3.5 N / inch, or 0.2 N / inch. In some embodiments, the crosslinked polydiorganosiloxane layer has a maximum elongation of at least 100%, 150%, 200%, or 350%. In some embodiments, the crosslinked polydiorganosiloxane layer has a maximum elongation of no more than 500%, 400%, or 300%. Tensile strength and elongation can be measured according to EN ISO 527-3 using a ZwickRoell Z010 machine equipped with a 500N force sensor. (Machine settings: jaw spacing: 50 mm, test speed: 100 mm / min, preload: 0.1 N.) Samples can be cut to 80 mm × 1 inch dimensions, with 1-inch tabs on each side placed in the jaws for test run. Tensile strength and elongation data for electron beam crosslinked polydiorganosiloxane compositions are reported in co-filed U.S. Application No. 63 / 595884; incorporated herein by reference. Peel adhesion to biological substrates such as human skin is known to be highly variable. Skin type, location on the body, and other factors can affect the results. Typically, the average peel adhesion to skin exhibits a large standard deviation. In some embodiments, the average peel adhesion to human skin can be less than 200 gm / 2.54 cm, and in some embodiments, less than 100 gm / 2.54 cm.

[0075] Additional components

[0076] (For example, medical) adhesive articles may include a variety of additional components known in the art. Such additional components are optional with respect to the most broad embodiments of the invention, but may be preferred for some medical articles.

[0077] In some embodiments, the crosslinked layer of the polydiorganosiloxane composition may also include a porous reinforcing layer, such as a fibrous web, an open-cell membrane, or a loosely woven fabric. The fibrous web may be nonwoven, woven, or knitted. When present, such a porous reinforcing layer is typically embedded within the crosslinked layer of the polydiorganosiloxane composition. This is typically achieved by applying a first layer of the polydiorganosiloxane composition to a substrate (e.g., a release liner), applying the porous reinforcing layer to the first layer, and then applying a second layer of the polydiorganosiloxane composition to the reinforcing layer. Alternatively, the porous reinforcing layer may be applied to the release liner prior to the application of the layers of the polydiorganosiloxane composition.

[0078] In some embodiments, when the adhesive article is a wound dressing, the article may also include an absorbent pad, such as that described in US2019 / 0231604; which is incorporated herein by reference.

[0079] Absorbent pads are typically positioned at the center of the surface of a pressure-sensitive adhesive, such that an adhesive or pressure-sensitive adhesive surrounds the absorbent pad on the opposite side.

[0080] The absorbent pad may be made of one or more layers, and each layer may be made of one or more absorbent materials. Preferably, the absorbent pad is relatively flexible. Flexibility allows the medical product incorporating the absorbent pad to be easily applied to flexible parts of the body, such as joints. The absorbent pad may be cut at one or more locations to provide additional flexibility. In some embodiments, the absorbent pad may be translucent or transparent, thus allowing visual inspection of the wound without removing the wound dressing.

[0081] Absorbent pads may be made of synthetic or natural materials and may include, but are not limited to, woven or nonwoven materials (e.g., woven or nonwoven cotton or rayon), hydrocolloids (e.g., pectin, gelatin, carboxymethyl cellulose (CMC), crosslinked carboxymethyl cellulose (X-link CMC), crosslinked polyacrylic acid (PAA), and hydrocolloids described in U.S. Patents 5,622,711 and 5,633,010), polymeric gels (e.g., hydrogels), foams, collagen, hydrocellulose, alginate, and combinations thereof. In some embodiments, the absorbent pad may comprise polymeric fabrics, polymeric foams, and combinations thereof. For example, the polymeric fabric may be a nonwoven fabric, and the polymeric foam may be a foam used in TEGADEM foam adhesive dressings, which are available from 3M Company, St. Paul, Minn. In some embodiments, the polymeric foam is a polyurethane foam.

[0082] The absorbent pad may optionally include other components, including one or more active agents, such as pharmacologically active agents, as further described in US2019 / 0231604.

[0083] The presence of a porous organic polymer substrate, such as a mask substrate (e.g., nonwoven, open-cell membrane), can provide enhanced web treatment and greater (e.g., tensile, tear) strength to the crosslinked polydiorganosiloxane layer. The article may optionally also include a porous organic polymer substrate on a first main surface, adjacent to a release liner or embedded within the crosslinked polydiorganosiloxane layer; as described in co-filed U.S. Application No. 63 / 595859, which is incorporated herein by reference.

[0084] In some embodiments, the article may optionally include a plurality of pores extending through a crosslinked layer of the polydiorganosiloxane adhesive composition. Additionally, the article may optionally include a plurality of pores extending through a mask substrate and the underlying crosslinked layer of the polydiorganosiloxane adhesive composition. The invention is further illustrated by the following non-limiting examples.

[0085] Example

[0086] Materials used in the examples

[0087] Test method: Adhesion Test. Adhesion (removal force) was measured using a TA-XT Plus texture analyzer equipped with a 5kg force sensor and a 7mm stainless steel cylindrical probe. The test sample was cut into 1-inch widths and laminated onto a brass rod with a 10mm diameter hole through it to allow the probe to reach the adhesive surface of the tape. The probe tip was cleaned with n-heptane after each measurement. Test parameters: Pre-test speed: 1.0mm / s, Test speed: 0.05mm / s, Applied force: 5g, Contact time: 5s, Trigger force: 60g, and Retraction distance: 12mm. Data represent the average of three measurements for each embodiment.

[0088] Sample preparation

[0089] Using SpeedMixer ®DAC150 (Hauschild GmbH, Germany) was used to uniformly mix silicone oil and silicone tackifying resin in 100g batches at a weight ratio of 70 / 30 to obtain a silicone composition for coating. The silicone composition was applied to a 50-micron polyethylene terephthalate film, including a release coating, to the thickness specified in Table 1 using a doctor blade coater. The film was then exposed to an electron beam radiation at an accelerating voltage of 280 kV using a CB-300 electron beam generator, available from Energy Sciences, Inc. (Wilmington, MA), to provide the dose specified in Table 1, thereby forming layer 1.

[0090] For Examples 2 and 3, the first electron beam step is skipped. A second layer of silicone oil (i.e., without silicone tackifying resin) is applied to Layer 1 at the thickness specified in Table 1 to form Layer 2. A mask material is laminated onto Layer 2, and the layer is then exposed to electron beam radiation at an accelerating voltage of 280 kV using a CB-300 electron beam generator available from Energy Sciences, Inc. (Wilmington, MA), to provide the dose specified in Table 1. For Examples 1-3, the mask material is the nonwoven mask material described above. For Example 4, the mask material is the film mask material described above. The mask shape is specified in Table 1. The thicknesses of Layer 1 and Layer 2 are shown in Table 1.

[0091]

[0092] about Figure 9B Surface A is an unmasked crosslinked PSA. Surface B is a masked crosslinked PSA. Higher viscosity is achieved at surface B because the mask blocks some of the radiation exposure. Surface C is the opposite surface of a crosslinked silicone oil. Surface C has lower viscosity than surface A because surface C is exposed to a higher dose of electron beam radiation and because surface C contains a polydiorganosiloxane composition without tackifying resins.

[0093] Since Examples 3-4 have the same materials, thickness and electron beam crosslinking dose as Example 2, the expected viscosity is the same as that of Example 2.

Claims

1. A method for manufacturing an adhesive article, the method comprising: a) Providing a mask between a layer of a polydiorganosiloxane composition and a radiation energy source, wherein the mask includes one or more openings that expose a portion of the layer of the polydiorganosiloxane composition and cover a portion of the layer of the polydiorganosiloxane composition; b) Crosslinking the layer of the polydiorganosiloxane composition by radiation, such that the portion of the layer of the polydiorganosiloxane composition exposed through the one or more openings of the mask has a greater crosslinking than the portion covered by the mask.

2. The method of claim 1, wherein the layer of the polydiorganosiloxane composition comprises a first primary surface near the substrate forming a pressure-sensitive adhesive and an opposite second primary surface near the mask and one or more openings thereof forming a film backing.

3. The method of claim 2, wherein the first primary surface of the layer of the polydiorganosiloxane composition is disposed on the release liner.

4. The method according to claims 2 to 3, wherein after crosslinking, the tack of the pressure-sensitive adhesive portion of the first main surface covered by the mask is at least 50 g / L, 60 g / L, 70 g / L, 80 g / L, 90 g / L, or 100 g / L, and the pressure-sensitive adhesive portion of the first main surface exposed by the mask has a lower tack than the covered portion.

5. The method of claim 3, wherein, after crosslinking, the adhesiveness of the film backing of the one or more openings of the mask substrate is less than 50, 45, 40, 35, 30, 25, 20, 15, or 10.

6. The method according to claims 1 to 5, wherein the mask comprises a porous substrate or an organic polymer membrane, or a combination thereof, wherein the porous substrate comprises a woven or nonwoven fabric, and the organic polymer membrane comprises polyurethane.

7. The method according to claims 1 to 6, wherein the mask is i) A mask substrate, which is permanently bonded to the layer of polydiorganosiloxane after crosslinking; ii) A release liner mask that can be removed from the polydiorganosiloxane layer after crosslinking; iii) Non-contact processing mask; or Their combination.

8. The method according to claims 1 to 7, wherein the mask comprises a plurality of main openings substantially surrounded by a frame of the mask.

9. The method according to claim 8, wherein i) The frame of the mask further includes a gap sized for inserting an intravenous catheter; or ii) The mask also includes a plurality of small openings sized to allow insertion of an intravenous catheter.

10. The method according to claims 1 to 9, wherein the opening of the mask forms a reinforcement system, or the reinforcement system is disposed between the mask substrate and the layer of the polydiorganosiloxane composition.

11. The method according to claims 1 to 10, wherein the layer of the polydiorganosiloxane composition comprises a single layer or multiple layers of the same or different polydiorganosiloxane compositions.

12. The method according to claims 1 to 11, wherein the layer of the polydiorganosiloxane composition comprises a first layer adjacent to the (e.g., release liner) substrate, wherein the polydiorganosiloxane composition contains (e.g., silicate) tackifying resin, and a second layer adjacent to the mask, the second layer containing less or no (e.g., silicate) tackifying resin.

13. The method according to claims 1 to 12, wherein the total thickness of one or more layers of the polydiorganosiloxane composition is at least 200 micrometers, 250 micrometers, 300 micrometers, 350 micrometers, 400 micrometers, 450 micrometers or 500 micrometers.

14. The method according to claims 1 to 13, the method further comprising an absorbent pad disposed between the membrane backing and the layer of the polydiorganosiloxane composition.

15. An adhesive article comprising: A layer of a crosslinked polydiorganosiloxane composition having two main surfaces, the first main surface comprising a pressure-sensitive adhesive, and the second main surface bonded to a mask substrate comprising at least one opening exposing a film backing of the crosslinked polydiorganosiloxane composition.

16. An adhesive article, said adhesive article comprising: A layer of a crosslinked polydiorganosiloxane composition having two main surfaces, the first main surface comprising a pressure-sensitive adhesive, and the second main surface bonded to a mask substrate; The first main surface includes a portion covered by the mask substrate and a portion exposed through an opening in the mask substrate, wherein the exposed portion includes a larger crosslinking than the covered portion.

17. An adhesive article, said adhesive article comprising: A layer of a crosslinked polydiorganosiloxane composition having two main surfaces, the first main surface comprising a pressure-sensitive adhesive and the second main surface comprising a film backing. The first main surface includes a first portion, which includes cross-links that are larger than those of adjacent portions.

18. The adhesive article of claim 17, wherein the first portion is a central (e.g., wound contact) portion and the second portion is a frame (e.g., skin contact) portion.

19. The adhesive article according to claims 15 to 17, wherein the adhesive article is further characterized by claims 2 to 14.

20. The adhesive article according to claims 15 to 19, wherein the adhesive article is used as a medical article.

21. The adhesive article according to claims 15 to 20, wherein the article is a medical tape, bandage, or wound dressing.

22. A method of using an adhesive article, the method comprising providing the article according to claims 15 to 21 and applying the pressure-sensitive adhesive to skin or a wound.

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