Skin patches

Abstract

To provide a skin patch that has excellent operability and enables medical instruments such as a catheter to be properly fixed at a puncture site.SOLUTION: A skin patch according to the present invention has, in a plan view, a non-adhesive part, and fixing parts located on at least both sides of the non-adhesive part in a width direction and has, in a cross-sectional view, a first base material and a first adhesive layer in this order from the surface side. The non-adhesive part has no adhesion to an adherend. In one embodiment, the skin patch further has a second base material and a second adhesive layer and, in a cross-sectional view, the first base material, the first adhesive layer, the second base material, and the second adhesive layer are arranged in this order.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] The present invention relates to a skin patch, and more particularly to a skin patch that is easy to operate and can satisfactorily fix a medical instrument such as a catheter at its puncture site. [Background technology]

[0002] Skin patches are widely used to fix medical instruments such as catheters. For example, a skin patch is attached to a puncture site of a catheter in a living body so as to cover a wide area including the puncture site, thereby fixing the catheter to the surface of the living body and preventing the intrusion of bacteria and the like from the outside (for example, Patent Document 1). In this case, if the catheter is not fixed to the surface of the living body insufficiently, there are problems such as leakage of medicinal fluid outside the blood vessel due to movement of the catheter's indwelling needle, risk of the indwelling needle being removed, and lifting or peeling of the skin patch due to the movement of the catheter, which can become a route for bacterial infection.

[0003] In order to solve the above problems, medical tape or bandage tape is used to reinforce the fixation from the upper side (opposite the living body surface) of the applied skin patch. However, such a method using medical tape or bandage tape is complicated, and medical professionals strongly demand improvement in operability. In addition, when fixing a medical instrument such as a catheter to a living body surface, there are problems such as indentations and discomfort caused by the medical instrument being pressed against the living body surface. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] JP 2014-068721 A [Patent Document 2] JP 2014-045874 A Summary of the Invention [Problem to be solved by the invention]

[0005] The present invention has been made to solve the above-mentioned conventional problems, and its object is to provide a skin patch that is easy to operate and can prevent pressure on the living body from medical instruments. [Means for solving the problem]

[0006] The skin patch of the present invention is a skin patch having a non-adhesive portion and a fixing portion in plan view, and is provided with a first substrate and a first adhesive layer in this order from the surface side in cross-sectional view, and is configured so that when the skin patch is attached to an adherend, the fixing portion sticks to the adherend and the non-adhesive portion does not stick to the adherend. With this configuration, when the skin patch is attached to the adherend, the position of the medical device part that may press against the living body can be adjusted by the non-adhesive portion, and after positioning, a series of operations of fixing with the fixing portion (hereinafter, this series of steps is referred to as operability in this specification) can be performed reliably and simply, and pressure on the living body by the medical device can be prevented. In one embodiment, the non-adhesive portion is a non-adhesive portion, and the non-adhesive portion is configured so as not to have adhesiveness to an adherend. In one embodiment, the skin patch further comprises a second substrate and a second adhesive layer, and in cross-sectional view, the first substrate, the first adhesive layer, the second substrate, and the second adhesive layer are arranged in this order. In one embodiment, a window is formed in the fixing portion. In one embodiment, the non-adhesive portion is transparent. In one embodiment, the skin patch further comprises a cover material, and in the non-adhesive portion, the first base material, the first adhesive layer, and the cover material are arranged in this order. In one embodiment, the skin patch further comprises a release liner that protects the side of the skin patch opposite the first substrate. In one embodiment, the release liner is composed of a plurality of divided pieces. In one embodiment, the second substrate is a nonwoven fabric. In one embodiment, the second base material has a thickness of 100 μm to 500 μm. In one embodiment, the material constituting the first base material is polyurethane. In one embodiment, the skin patch is configured such that, when the skin patch is attached, an upright portion is formed behind the non-adhesive portion. In one embodiment, the non-adhesive portion has adhesiveness, and is configured such that, when the skin patch is attached, an upright portion is formed behind the non-adhesive portion. Effect of the Invention

[0007] According to the present invention, by providing a non-adhesive portion, it is possible to provide a skin patch which is excellent in operability and can prevent pressure on the living body from a medical instrument. [Brief description of the drawings]

[0008] [Figure 1] FIG. 1(a) is a schematic plan view of a skin patch according to one embodiment of the present invention, and (b) is a schematic cross-sectional view of the skin patch of (a) taken along line Ib-Ib. [Diagram 2] 1(a) to 1(e) are schematic cross-sectional views illustrating the configuration of the non-adhesive part of a skin patch according to one embodiment of the present invention. [Diagram 3] FIG. 1 is a diagram illustrating a state in which a skin patch according to one embodiment of the present invention is used. [Figure 4] FIG. 4(a) is a schematic plan view of a skin patch according to another embodiment of the present invention, and (b) is a schematic cross-sectional view of the skin patch of (a) taken along line IVb-IVb. [Diagram 5] 1(a) and 1(b) are diagrams illustrating another cover material used in a skin patch according to one embodiment of the present invention. [Figure 6] FIG. 1 is a schematic back view of a skin patch according to one embodiment of the present invention. [Figure 7] FIG. 1 is a schematic cross-sectional view of a skin patch according to one embodiment of the present invention. [Figure 8] 1 is a schematic back view of a skin patch according to another embodiment of the present invention. FIG. [Figure 9] FIG. 1 is a schematic cross-sectional view of a skin patch according to one embodiment of the present invention. [Figure 10] FIG. 1(a) is a schematic plan view of a skin patch according to one embodiment of the present invention, and (b) is a schematic cross-sectional view of the skin patch of (a) taken along line Xb-Xb. [Figure 11] FIG. 2 is a schematic diagram for explaining a specific procedure for attaching a skin patch according to one embodiment of the present invention. [Figure 12] 10A to 10C are schematic diagrams for explaining a specific procedure for attaching a skin patch according to another embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0009] Preferred embodiments of the present invention will now be described with reference to the drawings, but the present invention is not limited to these specific embodiments.

[0010] A. Overall composition of the skin patch The skin patch of the present invention has, in plan view, a non-adhesive portion and a fixing portion located at least on both sides of the non-adhesive portion in the width direction. In cross-sectional view, the skin patch comprises a first substrate and a first adhesive layer in this order. The skin patch is configured such that, when the skin patch is attached to an adherend, the fixing portion is attached to the adherend (typically skin) and the non-adhesive portion is not attached to the adherend. When used, the skin patch is attached with the first adhesive layer facing the adherend. The non-adhesive portion "configured not to adhere to the adherend" refers to a portion configured to limit the adhesiveness of the first adhesive layer so that a part of the skin patch does not have adhesiveness to the adherend, or a portion configured so that the first adhesive layer has adhesiveness but can be separated from the adherend (details will be described later). In the present invention, by providing a non-adhesive portion, it is possible to provide a skin patch which is excellent in operability and can prevent the medical instrument from pressing against the living body.

[0011] As described above, in one embodiment, the non-adhesive portion is a non-adhesive portion (first embodiment). The non-adhesive portion is a portion that does not have an adhesive layer or the like on the adherend (skin) side and does not have adhesiveness to the adherend. In another embodiment, the non-adhesive portion has adhesiveness (second embodiment). In this embodiment, the skin patch is configured such that, when the skin patch is attached, a standing portion is formed behind the non-adhesive portion. The non-adhesive portion is configured such that it does not adhere to the adherend as the standing portion stands up. Either configuration can provide a skin patch that is excellent in operability and can prevent the medical instrument from pressing against the living body. In this specification, "not having adhesiveness" and "not showing adhesiveness" mean that the adhesive strength at 25°C to a SUS plate is 10 mN / 25 mm or less. In addition, "having adhesiveness" means that the adhesive strength at 25°C to a SUS plate is greater than 10 mN / 25 mm. Here, the adhesive strength is measured by a method in accordance with JIS Z 0237:2000 (lamination conditions: one reciprocation with a 2 kg roller, peel speed: 300 mm / min, peel angle: 180°).

[0012] A-1. First embodiment As described above, in the first embodiment, the non-adhesive portion is a non-adhesive portion. FIG. 1(a) is a schematic plan view of a skin patch according to a preferred embodiment of the present invention, and FIG. 1(b) is a schematic cross-sectional view of the skin patch of FIG. 1(a) taken along line Ib-Ib. Note that, for ease of viewing, the vertical, horizontal and thickness ratios of each layer and each part in the illustrated example are depicted differently from the actual ratios. As shown in FIG. 1(a), the skin patch 100 has a non-adhesive portion (non-adhesive portion) 110 and a fixing portion 120 in a plan view. The non-adhesive portion (non-adhesive portion) 110 is configured so that a space is formed around the medical device (catheter) to be fixed during use. The fixing portion 120 is a portion other than the non-adhesive portion 110, has adhesiveness to the adherend (skin), and contributes to the fixing of the medical device. As described above, the fixing portion 120 is located at least on both sides of the non-adhesive portion (non-adhesive portion) 110 in the width direction. Preferably, the fixing part 120 is located around the non-adhesive part (non-adhesive part) 110. If the fixing part 120 is located around the non-adhesive part (non-adhesive part) 110, a skin patch with better fixation can be obtained. For example, a skin patch that can exhibit sufficient fixation can be obtained without reinforcing fixation using a medical tape or bandage tape from the upper side (opposite side to the adherend) of the attached skin patch. Not requiring a separate member is also advantageous from the viewpoint of operability. In this specification, for convenience, the direction parallel to the medical device (e.g., catheter) when fixing the medical device is defined as the length direction L of the skin patch 100, and the direction perpendicular to the length direction L is defined as the width direction W. In addition, the direction facing the tip of the medical device (e.g., catheter) is defined as the front (the right side of the paper in FIG. 1(a)), and the opposite direction to the front is defined as the rear (the left side of the paper in FIG. 1(a)).

[0013] As shown in FIG. 1(b), the skin patch 100 comprises a first substrate 11 and a first adhesive layer 12 in this order from the front side (the side opposite to the adherend) in a cross-sectional view. Typically, the first adhesive layer 12 is transparent. In this embodiment, the first substrate 11 may be a film substrate. Typically, the film substrate is transparent. In one embodiment, a cover material 13 is disposed in the non-adhesive portion 110 so as to cover the first adhesive layer 12. By disposing the cover material, adhesion of the first adhesive layer to the adherend is inhibited, and non-adhesiveness of the non-adhesive portion can be achieved.

[0014] In one embodiment, as shown in FIG. 1(b), the skin patch 100 includes a second substrate 14. In this embodiment, the second substrate 14 may be a support substrate. The film substrate and the support substrate may be distinguished, for example, by the material, thickness, etc. In one embodiment, the support substrate is made of a nonwoven fabric. If the support substrate is provided, a skin patch having appropriate rigidity and excellent handling properties can be obtained. When the skin patch 100 includes the second substrate (support substrate) 14, the second substrate (support substrate) 14 may be disposed so as to be in contact with the first adhesive layer 12, and a second adhesive layer 15 may be disposed on the opposite side of the second substrate (support substrate) 14 from the first adhesive layer 12. That is, in this embodiment, the skin patch 100 includes the first substrate (film substrate) 11, the first adhesive layer 12, the second substrate (support substrate) 14, and the second adhesive layer 15 in this order. With this configuration, as described above, it is possible to obtain a skin patch having appropriate rigidity and excellent handling properties. When in use, the skin patch is attached with the second adhesive layer 15 facing the adherend. Furthermore, as described below, when the skin patch 100 has a window 121 formed thereon, the second substrate (support substrate) 14 has an opening having the same shape as the window 121 in plan view at a position corresponding to the window 121. Furthermore, as described below, when the non-adhesive portion 110 is transparent, the second substrate (support substrate) 14 has an opening having the same shape as the non-adhesive portion 110 in plan view at a position corresponding to the non-adhesive portion 110.

[0015] In one embodiment (for example, when the skin patch 100 has a second substrate (support substrate) 14), a window 121 is formed in the fixing portion 120. The window 121 is disposed in front of the non-adhesive portion (non-adhesive portion) 110. The window 121 is transparent. In one embodiment, the skin patch 100 having the window 121 may be configured so that at least a part of the medical instrument (for example, the catheter puncture portion) can be visually observed through the window 121. By using the skin patch 100 having a window, it is possible to attach a medical instrument such as a catheter while observing the fixed position. In this specification, "transparent" is a concept including so-called translucency, and a transparent portion (for example, a window portion) means a portion that is transparent enough to visually observe the medical instrument through the portion (for example, a light transmittance of 50% or more and / or a light reflectance of 50% or less).

[0016] 2 is a schematic cross-sectional view illustrating the shape of the non-adhesive part of a skin patch according to one embodiment of the present invention. The non-adhesive part 110 may be transparent or opaque. If the non-adhesive part 110 is transparent, it is possible to fix the medical device while visually checking the medical device, which provides excellent operability. In addition, it is possible to detect abnormalities (e.g., liquid leakage, detachment, etc.) early after the medical device is fixed. Examples of the transparent non-adhesive portion 110 include non-adhesive portion 110a formed as a hole, i.e., non-adhesive portion 110a formed by penetrating first substrate (film substrate) 11, first adhesive layer 12, and second substrate (support substrate) 14 and second adhesive layer 15 that are arranged as necessary (FIG. 2(a)); non-adhesive portion 110b having only transparent first substrate (film substrate) 11 (FIG. 2(b)); non-adhesive portion 110c having transparent first substrate (film substrate) 11, transparent first adhesive layer 12, and transparent cover material 13 in this order (FIG. 2(c)); and the like. Examples of the opaque non-adhesive portion 110 include a non-adhesive portion 110d (FIG. 2(d)) having a first substrate (film substrate) 11, a first adhesive layer 12, and a second substrate (support substrate) 14, and a non-adhesive portion 110e (FIG. 2(e)) having a first substrate (film substrate) 11, a first adhesive layer 12, and an opaque cover material 13'. The non-adhesive portion 110 may take any appropriate form as long as it does not exhibit adhesiveness to the adherend (skin), and is not limited to the above embodiment.

[0017] FIG. 3 is a diagram illustrating a state in which a skin patch according to one embodiment of the present invention is used. The skin patch 100 can be used to fix a puncture part of a medical instrument such as a catheter. FIG. 3 shows how the catheter 200 is fixed on a living body 300 by the skin patch 100. When fixing the catheter 200 on the living body 300, the uneven part of the catheter 200 (for example, the catheter hub 210) is placed at the position of the non-adhesive part (non-adhesive part) 110 of the skin patch 100. When the non-adhesive part 110 is formed as a hole, the uneven part 210 of the catheter 200 is passed through the non-adhesive part 110. In this way, the catheter can be well fixed by the non-adhesive part (hole part). Also, when the non-adhesive part 110 is not formed as a hole, the uneven part 210 of the catheter 200 is covered by the first base material or the like constituting the non-adhesive part 110. In this way, it is possible to prevent the intrusion of bacteria and the like from the outside while maintaining a predetermined fixation.

[0018] The skin patch of the present invention has the non-adhesive portion 110 as described above, and can reduce the pressure of the medical device on the skin. In addition, under the non-adhesive portion (non-adhesive portion) 110, a predetermined space is formed around the medical device, allowing the medical device to move appropriately. As a result, even when a force is applied to the medical device, the load generated by the skin being pulled by the medical device or the patch fixing it is reduced. The skin patch of the present invention, which exhibits such an effect, is particularly useful when fixing a part such as a catheter hub that has large irregularities and puts strong pressure on the skin. As described above, the skin patch of the present invention can be attached to the skin by matching the part of the medical device that puts strong pressure on the skin (e.g., a catheter hub) with the non-adhesive portion.

[0019] Furthermore, the skin patch of the present invention is easy to use because it can be applied stepwise while a part of the medical device (eg, a catheter hub) is temporarily fixed by the non-adhesive portion.

[0020] In one embodiment, when the catheter 200 is fixed, the standing portion 122 may be formed behind the non-adhesive portion 110. The standing portion 122 is formed by wrapping the fixing portion 120 near the non-adhesive portion 110 around a portion of the catheter 200 behind the non-adhesive portion 110 (opposite the puncture portion) once, and then bonding the fixing portions 120 on the left and right in the width direction below the wrapped portion. The standing portion 122 formed as described above can prevent the occurrence of indentations on the living body 300 and can satisfactorily fix the catheter 200. The above-mentioned skin patch can satisfactorily fix the catheter while preventing indentations without requiring complicated operations. The height of the standing portion is, for example, 5 mm to 20 mm.

[0021] The planar shape of the skin patch is not limited to the illustrated example, and any appropriate shape (e.g., circle, square, rectangle, trapezoid; shapes based on these shapes and having uneven or curved portions) can be adopted depending on the purpose.

[0022] The length of the skin patch is preferably 30 mm to 150 mm, and more preferably 50 mm to 100 mm.

[0023] The width of the widest part of the skin patch is preferably 30 mm to 140 mm, and more preferably 40 mm to 90 mm.

[0024] The width of the portion of the skin patch 10 mm from the front end toward the center in the longitudinal direction (width W1 in FIG. 1; hereinafter also referred to as width W1) is preferably 5 mm to 140 mm, more preferably 30 mm to 100 mm.

[0025] The width of the portion 10 mm from the rear end of the skin patch toward the center in the longitudinal direction (width W2 in FIG. 1; hereinafter also referred to as width W2) is preferably 45 mm to 140 mm, more preferably 60 mm to 120 mm.

[0026] In one embodiment, the width W2 is wider than the width W1. In one embodiment, the difference between the width W2 and the width W1 corresponds to 1.5 to 2.5 times (preferably 1.8 to 2.2 times, more preferably 2 times) the height of the upright portion. In this way, when the upright portion is appropriately provided and the skin patch is attached, the shape of the skin patch after attachment becomes close to an ellipse in plan view, and it becomes easy to determine whether the upright portion is appropriate or not depending on whether the shape of the skin patch after attachment is close to an ellipse in plan view. The difference between the width W2 and the width W1 is preferably 4 mm to 40 mm. In one embodiment, the ratio of W2 to W1 (W2 / W1) is greater than 1 and equal to or less than 2, and is preferably 1.2 to 1.8.

[0027] In one embodiment, a notch 123 is formed at the rear end of the skin patch. The notch 123 is preferably provided at the center in the width direction at the rear end of the skin patch. If the notch 123 is provided, it is possible to attach the skin patch while passing a medical instrument such as a catheter through the notch 123. Such a skin patch is easy to position relative to the medical instrument and has excellent fixation. The size of the notch 123 can be any appropriate size, but its length is, for example, 3 mm to 10 mm.

[0028] The planar shape of the non-adhesive portion may be any suitable shape. Examples of the shape of the non-adhesive portion include a rectangular shape, a triangular shape, a polygonal shape, a circular shape, an elliptical shape, and the like. In addition, the non-adhesive portion may have a shape having a concave portion and / or a convex portion based on these shapes. In addition, the non-adhesive portion may have a shape having a rectangular, triangular, or polygonal shape as a base, with the corners being curved.

[0029] The length Ln of the non-adhesive portion (non-adhesive portion) 110 is preferably 5 mm to 50 mm, more preferably 20 mm to 40 mm. The width Wn of the non-adhesive portion (non-adhesive portion) 110 is preferably 5 mm to 50 mm, more preferably 5 mm to 45 mm, and even more preferably 10 mm to 45 mm. If the size of the hole is within the above range, a skin patch capable of satisfactorily fixing a medical device such as a catheter can be obtained. As described above, the shape of the non-adhesive portion (non-adhesive portion) is not limited to a rectangular shape and may be any appropriate shape, but the length of the non-adhesive portion (non-adhesive portion) refers to the length of the longest portion, and the width of the non-adhesive portion (non-adhesive portion) refers to the width of the widest portion. In one embodiment, the ratio of Wn to W2 (Wn / W2) is 0.2 to 0.8, and preferably 0.3 to 0.7.

[0030] The distance L1 between the rear end of the non-adhesive portion (non-adhesive portion) 110 and the rear end of the skin patch 100 is preferably 3 mm to 25 mm, more preferably 3 mm to 20 mm, and particularly preferably 5 mm to 20 mm. Within this range, a skin patch capable of favorably fixing a medical device such as a catheter can be obtained. Also, a skin patch capable of easily forming an upright portion when fixing a medical device such as a catheter can be obtained. In one embodiment, the ratio of L1 to Ln (L1 / Ln) is 0.25 to 2, preferably 0.5 to 1.5. In one embodiment, the ratio of L1 to the length of the cutout (L1 / cutout length) is 1.5 to 4, preferably 2 to 3.2.

[0031] The shape and size of the window 121 may be any appropriate shape and size as long as the fixed position of the medical device such as a catheter can be observed. Examples of the shape of the window include a rectangular shape, a triangular shape, a polygonal shape, a circular shape, an elliptical shape, and the like. The window may also have a shape based on these shapes and have a concave and / or convex portion. The window may also have a shape based on a rectangular, triangular, or polygonal shape with curved corners.

[0032] The length Lw of the window 121 is preferably 10 mm to 100 mm, more preferably 15 mm to 70 mm, and even more preferably 30 mm to 50 mm. The width Ww of the window 121 is preferably 10 mm to 100 mm, more preferably 15 mm to 80 mm, and even more preferably 20 mm to 50 mm. If the size of the window is within the above range, it is easy to visually check the puncture part of the medical instrument during operation, and a skin patch with excellent workability can be obtained. As described above, the shape of the window is not limited to a rectangular shape and can be any appropriate shape, but the length of the window means the length of the longest part, and the width of the window means the width of the widest part. In one embodiment, the ratio of Lw to the length of the skin patch (Lw / length of skin patch) is 0.1 to 0.6, and preferably 0.2 to 0.4. In one embodiment, the ratio of Ww to W1 (Ww / W1) is from 0.5 to 0.85, preferably from 0.5 to 0.8, and preferably from 0.6 to 0.75.

[0033] Preferably, both the non-adhesive portion (non-adhesive portion) and the window portion have a closed shape in a plan view. That is, as described above, the fixing portion 120 may be located around the non-adhesive portion (non-adhesive portion) 110. Also, the fixing portion 120 may be located around the window portion 121.

[0034] FIG. 4(a) is a schematic plan view of a skin patch according to another embodiment of the present invention, and FIG. 4(b) is a schematic cross-sectional view of the skin patch of FIG. 4(a) taken along line IVb-IVb. In this skin patch 100', the non-adhesive portion 110' is transparent. In the skin patch 100', there is no window portion having adhesiveness as described above, and the fixed medical device can be visually confirmed through the non-adhesive portion 110'. As shown in FIG. 4(b), in a cross-sectional view of a portion other than the non-adhesive portion 110', the skin patch 100' includes a first base material 11' and a first adhesive layer 12 in this order. Typically, the first adhesive layer 12 is transparent. In this embodiment, the first base material 11' may be a film base material or a support base material. When the catheter 200 is fixed by the skin patch 100', the non-adhesive portion 110' may be covered with another cover material. Examples of the alternative cover material include a semi-capsule-type cover material 130a having a predetermined rigidity and forming a space above the non-adhesive portion 110' as shown in Fig. 5(a), and a transparent film 130b as shown in Fig. 5(b). The transparent film 130b is configured so as not to exhibit adhesiveness in the non-adhesive portion 110'. The alternative cover material may be provided as a set with a skin patch.

[0035] In one embodiment, as shown in FIG. 4(b), the skin patch 100' includes a second substrate 14. In this embodiment, the second substrate 14 may be a supporting substrate. When the skin patch 100' includes the second substrate (supporting substrate) 14, the first substrate 11' is preferably a film substrate. When the skin patch 100' includes the second substrate (supporting substrate) 14, the second substrate (supporting substrate) 14 may be disposed so as to be in contact with the first adhesive layer 12, and a second adhesive layer 15 may be disposed on the side of the second substrate (supporting substrate) 14 opposite to the first adhesive layer 12. That is, in this embodiment, the skin patch 100 includes the first substrate (film substrate) 11', the first adhesive layer 12, the second substrate (supporting substrate) 14, and the second adhesive layer 15 in this order.

[0036] In one embodiment, the skin patch further comprises a release liner that protects the side (adhesive surface) opposite to the first substrate. If a release liner is provided, the adhesive surface can be protected.

[0037] The release liner may be composed of one sheet or multiple divided pieces. Preferably, the release liner is composed of multiple divided pieces. If the release liner is composed of multiple divided pieces, the adhesive layer can be exposed in stages, and a skin patch with excellent operability can be obtained. The position at which the release liner is divided can be set at any appropriate position as long as the effects of the present invention can be obtained. Examples of divided release liners will be described below with reference to Figures 6 to 9.

[0038] Fig. 6 is a schematic rear view of a skin patch according to one embodiment of the present invention. Fig. 6 shows the form of the release liner 140 of the skin patch having the release liner 140, and the dotted lines are the division lines of the release liner 140. In one embodiment, as shown in Fig. 6, the release liner 140 is divided into three in the width direction, and is composed of a first divided piece 141, a second divided piece 142, and a third divided piece 143.

[0039] FIG. 7 is a schematic cross-sectional view of a skin adhesive material according to one embodiment of the present invention. In FIG. 7, a cross-sectional view of the skin adhesive material as seen from the front is shown. In one embodiment, as shown in FIG. 7, the divided pieces constituting the release liner may have folded parts 141a, 143a. The folded parts 141a, 143a are parts formed by folding back from the folded lines 141b, 14ba at any appropriate locations. More specifically, folded parts are provided in the first divided piece 141 and the third divided piece 143 located at both ends in the width direction. The folded part 141a of the first divided piece 141 has a folded line 141b at the boundary between the first divided piece 141 and the second divided piece 142, and is folded back based on the folded line. Furthermore, the folded portion 143a of the third divided piece 143 has a folding line 143b at the boundary between the third divided piece 143 and the second divided piece 142, and is folded back using the folding line as a reference.

[0040] Fig. 8 is a schematic rear view of a skin patch according to another embodiment of the present invention. Fig. 8 shows the form of the release liner 140 of the skin patch, with the dotted lines indicating the division lines of the release liner 140. In this embodiment, the release liner 140 is composed of a first segment 141', a second segment 142', and a third segment 143' that are divided into three in the width direction at the rear of the skin patch, and a fourth segment 144' that covers the entire width at the front of the skin patch.

[0041] Fig. 9 is a schematic cross-sectional view of a skin adhesive member according to another embodiment of the present invention. Fig. 9 shows a cross-sectional view of the skin adhesive member taken along line VIII-VIII. In one embodiment, as shown in Fig. 9, the first divided piece 141' has a folded portion 141a', and the folded portion 141a' has a folding line 141b' at the boundary between the first divided piece 141' and the second divided piece 142', and is folded back based on the folding line. The third divided piece 143' has a folded portion 143a', and the folded portion 143a' has a folding line 143b' at the boundary between the third divided piece 143' and the second divided piece 142', and is folded back based on the folding line. In addition, the second split piece 142' has a fold-back portion 142a' at both ends in the width direction, and the fold-back portion 142a' has a fold-back line 142b' at the boundary between the first split piece 141' and the second split piece 142' and at the boundary between the third split piece 143' and the second split piece 142', and is folded back based on the fold-back line.

[0042] In one embodiment, the folded portion of the first divided piece and / or the folded portion of the second divided piece has an extension portion. The extension portion is a portion that extends from the first base material of the skin patch when the divided pieces are folded. If the folded portion has an extension portion, it becomes a gripping portion, and a skin patch having significantly excellent operability for application to the surface of a living body can be obtained. The length of the extension portion is preferably 1 mm to 30 mm, and more preferably 5 mm to 20 mm.

[0043] A-2. Second embodiment As described above, in the second embodiment, the non-adhesive portion has adhesiveness. In this embodiment, the skin patch is configured such that, when the skin patch is applied, an upright portion is formed behind the non-adhesive portion. The non-adhesive portion is configured such that, as the upright portion stands up, it is not adhered to the adherend. FIG. 10(a) is a schematic plan view of a skin patch according to a preferred embodiment of the present invention, and FIG. 10(b) is a schematic cross-sectional view of the skin patch of FIG. 10(a) taken along line Xb-Xb. As shown in FIG. 10(a), the skin patch 200 has, in plan view, a non-adhesive portion 110'' and a fixing portion 120. The fixing portion 120 has adhesiveness to the adherend (skin) and contributes to fixing the medical device.

[0044] As shown in FIG. 10(b), the skin patch 200 comprises, in cross-sectional view, a first base material 11 and a first adhesive layer 12 in this order. Typically, the first adhesive layer 12 is transparent. In this embodiment, the first base material 11 may be a film base material. Typically, the film base material is transparent. The second embodiment differs from the first embodiment in that the non-adhesive portion is not covered with a cover material or the like, and the first adhesive layer is exposed during use.

[0045] In one embodiment, as shown in FIG. 10(b), the skin patch 200 includes a second substrate 14. In this embodiment, the second substrate 14 may be a support substrate. When the skin patch 100 includes the second substrate (support substrate) 14, the second substrate (support substrate) 14 may be disposed so as to be in contact with the first adhesive layer 12, and a second adhesive layer 15 may be disposed on the opposite side of the second substrate (support substrate) 14 to the first adhesive layer 12. That is, in this embodiment, the skin patch 100 includes a first substrate (film substrate) 11, a first adhesive layer 12, a second substrate (support substrate) 14, and a second adhesive layer 15 in this order. In addition, when the skin patch 100 includes a window portion 121, the second substrate (support substrate) 14 has an opening having the same shape as the window portion 121 in a plan view at a position corresponding to the window portion 121. Furthermore, when the non-adhesive portion 110'' is transparent, the support substrate 14 has an opening at a position corresponding to the non-adhesive portion 110'' and having the same shape as the non-adhesive portion 110'' in a plan view.

[0046] When the catheter 200 is fixed to the skin patch according to the second embodiment, as shown in FIG. 3, an upright portion 122 is formed behind the non-adhesive portion 110''. The upright portion 122 is formed by wrapping the fixing portions 120 near the non-adhesive portion 110'' half a turn each on both sides in the width direction around a portion of the catheter 200 behind the non-adhesive portion 110'' (opposite the puncture portion), and then bonding the fixing portions 120 on the left and right in the width direction together below the wrapped portion. The skin patch can satisfactorily fix the catheter while preventing indentations without requiring complicated operations. The height of the upright portion is, for example, 5 mm to 20 mm.

[0047] Other configurations (plan view configuration, window configuration, etc.) in the second embodiment may be as described in section A-1.

[0048] In the skin patch of this embodiment, the non-adhesive portion 110'' is formed as described above, thereby reducing the pressure that the medical instrument places on the skin. In addition, a predetermined space is formed around the medical instrument under the skin patch, allowing the medical instrument to move appropriately. As a result, even when force is applied to the medical instrument, the load generated when the skin is pulled by the medical instrument or the patch that fixes it is reduced. The skin patch of the present invention, which exerts such an effect, is particularly useful when fixing a part that has large irregularities and puts strong pressure on the skin, such as a catheter hub.

[0049] B. Description of each component B-1. Supporting base material As the material constituting the support substrate, any suitable material can be used as long as the effect of the present invention can be obtained. Specific examples of the material of the support substrate include cotton, rayon, nylon, urethane, polyethylene, polypropylene, polyester, pulp, etc. Such materials have appropriate strength and flexibility, so that a skin patch that causes little pressure from a medical device such as a catheter can be obtained. In addition, when fixing a medical device, the above-mentioned standing portion can be well formed.

[0050] In one embodiment, a nonwoven fabric is used as the support substrate. Since the nonwoven fabric has appropriate strength and flexibility, it is possible to obtain a skin patch that is less oppressive to medical instruments such as catheters. In addition, when fixing a medical instrument, the upright portion can be well formed. Examples of the form of the nonwoven fabric include spunlace nonwoven fabric, spunbond nonwoven fabric, and meltblown nonwoven fabric. The support substrate may have a single layer structure or a laminate structure of two or more layers. In the case of a laminate structure, each layer may be the same or different.

[0051] The thickness of the support substrate can be set to any appropriate thickness depending on the purpose. The thickness of the support substrate is preferably 100 μm to 500 μm, and more preferably 200 μm to 400 μm. Within such a range, the upright portion can be well formed when fixing the medical device. If the thickness of the support substrate is less than 100 μm, the strength required for the skin patch may not be obtained. If it is more than 500 μm, the appropriate flexibility may not be obtained.

[0052] B-2.Adhesive layer Any suitable adhesive may be used as the adhesive constituting the first adhesive layer and the second adhesive layer. Preferably, an adhesive that can be used by attaching to the surface of a living body is used. Specific examples of such adhesives include pressure-sensitive adhesives such as natural rubber, synthetic rubber, acrylic, silicone, and hot melt. Acrylic pressure-sensitive adhesives are preferred. This is because they can further increase the transparency of the transparent part of the skin patch and further reduce irritation to the skin. Among acrylic pressure-sensitive adhesives, oily gel acrylic pressure-sensitive adhesives are particularly preferred. This is because they are low irritation to scars, suture wounds, and skin with photosensitivity or photoallergy. Details of oily gel acrylic pressure-sensitive adhesives are described in, for example, JP-A-6-319793, the description of which is incorporated herein by reference.

[0053] The thickness of the first adhesive layer and the second adhesive layer may be any appropriate thickness depending on the purpose and use. The thickness of the first adhesive layer is preferably 5 μm to 60 μm, more preferably 10 μm to 50 μm. The thickness of the second adhesive layer is preferably 20 μm to 100 μm, more preferably 30 μm to 70 μm. If the thickness of the adhesive layer is within such a range, the adhesiveness to the surface of the living body is excellent, so that the adhered skin patch can be effectively prevented from floating or peeling off. In addition, the end of the skin patch can be effectively prevented from curling up when the skin patch is adhered for a long period of time.

[0054] Any suitable method may be adopted as a method for providing the first and second pressure-sensitive adhesive layers.Specific examples include a method of applying a pressure-sensitive adhesive composition to a surface on which the pressure-sensitive adhesive layer is to be disposed and drying the same, and a method of transferring and laminating a pressure-sensitive adhesive layer obtained by forming the pressure-sensitive adhesive composition into a predetermined shape onto the surface on which the pressure-sensitive adhesive layer is to be disposed.

[0055] B-3.Film substrate As the film substrate, any suitable film may be adopted as long as it can be used for a skin patch. Typically, a film that has transparency and flexibility and does not damage the surface of a living body such as the skin may be adopted. Specific examples of the material of such a film include acrylic polymer, polyethylene, ethylene-vinyl acetate copolymer, polyurethane, polyether polyester and polyamide derivative. Among them, acrylic polymer, polyurethane, polyether polyester or polyamide derivative is preferable, and polyurethane is more preferable. Film substrates made of these materials are preferable in that they have excellent water vapor permeability, so they do not interfere with the breathing of the covered skin, can suppress the whitening phenomenon of the skin, and have excellent transparency.

[0056] The thickness of the film substrate may be any appropriate thickness depending on the purpose and use. The thickness of the film substrate is preferably 5 μm to 150 μm, and more preferably 10 μm to 75 μm. If the thickness is as described above, the film substrate has excellent conformability to the irregularities of the body surface (for example, skin) and can function well as a substrate for a skin patch.

[0057] B-4. Cover material Any suitable film may be used as the cover material constituting the non-adhesive portion. For example, the material constituting the cover material may be the same as the material constituting the film substrate described in section B-3. Also, the material constituting the support substrate described in section B-1 may be the same as the material constituting the support substrate.

[0058] The thickness of the cover material is preferably from 5 μm to 150 μm, and more preferably from 10 μm to 75 μm.

[0059] B-5. Release liner As the release liner, any suitable release liner can be used as long as it can be used in the present invention and can be easily peeled off from the pressure-sensitive adhesive layer. Typically, the release liner has a substrate and a release treatment layer formed on the substrate surface. Specific examples of the substrate include plastic films (e.g., polyethylene, polypropylene, polyester, or laminated composites thereof) and paper (e.g., fine paper, kraft paper, etc.). The release treatment layer can be formed by subjecting the substrate surface to a silicone-based resin treatment, a fluorine-based resin treatment, or the like. In the present invention, the release treatment layer is preferably formed on both sides of the substrate.

[0060] The thickness of the release liner can be appropriately set depending on the purpose, and is preferably 50 μm to 250 μm, and more preferably 75 μm to 200 μm.

[0061] C. Specific steps for applying the skin patch Fig. 11 is a schematic diagram for explaining a specific procedure for attaching a skin patch according to one embodiment of the present invention. Fig. 11 shows a procedure for fixing the puncture site of a catheter by using a skin patch 100 having a release liner divided into three parts (i.e., a release liner 140 composed of a first divided piece 141, a second divided piece 142, and a third divided piece 143) as shown in Fig. 6.

[0062] When the release liner is divided into three parts, as shown in (a), the second divided piece 142 in the widthwise center can be peeled off first when attaching the skin patch 100. When the skin patch 100 has a window 121, this causes at least a part of the window 121 of the skin patch 100 to be exposed.

[0063] Thereafter, as shown in (b), the skin patch 100 is attached to the living body 300 on which the catheter 200 has been placed, by aligning the non-adhesive portion (non-adhesive portion) 110 with the position of the hub portion 210 of the catheter 200. In one embodiment, when the skin patch 100 is attached, an upright portion 122 is formed behind the non-adhesive portion (non-adhesive portion) 110. The upright portion 122 is formed by wrapping the fixing portion 120 around a portion behind (the opposite side to the puncture portion) the non-adhesive portion (non-adhesive portion) 110 of the catheter 200, and then bonding together the fixing portions 120 on the left and right in the width direction below the wrapped portion.

[0064] Next, as shown in (c), the first and third pieces 141 and 143 of the release liner are peeled off and the entire skin patch material 100 is adhered to the living body 300, completing the application operation of the skin patch material 100 in the state shown in (e).

[0065] Fig. 12 is a schematic diagram a for explaining a specific procedure for attaching a skin patch according to another embodiment of the present invention. Fig. 12 shows a procedure for fixing the puncture site of a catheter using a skin patch having a release liner divided into four parts as shown in Fig. 8 (i.e., release liner 140 composed of first divided piece 141', second divided piece 142', third divided piece 143', and fourth divided piece 144').

[0066] 12(a), the fourth divided piece 144' is peeled off first. If the skin adhesive member 100 has a window portion 121, this causes at least a part of the window portion 121 of the skin adhesive member 100 to be exposed.

[0067] Thereafter, as shown in FIG. 12(b), the skin patch 100 is attached to the living body 300 on which the catheter 200 is placed, by aligning the non-adhesive portion (non-adhesive portion) 110 with the position of the hub portion 210 of the catheter 200. Next, the second divided piece 142' is peeled off. In one embodiment, as shown in FIG. 12(c), when the skin patch 100 is attached, an upright portion 122 is formed behind the non-adhesive portion (non-adhesive portion) 110. The upright portion 122 is formed by wrapping the fixing portion 120 around a portion behind (opposite the puncture portion) the non-adhesive portion (non-adhesive portion) 110 of the catheter 200, and then bonding together the fixing portions 120 on the left and right in the width direction below the wrapped portion.

[0068] Next, as shown in Figure 12(d), the first piece 141' and the second piece 142' are peeled off and the entire skin patch material 100 is attached to the living body 300, completing the attachment operation of the skin patch material 100 in the state shown in Figure 12(e). [Industrial Applicability]

[0069] The skin patch of the present invention is suitable for medical applications, and can be particularly suitable for use in fixing medical instruments such as catheters. [Explanation of symbols]

[0070] 11 First substrate (film substrate) 12 First adhesive layer 13 Cover material 14 Second substrate (support substrate) 15 Second adhesive layer 100 Skin patches 110 Non-adhesive part 120 Fixed part 121 Window 122 Standing part 140 Release Liner

Claims

1. A skin patch having, in a plan view, a non-adhesive portion and fixing portions located on at least both sides of the non-adhesive portion in a width direction, In a cross-sectional view, the adhesive sheet has a first substrate and a first pressure-sensitive adhesive layer in this order from a surface side, the skin patch is configured so that, when the skin patch is attached to an adherend, the fixing part adheres to the adherend and the non-adhesive part does not adhere to the adherend, When the skin patch is attached, a standing portion is formed behind the non-adhesive portion. Skin patches.

2. The non-adhesive portion is a non-adhesive portion, The non-adhesive portion is configured so as not to have adhesiveness to an adherend. The skin patch according to claim 1.

3. A skin patch having, in a plan view, a non-adhesive portion and fixing portions located on at least both sides of the non-adhesive portion in a width direction, In a cross-sectional view, the adhesive sheet has a first substrate and a first pressure-sensitive adhesive layer in this order from a surface side, the skin patch is configured so that, when the skin patch is attached to an adherend, the fixing part adheres to the adherend and the non-adhesive part does not adhere to the adherend, The non-adhesive portion is a non-adhesive portion, The non-adhesive portion is configured so as not to have adhesiveness to an adherend, The skin patch further comprises a cover material, In the non-adhesive portion, the first substrate, the first adhesive layer, and the cover material are disposed in this order. Skin patches.

4. Further comprising a second substrate and a second pressure-sensitive adhesive layer; In a cross-sectional view, the first substrate, the first pressure-sensitive adhesive layer, the second substrate, and the second pressure-sensitive adhesive layer are arranged in this order. The skin patch according to claim 2 or 3.

5. The skin patch according to claim 4 , wherein the second substrate is a nonwoven fabric.

6. A skin patch having, in a plan view, a non-adhesive portion and fixing portions located on at least both sides of the non-adhesive portion in a width direction, In a cross-sectional view, the adhesive sheet has a first substrate and a first pressure-sensitive adhesive layer in this order from a surface side, the skin patch is configured so that, when the skin patch is attached to an adherend, the fixing part adheres to the adherend and the non-adhesive part does not adhere to the adherend, The non-adhesive portion is a non-adhesive portion, The non-adhesive portion is configured so as not to have adhesiveness to an adherend, The skin patch further comprises a second substrate and a second adhesive layer; In a cross-sectional view, the first substrate, the first pressure-sensitive adhesive layer, the second substrate, and the second pressure-sensitive adhesive layer are disposed in this order; The second substrate is a nonwoven fabric. Skin patches.

7. Further comprising a cover material; In the non-adhesive portion, the first base material, the first adhesive layer, and the cover material are arranged in this order. A skin patch according to claim 1, claim 2, claims 4 to 5 which cite claim 2, or claim 6.

8. The skin patch according to claim 1 , wherein the fixing part has a window formed therein.

9. The skin patch according to claim 2 , wherein the non-adhesive portion is transparent.

10. The skin patch according to claim 1 , further comprising a release liner that protects the side of the skin patch opposite the first substrate.

11. The skin patch according to claim 10, wherein the release liner is composed of a plurality of divided pieces.

12. A skin patch according to claim 4, claim 5, claim 6, claim 7 citing any of claims 4 to 6, claim 8 citing any of claims 4 to 7, claim 9 citing any of claims 4 to 8, claim 10 citing any of claims 4 to 9, or claim 11 citing any of claims 4 to 10, wherein the thickness of the second substrate is 100 μm to 500 μm.

13. A skin patch having, in a plan view, a non-adhesive portion and fixing portions located on at least both sides of the non-adhesive portion in a width direction, In a cross-sectional view, the adhesive sheet has a first substrate and a first pressure-sensitive adhesive layer in this order from a surface side, the skin patch is configured so that, when the skin patch is attached to an adherend, the fixing part adheres to the adherend and the non-adhesive part does not adhere to the adherend, The non-adhesive portion has adhesiveness, and When the skin patch is attached, a standing portion is formed behind the non-adhered portion. Skin patches.

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