Dressing for CV port

Abstract

The present invention is provided with: a substrate layer (10) in which a first adhesive layer is provided on one surface of a film; a release sheet (30) which covers the surface of the first adhesive layer and is laminated in a peelable manner; and a non-woven fabric sheet (20) laminated on the surface side of the base material layer opposite to the first adhesive layer, the non-woven fabric sheet (20) being adhered to the film by providing a second adhesive layer on one surface of a perforated non-woven fabric, the perforated portion (23) of the non-woven fabric sheet forming a window portion, the release sheet (30) being capable of being divided into a first portion (31), a second portion (32), and a third portion (33), the first portion (31) being separated from the second portion (32), and the third portion (33) being separated from the second portion (32). The second portion (32) is in the shape of a belt that traverses the open hole portion (23), the first portion (31) and the third portion (33) are disposed on both sides of the second portion (32), the width (E) of the second portion is 20-80 mm without including the width of a portion overlapping the first portion or the third portion, the dimension (B) of a window portion formed by the open hole portion (23) is 60 mm or more, and the width (C) of the nonwoven fabric sheet around the open hole portion (23) is 10 mm or more.

Description

CV Hong Kong Dressing Technical Field

[0001] This invention relates to CV dressings for use in Hong Kong. Background Technology

[0002] A CV port is known to be implanted in the human body for administering drugs or infusing essential nutrients via a central vein.

[0003] A CV port, or subcutaneous implantable central venous port, consists of a roughly circular container (approximately 2-3 cm in diameter) in top view, and a silicone rubber septum that functions as a cap for the container. A huber needle, acting as a specialized needle, is inserted into the septum to allow the prescribed medication to flow into the container. The container is also connected to a catheter through which the medication is delivered into the body.

[0004] Depending on the treatment, there are situations where the needle is left in place at the CV port for an extended period. In such cases, to prevent the needle from falling out or shifting, it is typically secured to the skin using tape, dressings, or similar materials. Patent documents 1 and 2 disclose an example of a conventional membrane dressing.

[0005] However, due to the raised CV port implantation site and the thickness of the atraumatic needle with its safety device, conventional dressings are difficult to adhere when fixing the atraumatic needle and protecting the puncture site. Furthermore, the following issues exist: for some patients, the atraumatic needle length is unsuitable, creating a gap between the needle and the skin, leading to dangerous needle movement; to prevent movement, additional cushioning material must be prepared; and if the cushioning material is not sterilized, there is a risk of infection.

[0006] Existing technical documents

[0007] Patent documents

[0008] Patent Document 1: Japanese Patent Application Publication No. 2011-4850

[0009] Patent Document 2: Japanese Patent Application Publication No. 2014-68721 Summary of the Invention

[0010] The problem that the invention aims to solve

[0011] The present invention was made in view of the above circumstances, and its object is to provide a dressing for CV port that can effectively fix a non-abrasive needle for CV port users.

[0012] Technical means for solving problems

[0013] The CV port dressing of the present invention comprises: a substrate layer having a first adhesive layer disposed on one side of a film; a release sheet covering the surface of the first adhesive layer and laminated in a peelable manner; and a nonwoven fabric sheet laminated on the side of the substrate layer opposite to the first adhesive layer, wherein the nonwoven fabric sheet is adhered to the film by a second adhesive layer disposed on one side of the nonwoven fabric with an opening shape, and a window portion is formed by the opening portion of the nonwoven fabric sheet; the release sheet can be divided into a first part, a second part, and a third part, the second part being a strip-shaped portion that traverses the opening portion of the nonwoven fabric; the first part and the third part being disposed on both sides of the second part with the second part in the center; the width of the second part, excluding the width of the portion overlapping with the first part or the third part, is 20 mm to 80 mm; the size of the window portion formed by the opening portion is 60 mm or more; and the width of the nonwoven fabric sheet surrounding the opening portion is 10 mm or more.

[0014] Preferably, the substrate layer is a polyurethane film or a polyethylene film.

[0015] Preferably, the substrate layer is circular or elliptical.

[0016] Preferably, the nonwoven fabric is PET nonwoven fabric or polyurethane nonwoven fabric.

[0017] Alternatively, the substrate layer and the nonwoven fabric sheet may be circular in the same shape, with a diameter of 70 mm to 170 mm, and the diameter of the opening may be 60 mm or more.

[0018] Alternatively, the substrate layer and the nonwoven fabric sheet may be elliptical in shape, with the length of their major axis and minor axis being 70 mm to 170 mm, and the length of the major axis and minor axis of the opening being 60 mm or more.

[0019] Alternatively, the first adhesive layer may be a polyurethane-based adhesive or an acrylic-based adhesive.

[0020] Invention Effects

[0021] According to the CV port dressing of the present invention, when fixing a non-abrasive needle facing the CV port user, due to the expansion of the non-abrasive needle and the softness of the membrane, when the CV port dressing of the present invention is pasted to the tube of the non-abrasive needle, an Ω-adhesion (Ω-paste) is naturally formed. The safety device of the non-abrasive needle and the tube are maintained at a certain height in a straight line, thereby reducing the shaking of the non-abrasive needle, which is a problem of CV port fixing. Attached Figure Description

[0022] Figure 1 is a top view of the CV port dressing according to the first embodiment.

[0023] Figure 2 is a cross-sectional view of the CV port dressing according to the first embodiment.

[0024] Figure 3 is a top view of the CV port dressing according to the second embodiment.

[0025] Figure 4 is a cross-sectional view of the CV port dressing according to the second embodiment.

[0026] Figure 5 is a top view of the CV port dressing according to the third embodiment.

[0027] Figure 6 is a cross-sectional view of the CV port dressing according to the third embodiment.

[0028] Figure 7 is a top view of the CV port dressing according to the fourth embodiment.

[0029] Figure 8 is a cross-sectional view of the CV port dressing according to the fourth embodiment. Detailed Implementation

[0030] The present invention will now be described based on preferred embodiments.

[0031] Figures 1 and 2 show the CV port dressing 100 according to the first embodiment.

[0032] Figures 3 and 4 show the CV port dressing 200 according to the second embodiment.

[0033] Figures 5 and 6 show the CV port dressing 300 according to the third embodiment.

[0034] Figures 7 and 8 show the CV port dressing 400 according to the fourth embodiment.

[0035] These CV port dressings 100, 200, 300, and 400 have: a substrate layer 10 having a first adhesive layer 12 disposed on one side 11a of the film 11; a release sheet 30 covering the surface 12a of the first adhesive layer 12 and laminated in a peelable manner; and a nonwoven sheet 20 laminated on the side 11b of the substrate layer 10 opposite to the first adhesive layer 12.

[0036] The nonwoven fabric sheet 20 is adhered to the film 11 by providing a second adhesive layer 22 on one side of the perforated nonwoven fabric 21. The perforation 23 of the nonwoven fabric 21 contains the thickness region of the second adhesive layer 22 and extends through the nonwoven fabric sheet 20. The perforation 23 forms a through hole in the central portion of the planar shape of the substrate layer 10, excluding the outer edge portion, thus forming a window portion. The nonwoven fabric sheet 20 is only laminated on the outer edge portion of the substrate layer 10 on surface 11b, thereby reinforcing the outer edge portion of the substrate layer 10.

[0037] In these CV port dressings 100 and 200, the planar shape of the substrate layer 10 is circular. Furthermore, in CV port dressings 300 and 400, the planar shape of the substrate layer 10 is elliptical (as shown horizontally in Figures 5 and 6). Although not shown, the planar shape of the substrate layer 10 can also be a square, a rectangle, a quadrilateral, other polygons, an oval, etc. When the planar shape is a quadrilateral or other polygon, rounded corners can be provided at locations corresponding to the vertices of the polygon. A circular or elliptical shape is preferred.

[0038] In this specification, a circle is defined as a planar shape in which all distances from the center to the outer perimeter are equal.

[0039] Furthermore, in this specification, the term "ellipse" includes not only a planar shape formed by a curve of a set of points on a plane whose sum of distances from two fixed points is constant, but also a planar shape formed by a long circle formed by two semicircles of the same radius connected by two parallel tangents, and a shape slightly modified from a regular ellipse (approximately elliptical). That is, even if slightly modified from a regular ellipse, as long as the major and minor axes can be determined and produce the same effect as the present invention, it is included in the ellipse of the present invention. In this case, the ratio of the length of the major axis to the length of the minor axis of the ellipse (which also includes the shape of a long circle) can be set, for example, in the range of major axis:minor axis = 100:99 to 100:50, or in the range of 100:80 to 100:60, but is not limited thereto.

[0040] The planar shape of the inner peripheral side (i.e., the opening 23) of the substrate layer 10 can be similar to or dissimilar to the planar shape of the outer peripheral side of the substrate layer 10. However, it is preferable that, as in the example substrate layer 10 shown in the figures, the planar shapes of the outer and inner peripheral sides are concentric circles (Figures 1 and 3) or concentric ellipses (Figures 5 and 7). Furthermore, the planar shape of the inner peripheral side can be concentric with or eccentric to the planar shape of the outer peripheral side. Here, the center of the planar shape can be determined, for example, based on the location of the center of gravity.

[0041] Regarding the release tab 30, it can be divided into a first part 31, a second part 32, and a third part 33. The second part 32 is a strip that runs across the opening 23 of the nonwoven fabric 21. The first part 31 and the third part 33 are arranged on both sides of the second part 32 with the second part 32 in the center. The width of the second part 32 (in the figures, in the left-right direction) is 20 mm to 80 mm, excluding the width of the portion overlapping with the first part or the third part. Here, the second part 32 is referred to as being strip-shaped because, when viewed from above, the dimension (length) of the second part 32 in the direction perpendicular to its width is longer than its width.

[0042] In the illustrated examples, the length of the second portion 32 (vertical direction in each figure) extends along the diameter direction of the circular substrate layer 10 in the first and second embodiments (Figures 2 and 4), and along the minor axis direction of the elliptical substrate layer 10 in the third and fourth embodiments (Figures 6 and 8). In the illustrated examples, the width of the second portion 32 (horizontal direction in each figure) is approximately constant along the diameter direction of the circular substrate layer 10 or the minor axis direction of the elliptical substrate layer 10, but the width can vary within the aforementioned range. For example, the width can gradually increase or gradually decrease from one end in the diameter direction towards the other. Alternatively, the width can gradually increase beyond the center and then gradually decrease. The width of the first portion 31 and the width of the third portion 33 can be the same or different.

[0043] The material of the release sheet 30 only needs to have a certain degree of toughness (thickness) for operability and is not particularly limited. Release sheets and release films commonly used in the field of adhesive materials can be used. For example, high-quality paper substrates such as paper or cellophane that have undergone silicone release treatment or polyester films can be used. In addition, the thickness of the release sheet 30 can be set from 20 μm to 300 μm, preferably from 30 μm to 200 μm.

[0044] The membrane 11 of the substrate layer 10 is preferably a transparent or translucent membrane that allows the retention of the non-damaging needle to be visually observed after the dressing is applied. Furthermore, it is preferably a polyurethane or polyethylene membrane with moderate flexibility and stretchability along the skin surface. These membranes are soft and excellent in terms of deformability and conformability required for CV port dressings 100, 200, 300, and 400.

[0045] The thickness of the film 11 in the substrate layer 10 is preferably 5 g / m in most cases. 2 Up to 100 g / m 2 More preferably 10 g / m 2 Up to 80 g / m 2 .

[0046] As for the nonwoven fabric 21, various fibers such as natural fibers, synthetic fibers, regenerated fibers, and appropriate combinations thereof can be used. For example, acrylic nonwoven fabric, polyamide nonwoven fabric, PET nonwoven fabric, and polyurethane nonwoven fabric can be used. If PET nonwoven fabric and polyurethane nonwoven fabric are used, they are preferred in most cases from the perspective of moderate elongation and compatibility with the skin surface.

[0047] The areal density of the nonwoven fabric is not particularly limited, as long as it is within the range of areal densities of nonwoven fabrics commonly used as the base material for adhesive tapes, but in most cases it is preferred to be about 30 g / m. 2 Up to 150 g / m 2More preferably 40 g / m 2 Up to 100 g / m 2 .

[0048] PET stands for polyethylene terephthalate.

[0049] As the adhesive (first adhesive layer 12) for the substrate layer 10, various adhesives such as natural rubber-based, synthetic rubber-based, acrylic-based, polyurethane-based, vinyl ether-based, and silicone-based adhesives can be used. The substrate layer 10, to which this first adhesive layer 12 is provided, is adhered to the skin as described later. Therefore, an adhesive that provides sufficient adhesion to the skin surface, causes minimal skin irritation, and is expected to have a certain degree of moisture permeability is ideal. Thus, polyurethane-based or acrylic-based adhesives are preferred in most cases.

[0050] As acrylic adhesives, homopolymers of alkyl methacrylate monomers such as butyl acrylate, 2-ethylhexyl acrylate, and isononyl acrylate, or copolymers composed of multiple such monomers, can be used. Copolymers of (meth)acrylic acid, (meth)acrylate hydroxyalkyl esters, vinyl acetate, styrene, vinylpyrrolidone, (meth)acrylate amine, (meth)acrylate alkoxyalkyl esters, and other monomers capable of copolymerizing with the aforementioned alkyl methacrylate monomers can also be used. Among these, acrylic adhesives containing copolymers with (meth)acrylate alkyl esters as the main component are more preferred.

[0051] The thickness of the first adhesive layer 12 is typically around 10 μm to 200 μm, preferably 20 μm to 100 μm.

[0052] Examples of polyurethane-based adhesives include polyurethane polymers obtained using polyols and polyisocyanates. From the viewpoint of skin irritation, adhesives with a mass ratio (OH / NCO) of 1.55 to 1.90 between a polyol containing one to three hydroxyl groups (OH) or a polyurethane polyol and a polyisocyanate containing two to three isocyanate groups (NCO) or a polyurethane prepolymer are preferred, more preferably in the range of 1.60 to 1.85. If the OH / NCO ratio is lower than this, long-term adhesion to the skin deteriorates; if it is higher, aggregation and breakage easily occur upon peeling from the skin.

[0053] Polyols are not particularly limited, but examples include hydroxyl compounds, amine compounds, carboxylic acid compounds, thiols, and polyether polyols containing hydroxyl groups. Examples of hydroxyl compounds include ethylene glycol, diethylene glycol, propylene glycol, dipropylene glycol, tripropylene glycol, 1,3-propanediol, 1,3-butanediol, 1,4-butanediol, 2,3-butanediol, 1,6-hexanediol, 1,9-nonanediol, 2,5-hexanediol, 1,3-cyclohexanediol, 2-methylpentan-2,4-diol, 2,5-dimethyl-2,5-hexanediol, glycerol, trimethylolpropane, hexanol, pentaerythritol, diglycerol, sorbitol, sucrose, glucose, 2-naphthol, and bisphenol. Examples of amine compounds include ethylenediamine, 1,3-propanediamine, 1,4-butanediamine, and 1,2-butanediamine. Examples of carboxylic acid compounds include phthalic acid and adipic acid. Examples of thiol compounds include ethylenedithiol and butanedithiol. Examples of polyether polyols containing hydroxyl groups include polyether polyols with a molecular weight of 200 or more and 10,000 or less.

[0054] As polyisocyanates, compounds having at least two isocyanate groups can be used, but are not particularly limited. Examples include 2,4-toluene diisocyanate, 2,6-toluene diisocyanate, 2,4'-diphenylmethane diisocyanate, 4,4'-diphenylmethane diisocyanate, 1,5-naphthalene diisocyanate, triazine diisocyanate, xylene diisocyanate, 1,3-phenylene diisocyanate, 1,4-phenylene diisocyanate, lysine diisocyanate, triphenylmethane triisocyanate, tetramethylxylene diisocyanate, 1,6-hexamethylene diisocyanate, and 4,4'-dicyclohexylmethyl... This includes isocyanates such as alkyl diisocyanates, isophorone diisocyanates, 1,4-cyclohexane diisocyanates, norbornene diisocyanates, lysine ester triisocyanates, 1,6,11-undecane triisocyanates, 1,8-diisocyanate-4-isocyanate methyl octane, 1,3,6-hexamethylene triisocyanates, dicycloheptane triisocyanates, trimethylhexamethylene diisocyanates, polyurethane prepolymers containing isocyanates obtained by reacting them with polyols, and mixtures of two or more of these. Furthermore, it also includes modified versions of these isocyanates (modified versions containing urethane groups, carbodiimide groups, urea groups, biuret groups, isocyanurate groups, amide groups, imide groups, urethaneimide groups, urethanedione groups, or oxazolinone groups), condensates (sometimes called polynuclear compounds) such as polymethylene polyphenyl polyisocyanates (polymeric MDI).

[0055] As an adhesive (second adhesive layer 22) for the nonwoven fabric sheet 20, it can be used as long as it has sufficient adhesion to the substrate layer 10. Therefore, various adhesives such as natural rubber, synthetic rubber, acrylic, polyurethane, vinyl ether, and silicone can be used.

[0056] As described above, the CV port has a roughly circular container with a diameter of about 2 to 3 cm when viewed from above, and a septum made of silicone rubber that functions as a lid for the container. With an atraumatic needle (a specialized needle) inserted into the septum, the container is connected to a catheter. The catheter is inserted into a vein, etc. The atraumatic needle is connected to a syringe, etc., via a tube. Medication from the syringe, etc., is injected into a vein, etc., via the atraumatic needle and the CV port. The CV port covers and secures the atraumatic needle and its tube with a dressing.

[0057] The CV port dressing is preferably Ω-bonded relative to the tube of the non-abrasive needle. In Ω-bonding, it is preferable to wrap the outer periphery of the tube at an angle of about 360° in the circumferential direction, so that the adhesive surfaces of the dressing (surface 12a of the first adhesive layer 12) are in contact with each other. As a result, a fixing part is formed between the CV port setting surface (skin surface, etc.) and the tube, so that the adhesive surfaces of the dressing are in contact with each other, and therefore the dressing is not easily peeled off.

[0058] To secure the non-abrasive needle using CV port dressings 100, 200, 300, and 400, the second portion 32 is removed to expose the adhesive surface of the dressing (surface 12a of the first adhesive layer 12) in an area comparable to the width of the second portion 32. The width of this adhesive surface, comparable to the width of the second portion 32, is sufficiently large relative to the non-abrasive needle connected to the CV port, thus facilitating the Ω-adhesion of the non-abrasive needle.

[0059] On the adhesive surface, which is approximately the same width as the second part 32, after the tube is bonded in an Ω-shape, the first part 31 and the third part 33 can be peeled off and attached to the setting surface of the CV port (the surface of the skin, etc.), the area around the non-traumatic needle, etc. Preferably, after peeling off one of the first part 31 and the third part 33 (one of the left and one of the right sides relative to the second part 32) and attaching the exposed adhesive surface to the non-traumatic needle, etc., the remaining adhesive surface of the first part 31 and the third part 33 is then peeled off and attached to the non-traumatic needle, etc.

[0060] The membrane 11 of the substrate layer 10 is thin and soft, and a non-woven fabric sheet 20 is laminated around the substrate layer 10. Furthermore, the release stencil 30 can be divided into three pieces, thereby naturally forming an Ω-shaped adhesive when attaching to the adhesive surface, preventing the tube portion from prolonged contact with the skin. In addition, the Ω-shaped adhesive can be formed at the same height as the CV port installation surface, thereby maintaining the non-traumatic needle at the same height as the upper part of the CV port implantation portion, thereby reducing needle wobbling, a problem related to non-traumatic needle fixation.

[0061] In the CV port dressing 100 of the first embodiment and the CV port dressing 300 of the third embodiment, the planar shape of the release tab 30 is the same as the planar shape of the substrate layer 10. The outer periphery can be punched together while the substrate layer 10, the nonwoven fabric sheet 20, and the release tab 30 are overlapping. Since only the second part 32 is peeled off from the first adhesive layer 12 instead of the first part 31 and the third part 33, the first part 31 and the third part 33 have folded-back portions 31a and 33a, and the second part 32 has an overlapping portion 32a that overlaps the first part 31 or the third part 33. The second part 32 is easily peeled off by pinching the overlapping portion 32a. Additionally, the first part 31 and the third part 33 are easily peeled off by pinching the folded-back portions 31a and 33a.

[0062] In the CV port dressing 200 of the second embodiment and the CV port dressing 400 of the fourth embodiment, the planar shape of the release tab 30 is formed to be larger than the planar shape of the substrate layer 10. The release tab 30 can be attached after the outer periphery is punched together while the substrate layer 10 and the nonwoven fabric sheet 20 are overlapping. Since the area of ​​the release tab 30 extending beyond the substrate layer 10 can be pinched, the first part 31, the second part 32, and the third part 33 can be easily peeled off individually even if the aforementioned folded portions 31a, 33a, and overlapping portion 32a are omitted.

[0063] The shape of the peeling sheet 30 in the second and fourth embodiments is not particularly limited, and can include polygons such as quadrilaterals, circles, ellipses, etc. It is preferable that the first portion 31 and the second portion 32, and the second portion 32 and the third portion 33, are cut separately. The cutting line can be the entire thickness of the peeling sheet 30, or a portion of the thickness can be left uncut and connected.

[0064] Dimension A in Figures 2, 4, 6, and 8 is the width of the second part 32, which includes the width of the overlapping part 32a when the second part 32 has an overlapping part 32a.

[0065] In Figures 1 to 4, dimension B represents the diameter of the inner peripheral side (i.e., the opening portion 23) of the substrate layer 10, and in Figures 5 to 8, dimension B represents the length of the major axis of the inner peripheral side (i.e., the opening portion 23) of the substrate layer 10.

[0066] In Figures 1 to 4 and Figures 5 to 8, dimension C represents the width of the nonwoven fabric sheet 20 surrounding the opening 23.

[0067] In Figures 1 and 3, dimension D represents the diameter of the outer periphery of the substrate layer 10, and in Figures 5 and 7, dimension D represents the length of the major axis of the outer periphery of the substrate layer 10.

[0068] Dimension E in Figures 1, 3, 5, and 7 represents the width of the second part 32, but refers to the width excluding the portion overlapping with the first part 31 or the third part 33. It is the width of the adhesive surface exposed after the second part 32 is peeled off.

[0069] Dimensions F and G in Figure 3 and Dimensions F and G in Figure 7 represent the width of the blank space around the substrate layer 10 extended from the release sheet 30.

[0070] The product size (e.g., size D in Figures 1 and 3, and Figures 5 and 7) is preferably 70 mm or more and 170 mm or less, more preferably 80 mm or more and 150 mm or less. If the product size is less than the lower limit, the size of the window portion (i.e., the opening portion 23) (e.g., size B in Figures 1 to 4, and size B in Figures 5 to 7) will be smaller than the non-abrasive needle, which is not preferred. If the product size exceeds the upper limit, for example, in the case of placing the CV port on the front of the chest, the product size will become a size that gets stuck on the collarbone or chest, which is also not preferred.

[0071] The window width (e.g., dimension C in Figures 1 and 3, and Figures 5 and 7), defined as the width of the nonwoven fabric sheet 20 surrounding the opening 23, is set within the range of product dimensions, but is preferably 10 mm or more. If the window width is less than the lower limit, the nonwoven fabric sheet 20 loses its toughness, and therefore the Ω-bonding becomes unstable, which is not preferred. The size of the opening 23 (dimensional B in Figures 1 and 3, and Figures 5 and 7) is set within the range of product dimensions, but from the viewpoint of the visibility of the membrane 11, it is preferably 50 mm or more, and more preferably 60 mm or more.

[0072] The size of the window portion formed by the opening 23 is preferably 60 mm or more. When the substrate layer 10 and the nonwoven fabric sheet 20 are circular in shape, it is preferable that the diameter is 70 mm to 170 mm, the radial width of the nonwoven fabric sheet 20 surrounding the opening 23 is 10 mm or more, and the diameter of the opening 23 is 60 mm or more. Alternatively, when the substrate layer 10 and the nonwoven fabric sheet 20 are elliptical in shape, it is preferable that the lengths of their major and minor axes are 70 mm to 170 mm (the length of the major axis > the length of the minor axis), and the lengths of the major and minor axes of the opening are 60 mm or more (the length of the major axis of the opening > the length of the minor axis of the opening).

[0073] The present invention has been described above based on preferred embodiments, but the present invention is not limited to the above embodiments and can be modified in various ways without departing from the spirit of the present invention.

[0074] [Example]

[0075] The present invention will be specifically described below with the aid of examples.

[0076] After preparing a substrate layer coated with adhesive on a substrate film and a nonwoven fabric sheet coated with adhesive on a nonwoven fabric, openings are punched out on the nonwoven fabric sheet and attached to the substrate layer. Then, the substrate layer and the nonwoven fabric sheet are punched together into the same circular or elliptical shape to create a sample of the dressing.

[0077] In the substrate layer of the film tape constituting the CV port dressing, a polyurethane film or a polyethylene film is used as the support film, and a polyurethane adhesive or an acrylic adhesive is used as the adhesive for the substrate layer, as shown in Table 1.

[0078] The nonwoven fabric used as the support for the nonwoven sheet is PET nonwoven fabric (85% polyethylene staple fiber, 15% polyester fiber) with an areal density of 42.5 g / m². 2 Alternatively, thermoplastic polyurethane nonwoven fabric (100% polyester-based polyurethane) with an areal density of 98 g / m². 2 Acrylic adhesive was used as the adhesive for the nonwoven fabric sheet.

[0079] As the polyurethane adhesive used in the membrane tape, a material containing 100 parts by weight of a polyether polyol mixture, 22.3 parts by weight of a polyurethane polymer mixture was used.

[0080] As an acrylic adhesive used in the membrane tape, an adhesive was used in which 0.06 parts by weight of Tetrad (registered trademark)-X (manufactured by Mitsubishi Gas Chemical Co., Ltd.) was added to a copolymer of isononyl acrylate / acrylic acid (96 / 4) in total, and 10 parts by weight of oleic acid ester was added as a crosslinking agent.

[0081] As acrylic adhesives used in nonwoven fabrics, adhesives using 1 (acrylic adhesive for PET nonwoven fabrics) are as follows: 1) an adhesive containing 0.12 parts by weight of TETRAD-X (manufactured by Mitsubishi Gas Chemical Co., Ltd.) as a crosslinking agent and 0.031 parts by weight of NACEM aluminum (manufactured by Nippon Chemical Industry Co., Ltd.) as a crosslinking agent; 2) an adhesive containing 0.2 parts by weight of TETRAD-X (manufactured by Mitsubishi Gas Chemical Co., Ltd.) as a crosslinking agent and 100 parts by weight of isononyl acrylate / acrylic acid (96 / 4).

[0082] The release sheet (three-piece structure) is made of high-quality polyethylene film paper that has undergone silicone treatment. A cut line is provided on one of the release sheets to form a three-piece structure.

[0083] Table 1 shows the ease of Ω-bonding and the degree of wobbling prevention when the product shape, material, thickness, and release tab width are changed. The release tab width shown in Table 1 is the width of the portion of the second part that is exposed between the first and third parts (e.g., dimension E in Figures 1 and 3, and Figures 5 and 7).

[0084] When the product shape is circular, the outer periphery of the substrate layer is a circle with a diameter of 120 mm, and the inner periphery (opening portion) of the substrate layer is a circle with a diameter of 95 mm. The width of the nonwoven fabric sheet around the opening portion is 12.5 mm.

[0085] When the product shape is elliptical, the outer periphery of the substrate layer is an ellipse with a major axis of 120 mm and a minor axis of 85 mm, and the inner periphery (opening portion) of the substrate layer is an ellipse with a major axis of 90 mm and a minor axis of 60 mm. The width of the nonwoven fabric sheet surrounding the opening portion is 12.5 mm.

[0086] When the product shape is quadrilateral, the outer periphery of the substrate layer is a rectangle with a long side of 140 mm and a short side of 110 mm, and rounded corners at all four corners. The opening on the inner periphery is a rectangle with a long side of 120 mm and a short side of 90 mm, and rounded corners at all four corners. The width of the nonwoven fabric sheet surrounding the opening is 10 mm.

[0087] As commercially available product A, a product with a long side of 120 mm and a short side of 100 mm is used. The peel-off sheet of commercially available product A consists of a single piece, and there is no structure with a width equivalent to that of the peel-off sheet. The surface of the dressing that comes into contact with the skin is made of acrylic adhesive.

[0088] Product B, a commercially available product, uses a material with a long side of 115 mm and a short side of 100 mm. Product B's release liner consists of a single piece and does not have a structure with a width equivalent to the release liner. The surface of the dressing that contacts the skin is made of polyurethane adhesive.

[0089] Regarding the thicknesses in Table 1, the thickness of the substrate film is shown, except for the thickness including the adhesive, which is shown for commercially available product A.

[0090] Product evaluation is conducted using two methods: "needle and model" (with a CV port model of 10 mm height set with a non-damaging needle) and "needle only" (with the CV port model omitted with a non-damaging needle). Commercially available products A and B are used according to their respective instructions; the usage methods for other products are as follows.

[0091] (1) Peel off the central peeling sheet and attach the central part of the membrane strip to the non-damaging needle.

[0092] (2) Attach the upper side of the membrane to the skin around the CV Harbor implant (CV Harbor model in the evaluation).

[0093] (3) Taking advantage of the fact that the membrane tape naturally concentrates around the tube due to the expansion of the non-damaging needle and the softness of the membrane, the lower side Ω of the membrane tape is attached to the tube.

[0094] (4) Peel off the release tab on the right side of the membrane strip and attach it from the top of the membrane strip along the non-damaging needle.

[0095] (5) Peel off the release tab on the left side of the membrane strip and attach it from the top of the membrane strip along the non-damaging needle.

[0096] The evaluation criteria are as follows.

[0097] [Ω Paste]

[0098] ◎: Formed naturally.

[0099] ○: Naturally formed but not easy to paste Ω.

[0100] △: The Ω symbol was successfully pasted even though it did not form naturally.

[0101] ×: Failed to paste Ω.

[0102] [Prevent shaking]

[0103] ○: Does not shake.

[0104] ×: Shaking.

[0105] [Table 1]

[0106]

[0107] Based on the results in Table 1, it can be concluded that: compared to quadrilaterals, Ω-shaped bonding is easier to achieve when the product shape is circular or elliptical. Ω-shaped bonding easily creates height, thus reducing needle wobble. It is taught that: when a nonwoven fabric sheet is present around the product, Ω-shaped bonding can be achieved, creating height and reducing wobble. It is clarified that: in circular shapes, when the substrate is a soft substrate (polyurethane or polyethylene) and the release liner width is 20 mm to 80 mm, Ω-shaped bonding is easily and naturally formed. Furthermore, it is also taught that: because Ω-shaped bonding can be achieved, creating height and reducing wobble. Based on the above, it can be said that for Ω-shaped bonding to be formed naturally, the circular or elliptical shape, the nonwoven fabric sheet, the softness and thickness of the substrate, and the width of the release liner are important (furthermore, regardless of the planar shape of the release liner, the same result is achieved whether the planar shape of the release liner is the same as the planar shape of the substrate layer (e.g., the first embodiment, the third embodiment) or larger than the planar shape of the substrate layer (e.g., the second embodiment, the fourth embodiment)).

[0108] In addition, Table 2 shows the ease of Ω-attachment and the degree of shaking when the width of the release tab is 40 mm and the product size (e.g., dimension D in Figures 1 and 3), window size (e.g., dimension B in Figures 1 and 3), and window width (e.g., dimension C in Figures 1 and 3) are changed. (Product shape: circular; regardless of the planar shape of the release tab, the same result is achieved in the case where the planar shape of the release tab is the same as the planar shape of the substrate layer (e.g., the first embodiment) or in the case where it is larger than the planar shape of the substrate layer (e.g., the second embodiment).

[0109] [Table 2]

[0110]

[0111] Industrial availability

[0112] The CV port dressing of the present invention can be used for the fixation of the CV port. The CV port can be used in methods for surgery, treatment or diagnosis in humans.

[0113] Explanation of reference numerals in the attached figures

[0114] 10…substrate layer, 11…film, 11a…one side of the film, 11b…the side of the film opposite to the first adhesive layer, 12…first adhesive layer, 12a…the surface of the first adhesive layer, 20…non-woven sheet, 21…non-woven fabric, 22…second adhesive layer, 23…opening, 30…release sheet, 31…first part, 31a…folded-back part of the first part, 32…second part, 32a…overlapping part of the second part, 33…third part, 33a…folded-back part of the third part, 100, 200, 300, 400…CV port dressing.

Claims

1. A CV port dressing, comprising: a substrate layer having a first adhesive layer disposed on one side of the film; a release sheet covering the surface of the first adhesive layer and laminated in a peelable manner; and a nonwoven fabric sheet laminated on the side of the substrate layer opposite to the first adhesive layer, wherein, The nonwoven fabric sheet is adhered to the film by providing a second adhesive layer on one side of the nonwoven fabric with an open-shaped opening. A window is formed by the opening portion of the nonwoven fabric sheet. Regarding the release sheet, the release sheet can be divided into a first part, a second part, and a third part. The second part is a strip that runs through the opening portion of the nonwoven fabric. The first part and the third part are arranged on both sides of the second part with the second part in the center. The width of the second part, excluding the width of the portion overlapping with the first part or the third part, is 20 mm to 80 mm. The size of the window formed by the opening portion is 60 mm or more. The width of the nonwoven fabric sheet around the opening portion is 10 mm or more.

2. The CV port dressing according to claim 1, wherein, The substrate layer is a polyurethane film or a polyethylene film.

3. The CV port dressing according to claim 1, wherein, The substrate layer is circular or elliptical.

4. The CV port dressing according to claim 1, wherein, The nonwoven fabric is PET nonwoven fabric or polyurethane nonwoven fabric.

5. The CV port dressing according to claim 1, wherein, The substrate layer and the nonwoven fabric sheet are circular in shape with a diameter of 70 mm to 170 mm, and the diameter of the opening is 60 mm or more.

6. The CV port dressing according to claim 1, wherein, The substrate layer and the nonwoven fabric sheet are elliptical in shape, with the length of their major axis and minor axis being 70 mm to 170 mm, and the length of the major axis and minor axis of the opening being 60 mm or more.

7. The CV port dressing according to claim 1, wherein, The first adhesive layer is a polyurethane-based adhesive or an acrylic-based adhesive.

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