Dressing for cv port

Abstract

The present invention includes: a base material layer (10) in which a first adhesive layer is provided on one surface of a film; a release sheet (30) that is releasably laminated to cover the surface of the first adhesive layer; and a nonwoven fabric sheet (20) that is laminated on the surface side of the base material layer that is opposite the first adhesive layer. The nonwoven fabric sheet (20) is affixed to the film by providing a second adhesive layer on one surface of a nonwoven fabric having a hollow formed therein, and a window section is formed by a hollow section (23) of the nonwoven fabric sheet. The release sheet (30) can be separated into a first portion (31), a second portion (32), and a third portion (33), and the second portion (32) is in the form of a strip that crosses the hollow section (23). The first portion (31) and the third portion (33) are disposed on both sides of the second portion (32), and the width (E) of the second portion is 20–80 mm, without including the width of a portion overlapping with the first portion or the third portion. The size (B) of the window section formed by the hollow section (23) is 60 mm or more, and the width (C) of the nonwoven fabric sheet around the hollow section (23) is 10 mm or more.

Description

CV port dressing

[0001] The present invention relates to a dressing for a CV port.

[0002] CV ports are known that are implanted in the human body for the purpose of administering medicines or administering necessary nutrients intravenously into a central vein.

[0003] A CV port is a subcutaneously implantable central venous access port, and consists of a roughly circular container with a diameter of 2 to 3 cm in plan view and a silicone rubber septum that functions as a lid for the container. A specially designed Huber needle is inserted into the septum, and a specific medication is poured into the container. The container is further connected to a catheter, and the medication is delivered into the body via this catheter.

[0004] Depending on the treatment, a needle may be left in the CV port for a long period of time. In such cases, it is common to fix the needle to the skin with adhesive tape or a dressing material to prevent it from coming loose or slipping out. Patent Documents 1 and 2 disclose examples of conventional film dressings.

[0005] However, due to the raised portion of the CV port implantation site and the thickness of the Huber needle due to its safety device, it is difficult to apply conventional dressings to secure the Huber needle and protect the puncture site. Furthermore, there are issues such as the Huber needle being of an inappropriate length for some patients, which can cause a gap between the skin and the Huber needle, causing the needle to wobble, requiring the use of separate cushioning material to prevent wobbling, and the risk of infection if the cushioning material is not sterilized.

[0006] Japanese Patent Publication No. 2011-4850 Japanese Patent Publication No. 2014-68721

[0007] The present invention has been made in view of the above circumstances, and an object of the present invention is to provide a CV port dressing that can satisfactorily fix a Huber needle for CV port users.

[0008] The CV port dressing of the present invention is a CV port dressing comprising a base layer having a first pressure-sensitive adhesive layer on one side of the film, a release sheet releasably laminated to cover the surface of the first pressure-sensitive adhesive layer, and a nonwoven fabric sheet laminated on the side of the base layer opposite the first pressure-sensitive adhesive layer, wherein the nonwoven fabric sheet is attached to the film by providing a second pressure-sensitive adhesive layer on one side of the perforated nonwoven fabric, and window portions are formed by the perforations in the nonwoven fabric sheet, the release sheet is divisible into a first portion, a second portion, and a third portion, the second portion is in the shape of a strip that crosses the perforated portion of the nonwoven fabric, the first portion and the third portion are located on either side of the second portion so that the second portion is in the center, the width of the second portion is 20 to 80 mm, excluding the widths of the portions that overlap with the first portion or the third portion, the size of the window portion formed by the perforated portion is 60 mm or more, and the width of the nonwoven fabric sheet around the perforated portion is 10 mm or more.

[0009] The base layer is preferably a urethane film or a polyethylene film. The base layer is preferably circular or elliptical. The nonwoven fabric is preferably a PET nonwoven fabric or a urethane nonwoven fabric. The base layer and the nonwoven fabric sheet may be identically circular, with a diameter of 70 to 170 mm, and the diameter of the perforated portions may be 60 mm or more. The base layer and the nonwoven fabric sheet may be identically elliptical, with the lengths of the major and minor axes of 70 to 170 mm, and the lengths of the major and minor axes of the perforated portions may be 60 mm or more. The first pressure-sensitive adhesive layer may be a urethane-based pressure-sensitive adhesive or an acrylic-based pressure-sensitive adhesive.

[0010] With the CV port dressing of the present invention, when a Huber needle for a CV port user is secured in place, the bulge of the Huber needle and the flexibility of the film allow the dressing to be naturally secured to the tube of the Huber needle in an Ω-like manner, and the Huber needle safety device and tube are maintained in a straight line at a constant height, thereby reducing the wobbling of the Huber needle, which is a problem when securing a CV port.

[0011] FIG. 1 is a plan view of a CV port dressing according to a first embodiment. FIG. 2 is a cross-sectional view of a CV port dressing according to the first embodiment. FIG. 3 is a plan view of a CV port dressing according to a second embodiment. FIG. 4 is a cross-sectional view of a CV port dressing according to the second embodiment. FIG. 5 is a plan view of a CV port dressing according to a third embodiment. FIG. 6 is a cross-sectional view of a CV port dressing according to the third embodiment. FIG. 7 is a plan view of a CV port dressing according to a fourth embodiment. FIG. 8 is a cross-sectional view of a CV port dressing according to the fourth embodiment.

[0012] The present invention will be described below based on preferred embodiments.

[0013] Figures 1 and 2 show a CV port dressing 100 according to a first embodiment. Figures 3 and 4 show a CV port dressing 200 according to a second embodiment. Figures 5 and 6 show a CV port dressing 300 according to a third embodiment. Figures 7 and 8 show a CV port dressing 400 according to a fourth embodiment.

[0014] These CV port dressings 100, 200, 300, and 400 have a base layer 10 with a first adhesive layer 12 provided on one surface 11a of a film 11, a release sheet 30 releasably laminated to cover the surface 12a of the first adhesive layer 12, and a nonwoven fabric sheet 20 laminated on the surface 11b of the base layer 10 opposite the first adhesive layer 12.

[0015] The nonwoven fabric sheet 20 is attached to the film 11 with a second pressure-sensitive adhesive layer 22 provided on one surface of a perforated nonwoven fabric 21. The perforated portion 23 of the nonwoven fabric 21 penetrates the nonwoven fabric sheet 20, including the thickness region of the second pressure-sensitive adhesive layer 22. The perforated portion 23 forms a single through-hole in the central portion of the planar shape of the base material layer 10, excluding the outer edge portions, and a window portion is formed by the perforated portion 23. The nonwoven fabric sheet 20 is laminated only on the outer edge portions of the base material layer 10 on surface 11b, and reinforces the outer edge portions of the base material layer 10.

[0016] In these CV port dressings 100 and 200, the planar shape of the base layer 10 is circular. In addition, in the CV port dressings 300 and 400, the planar shape of the base layer 10 is elliptical (horizontally elongated in FIGS. 5 and 6). The planar shape of the base layer 10 may be, although not specifically shown, a quadrilateral such as a square or rectangle, or other polygonal or oval shape. If the planar shape is a polygon such as a quadrilateral, the vertices of the polygon may be rounded. A circular or elliptical shape is preferred. In this specification, a circular shape refers to a planar shape in which all distances from the center to the periphery are equal. In this specification, an elliptical shape includes a planar shape formed by a curved line drawn from a set of points such that the sum of the distances from two fixed points on the plane is constant, a planar shape formed by an ellipse formed by connecting two semicircles of the same radius with two parallel tangents, and a shape that is slightly deformed from a true ellipse (approximately elliptical). In other words, even if the shape is slightly deformed from a true ellipse, as long as the major and minor axes can be identified and the shape exhibits effects equivalent to those of the present invention, it is included in the elliptical shape of the present invention. In this case, the ratio of the major axis to the minor axis of the elliptical shape (including the shape of an oval) can be set to, for example, a range of 100:99 to 100:50, or 100:80 to 100:60, but is not limited to these.

[0017] The planar shape of the inner peripheral side of the base layer 10 (i.e., the perforated portion 23) may be similar or dissimilar to the planar shape of the outer peripheral side of the base layer 10. However, as in the illustrated example of the base layer 10, the planar shapes of the inner and outer peripheral sides are preferably concentric circular shapes (FIGS. 1 and 3) or concentric elliptical shapes (FIGS. 5 and 7). Furthermore, the planar shape of the inner peripheral side may be concentric or eccentric with the planar shape of the outer peripheral side. Here, the center of the planar shape may be determined, for example, by the position of the center of gravity.

[0018] The release sheet 30 can be divided into a first portion 31, a second portion 32, and a third portion 33. The second portion 32 is strip-shaped and crosses the perforated portion 23 of the nonwoven fabric 21. The first portion 31 and the third portion 33 are arranged on either side of the second portion 32 so that the second portion 32 is in the center. The width of the second portion 32 (left-right direction in each figure) is 20 to 80 mm, not including the width of the portion overlapping with the first portion or the third portion. Here, the second portion 32 being strip-shaped means that the dimension (length) of the second portion 32 in the direction perpendicular to the width is longer than the width in a plan view.

[0019] In the illustrated examples, the length (vertical direction in each figure) of the second portion 32 extends along the diameter direction of the circular base layer 10 of the first and second embodiments ( FIGS. 2 and 4 ), and along the minor axis direction of the elliptical base layer 10 of the third and fourth embodiments ( FIGS. 6 and 8 ). In the illustrated examples, the width (horizontal direction in each figure) of the second portion 32 is substantially constant along the diameter direction of the circular base layer 10 or the minor axis direction of the elliptical base layer 10, but may vary within the above-mentioned range. For example, the width may gradually increase or decrease from one end to the other in the diameter direction. The width may gradually increase and then decrease beyond the center. The widths of the first portion 31 and the third portion 33 may be the same or different from each other.

[0020] The material for the release sheet 30 is not particularly limited as long as it has a certain degree of stiffness (thickness) for ease of handling, and release sheets and release films commonly used in the field of adhesive materials can be used. For example, paper substrates such as high-quality paper or glassine paper with a silicone release treatment, or polyester films can be used. The thickness of the release sheet 30 can be set to 20 to 300 μm, and preferably 30 to 200 μm.

[0021] The film 11 of the base layer 10 is preferably a transparent or semi-transparent film that allows the user to visually check the status of the Huber needle retention after the dressing is installed, and is preferably a urethane or polyethylene film that has adequate flexibility and stretchability so that it can conform to the skin surface. These films are flexible and have the excellent deformability and conformability required for CV port dressings 100, 200, 300, and 400. The thickness of the film 11 of the base layer 10 is 5 to 100 g / m ２ It is often preferable to set the thickness to 10 to 80 g / m. ２ is.

[0022] Various fibers such as natural fibers, synthetic fibers, recycled fibers, and appropriate combinations thereof can be used for the nonwoven fabric 21, but for example, acrylic nonwoven fabric, polyamide nonwoven fabric, PET nonwoven fabric, polyurethane nonwoven fabric, etc. can be used, and PET nonwoven fabric and polyurethane nonwoven fabric are often preferred in terms of appropriate extensibility and compatibility with the skin surface. The basis weight of the nonwoven fabric is not particularly limited, and may be within the range of basis weights of nonwoven fabrics generally used as base materials for adhesive tapes, but is preferably about 30 to 150 g / m ２ It is often preferable to set the thickness to 40 to 100 g / m ２ More preferred is PET, which means polyethylene terephthalate.

[0023] The adhesive (first adhesive layer 12) of the base layer 10 can be a variety of types, including natural rubber, synthetic rubber, acrylic, urethane, vinyl ether, and silicone. Since the base layer 10 provided with this first adhesive layer 12 is to be attached to the skin as described below, the adhesive should have sufficient adhesion to the skin surface, be minimally irritating to the skin, and have a certain degree of moisture permeability. For these reasons, it is often preferable to use a urethane-based adhesive or an acrylic-based adhesive.

[0024] Examples of acrylic adhesives that can be used include homopolymers of (meth)acrylic acid alkyl ester monomers such as butyl acrylate, 2-ethylhexyl acrylate, and isononyl acrylate, as well as copolymers of multiple of these monomers. They can also include copolymers of the (meth)acrylic acid alkyl ester monomers with other monomers copolymerizable therewith, such as (meth)acrylic acid, hydroxyalkyl esters of (meth)acrylic acid, vinyl acetate, styrene, vinylpyrrolidone, (meth)acrylamide, and alkoxyalkyl (meth)acrylates. Among these, acrylic adhesives containing copolymers primarily composed of (meth)acrylic acid alkyl esters are more preferred. The thickness of the first adhesive layer 12 is typically about 10 to 200 μm, preferably 20 to 100 μm.

[0025] An example of a urethane-based adhesive is a urethane polymer obtained using a polyol and a polyisocyanate. From the viewpoint of skin irritation, an adhesive having a mass ratio (OH / NCO) of a polyol or polyurethane polyol containing 1 to 3 hydroxy groups (OH) to a polyisocyanate or polyurethane prepolymer containing 2 to 3 isocyanate groups (NCO) in the range of 1.55 to 1.90 is preferred, with a range of 1.60 to 1.85 being more preferred. If the OH / NCO ratio is smaller than this range, long-term adhesion to the skin will be poor, and if it is larger, cohesive failure will likely occur when peeled from the skin.

[0026] The polyol is not particularly limited, and examples thereof include hydroxy compounds, amine compounds, carboxylic acid compounds, thiol compounds, polyether polyols having a hydroxy group, etc. Examples of the hydroxy 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-methylpentane-2,4-diol, 2,5-dimethyl-2,5-hexanediol, glycerin, trimethylolpropane, hexanetriol, pentaerythritol, diglycerin, sorbitol, sucrose, glucose, 2-naphthol, bisphenol, etc. Examples of amine compounds include ethylenediamine, 1,3-propylenediamine, 1,4-butylenediamine, and 1,2-butylenediamine. Examples of carboxylic acid compounds include phthalic acid and adipic acid. Examples of thiol compounds include ethanedithiol and butanedithiol. Examples of polyether polyols having a hydroxy group include polyether polyols having a molecular weight of 200 or more and 10,000 or less.

[0027] The polyisocyanate may be any compound having at least two isocyanate groups, and is not particularly limited. Examples include 2,4-tolylene diisocyanate, 2,6-tolylene diisocyanate, 2,4'-diphenylmethane diisocyanate, 4,4'-diphenylmethane diisocyanate, 1,5-naphthalene diisocyanate, tolidine diisocyanate, xylylene diisocyanate, 1,3-phenylene diisocyanate, 1,4-phenylene diisocyanate, lysine diisocyanate, triphenylmethane triisocyanate, tetramethylxylene diisocyanate, 1,6-hexamethylene diisocyanate, and 4,4'-dicyclohexylmethan. Examples of the isocyanate-containing urethane prepolymer include hexane diisocyanate, isophorone diisocyanate, 1,4-cyclohexane diisocyanate, norbornane diisocyanate, lysine ester triisocyanate, 1,6,11-undecane triisocyanate, 1,8-diisocyanate-4-isocyanatomethyloctane, 1,3,6-hexamethylene triisocyanate, bicycloheptane triisocyanate, trimethylhexamethylene diisocyanate, isocyanate-containing urethane prepolymers obtained by reacting these with polyols, and mixtures of two or more of these. Furthermore, modified products of these isocyanates (modified products containing a urethane group, a carbodiimide group, an allophanate group, a urea group, a biuret group, an isocyanurate group, an amide group, an imide group, a uretonimine group, a uretdione group, or an oxazolidone group) and condensates (sometimes referred to as polynuclear compounds) of polymethylene polyphenylene polyisocyanate (polymeric MDI) and the like are also included.

[0028] Any adhesive (second adhesive layer 22) can be used for the nonwoven fabric sheet 20 as long as it has sufficient adhesion to the base material layer 10, and various types of adhesives can be used, including natural rubber, synthetic rubber, acrylic, urethane, vinyl ether, and silicone.

[0029] As described above, a CV port has a container that is approximately circular in plan view and has a diameter of approximately 2 cm to 3 cm, and a septum made of silicone rubber that functions as a lid for the container. The container is connected to a catheter with a dedicated Huber needle inserted into the septum. The catheter is inserted into a vein or the like. The Huber needle is connected to a syringe or the like via a tube. A medicinal solution from the syringe or the like is injected into the vein or the like via the Huber needle and the CV port. The objects that the CV port dressing covers and fixes include the Huber needle and the tube of the Huber needle.

[0030] The CV port dressing is preferably attached to the tube of the Huber needle in an Ω-type manner. In this Ω-type attachment, it is preferable to wrap the outer circumference of the tube at an angle of approximately 360° in the circumferential direction and attach the adhesive surfaces of the dressing (surface 12a of first adhesive layer 12) face-to-face. This forms a fixed portion between the CV port installation surface (such as the surface of the skin) and the tube, with the adhesive surfaces of the dressing attached face-to-face, making the dressing less likely to peel off.

[0031] To fix a Huber needle using CV port dressings 100, 200, 300, and 400, second portion 32 is removed to expose the adhesive surface of the dressing (surface 12a of first adhesive layer 12) in a region corresponding to the width of second portion 32. The width of the adhesive surface corresponding to the width of second portion 32 is sufficiently large for a Huber needle connected to a CV port, making it easy to apply an Ω-shaped adhesive to the Huber needle tube.

[0032] After the tube is Ω-pasted on the adhesive surface corresponding to the width of second portion 32, first portion 31 and third portion 33 can be peeled off and attached to the installation surface of the CV port (such as the surface of the skin) or around a Huber needle, etc. It is preferable to first peel off either first portion 31 or third portion 33 (either the left or right side of second portion 32) and attach the exposed adhesive surface to a Huber needle, etc., and then peel off the remaining first portion 31 or third portion 33 and attach the exposed adhesive surface to a Huber needle, etc.

[0033] The film 11 of the base layer 10 is thin and soft, and the nonwoven fabric sheet 20 is laminated around the base layer 10. Furthermore, the release sheet 30 can be separated into three pieces, which allows for a natural Ω-like adhesion when the adhesive surface is applied, preventing the tubing from coming into contact with the skin for an extended period of time. Furthermore, the Ω-like adhesion allows for the same height as the installation surface of the CV port, and furthermore, by maintaining the Huber needle tubing at the same height as the top of the CV port implantation site, it is possible to reduce needle wobble, a problem with Huber needle fixation.

[0034] 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 sheet 30 is the same as the planar shape of the base material layer 10. The outer peripheries of the base material layer 10, nonwoven fabric sheet 20, and release sheet 30 may be punched together while they are stacked. To peel only the second portion 32 without peeling the first portion 31 and the third portion 33 from the first pressure-sensitive adhesive layer 12, the first portion 31 and the third portion 33 have folded portions 31 a, 33 a, respectively, and the second portion 32 has an overlapping portion 32 a that overlaps the first portion 31 or the third portion 33. The second portion 32 can be easily peeled by pinching the overlapping portion 32 a. Furthermore, the first portion 31 and the third portion 33 can be easily peeled by pinching the folded portions 31 a, 33 a.

[0035] 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 sheet 30 is formed to be larger than the planar shape of the base material layer 10. The base material layer 10 and the nonwoven fabric sheet 20 may be overlapped and their outer peripheries may be punched together, and then the release sheet 30 may be attached. Because the release sheet 30 can pinch the area extending outward from the base material layer 10, the first portion 31, the second portion 32, and the third portion 33 can be easily peeled individually even if the above-mentioned folded portions 31 a, 33 a and overlapping portion 32 a are omitted.

[0036] The shape of the release sheet 30 in the second and fourth embodiments is not particularly limited, but examples include a polygon such as a rectangle, a circle, an ellipse, etc. It is preferable that a cut is made between the first portion 31 and the second portion 32, and between the second portion 32 and the third portion 33. The cut line may extend through the entire thickness of the release sheet 30, or a portion of the thickness may be left uncut and connected.

[0037] Dimension A in Figures 2 and 4 and Figures 6 and 8 is the width of the second portion 32, and if the second portion 32 has an overlapping portion 32a, it includes the width of the overlapping portion 32a. Dimension B in Figures 1 to 4 is the diameter of the inner periphery of the base layer 10 (i.e., the perforated portion 23), and dimension B in Figures 5 to 8 is the length of the major axis of the inner periphery of the base layer 10 (i.e., the perforated portion 23). Dimension C in Figures 1 to 4 and Figures 5 to 8 is the width of the nonwoven fabric sheet 20 around the perforated portion 23. Dimension D in Figures 1 and 3 is the diameter of the outer periphery of the base layer 10, and dimension D in Figures 5 and 7 is the length of the major axis of the outer periphery of the base layer 10. Dimension E in Figures 1 and 3 and Figures 5 and 7 is the width of the second portion 32, but does not include the width of the portion overlapping with the first portion 31 or the third portion 33, and is the width of the adhesive surface exposed after the second portion 32 is peeled and removed. Dimensions F and G in FIG. 3 and dimensions F and G in FIG. 7 are the widths of the margins of the release sheet 30 that extend around the periphery of the base material layer 10.

[0038] The product size (e.g., dimension D in Figures 1 and 3 and Figures 5 and 7) is preferably 70 mm or more and 170 mm or less, and more preferably 80 mm or more and 150 mm or less. If the product size is below the lower limit, the size of the window portion (i.e., perforated portion 23) (e.g., dimension B in Figures 1 to 4 and dimension B in Figures 5 to 7) will be smaller than that of a Huber needle, which is undesirable. If the product size exceeds the upper limit, for example, when placing a CV port in the anterior chest, the product size will be large enough to cover the collarbone or chest, which is undesirable.

[0039] The window width (e.g., dimension C in Figures 1 and 3, 5 and 7), defined as the width of the nonwoven fabric sheet 20 around the perforated portion 23, is set within the product size range, but is preferably 10 mm or more. If the window width is below the lower limit, the nonwoven fabric sheet 20 will lose its stiffness, making Ω-attachment unstable, which is undesirable. The size of the perforated portion 23 (dimension B in Figures 1 and 3, 5 and 7) is set within the product size range, but is preferably 50 mm or more, and more preferably 60 mm or more, from the viewpoint of visibility through the film 11.

[0040] The size of the window portion formed by the perforated portion 23 is preferably 60 mm or more. When the base material layer 10 and the nonwoven fabric sheet 20 are the same circular shape, it is preferable that the diameter is 70 to 170 mm, the radial width of the nonwoven fabric sheet 20 around the perforated portion 23 is 10 mm or more, and the diameter of the perforated portion 23 is 60 mm or more. When the base material layer 10 and the nonwoven fabric sheet 20 are the same elliptical shape, it is preferable that the lengths of the major and minor axes are 70 to 170 mm (length of major axis > length of minor axis), and the lengths of the major and minor axes of the perforated portion are 60 mm or more (length of major axis of perforated portion > length of minor axis of perforated portion).

[0041] The present invention has been described above based on preferred embodiments, but the present invention is not limited to the above-described embodiments, and various modifications are possible within the scope of the gist of the present invention.

[0042] The present invention will be specifically described below with reference to examples.

[0043] After preparing a base layer made by applying an adhesive to a base film and a nonwoven fabric sheet made by applying an adhesive to a nonwoven fabric, perforations were punched into the nonwoven fabric sheet and it was bonded to the base layer. The base layer and nonwoven fabric sheet were then punched together into identical circular or oval shapes to produce dressing samples.

[0044] In the base layer constituting the film tape of the CV port dressing, a urethane film or a polyethylene film was used as the support film, and a urethane adhesive or an acrylic adhesive was used as the adhesive for the base layer, as shown in Table 1.

[0045] The nonwoven fabric constituting the support of the nonwoven fabric sheet is a PET nonwoven fabric (85% polyethylene short fiber, 15% polyester fiber) with a basis weight of 42.5 g / m ２ or thermoplastic polyurethane nonwoven fabric (100%, polyester polyurethane) basis weight 98 g / m ２ An acrylic adhesive was used as the adhesive for the nonwoven fabric sheet.

[0046] The urethane adhesive used in the film tape was a material containing a polyether polyol mixture, 100 parts of a urethane polymer mixture, and 22.3 parts of a urethane polymer mixture.The acrylic adhesive used in the film tape was a copolymer of isononyl acrylate / acrylic acid (96 / 4) totaling 100 parts by mass, to which 0.06 parts by mass of Tetrad (registered trademark)-X (manufactured by Mitsubishi Gas Chemical Company, Inc.) as a crosslinking agent and 10 parts by mass of oleyl oleate were added.

[0047] The acrylic adhesive used for the nonwoven fabric sheet was prepared by adding 0.12 parts by mass of TETRAD®-X (manufactured by Mitsubishi Gas Chemical Company, Inc.) and 0.031 parts by mass of Narcem® aluminum (manufactured by Nippon Chemical Industry Co., Ltd.) as crosslinking agents to a total of 100 parts by mass of isononyl acrylate / acrylic acid (98 / 2) copolymer (acrylic adhesive 1, for PET nonwoven fabric); or by adding 0.2 parts by mass of TETRAD-X® (manufactured by Mitsubishi Gas Chemical Company, Inc.) as crosslinking agent to a total of 100 parts by mass of isononyl acrylate / acrylic acid (96 / 4) copolymer (acrylic adhesive 2, for urethane nonwoven fabric).

[0048] Silicone-treated polyethylene-laminated fine paper was used as the release sheets (three sheets), and a cutting line was provided on one release sheet to form a three-sheet configuration.

[0049] Table 1 shows the ease of Ω adhesion and the degree of wobble prevention when the product shape, material, thickness, and release sheet width are changed. The release sheet width shown in Table 1 is the width of the part of the second portion where the adhesive surface is exposed between the first and third portions (e.g., dimension E in Figures 1 and 3 and Figures 5 and 7).

[0050] When the product shape was circular, the outer periphery of the substrate layer was a circle with a diameter of 120 mm, and the inner periphery (perforated portion) of the substrate layer was a circle with a diameter of 95 mm. The width of the nonwoven fabric sheet around the perforated portion was 12.5 mm. When the product shape was elliptical, the outer periphery of the substrate layer was an ellipse with a long axis length of 120 mm and a short axis length of 85 mm, and the inner periphery (perforated portion) of the substrate layer was an ellipse with a long axis length of 90 mm and a short axis length of 60 mm. The width of the nonwoven fabric sheet around the perforated portion was 12.5 mm. When the product shape was square, the outer periphery of the substrate layer was a rectangle with long sides of 140 mm, short sides of 110 mm, and rounded corners, and the inner perforated portion was a rectangle with long sides of 120 mm x short sides of 90 mm, and rounded corners. The width of the nonwoven fabric sheet around the perforated portion was 10 mm.

[0051] Commercially available product A was a product with a long side of 120 mm and a short side of 100 mm. Commercially available product A consisted of a single release sheet, did not have a structure corresponding to the release sheet width, and the surface of the dressing that came into contact with the skin was made of acrylic adhesive. Commercially available product B was a product with a long side of 115 mm and a short side of 100 mm. Commercially available product B consisted of a single release sheet, did not have a structure corresponding to the release sheet width, and the surface of the dressing that came into contact with the skin was made of urethane adhesive.

[0052] The thickness in Table 1 indicates the thickness of the substrate film, except for the commercially available product A, which shows the thickness including the adhesive.

[0053] The products were evaluated in two ways: "needle and model" (a 10 mm high CV port model was placed under the Huber needle) and "needle only" (the CV port model was omitted under the Huber needle). The usage methods for commercial products A and B were as per their respective instructions, and the usage methods for the other products were as follows.

[0054] (1) Peel off the central release sheet and attach the central part of the film tape to the Huber needle. (2) Attach the upper side of the film tape to the skin surrounding the CV port implantation site (CV port model in the evaluation). (3) Due to the bulge of the Huber needle and the flexibility of the film, the film tape naturally gathers around the tube, so take advantage of this and attach the lower side of the film tape to the tube in an Ω pattern. (4) Peel off the release sheet on the right side of the film tape and attach it from the top so that it fits along the Huber needle. (5) Peel off the release sheet on the left side of the film tape and attach it from the top so that it fits along the Huber needle.

[0055] The evaluation criteria were as follows: [Ω adhesion] ◎: Achieved naturally. ○: Achieved naturally but difficult to adhere to Ω. △: Cannot be adhered naturally but was able to adhere to Ω. ×: Cannot be adhered to Ω. [Wobble prevention] ○: No wobble. ×: Wobble.

[0056]

[0057] The results in Table 1 suggest that Ω-type adhesion is easier for circular and elliptical product shapes than for rectangular shapes, and that Ω-type adhesion tends to increase height, which is thought to reduce needle wobble. This suggests that when a nonwoven fabric sheet is present around the product, Ω-type adhesion is possible and height increases, reducing wobble. It was revealed that for circular shapes, Ω-type adhesion is more likely to occur naturally when the substrate is soft (urethane or polyethylene) and the release sheet width is 20 to 80 mm. It was also suggested that Ω-type adhesion and height increase reduce wobble. From the above, it can be said that the circular or elliptical shape, the nonwoven fabric sheet, the softness and thickness of the substrate, and the width of the release sheet are important for natural Ω-type adhesion (note that similar results were obtained regardless of the planar shape of the release sheet, whether the planar shape of the release sheet is the same as the planar shape of the substrate layer (e.g., the first and third embodiments) or larger than the planar shape of the substrate layer (e.g., the second and fourth embodiments)).

[0058] Table 2 also shows the ease of Ω-adhesion and the degree of wobbling when the release sheet width is set to 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; similar results were obtained regardless of the planar shape of the release sheet, whether the planar shape of the release sheet was the same as the planar shape of the base layer (e.g., the first embodiment) or larger than the planar shape of the base layer (e.g., the second embodiment)).

[0059]

[0060] The CV port dressing of the present invention can be used to fixate a CV port, which can be used in a surgical, therapeutic, or diagnostic procedure in a human.

[0061] 10...base material layer, 11...film, 11a...one side of film, 11b...side of film opposite to first adhesive layer, 12...first adhesive layer, 12a...surface of first adhesive layer, 20...nonwoven fabric sheet, 21...nonwoven fabric, 22...second adhesive layer, 23...perforated portion, 30...release sheet, 31...first portion, 31a...folded-back portion of first portion, 32...second portion, 32a...overlapped portion of second portion, 33...third portion, 33a...folded-back portion of third portion, 100, 200, 300, 400...CV port dressing.

Claims

1. A CV port dressing comprising a base layer having a first adhesive layer on one side of the film, a release sheet releasably laminated covering the surface of the first adhesive layer, and a nonwoven fabric sheet laminated on the side of the base layer opposite the first adhesive layer, wherein the nonwoven fabric sheet is attached to the film by providing a second adhesive layer on one side of the nonwoven fabric having a perforated shape, and a window portion is formed by the perforated portion of the nonwoven fabric sheet, the release sheet is capable of being divided into a first portion, a second portion, and a third portion, the second portion is in the shape of a strip that crosses the perforated portion of the nonwoven fabric, the first portion and the third portion are arranged on either side of the second portion so that the second portion is in the center, and the width of the second portion is 20 to 80 mm excluding the width of the portion that overlaps with the first portion or the third portion, the size of the window portion formed by the perforated portion is 60 mm or more, and the width of the nonwoven fabric sheet around the perforated portion is 10 mm or more.

2. A CV port dressing according to claim 1, wherein said base layer is a urethane film or a polyethylene film.

3. A CV port dressing according to claim 1, wherein said base layer is circular or elliptical in shape.

4. A CV port dressing according to claim 1, wherein the nonwoven fabric is a PET nonwoven fabric or a urethane nonwoven fabric.

5. A CV port dressing as described in claim 1, wherein said base layer and said nonwoven fabric sheet are of the same circular shape, the diameter of said circular shape being 70 to 170 mm, and the diameter of said perforated portion being 60 mm or more.

6. A CV port dressing as described in claim 1, wherein the base layer and the nonwoven fabric sheet are of the same elliptical shape, the lengths of the major and minor axes of which are 70 to 170 mm, and the lengths of the major and minor axes of the perforated portion are 60 mm or more.

7. A CV port dressing according to claim 1, wherein said first adhesive layer is a urethane adhesive or an acrylic adhesive.