JP5416547B2 - Film dressing - Google Patents

Description

  The present invention relates to a film dressing. More specifically, the present invention relates to a film dressing that is excellent in operability and that can favorably fix a medical instrument such as a catheter at the puncture portion.

  Film dressing is widely used for fixing medical devices such as catheters. For example, a film dressing is affixed to the puncture part of the catheter to the living body so as to cover a wide area including the puncture part, and the catheter is fixed to the surface of the living body, and invasion of bacteria or the like from the outside To prevent. However, when the catheter is fixed only by film dressing, the catheter is often insufficiently fixed to the surface of the living body. As a result, there is a problem that the chemical solution leaks out of the blood vessel due to the movement of the indwelling needle of the catheter, the risk of removing the indwelling needle, and the film dressing floats or peels off due to the movement of the catheter, and this part becomes a bacterial infection route.

  In order to solve the above problems, the fixation is reinforced using a medical tape or a bandage tape from the upper side (opposite to the surface of the living body) of the attached film dressing. However, such a method using a medical tape or a bandage tape is complicated to operate, and there is a strong demand for improvement in operability by medical staff. Furthermore, even if the reinforcement is made only from the upper side of the catheter, the deviation or slippage between the living body surface and the catheter is not sufficiently eliminated.

Special table 2002-512865

  The present invention has been made in order to solve the above-described conventional problems. The object of the present invention is to provide a film dressing that is excellent in operability and that can favorably fix a medical instrument such as a catheter at the puncture portion. It is to provide.

The film dressing of the present invention is a film dressing having a film part and a fixing auxiliary part, wherein the film part and the fixing auxiliary part are a common support, a common first adhesive layer, and a common A release liner is provided in this order, the film part further includes a film base and a second pressure-sensitive adhesive layer, and a cut part is provided in a direction substantially parallel to the boundary between the film part and the fixing auxiliary part. A window portion is provided on the support of the film portion.
In a preferred embodiment, in the film dressing of the present invention, the fixing auxiliary part further has a fixing material on the side of the support opposite to the first pressure-sensitive adhesive layer.
In preferable embodiment, in the said film part, the said film base material is arrange | positioned between the said 1st adhesive layer and the said release liner, and the said 2nd adhesive layer is the said film base material and the said release liner. It is arranged between.
In preferable embodiment, in the said film part, the said film base material is arrange | positioned on the opposite side to the said 1st adhesive layer of the said support body, and the said 2nd adhesive layer is the said film base material and the said support. It is placed between the body.
In a preferred embodiment, in the fixing auxiliary portion, the film base is disposed between the fixing material and the support, and the second pressure-sensitive adhesive layer is between the film base and the support. Is arranged.
In a preferred embodiment, the release liner is divided into a first divided piece and a second divided piece at or near the boundary between the film portion and the fixing auxiliary portion, and the first divided piece and The second divided piece has a folded portion that is folded by providing a folding line substantially parallel to the boundary between the film portion and the fixing auxiliary portion at or near the boundary between the film portion and the fixing auxiliary portion. .
In a preferred embodiment, the release liner has a notch on the fold line.
In a preferred embodiment, the depth of the notch is 2 mm to 6 mm.
In a preferred embodiment, an end portion on the folding line side of the first divided piece and an end portion on the folding line side of the second divided piece overlap each other.
In a preferred embodiment, the overlapping width of the first divided piece and the second divided piece is 2 mm to 6 mm.
In a preferred embodiment, the release liner is divided into a first divided piece, a second divided piece, and a third divided piece, and the first divided piece and the second divided piece are cut into the cut pieces. The first divided piece, the second divided piece, and the third divided piece are divided along a line extending from an end of the cut portion and extending in a direction perpendicular to the cut portion. The first divided piece is disposed in the film portion, the second divided piece is disposed in the fixing auxiliary portion, and the first divided piece, the second divided piece, and the third divided piece. The piece has a folded portion that is folded back by providing a folding line along a line extending from the end of the cut portion and extending in a direction perpendicular to the cut portion.
In a preferred embodiment, an extended portion that extends to the outside of the first pressure-sensitive adhesive layer or the second pressure-sensitive adhesive layer is provided at the end of the folded portion opposite to the folding line.
In preferable embodiment, the thickness of the said fixing material is 1 mm-13 mm.
In a preferred embodiment, the length of the side of the fixing material in the direction orthogonal to the boundary between the film portion and the fixing auxiliary portion is 5 mm or more, and is substantially parallel to the boundary between the film portion and the fixing auxiliary portion. The length of the side in the proper direction is 2 mm or more.
In preferable embodiment, the shortest length from the said cut part to the edge part by the side of the said cut part of the said fixing material is 5 mm-50 mm.
In preferable embodiment, the length of the said cut part is 20%-90% with respect to the full length of the boundary of the said film part and the said fixing auxiliary | assistant part.
In a preferred embodiment, the film dressing of the present invention further comprises a fixing tape.

  ADVANTAGE OF THE INVENTION According to this invention, by providing a cut part, the film dressing which is excellent in operativity and can fix medical instruments, such as a catheter, favorably in the puncture part can be provided.

(A) is a schematic plan view of the film dressing by preferable embodiment of this invention, (b) is a schematic sectional drawing by the Ib-Ib line of the film dressing of (a). It is a schematic sectional drawing of the film dressing by another embodiment of this invention. It is a schematic sectional drawing of the film dressing by another embodiment of this invention. It is a schematic sectional drawing of the film dressing by another embodiment of this invention. It is a schematic sectional drawing of the film dressing by another embodiment of this invention. (A) And (b) is a schematic diagram explaining the notch of a release liner, (c) is a schematic perspective view explaining the state by which the opening of the film part and the fixing auxiliary part was maintained by the notch of a release liner It is. It is the schematic for demonstrating the specific affixing procedure of the film dressing of this invention when a peeling liner is divided into two. It is the schematic for demonstrating the specific sticking procedure of the said film dressing in case a peeling liner is divided into 3 parts. It is a schematic perspective view for demonstrating the sticking state of the film dressing of this invention.

  Hereinafter, preferred embodiments of the present invention will be described with reference to the drawings, but the present invention is not limited to these specific embodiments.

A. Overall Configuration of Film Dressing FIG. 1 (a) is a schematic plan view of a film dressing according to a preferred embodiment of the present invention, and FIG. 1 (b) is a schematic diagram of the film dressing of FIG. 1 (a) taken along line Ib-Ib. It is sectional drawing. It should be noted that for the sake of easy understanding, the ratio of the vertical, horizontal, and thickness of each layer and each part in the illustrated example is different from the actual ratio. The film dressing 100 includes a film part 110 and a fixing auxiliary part 120. The film part 110 and the fixing auxiliary part 120 have a common support 111, a common first pressure-sensitive adhesive layer 112, and a common release liner 113. The film part 110 further includes a film base material 114 and a second pressure-sensitive adhesive layer 115. The film substrate 114 is disposed between the first adhesive layer 112 and the release liner 113, and the second adhesive layer 115 is disposed between the film substrate 114 and the release liner 113. Preferably, the fixing auxiliary portion 120 further includes a fixing material 121 on the opposite side of the support 111 from the first pressure-sensitive adhesive layer 112. The release liner 113 is laminated so as to cover the surface of the second pressure-sensitive adhesive layer 115 in the film part 110 and the first pressure-sensitive adhesive layer 112 in the fixing auxiliary part 120 so as to be peelable. The film dressing 100 is provided with a cut portion 140 in a direction substantially parallel to the boundary 130 between the film portion 110 and the fixing auxiliary portion 120. A window part 150 is provided on the support 111 of the film part 110. Preferably, the film dressing of the present invention may further include a fixing tape 160. The fixing tape 160 is preferably detachably laminated on a portion of the release liner 113 that is not in contact with the first adhesive layer 112 or the second adhesive layer 115. Although not shown, the support 111 and the fixing material 121, and the release liner 113 and the fixing tape 160 are laminated via any appropriate adhesive or pressure-sensitive adhesive. In addition, the planar shape of the film dressing is not limited to the illustrated example, and it is needless to say that any appropriate shape (for example, a circle, a square, a rectangle, or a trapezoid) can be adopted depending on the purpose.

  The film dressing of the present invention fixes the coupling portion between the infusion tube and the puncture portion of a medical instrument such as a catheter on the fixing auxiliary portion (that is, on the fixing material) by providing the cut portion 140, and The puncture part of a medical instrument such as a catheter can be covered with the film base material of the film part. Preferably, as shown to Fig.1 (a), the cut part 140 is extended along the boundary 130 of the said film part 110 and the said fixed auxiliary | assistant part 120 from the width direction edge part of film dressing. The cut portion can be provided at any appropriate position in the length direction of the film dressing as long as the effect of the present invention is obtained. Any appropriate shape can be adopted as the shape of the cut portion as long as the effect of the present invention is obtained. Examples of the shape of the cut portion include a straight shape, a waveform, an arc shape, and a combination thereof. The length of the cut part is preferably 20% to 90%, more preferably 30% to 90%, with respect to the total length of the boundary between the film part and the fixing auxiliary part (that is, the width of the film dressing). %, Particularly preferably 50% to 70%. If the length of the cut part is in such a range, a medical device such as a catheter can be fixed well, and the film dressing is difficult to twist when peeling the release liner, and prevents wrinkles and breakage. Can do. The shortest length from the cut part to the end part on the cut part side of the fixing member is preferably 5 mm to 50 mm, more preferably 10 mm to 35 mm, and particularly preferably 14 mm to 30 mm. When the shortest length from the cut part to the end part on the cut part side of the fixing material is shorter than 5 mm, it is difficult to cover the puncture part of a medical instrument such as a catheter with the film part. When it is longer than 50 mm, there is a possibility that a medical instrument such as a catheter cannot be fixed satisfactorily.

  The release liner 113 is preferably divided. The position where the release liner is divided can be set to any appropriate position as long as the effect of the present invention is obtained. Preferably, it is the boundary between the film part and the fixing auxiliary part or the vicinity thereof. In one embodiment, as shown in FIG. 1 (b), the release liner 113 has a first divided piece 113 a and a second divided portion along the boundary 130 between the film part 110 and the fixing auxiliary part 120. It is divided into two pieces 113b. The 1st division | segmentation piece 113a covers the surface of the 2nd adhesive layer 115 in the film part 110, and is laminated | stacked so that peeling is possible. The 2nd division | segmentation piece 113b covers the surface of the 1st adhesive layer 112 in the fixing auxiliary | assistant part 120, and is laminated | stacked so that peeling is possible.

  The first divided piece 113a and the second divided piece 113b preferably have a folded portion. If the release liner has a folded portion, the release liner can be easily peeled without touching the pressure-sensitive adhesive layer. As a result, when the film dressing is applied to the surface of a living body (for example, skin), excellent operability can be obtained. In one embodiment, as shown in FIG. 1B, the first divided piece 113a and the second divided piece 113b are substantially the same as the boundary 130 at the boundary 130 between the film part 110 and the fixing auxiliary part 120. There are folded portions 113a-1 and 113b-1 which are folded by providing folded lines 113a-2 and 113b-2 in parallel. The peeling direction of the 1st division | segmentation piece 113a and the 2nd division | segmentation piece 113b is a direction substantially orthogonal to the folding lines 113a-2 and 113b-2. In the schematic cross-sectional view, for convenience, the fold line portion is shown by a curve, but it should be noted that the release liner is actually folded at an acute angle at the fold line portion. Thus, when the 1st division | segmentation piece 113a and the 2nd division | segmentation piece 113b have the folding | returning parts 113a-1 and 113b-1, the fixing tape 160 can be arrange | positioned on the opposite side to the adhesive layer of a folding | turning part.

  The folded portions 113a-1 and 113b-1 preferably have an extending portion. If the folded portion has an extending portion, a film dressing having a remarkably excellent adhesion operability to the surface of the living body can be obtained as a grip portion. In one embodiment, as shown in FIGS. 1 (a) and 1 (b), an extended portion 113a-3 is provided at the end of the folded portion 113a-1 opposite to the folded line 113a-2. The extending portion 113b-3 is provided at the end of the folding portion 113b-1 opposite to the folding line 113b-2. About the surface view shape of the said extension part, it is not limited to the example of illustration, Arbitrary appropriate surface view shapes may be employ | adopted according to the objective. Specific examples of the surface-view shape of the extension part include a quadrangle (including a trapezoid), a semi-elliptical shape, and the like. Further, the end portion of the extending portion may be corrugated. The length of the extending portion in the peeling direction is preferably 1 mm to 30 mm, and more preferably 5 mm to 20 mm. If the length of the extending portion in the peeling direction is within such a range, it has excellent peeling operability, and an appropriate size film dressing can be obtained.

  FIG. 2 is a schematic cross-sectional view of a film dressing according to still another embodiment when the release liner is divided into two. In this film dressing 200, the end on the folding line side of the first divided piece 213a and the end on the folding line side of the second divided piece 213b overlap each other. Furthermore, preferably, one of the fold line 213a-2 of the first divided piece 213a and the fold line 213b-2 of the second divided piece 213b is configured to be located directly below the cut portion ( In the illustrated example, the fold line 213a-2 of the first divided piece 213a is located directly below the cut portion). The overlapping width a of the first divided piece 213a and the second divided piece 213b is preferably 2 mm to 6 mm, and more preferably 3 mm to 5 mm.

  FIG. 3 is a schematic back view of a film dressing according to still another embodiment of the present invention. In this film dressing 300, instead of the two-divided release liner of the embodiment shown in FIG. 1, a three-divided release liner is used. That is, the release liner is divided into a first divided piece 313a, a second divided piece 313b, and a third divided piece 313c. The first divided piece 313a and the second divided piece 313b are divided by a cut portion 340. The first divided piece 313a, the second divided piece 313b, and the third divided piece 313c are divided along a line 370 that extends from the end of the cut portion 340 and extends in a direction perpendicular to the cut portion 340. . The 1st division | segmentation piece 313a is laminated | stacked so that peeling is possible covering a part of surface of a 2nd adhesive layer. The second divided piece 313b is laminated in the fixing auxiliary portion 320 so as to cover a part of the surface of the first pressure-sensitive adhesive layer so as to be peeled off. The third divided piece 313c is a surface of the second adhesive layer of the film part 310 that is not covered with the first divided piece 313a, and the second divided piece of the first adhesive layer in the fixing auxiliary part 320. The surface which is not covered with 313b is covered so that peeling is possible. Furthermore, the first divided piece 313a, the second divided piece 313b, and the third divided piece 313c have a folded portion that is folded by providing a folding line along a line 370 extending in a direction perpendicular to the cut portion 340. . The peeling direction of the first divided piece 313a, the second divided piece 313b, and the third divided piece 313c is a direction substantially orthogonal to the folding line. If the release liner is thus divided into three parts, when fixing a medical instrument such as a catheter, a film corresponding to the third divided piece 313c of the film dressing is attached to the surface of the living body as a first operation. Since the subsequent sticking operation can be performed after the dressing alignment, the operability is excellent. Preferably, the folded portion has extension portions 313a-3, 313b-3, and 313c-3 extending outward from the first pressure-sensitive adhesive layer and the second pressure-sensitive adhesive layer at the end opposite to the folding line. Provided. Although not shown, when the release liner is divided into three in this way, the fixing tape is disposed on the side opposite to the adhesive layer of the third divided piece 313c, for example.

  FIG. 4 is a schematic cross-sectional view of a film dressing according to still another embodiment of the present invention. In this film dressing 400, in the film part 410, the film base 414 is disposed on the opposite side of the support 411 from the first pressure-sensitive adhesive layer 412, and the second pressure-sensitive adhesive layer 415 is supported by the film base 414. It is arranged between the body 411.

  FIG. 5 is a schematic cross-sectional view of a film dressing according to still another embodiment of the present invention. In the film dressing 500, the film part 510 and the fixing auxiliary part 520 have a common film base 514 and a common second adhesive layer 515. In the film portion 510, the film base 514 is disposed on the opposite side of the support 511 from the first pressure-sensitive adhesive layer 512, and the second pressure-sensitive adhesive layer 515 is disposed between the film base 514 and the support 511. Has been. Further, in the fixing auxiliary portion 520, the film base 514 is disposed between the fixing member 521 and the support 511, and the second pressure-sensitive adhesive layer 515 is disposed between the film base 514 and the support 511. Yes. Although not shown, the film base 514 and the fixing material 521 are attached with any appropriate adhesive or pressure-sensitive adhesive.

  The film dressing of the present invention can be appropriately combined with the embodiments described above as long as the effects of the present invention are obtained.

B. Explanation of each component B-1. Support As the support, any appropriate material can be used as long as the effects of the present invention can be obtained. Specific examples of the material for the support include cotton, rayon, nylon, urethane, polyethylene, polypropylene, polyester, and pulp. Such a material has appropriate strength and flexibility, so that it is possible to obtain a film dressing with a small feeling of pressure by a medical instrument such as a catheter. More specific forms of the support include, for example, spunlace nonwoven fabric, spunbond nonwoven fabric, melt blown nonwoven fabric, urethane nonwoven fabric, urethane foam sheet, polyethylene foam sheet, polypropylene foam sheet, and mixed nonwoven fabric of pulp and acrylic ester. Can be mentioned. The support may have a single layer structure or a laminated structure of two or more layers. In the case of a laminated structure, each layer may be the same or different.

  The thickness of the support can be set to any appropriate thickness depending on the purpose. The thickness of the support is preferably 100 μm to 500 μm, more preferably 200 μm to 400 μm. If the thickness of the support is less than 100 μm, the strength required for film dressing may not be obtained. When it is larger than 500 μm, there is a possibility that moderate flexibility cannot be obtained.

  The said support body has a window part, as shown to Fig.1 (a). If the said support body has a window part, it can affix, observing the fixed position of medical instruments, such as a catheter. As the shape and size of the window portion, any appropriate shape and size can be adopted as long as the fixing position of a medical instrument such as a catheter can be observed.

B-2. Adhesive Layer Any suitable adhesive can be adopted as the adhesive constituting the first adhesive layer and the second adhesive layer as long as they can be used by being attached to the surface of a living body. Specific examples of such pressure-sensitive adhesives include pressure sensitive pressure-sensitive adhesives such as natural rubber, synthetic rubber, acrylic, silicone, and hot melt. Acrylic pressure sensitive adhesive is preferred. This is because the transparency of the transparent part of the film dressing can be further increased and the irritation to the skin can be further suppressed. Among acrylic pressure-sensitive adhesives, an oily gel-like acrylic pressure-sensitive adhesive is particularly preferable. This is because it is hypoallergenic to scars and suture wounds as well as to skin with photosensitivity and photoallergy. Details of the oily gel-like acrylic pressure-sensitive adhesive are described in, for example, JP-A-6-319793, the description of which is incorporated herein by reference.

  Any appropriate thickness can be adopted as the thickness of the first pressure-sensitive adhesive layer and the second pressure-sensitive adhesive layer depending on the purpose and application. The thickness of the first pressure-sensitive adhesive layer is preferably 5 μm to 60 μm, and more preferably 10 μm to 50 μm. The thickness of the second pressure-sensitive adhesive layer is preferably 20 μm to 100 μm, more preferably 30 μm to 70 μm. If the thickness of the said adhesive layer is such a range, since it is excellent in the adhesiveness to the biological body surface, the sticking and peeling of the stuck film dressing can be prevented favorably. Moreover, the film dressing end portion can be prevented well when the film dressing is pasted for a long time.

  Any appropriate method can be adopted as a method of providing the first pressure-sensitive adhesive layer and the second pressure-sensitive adhesive layer. Specific examples include a method of applying and drying the pressure-sensitive adhesive composition on the pressure-sensitive adhesive layer arrangement surface, and a method of transferring and laminating the pressure-sensitive adhesive layer formed into a predetermined shape on the pressure-sensitive adhesive layer arrangement surface. It is done.

B-3. Release liner Any appropriate release liner can be adopted as the release liner as long as it can be satisfactorily released from the pressure-sensitive adhesive layer used in the present invention. Typically, the release liner has a substrate and a release treatment layer formed on the surface of the substrate. Specific examples of the substrate include plastic films (for example, polyethylene, polypropylene, polyester, or laminated composites thereof) and paper (for example, fine paper, kraft paper, etc.). The release treatment layer can be formed by subjecting the substrate surface to a silicone resin treatment, a fluorine resin treatment, or the like. In the present invention, the release treatment layer is preferably formed on both surfaces of the substrate.

  The thickness of the release liner can be appropriately set according to the purpose. The thickness of the release liner is preferably 50 μm to 250 μm, more preferably 75 μm to 200 μm.

  Preferably, as shown in FIGS. 6A and 6B, the release liner has a notch 216 on the fold line. FIG. 6A is a view showing the notch 216 in a state where the release liner is folded, and FIG. 6B is a view showing the notch 216 in a state where the release liner is developed. If the release liner has a notch, the release liner is divided into two and the first divided piece and the second divided piece overlap each other (that is, the embodiment shown in FIG. 2). 6), when the cut portion is opened, as shown in FIG. 6C, the cut portion is opened by holding one divided piece by the notch. It can be kept stable.

  Any appropriate shape can be adopted as the shape of the cutout as long as such an effect is obtained. Specific examples of the shape of the notch include a triangle, a straight line, and a rectangle (a triangle in the illustrated example). The depth b of the notch is preferably 2 mm to 6 mm, and more preferably 3 mm to 5 mm. More preferably, the depth b of the notch coincides with the overlap width between the first divided piece and the second divided piece. If the depth b of the notch is in such a range, the state in which the cut portion is open can be stably maintained, and the first divided piece and the second division can be easily performed when the cut portion is closed. The piece can be separated. The notch may be provided only in the first divided piece, may be provided only in the second divided piece, or may be provided in both the first divided piece and the second divided piece. .

B-4. Film Base Any suitable film can be adopted as the film base as long as it can be used for film dressing. Typically, a film that has flexibility and does not damage the surface of a living body such as skin may be employed. Specific examples of such film materials include acrylic polymers, polyethylene, ethylene-vinyl acetate copolymers, polyurethanes, polyether polyesters, and polyamide derivatives. Acrylic polymers, polyurethanes, polyether polyesters and polyamide derivatives are preferred. Since the film has excellent water vapor permeability, it can hardly prevent breathing of the covered skin, can suppress the whitening phenomenon of the skin, and has excellent transparency. (For example, when fixing a punctured catheter, it can be affixed while observing the catheter insertion portion).

  As the thickness of the film substrate, any appropriate thickness can be adopted depending on the purpose and application. The thickness of the film substrate is preferably 5 μm to 150 μm, more preferably 10 μm to 75 μm. If it is such thickness, it is excellent in the followability to the unevenness | corrugation of the biological body surface (for example, skin), and can function favorably as a base material of a film dressing.

B-5. Fixing Material The film dressing of the present invention preferably has a fixing material as shown in FIG. By having the fixing material, it is possible to obtain a film dressing that is excellent in operability and that can satisfactorily fix a medical instrument such as a catheter at the puncture portion. Specifically, by providing a fixing material, positioning of a medical instrument such as a catheter and a film dressing can be performed simultaneously. In addition, since the fixing material assists in fixing the medical instrument such as a catheter, excellent fixability can be obtained, and a difference in fixability due to the operator is unlikely to occur. Furthermore, since it is excellent in fixability as described above, the amount of tape used for fixing assistance can be reduced, and the cost and the burden on the skin to which the film dressing is applied can be reduced.

  Any appropriate fixing material can be used as the fixing material as long as the effects of the present invention can be obtained. Specific examples of the fixing material include cotton, rayon, nylon, urethane, polyethylene, polypropylene, polyester, acrylic ester, pulp, and rubber. Such a material has appropriate strength and flexibility, so that it is possible to obtain a film dressing with a small feeling of pressure by a medical instrument such as a catheter. More specific forms of the fixing material include, for example, spunlace nonwoven fabric, spunbond nonwoven fabric, meltblown nonwoven fabric, urethane nonwoven fabric, urethane foam, polyethylene foam, polypropylene foam, and mixed nonwoven fabric of pulp and acrylic ester. Can be mentioned. Of these, urethane foam and polyethylene foam are preferred. If the fixing material is formed of urethane foam or polyethylene foam, a film dressing that is excellent in the fixation of medical devices such as catheters and has low physical irritation to the living body surface by medical devices such as catheters. Can be obtained. The fixing material may have a single layer structure or a laminated structure of two or more layers. In the case of a laminated structure, each layer may be the same or different.

  The fixing material is preferably provided with a cut. By providing the notch, a medical instrument such as a catheter can be more satisfactorily fixed. The notch is provided in any appropriate shape at any appropriate position as long as a medical instrument such as a catheter can be satisfactorily fixed. Examples of the position where the notch is provided include a surface on the opposite side to the support of the fixing material, a side surface on the boundary side between the film portion and the fixing auxiliary portion of the fixing material, and an angle formed from these surfaces Is mentioned. Examples of the cross-sectional shape of the cut include a triangle, a quadrangle, and a semicircle.

  The thickness of the fixing material is preferably 1 mm to 13 mm, and more preferably 2 mm to 8 mm. When the thickness of the fixing material is less than 1 mm, the unevenness of the joint portion between the puncture portion and the infusion tube cannot be absorbed, and sufficient fixability may not be obtained. Moreover, there exists a possibility that the intensity | strength as a fixing material may be insufficient. When the thickness of the fixing material is larger than 13 mm, the joint between the puncture portion and the infusion tube is not stably disposed on the upper surface of the fixing material, and there is a possibility that sufficient fixability may not be obtained. In addition, when the fixing material is too thick, the fixing portion is easily caught on clothes, a bed, or the like, and there is a risk of needle removal.

  The length of the side of the fixing material in the direction orthogonal to the boundary between the film part and the fixing auxiliary part is preferably 5 mm or more, more preferably 5 mm to 50 mm, and particularly preferably 10 mm to 30 mm. . If the length of the side of the fixing material in the direction orthogonal to the boundary between the film portion and the fixing auxiliary portion is within such a range, the fixing material has sufficient strength for fixing a medical instrument such as a catheter satisfactorily. An appropriate size film dressing can be obtained. The length of the side of the fixing material in the direction parallel to the boundary between the film part and the fixing auxiliary part is preferably 2 mm or more, more preferably 2 mm to 50 mm, and particularly preferably 5 mm to 50 mm. . If the length of the side of the fixing material in the direction parallel to the boundary between the film portion and the fixing auxiliary portion is in such a range, a film of an appropriate size that prevents medical instruments such as catheters from falling off the fixing material. A dressing can be obtained.

B-6. Fixing tape The fixing tape is affixed from the upper side of the film dressing body that is affixed to the surface of the living body, and assists in fixing the medical instrument by the film dressing. By providing the fixing tape integrally with the film dressing, the operability at the time of attaching and fixing the film dressing can be remarkably improved. The fixing tape can have a substrate and an adhesive layer. Since the structure of the medical tape and the bandage tape normally used in the industry is employ | adopted about the said base | substrate, these detailed description is abbreviate | omitted. The pressure-sensitive adhesive layer is as described in the above section B-2.

C. Specific Procedure for Attaching Film Dressing FIG. 7 is a schematic diagram for explaining a specific application procedure for the film dressing when the release liner is divided into two parts. First, as shown in (a), a medical instrument (a catheter in the illustrated example) 600 is punctured into the living body surface 700, and film dressing is applied in that state. Hereinafter, the film dressing of the embodiment shown in FIG. 2 will be specifically described as a representative.

  When the release liner is divided into two parts, in attaching the film dressing 200, first, the end of the film part 210 is twisted, and the film part 210 and the fixing auxiliary part 220 are twisted. As a result, as shown in (b), the cut portion 240 is opened. At this time, if the release liner has the notch 216 as described in the above section B-3, the state in which the cut portion 240 is open can be stably maintained. Next, as shown in (c), the fixation assisting part 220 is disposed between the medical instrument 600 and the living body surface 700, and the film part 210 is placed on the upper part of the medical instrument 600. That is, the medical instrument 600 is fixed on the fixing auxiliary part 220 and is made to puncture the living body surface 700 below the film part 210 so as to pass through the cut part 240.

  Next, as shown in (d), the first divided piece 213a (that is, the release liner of the film part) is peeled downward in the drawing, and as shown in (e), the film part 210 is replaced with a medical device. It is affixed to the living body surface 700 so as to cover 600 puncture portions. Further, as shown in (f), the second divided piece 213b (that is, the release liner of the fixing auxiliary part) is peeled upward in the drawing, and as shown in (g), the fixing auxiliary part 220 is attached to the living body surface. 700 is attached. Furthermore, if necessary, the fixing tape 260 is peeled off from the release liner, and then attached so as to cover the fixing material, and the application of the film dressing 200 is completed.

  FIG. 8 is a schematic diagram for explaining a specific application procedure of the film dressing when the release liner is divided into three parts. First, as shown in (a), a medical instrument (a catheter in the illustrated example) 600 is punctured into the living body surface 700, and film dressing is applied in that state. Hereinafter, the film dressing of the embodiment shown in FIG. 3 will be specifically described as a representative.

  When the release liner is divided into three parts, when the film dressing 300 is affixed, first, the end of the film part 310 is twisted, and the film part 310 and the fixing auxiliary part 320 are twisted and cut. Part 340 is left open. Next, as shown in (b), the fixation assisting part 320 is disposed between the medical instrument 600 and the living body surface 700, and the film part 310 is placed on the upper part of the medical instrument 600. That is, the medical instrument 600 is fixed on the fixing auxiliary part 320 and is punctured on the living body surface 700 below the film part 310 so as to pass through the cut part 340.

  Next, as shown in (c), the third divided piece 313c is peeled downward in the drawing, and the portion corresponding to the third divided piece 313c of the film part 310 and the fixing auxiliary part 320 is the biological surface 700. Is pasted. Further, as shown in (d), the first divided piece 313a is peeled upward in the drawing, and the remaining part of the film part 310 covers the puncture part of the medical instrument 600 so as to cover the living body surface 700. As shown in (e), the second divided piece 313b is peeled upward in the drawing, and as shown in (f), the remaining part of the fixation assisting part 320 is attached to the living body surface 700. It is done. Further, if necessary, the fixing tape 360 is peeled off from the release liner, and then attached so as to cover the fixing material, and the application of the film dressing 300 is completed.

  FIG. 9 is a schematic perspective view for explaining a state where the film dressing of the present invention is attached to the surface of a living body. As shown in FIG. 9, when the film dressing of the present invention is applied, the film part 110 is attached to the living body surface 700 so as to cover the puncture part 610 of a medical instrument such as a catheter. Further, the fixation assisting part 120 is affixed to the living body surface 700, and an infusion tube 620 and / or an infusion tube 630 of a medical instrument such as a catheter is disposed on the fixing material 121, and these are fixed. Assist. Although not shown, when a fixing tape is used, the fixing tape preferably covers the fixing member 121, the infusion tube 620 of the medical device such as a catheter and the puncture unit, and the infusion tube 630 in the fixing auxiliary unit 120. To be pasted. By fixing a medical device such as a catheter in such a state, leakage of the chemical solution from the blood vessel due to movement of the indwelling needle of the catheter, risk of removal of the indwelling needle, and floating or peeling of the film dressing due to movement of the catheter are improved. Can be prevented.

  EXAMPLES Hereinafter, although an Example demonstrates this invention concretely, this invention is not limited by these Examples.

[Example 1]
1. Laminate 1 of film base material and second pressure-sensitive adhesive layer
A polyurethane film having a thickness of 30 μm was used as the film substrate.
A pressure-sensitive adhesive layer (second pressure-sensitive adhesive layer) made of an acrylic pressure-sensitive adhesive was provided on the surface of the film base so as to have a thickness of 30 μm to obtain a laminate 1 of the film base and the second pressure-sensitive adhesive. . The size of the laminate 1 was 50 mm × 40 mm.
2. Laminated body 2 of support and first adhesive layer
A spunlace nonwoven fabric having a thickness of 300 μm was used as the support.
A pressure-sensitive adhesive layer (first pressure-sensitive adhesive layer) made of an acrylic pressure-sensitive adhesive was provided on the surface of the support so as to have a thickness of 50 μm to obtain a laminate 2 of the support and the first pressure-sensitive adhesive layer. The size of the laminate 2 was 50 mm × 130 mm. Furthermore, the laminated body 2 was provided with a 40 mm (short side) × 30 mm (long side) window portion at a position 5 mm from the short side and 5 mm from the long side, using a spring blade.
3. Laminated body 10 of support, first pressure-sensitive adhesive layer, film base material, and second pressure-sensitive adhesive layer
One of the long sides of the laminate 1 and one of the short sides of the laminate 2 are aligned (that is, the sides of 50 mm are aligned), and the film base material is laminated at a position corresponding to the window portion. The 1st adhesive layer of the said laminated body 2 and the film base material of the said laminated body 1 were bonded together, and the laminated body 10 (50 mm x 130 mm) was obtained. The size of the portion corresponding to the film portion of the laminate 10 was 50 mm × 40 mm, and the size of the portion corresponding to the fixing auxiliary portion was 50 mm × 90 mm.
Furthermore, a cut part having a length of 30 mm was provided perpendicularly from the long side of the laminate 10 at a position corresponding to the inner end of the film substrate.
4). Release liner A silicone resin treatment was applied to one side of a 100 μm thick paper to obtain a release liner. The obtained release liner was divided into a first divided piece and a second divided piece. The size of the first divided piece was 50 mm × 90 mm, and the size of the second divided piece was 50 mm × 198 mm.
The short side (50 mm side) end of the side of the laminate 10 that is not provided with the film base (that is, the part corresponding to the fixing auxiliary part) and the short side of the second divided piece are combined and the combined end The second divided piece was folded back at a position of 94 mm from the part, and the first pressure-sensitive adhesive layer and the surface of the second divided piece subjected to the silicone resin treatment were bonded together. At this time, the length of the folded portion of the first divided piece was 104 mm. The first divided piece was continuously provided with notches having a depth of 4 mm and a width of 4 mm in the shape shown in FIG. 6 at intervals of 10 mm.
Furthermore, the short side (side of 50 mm) of the side (that is, the part corresponding to the film part) of the laminate 10 provided with the film base is aligned with the short side of the first divided piece. The first divided piece was folded back at a position 40 mm from the end, and the second pressure-sensitive adhesive layer was bonded to the surface of the first divided piece that had been treated with the silicone resin. At this time, the length of the folded portion of the second divided piece was 50 mm.
Each of the first divided piece and the second divided piece had an extending portion extending 10 mm from the short side end portion of the laminate 10. Further, the first divided piece and the second divided piece overlapped with a width of 4 mm.
5. Fixing material As the fixing material, a polyethylene foam (Sekisui Chemical Co., Ltd., Bollara ES series, thickness 5 mm) cut into a length of 35 mm and a width of 25 mm was used. The fixing member is a film base material of the laminate 10 such that the vertical side of the fixing member is substantially parallel to the long side of the laminate 10 and the side of the fixing member is substantially parallel to the short side of the laminate 10. Olefin hot melt adhesive at a position where the shortest length from the cut part to the end part on the cut part side of the fixing material is 45 mm on the support on the side not provided with (that is, the part corresponding to the fixing auxiliary part) Pasted through.
6). Fixing Tape An adhesive layer made of an acrylic adhesive was provided on a spunlace nonwoven fabric having a thickness of 300 μm so as to have a thickness of 50 μm to obtain a fixing tape. This fixing tape was cut into a width of 25 mm and a length of 50 mm, and the outside of the folded first divided piece (the side subjected to the silicone resin treatment) and the adhesive layer of the fixing tape were bonded together.
As described above, a film dressing similar to that shown in FIG. 4 was prepared except that the fixed tape portion was provided.

[Example 2]
The length of the cut part is 40 mm, and the fixed part cut from the cut part is made of polyethylene foam (Sekisui Chemical Co., Ltd., Bollara IF series, thickness 2 mm). A film dressing was produced in the same manner as in Example 1 except that the shortest length to the end of was set to 20 mm.

[Example 3]
The length of the cut part is 35 mm, and an acrylic / olefin non-woven fabric (Nippon Vilene Co., Ltd., thickness 2.4 mm) cut into 10 mm vertical x 25 mm wide is used as the fixing material. A film dressing was produced in the same manner as in Example 1 except that the shortest length to the end was 15 mm.

[Example 4]
The length of the cut part is 25 mm, and a polyethylene foam (Sekisui Chemical Co., Ltd., Borara IF series, thickness 1 mm) cut into a vertical 35 mm x horizontal 25 mm as the fixing material is used. A film dressing was prepared in the same manner as in Example 1 except that the shortest length to the end of the film was 5 mm.

[Example 5]
The length of the cut part is 45 mm, and the fixed material is cut from the cut part using a polyethylene foam (product name: P-E-light, thickness: 13 mm, manufactured by INOAC) that is cut into a vertical 5 mm x horizontal 15 mm as the fixing material. A film dressing was produced in the same manner as in Example 1 except that the shortest length to the end on the part side was 25 mm.

[Example 6]
The length of the cut part is 10 mm, and the end of the fixed part cut from the cut part is made of polyethylene foam (Takiron Co., Calsoft, 3 mm thick) cut into 50 mm vertical and 50 mm wide as the fixing material. A film dressing was produced in the same manner as in Example 1 except that the shortest length was 25 mm.

[Example 7]
The length of the cut part is 5 mm, a spunlace nonwoven fabric cut into a length of 20 mm × width of 25 mm is used as a fixing material, the size of the second divided piece is 50 mm × 95 mm, the length of the folded part is 5 mm, The shortest length from the cut part to the end of the fixed material on the cut part side is such that the first divided piece overlaps the second divided piece with a width of 10 mm without folding back with the size of the divided piece being 50 mm × 50 mm. A film dressing was produced in the same manner as in Example 1 except that the thickness was changed to 30 mm.

[Example 8]
The length of the cut part is 48mm, and the fixed material is cut from the cut part using polyethylene foam (product name: P-E-light, thickness 16mm, manufactured by INOAC) cut into 10mm vertical x 10mm wide as the fixing material. A film dressing was produced in the same manner as in Example 7 except that the shortest length to the end on the part side was 50 mm.

[Example 9]
The length of the cut part is 48mm and the fixing material is cut from the cut part using polyethylene foam (Sekisui Chemical Co., Ltd., Bollara IF series, thickness 2mm) cut into 3mm vertical x 1.5mm wide as the fixing material. A film dressing was produced in the same manner as in Example 7 except that the shortest length to the end on the part side was 3 mm.

[Example 10]
A film dressing was produced in the same manner as in Example 1 except that no fixing material was used.

[Comparative Example 1]
A silicone resin treatment of a release liner in which a pressure-sensitive adhesive layer made of an acrylic pressure-sensitive adhesive is provided on a polyurethane film having a thickness of 30 microns so as to have a thickness of 30 μm, and one side of a paper having a thickness of 100 μm is treated with a silicone resin. The face and the pressure-sensitive adhesive layer were bonded together to produce a 40 mm × 50 mm film dressing.

<Evaluation method>
Apply a medical catheter (Terumo Sureplug Infusion Set, Terumo Surfflow Flash 22G) on the skin, and cover the catheter according to the procedure shown in FIG. The fixing state was reinforced by attaching a fixing tape from the fixing material and the upper part of the catheter. For the film dressing of the comparative example, after peeling off the release liner, the tip of the catheter was covered with a polyurethane film. The operability when fixing the catheter and the practical fixability when the catheter tube was pulled by hand were evaluated according to the following evaluation criteria.
(1) Operability
A: Good operability
Y: No operability
Δ: Slightly difficult to operate
×: Difficult to operate (2) Practical fixability
A: There is a sense of stability
○: Misalignment is not seen
Δ: Almost no deviation
X: Deviation is observed Furthermore, the catheter tensile strength was measured and evaluated by the following procedure.
(3) Tensile strength A catheter was placed on the forearm and a film dressing was applied in the same manner as described above. After pasting, aging is performed for 30 minutes, and then tensile strength (shearing) when 20 mm is pulled in a direction parallel to the catheter fixing direction at a speed of 100 mm / min using an autograph (manufactured by Shimadzu Corporation, AG-IS autograph). Peel strength) was measured.
Table 1 shows the evaluation results of the above (1) to (3).

<Result>
As shown in Examples 1-10, the film dressing of this invention is excellent in operativity and fixability by providing the cut part. Moreover, as shown in Examples 1-9, the film dressing which is excellent by fixability can be obtained by providing a fixing material. Furthermore, as shown in Examples 1 to 6, by using a fixing material having a specific thickness and size, it is possible to obtain a film dressing that is remarkably excellent in fixability, and by using an extension part in the release liner, A film dressing with remarkably excellent operability can be obtained.

  Further, in the film dressing of the example, the fixing tape was easy to peel off, and the replacement operation was very easy.

  The film dressing of the present invention is suitably used for medical applications, and can be particularly suitably used for fixing medical devices such as catheters.

100, 200, 300, 400, 500 Film dressing 110, 210, 310, 410, 510 Film part 111, 211, 411, 511 Support 112, 212, 412, 512 First adhesive layer 113, 213 Release liner 113a 213a, 313a Release liner (first divided piece)
113b, 213b, 313b Release liner (second divided piece)
313c Release liner (third segment)
113a-1, 113b-1 Folding part 113a-2, 113b-2, 213a-2, 213b-2 Folding line 113a-3, 113b-3, 313a-3, 313b-3, 313c-3 Extension part 213- 4 Notches 114, 214, 414, 514 Film substrate 115, 215, 415, 515 Second adhesive layer 120, 220, 320, 420, 520 Fixing auxiliary part 121, 221, 421, 521 Fixing material 140, 340 Cut portion 150 Window portion 160, 260, 460, 560 Fixed tape 600 Medical instrument 700 Living body surface

Claims (16)

A film dressing having a film part and a fixing auxiliary part,
The film part and the fixing auxiliary part have a common support, a common first pressure-sensitive adhesive layer, and a common release liner in this order,
The film part further includes a film base and a second pressure-sensitive adhesive layer,
In the film portion, the film base is disposed between the first pressure-sensitive adhesive layer and the release liner, and the second pressure-sensitive adhesive layer is disposed between the film base and the release liner. ,
A cut part is provided in a direction substantially parallel to the boundary between the film part and the fixing auxiliary part,
A window portion is provided on the support of the film portion.
Film dressing. A film dressing having a film part and a fixing auxiliary part,
The film part and the fixing auxiliary part have a common support, a common first pressure-sensitive adhesive layer, and a common release liner in this order,
The film part further includes a film base and a second pressure-sensitive adhesive layer,
In the film portion, the film base is disposed on the opposite side of the support from the first pressure-sensitive adhesive layer, and the second pressure-sensitive adhesive layer is disposed between the film base and the support. And
A cut part is provided in a direction substantially parallel to the boundary between the film part and the fixing auxiliary part,
A window portion is provided on the support of the film portion.
Film dressing. The film dressing according to claim 1 or 2 , wherein the fixing auxiliary part further has a fixing material on the side of the support opposite to the first pressure-sensitive adhesive layer. In the fixing auxiliary part, the film base is disposed between the fixing member and the support, and the second pressure-sensitive adhesive layer is disposed between the film base and the support. The film dressing according to claim 2 . The release liner is divided into a first divided piece and a second divided piece at or near the boundary between the film part and the fixing auxiliary part,
The first divided piece and the second divided piece have a folding line substantially parallel to the boundary between the film portion and the fixing auxiliary portion at or near the boundary between the film portion and the fixing auxiliary portion. The film dressing according to any one of claims 1 to 4 , wherein the film dressing has a folded back portion. The film dressing according to claim 5 , wherein the release liner has a notch on the fold line. The film dressing of Claim 6 whose depth of the said notch is 2 mm- 6 mm. The film dressing according to any one of claims 5 to 7 , wherein an end portion on the folding line side of the first divided piece and an end portion on the folding line side of the second divided piece overlap each other. The film dressing according to claim 8 , wherein an overlap width between the first divided piece and the second divided piece is 2 mm to 6 mm. The release liner is divided into a first divided piece, a second divided piece, and a third divided piece,
The first divided piece and the second divided piece are divided by the cut portion,
The first divided piece and the second divided piece and the third divided piece are divided along a line extending from an end portion of the cut portion and extending in a direction perpendicular to the cut portion,
The first divided piece is disposed in the film portion, the second divided piece is disposed in the fixing auxiliary portion,
The first divided piece, the second divided piece, and the third divided piece are folded back by providing a folding line along a line extending from an end portion of the cut portion and extending in a direction perpendicular to the cut portion. The film dressing in any one of Claim 1 to 4 which has a turned-back part. The end opposite to the folding line of the folded portion, the extending portion extending from the to the outside the first adhesive layer or the second adhesive layer is provided, one of claims 5 10, The film dressing according to crab. The film dressing in any one of Claim 3 to 11 whose thickness of the said fixing material is 1 mm-13 mm. The length of the side of the fixing material in the direction perpendicular to the boundary between the film part and the fixing auxiliary part is 5 mm or more, and the length of the side in a direction substantially parallel to the boundary between the film part and the fixing auxiliary part The film dressing in any one of Claim 3 to 12 whose length is 2 mm or more. The film dressing in any one of Claim 3 to 13 whose shortest length from the said cut part to the edge part by the side of the said cut part of the said fixing material is 5 mm-50 mm. The film dressing according to any one of claims 1 to 14 , wherein a length of the cut portion is 20% to 90% with respect to a total length of a boundary between the film portion and the fixing auxiliary portion. Further comprising a fixing tape, film dressing according to any of claims 1 to 15.

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