JP2014168573A - Film dressing with sweating visual recognition function and through hole - Google Patents

Abstract

PROBLEM TO BE SOLVED: To facilitate specifying a sweating part when performing treatment for preventing excessive sweating and to easily enable medication to the part at predetermined intervals.SOLUTION: A film dressing is provided which includes a sweating visual recognition function and through holes for enabling medication at predetermined intervals. A liquid absorbing sheet 3 is provided by covering the area of a portion or all of an adhesive surface 2a to a film dressing body A having a film body 1 and a first adhesive layer 2. The adhesive surface to be affixed to a skin surface is ensured properly. The liquid absorbing sheet 3 is a sheet such as the sebum-absorbent paper that can absorb sweat and has a light transmittance or an optical reflection coefficient varied by the sweat soaking. In the film dressing, the plurality of through holes H penetrating through at least the film dressing body A and the liquid absorbing sheet 3 are formed, and the specification of the sweating part and the positioning of the medication are enabled only by affixing the film dressing.

Description

  The present invention relates to a novel auxiliary device for enabling easier administration of a drug administered to suppress sweating in the treatment of hyperhidrosis, particularly a drug administered by intradermal injection. .

  Although the human body has a sweating function as a body temperature regulation function, sweating is caused not only by a normal body temperature regulation function but also by psychological stress such as tension and emotional stimulation. Although the amount of sweating varies from person to person, sweating can be uncomfortable for those who sweat excessively. In particular, hyperhidrosis in which the amount of sweating abnormally increases due to mental factors or neurological diseases often interferes with daily life.

Methods for treating local hyperhidrosis include a method of locally applying an antiperspirant for external use such as an aqueous solution of aluminum chloride, glutaraldehyde, and tannic acid, and a drug therapy such as administration of an anticholinergic agent. However, administration of such drugs can cause side effects such as dermatitis and the skin turning brown.
In addition, as a method for surgical treatment of hyperhidrosis, there is excision of sweat glands, but it is not a preferable method because it not only increases the cost but also removes healthy skin.

In recent years, as a method for treating hyperhidrosis, a treatment method in which a botulinum toxic preparation (Botox (registered trademark), type A botulinum toxin preparation) is injected into the deep dermis at a sweat site (particularly the axilla) has been used in medical treatment such as cosmetic surgery and dermatology. Has been implemented in the field.
In this treatment method, in order to inject a botulinum toxic preparation intradermally at a predetermined interval, a marking serving as a guide for an injection position is provided on the skin surface prior to injection.
For example, in the administration of a botulinum toxic preparation to the axilla, as schematically shown in FIG. 9, a line surrounding the area where the hair root of the axillary (armpit) hair exists on the skin surface 100 of the axilla subjected to shaving treatment. Draw 110 with an oil-based pen. Next, the parallel lines 120 are drawn so that the range is divided into 5 to 10 mm widths along the ridges of the ridges, and parallel lines are drawn in the lateral direction as necessary (to draw an orthogonal grid) (see FIG. Not shown). As shown in FIG. 9, along the belt-like region between the drawn parallel lines, the injection needle 130 is punctured in a state of being laid at an angle close to parallel to the skin surface, and the botulinum toxic preparation is injected into the deep dermis. The number of injection locations varies from individual to individual, but is about 10 to 25 locations per side.

In the injection method as shown in FIG. 9, prior to the marking on the skin surface, a treatment for specifying a sweat site may be performed. The treatment is a treatment using color development by iodine starch reaction. For example, an iodine solution is applied to the skin surface of the axilla subjected to shaving treatment, dried, and starch (powder) is sprinkled on it. As a result, the sweating site is colored from violet to reddish brown, so that the sweating site can be known. By adding such a method, it is possible to know more reliably the site to be treated where the drug is to be injected.
After the perspiration site is specified, as shown in FIG. 9, the line 110 and the parallel line 120 surrounding the colored area are drawn with an oil marker (oil ink pen), etc., the injection needle 130 is punctured, and the botulinum toxic preparation is applied to the deep dermis. Just inject.

  Further, as a marking tool for assisting the marking operation as described above, a marking template (template) as shown in Patent Document 1 has been proposed. The template is a kind of drawing tool for drawing dots at regular intervals at a predetermined pitch on the skin surface, and a large number of penetrations are formed in a matrix at a predetermined pitch on the main surface of the plastic plate. The holes are provided at equal intervals. By placing the plate surface of this template on the skin surface to be marked, inserting a pen tip of an oily marker into each through-hole of the template and drawing a point on the skin surface, a group of points is set on the skin surface. It can be drawn relatively easily so as to form a matrix at a pitch.

JP-T-2007-523689

However, the present inventors examined in detail the actual work of the above pretreatment for injecting the botulinum toxic preparation into the perspiration site, and as a result, applied and dried iodine for iodine starch reaction, starch powder The task of evenly spraying the body takes time, and after that, even when using a template to create a grid or dot marking on the area discolored by perspiration, doctors and nurses in the medical field It turned out to be a cumbersome task for them.
It was also found that discoloration of the iodine starch reaction adhering to the skin and marking on the skin surface with an oily marker are difficult to remove even after washing and are not preferable for the patient.

  The above-mentioned problems are not only caused by the injection of botulinum toxic preparations, but also occur when various antiperspirants are dispersed and administered to the perspiration site on the skin surface.

  The object of the present invention is to solve the above-mentioned problems, and when performing treatment to suppress excessive sweating, it eliminates the labor of applying a reagent for identifying the sweating site and marking for subsequent drug administration. In other words, it is possible to easily identify a sweating site and easily administer a drug to the site at a predetermined interval.

  As a result of intensive studies to solve the above-mentioned problems, the present inventors laminated a liquid-absorbent sheet that can visually distinguish between a portion permeated with sweat and a portion not permeated with the adhesive on the film dressing. The present inventors have found that the above problems can be solved by forming through holes for positioning in the film dressing so that the injection needles can be punctured into the skin at predetermined equal intervals, and the present invention has been completed.

The present invention has the following features.
(1) having a film dressing body comprising a film body and a first pressure-sensitive adhesive layer provided on one main surface of the film body;
A part of the adhesive surface of the first pressure-sensitive adhesive layer is provided with a liquid-absorbent sheet that changes the light transmittance or light reflectivity by permeating sweat, and the permeation of the sweat can be visually recognized. The remaining area of the adhesive surface is an adhesive surface for adhering to the skin surface of a living body,
A plurality of through-holes penetrating the film dressing body and the liquid-absorbent sheet are formed, and when the film dressing body is attached to the skin surface of a living body together with the liquid-absorbent sheet, the skin is placed in the through-hole. The surface is exposed,
Film dressing with sweat perception and through holes.
(2) having a film dressing body comprising a film body and a first pressure-sensitive adhesive layer provided on one main surface of the film body;
The entire pressure-sensitive adhesive surface of the first pressure-sensitive adhesive layer is provided with a liquid-absorbent sheet that allows light permeation or light reflectance to change due to permeation of sweat, so that the permeation of perspiration can be visually recognized,
A part or all of the outer surface of the liquid-absorbent sheet is provided with a second adhesive material layer for adhering to the skin surface of the living body, and the second adhesive material layer adheres to the skin surface. In this state, it is a layer formed so that sweat secreted from the skin surface can reach the liquid-absorbent sheet,
A plurality of through-holes penetrating from the film dressing body to the second adhesive material layer are formed, and when the film dressing body is attached to the skin surface of a living body together with the liquid-absorbent sheet, The skin surface is exposed,
Film dressing with sweat perception and through holes.
(3) A part or all of the outer surface of the liquid-absorbent sheet is further provided with a second adhesive layer for adhering to the skin surface of the living body,
The second pressure-sensitive adhesive layer is a layer formed so that sweat secreted from the skin surface can reach the liquid-absorbent sheet in a state of being adhered to the skin surface,
A plurality of through-holes penetrating from the film dressing body to the second adhesive material layer are formed, and when the film dressing body is attached to the skin surface of a living body together with the liquid-absorbent sheet, The film dressing according to the above (1), wherein the skin surface is exposed.
(4) The film dressing according to (1) or (3), wherein the liquid-absorbent sheet is provided so as to cover a central region excluding the outer peripheral edge portion of the adhesive surface of the first adhesive layer.
(5) The film dressing according to any one of (1) to (4) above, wherein the liquid-absorbent sheet is a degreased paper or a porous sheet that can be used as a degreased paper.
(6) The film dressing according to the above (2) or (3), wherein the second pressure-sensitive adhesive layer is the pressure-sensitive adhesive layer of the following (A) or (B).
(A) An adhesive is provided on the outer surface of the liquid-absorbent sheet so as to draw a predetermined pattern, the outer surface is exposed between the patterns, and the exposed portion is secreted from the skin surface of the living body. A second pressure-sensitive adhesive layer that allows the sweat to reach the liquid-absorbent sheet.
(B) The 2nd adhesive layer which has a porous structure which can permeate | transmit sweat.
(7) The above (6), wherein the second pressure-sensitive adhesive layer having the porous structure (B) is a pressure-sensitive adhesive layer having a fibrous structure in which the pressure-sensitive adhesive is deposited by spray coating. ) Film dressing as described.
(8) The area of the main surface of the film body is 2000 to 10000 mm ² , and the number of through holes formed in the film dressing is 10 to 150, according to any one of (1) to (7) above. Film dressing.
(9) The film dressing according to any one of (1) to (8), wherein the opening shape of the through hole is a circle having a diameter of 4 to 20 mm.
(10) The film dressing according to any one of the above (1) to (9), wherein the through-hole is for passing an injection needle for intradermal injection of the botulinum toxin preparation.
(11) The above (1) to (1), further comprising a peelable backing sheet provided to cover the other main surface of the film body and a release sheet provided to cover at least the adhesive surface of the film dressing. (10) The film dressing in any one of.

The film dressing (hereinafter also referred to as “film dressing according to the present invention” or “the film dressing” according to the present invention) having a sweat perception function and a through hole according to the present invention is an adhesive surface of the film dressing main body A as shown in FIG. The liquid absorbent sheet 3 is laminated on 2a, and the sweat secreted from the skin surface can be soaked into the liquid absorbent sheet directly or through the second adhesive layer 4 described later. ing. In the film dressing, a large number of through holes H are provided at predetermined equal intervals (intervals suitable for administration of drugs), and when the skin is applied to the skin surface, the skin surface is in the through holes H. The needle can be punctured with an injection needle.
Here, the liquid-absorbent sheet 3 is a sheet made of a material capable of absorbing sweat and changing light transmittance and light reflectance by permeating the sweat. For example, when paper or cloth gets wet with a liquid such as water, the portion becomes translucent or dark due to a change in light transmittance or light reflectance. Similarly, the material of the liquid-absorbent sheet 3 has a difference in appearance (translucent) due to a change in light transmittance or light reflectance between the portion where the sweat is soaked and the portion where the sweat is not soaked. Or materials that show a difference in color).
With the above configuration, when the film dressing is applied to a treatment target site such as an axilla so that the liquid-absorbent sheet is on the skin surface side, a region where sweat permeates in the liquid-absorbent sheet is shown in FIG. As shown as the hatched region S, the region changes to translucent or the like, so that the perspiration site can be easily identified visually. Then, a hyperhidrosis therapeutic agent such as a botulinum toxin preparation can be injected intradermally through a through hole (a through hole marked with an X in FIG. 2B) existing in the region S of the identified sweat site. it can.
That is, the film dressing is a film dressing having a function of displaying a sweat site to a user and a function of determining a drug administration position (such as a puncture position of an injection needle) on the skin surface by a through-hole. Since the sweating site can be identified simply by applying the film dressing to the site to be treated, laborious pretreatment such as application / drying of an iodine solution and spraying of starch on it is basically unnecessary. In addition, since the film dressing has many through-holes at a predetermined interval, it is possible to administer drugs into the skin through injection or application from the through-hole while the sweating site is specified. Thus, there is no need to draw a mark line on the skin surface or draw a mark point using a template as in the prior art.
As described above, since the film dressing can be identified by simply attaching the film dressing to the site to be treated, and the drug can be administered to the sweat area at regular intervals in that state. Compared to the procedure of, it is extremely simple.

FIG. 1 is a cross-sectional view illustrating a laminated structure of a film dressing according to the present invention. Fig.1 (a) has shown the 1st aspect of this invention, and the liquid absorbing sheet is provided in the one part area | region of the adhesive surface of the 1st adhesive layer. FIG.1 (b) has shown the 2nd aspect of this invention, and the liquid absorbing sheet is provided in the whole adhesive surface of the 1st adhesive layer. In these drawings, the thickness of each layer is exaggerated and drawn in order to easily show the laminated structure. Further, only two through holes are drawn on one cross section. Further, in order to show the through holes in an easy-to-understand manner, boundary lines between layers that should be originally drawn in the through holes are omitted. FIG. 2 is a view for explaining the action of the film dressing according to the present invention, and is a view of the film dressing affixed to the skin surface as seen from the outside. FIG. 3 is a diagram illustrating an embodiment of the liquid-absorbent sheet in the first embodiment of the film dressing according to the present invention. It is the figure which looked at the outer surface (surface which faces the skin side at the time of sticking) of a liquid absorbing sheet. The pressure-sensitive adhesive surface of the first pressure-sensitive adhesive layer exposed in a large number of square through holes provided in the liquid-absorbent sheet is hatched. FIG. 4 is a cross-sectional view showing another embodiment of the second adhesive layer provided in the film dressing according to the present invention. FIG. 5 is a view of the pressure-sensitive adhesive surface of the second adhesive layer provided in the film dressing according to the present invention, and illustrates the formation pattern of the second adhesive layer. FIG. 6 is a diagram illustrating an arrangement pattern of through holes provided in the film dressing according to the present invention. FIG. 7 is a diagram illustrating the opening shape of the through hole provided in the film dressing according to the present invention. FIG. 8 is a view showing an example of the form of the product of the film dressing according to the present invention, and shows a state in which a release sheet and a backing sheet are provided. 8A is a view of the outer surface of the backing sheet, FIG. 8B is a cross-sectional view taken along the line XX of FIG. 8A, and FIG. 8C is a release sheet. FIG. Since the thickness of each layer is exaggerated in FIG. 8B, for example, both end portions of the liquid absorbent sheet 3 are large steps with respect to the adhesive surface of the first adhesive layer 2. Actually, however, the absorbent sheet 3 is sufficiently thin. Therefore, actually, the release sheet 5 is not extremely bent at the portion covering the step as shown in FIG. FIG. 9 is a diagram showing a state of marking on the skin surface when a botulinum toxic preparation is intradermally injected into the axilla at regular intervals.

Hereinafter, the configuration example of the present invention will be described in detail with reference to examples.
The film dressing according to the present invention includes a film main body 1 and a first pressure-sensitive adhesive layer 2 provided on one main surface 1a of the film main body as illustrated in FIGS. 1 (a) and 1 (b). The film dressing body A, the liquid-absorbent sheet 3 and the through-hole H are provided as essential components, and has a function of visually perspiring by the liquid-absorbent sheet and a function of positioning drug administration through the through-hole. It is a thing.
In the first aspect of the present invention, as shown in FIG. 1A, the liquid-absorbent sheet 3 is provided in a partial region of the pressure-sensitive adhesive surface 2 a of the first pressure-sensitive adhesive layer 2. The remaining area (exposed area) of the adhesive surface 2a is an adhesive surface for adhering to the skin surface of the living body. The liquid-absorbent sheet 3 is a sheet made of a material that can absorb sweat and changes its light transmittance or light reflectance when the sweat permeates. A plurality of through-holes H penetrating the film dressing body A and the liquid-absorbent sheet 3 are formed, and when the film dressing is applied to the skin surface of a living body, the skin surface is in the through-holes. It is supposed to be exposed.
Moreover, in the 2nd aspect of this invention, as shown in FIG.1 (b), the said liquid absorbing sheet 3 is provided in the whole adhesive surface 2a of the 1st adhesive layer 2. As shown in FIG. Therefore, in the second aspect, the second adhesive layer 4 is provided on a part or all of the outer surface 3a of the liquid absorbent sheet 3 so that the film dressing can be applied to the skin surface. A plurality of through holes penetrating from the film dressing main body A to the second adhesive material layer 4 are formed, and when the film dressing is applied to the skin surface of a living body, the skin surface is in the through holes. It is supposed to be exposed.

The difference between the first embodiment and the second embodiment is that in the first embodiment, the liquid-absorbent sheet 3 covers a part of the adhesive surface 2a of the film dressing body A (that is, the remaining portion of the adhesive surface 2a is In contrast, in the second aspect, the liquid-absorbent sheet 3 covers the entire adhesive surface 2a of the film dressing body A. Therefore, in the second embodiment, the second adhesive layer 4 is further provided so that the film dressing can be applied to the skin surface.
The second adhesive layer 4 is formed so that sweat secreted from the skin surface can reach the liquid-absorbent sheet. Therefore, the second adhesive layer 4 does not itself become an obstacle when permeating the liquid-absorbent sheet 3. (A specific configuration will be described later).
In the first embodiment, the second adhesive layer 4 is further provided on a part or the whole of the outer surface 3a of the liquid absorbent sheet 3 so that the liquid absorbent sheet does not float from the skin surface at the time of application. May be. In such a case, the structural difference between the first aspect and the second aspect is that the adhesive surface 2a of the film dressing main body is partially exposed or entirely covered by the liquid-absorbent sheet (adhesive surface). Whether or not 2a contributes to sticking).
In the following description, the configuration of the present invention will be described with reference to the first embodiment as a representative example. However, the description of each part excluding the liquid absorbent sheet itself is the same as in the second embodiment. In addition, about the structure (for example, material of a 1st adhesive layer etc.) employable only in a 2nd aspect, it mentions suitably.

(Film body)
The material of the film body 1 constituting the film dressing body A is preferably flexible so that it can adhere along the irregularities of the skin surface to be applied. For example, an acrylic polymer, polyethylene, polyester, Examples thereof include polymers such as polyvinyl chloride, polyvinylidene chloride, polyamide, polyvinyl alcohol, cellophane, ethylene-vinyl acetate copolymer, polypropylene, polyurethane, polyether polyester, polyamide, and derivatives thereof. Among these materials, polymers such as acrylic polymers, polyurethanes, polyether polyesters and polyamides, or derivatives thereof have transparency so that they can be applied while looking at the application location. This is particularly preferable because changes in light transmittance and light reflectance of the liquid-absorbent sheet can be sufficiently observed from the outside. Further, from the viewpoint of promoting sweating in a state where the film dressing is applied, the material of the film body preferably has a low moisture permeability.

  The thickness of the film body varies depending on the flexibility and mechanical strength of the material, but it is preferable that the thickness of the film body can be intimately adhered to the unevenness of the skin surface to be applied. 10 to 150 μm is preferable, and 15 to 75 μm is more preferable.

The outer peripheral shape of the film body (= the outer peripheral shape of the film dressing when the release sheet or backing sheet described later is removed) is not particularly limited, covers the skin surface to be treated, and further if necessary The shape which added the area | region used as an adhesion surface to the outer periphery is preferable. Specific preferred outer peripheral shapes include, for example, a square, a rectangle, an ellipse, an oval (a shape in which both sides (short sides) in the longitudinal direction of the rectangle are swelled outward). . In the case of a square or rectangle, the corner may be chamfered or rounded. Alternatively, a relatively large outer peripheral sheet may be provided to a medical site, and a medical worker such as a doctor may appropriately cut out according to the area of the skin surface to be treated.
As a specific size, for example, the region to be treated is an axilla, and the outer peripheral shape of the film body is rectangular (an example of the aspect ratio is (long side 1: short side 0.6) to (long) Side 1: about short side 0.8)), the length of the long side is preferably about 50 to 120 mm. In the case of other outer peripheral shapes, those having the same area as the rectangular area are preferable.

(First adhesive layer)
As the material of the first pressure-sensitive adhesive layer, a conventionally known medical-use film dressing pressure-sensitive adhesive layer material can be used, and various pressure-sensitive pressure-sensitive adhesives, for example, natural rubber-based, synthetic rubber-based, acrylic-based Silicone-based and vinyl ether-based pressure-sensitive adhesives are preferred.
In the present invention, it is necessary to discriminate from the outside through the film dressing body the change in light transmittance and light reflectance of the liquid-absorbent sheet due to perspiration. In addition, the material of the first pressure-sensitive adhesive layer should not penetrate into the liquid-absorbing sheet and impair the liquid-absorbing property of the liquid-absorbing sheet. Therefore, an acrylic pressure-sensitive adhesive is particularly preferable from the viewpoint of ensuring transparency, reducing irritation to the skin surface, and suppressing penetration into the liquid absorbent sheet.

The method for forming the first pressure-sensitive adhesive layer on one main surface of the film body may refer to a conventionally known production method, for example, a method of directly applying the pressure-sensitive adhesive composition to one main surface of the film main body. And a method of transferring a pressure-sensitive adhesive layer formed by coating on a support sheet which has been subjected to a peeling treatment in a separate step onto the film body.
The thickness of the first pressure-sensitive adhesive layer is not particularly limited. In the first aspect, when the purpose is also to adhere to the skin surface, the thickness is preferably about 10 to 60 μm, more preferably about 20 to 50 μm. Is the thickness.
On the other hand, in the case of the second aspect, the first pressure-sensitive adhesive layer is an adhesive layer only for laminating the liquid-absorbent sheet on the film body, and does not contact the skin surface. Therefore, in the second aspect, the first pressure-sensitive adhesive layer may be an adhesive that does not affect the liquid-absorbing property of the liquid-absorbent sheet, in addition to the material of the pressure-sensitive adhesive layer described above. Examples of such an adhesive include natural rubber, synthetic rubber, acrylic resin, ethylene / vinyl acetate, polyurethane, silicone, vinyl ether, and epoxy.
In the second aspect, the thickness of the first pressure-sensitive adhesive layer is preferably about 1 to 200 μm, and more preferably about 5 to 100 μm.

(Liquid absorbent sheet)
The liquid-absorbent sheet may be a sheet that can be permeated with sweat and whose light transmittance and light reflectance are changed by permeation of the sweat. Typical examples of such a material include paper (including synthetic paper), cloth, and non-woven fabric, but porous materials such as polyethylene, polypropylene, polyester, fluorine resin, polyurethane, and silicone resin. It may be a sheet made of a sex material.
Among the above materials, paper such as western paper, Japanese paper, and synthetic paper is preferable from the viewpoint of being thin and excellent in flexibility. In particular, a degreased paper that is used as a cosmetic miscellaneous paper or a porous sheet that can be used as a substitute for the degreased paper is thin and excellent in flexibility and absorbs sweat smoothly. Since the light transmittance increases and becomes translucent when it penetrates, it is exemplified as a preferable material that can determine the sweat site.

  The degreased paper is, for example, a paper using pulp or the like as a raw material, Japanese paper using a raw material such as koji, mitsumata, or a synthetic paper using a synthetic resin as a main material. Good. In addition, porous sheets such as polyethylene, polypropylene, polyester, fluorine-based resin, polyurethane, and silicone-based resin can be used as substitutes for degreasing paper. In any case, it is preferable to absorb the sweat more smoothly, and the light transmittance and the light reflectance change more greatly when the sweat permeates.

Among the materials used as degreased paper, the property (visibility) for visually confirming the fact that sebum has been absorbed is improved, and even if a small amount of sebum secreted on the skin surface is more transparent (For example, JP-A 2007-190146 “grease paper”, JP-A 2008-183384 “grease paper”, JP-A 2002-17445 “cosmetic degreasing sheet”, JP-A-11-239517 “Degreasing sheet for cosmetics”).
The secretions to be absorbed by these oil-absorbing papers are sebum, but according to the study by the present inventors, they show favorable visibility even for sweat and can be used as the liquid-absorbent sheet in the present invention. It is.

  The thickness of the liquid-absorbent sheet is not particularly limited. However, the thickness of the liquid-absorbent sheet is moderately conformed to the unevenness of the skin surface (soft), and even on a small amount of liquid such as sweat, From the point that it can reach (light transmittance and light reflectance change), 20 to 200 μm is preferable, and 50 to 150 μm is more preferable. If the absorbent sheet is too thin, it is almost transparent in the first place, making it difficult to distinguish between changes in light transmittance and reflectance.If the absorbent sheet is too thick, it becomes difficult to follow the irregularities on the skin surface. Since sweat hardly reaches the main surface on the film dressing side, and changes in light transmittance and light reflectivity hardly appear on the main surface on the film dressing side, it is difficult to determine the sweating site.

  If the liquid-absorbent sheet is white, the light transmittance increases due to permeation of sweat, and the color of the skin surface is seen through well, and the light reflectance decreases and changes to a dark color (gray). Therefore, it is preferable because it is easy to determine a sweating site. Moreover, even if it is light colored such as light blue, pink, yellow, etc., the permeation site is easily discriminated because the light reflectance decreases and the color changes to dark when sweat permeates.

  In the first aspect of the present invention, the liquid-absorbent sheet is provided as a layer that covers a “part” region of the pressure-sensitive adhesive surface of the first pressure-sensitive adhesive layer. Since the original purpose of the liquid-absorbent sheet is to detect and indicate a sweat site, it is preferable to cover the adhesive surface in a wider range. Therefore, as shown to Fig.1 (a), the aspect which provides the liquid absorptive sheet | seat 3 so that all the center area | regions except the outer periphery part of the adhesive surface 2a of the 1st adhesive layer 2 may be covered is preferable. In this case, the band width of the band-shaped region exposed as the adhesive surface on the outer peripheral edge may be about 5 to 20 mm.

While it is preferable that the liquid-absorbing sheet has a wider range, in order to use the adhesive surface 2a as an adhesive surface to the skin surface, the adhesive surface 2a is preferably exposed as widely as possible. As a configuration example satisfying these conflicting requirements, as shown in FIG. 3, the liquid-absorbent sheet 3 is provided with a large number of through-holes (in the example shown, the opening shape is a hatched square) 3h. An embodiment in which the liquid sheet 3 is a net (in the example shown in the figure, a lattice net) is exemplified.
Such an embodiment is also an embodiment in which a liquid-absorbing sheet is provided in a “part” region of the adhesive surface 2a of the first adhesive layer. This makes it possible to expose the adhesive surface 2a in a wide range by the through-holes 3h of the liquid absorbent sheet 3 while providing the liquid absorbent sheet 3 in a wide range to indicate a sweating site.

As shown in FIG. 3, when the through-hole 3h is provided in the liquid-absorbent sheet 3, the opening shape, the opening area, and the degree of dispersion of the through-hole 3h are determined by the adhesiveness to the skin surface by the exposed adhesive surface and the absorption. What is necessary is just to determine suitably considering the balance with the visibility with respect to the perspiration site | part of a liquid sheet.
In the example of FIG. 3, the position of the through hole 3 h of the liquid absorbent sheet 3 and the position of the through hole H provided in the entire film dressing are not associated with each other. Such a configuration is easy to manufacture. On the other hand, one through-hole 3h of the liquid-absorbent sheet 3 is arranged at the same position from the adjacent through-hole H to expose the adhesive surface, and the through-hole of the liquid-absorbent sheet 3 is concentrically surrounding the through-hole H. The position of the through hole 3h of the liquid absorbent sheet 3 and the position of the through hole H of the film dressing may be associated with each other, such as by providing 3h.

  The method for attaching the liquid-absorbent sheet to the pressure-sensitive adhesive surface of the first pressure-sensitive adhesive layer is not particularly limited, and a conventionally known lamination method may be used. For example, a dry lamination method using a roll, a heating lamination method, Examples include a wet lamination method. In addition, you may affix the liquid absorbing sheet cut | judged to the size of a product specification one by one on the adhesive surface of a 1st adhesive layer.

(Second adhesive layer)
In the second aspect of the present invention, since the liquid-absorbent sheet covers the entire adhesive surface of the first adhesive layer, the second adhesive material layer is essential for adhesion to the skin surface. . On the other hand, also in the first aspect of the present invention, when the liquid absorbent sheet covers the adhesive surface of the first pressure-sensitive adhesive layer widely, the liquid absorbent sheet may float from the skin surface. Therefore, also in the first aspect of the present invention, as shown in FIG. 4A, a second adhesive layer 4 may be provided on the outer surface 3a of the liquid absorbent sheet 3 as necessary.
Since the second adhesive layer is a layer covering the outer surface of the liquid-absorbent sheet, sweat secreted from the skin surface immediately below the liquid-absorbent sheet can reach the liquid-absorbent sheet, that is, sweating It should be configured so as not to interfere with site detection.
As such a 2nd adhesive layer, the aspect of following (A) or (B) is mentioned as a preferable thing.
(A) As shown in FIGS. 4A and 4B, the second adhesive 4 is partially provided on the outer surface 3a of the liquid-absorbent sheet 3 so as to draw a predetermined pattern. A mode in which the outer surface 3a of the sheet 3 is exposed during the formation pattern of the second pressure-sensitive adhesive 4, and sweat from the skin surface can reach the liquid-absorbent sheet 3 in the exposed portion. .
(B) A mode in which the second pressure-sensitive adhesive layer itself is a layer formed of a porous tissue that can permeate sweat.

If the second pressure-sensitive adhesive layer is the above-described embodiment (A), the second pressure-sensitive adhesive layer 4 is provided over a wide area on the outer surface 3a of the liquid-absorbent sheet 3, so that it preferably adheres to the skin surface and absorbs water. Since the outer surface 3a of the liquid sheet 3 is exposed over a wide range, detection of a sweating site is not hindered.
The formation pattern when the second pressure-sensitive adhesive layer 4 is partially provided on the outer surface 3a of the liquid-absorbent sheet 3 so as to draw a predetermined pattern is not particularly limited. For example, as shown in FIG. Such a wavy meandering stripe pattern (a striped pattern in which wavy meandering strip-like coated portions and wavy meandering strip-like non-coated portions are alternately arranged) and FIG. ), Linear stripe pattern meandering in a triangular wave pattern, a pattern in which the area where the adhesive is provided is a net-like pattern, the adhesive is formed in dots and dispersed like a polka dot pattern Pattern (pattern in which the area without the adhesive is mesh-like).

The method for forming the pressure-sensitive adhesive so as to draw a specific pattern as shown in FIG. 5 is not particularly limited, but as a preferable method, for example, “comb” described in JP-A-10-328231 “pressure-sensitive adhesive sheet” can be used. "Scratching method".
The rough processing procedure of the combing method is as follows: (1) An adhesive paint is applied to the upper surface of a temporary base sheet that continuously runs at a predetermined line speed; (2) The applied pressure-sensitive adhesive paint layer is scraped and removed in a wavy stripe shape with a comb having a number of scratches reciprocating at a predetermined speed in a direction perpendicular to the traveling direction (ie, adhesive (3) Finally, the wavy pressure-sensitive adhesive paint layer remaining on the temporary base sheet is dried and the surface on which it is formed (the outer surface of the liquid-absorbent sheet) It is to transfer to.
If the movement of the comb is stopped or the moving direction is rapidly reversed in this method, the adhesive layer becomes a linear stripe pattern or various wavy stripe patterns.

If the second pressure-sensitive adhesive layer is in the form of (B) above, the second pressure-sensitive adhesive layer 4 itself is a layer composed of a tissue that can pass sweat in the first place, as shown in FIG. Even though the second pressure-sensitive adhesive layer 4 is entirely provided on the outer surface 3a of the liquid-absorbent sheet 3, detection of sweating sites is not hindered.
As a 2nd adhesive layer which has a porous structure like the said (B) aspect, for example, the adhesive layer which consists of a nonwoven fabric-like structure | tissue formed by making an adhesive into a fiber form by spray coating, for example The aspect of this is mentioned. Examples of the pressure-sensitive adhesive layer having such a nonwoven fabric structure and a method for producing the pressure-sensitive adhesive layer include, for example, Japanese Patent Laid-Open No. 6-108018 “Manufacturing Method of Breathable Adhesive Layer, Adhesive Sheet and Breathable Material”, Japanese Patent Laid-Open No. 7-1094943 Reference can be made to the materials and production methods described in “Adhesive Adhesive Sheets” and the like (adhesive fiberization by melt blow).
The pressure-sensitive adhesive sheets described in these patent publications are characterized by having adhesiveness and air permeability, but also have sufficient properties to allow permeation of sweat, and the second pressure-sensitive adhesive layer in the present invention. Can be preferably used.

  The “(A) or (B) pressure-sensitive adhesive layer” as used in the present invention includes a pressure-sensitive adhesive layer in which the above aspects (A) and (B) are simultaneously performed. Such an adhesive layer (an embodiment in which an adhesive layer having a porous structure capable of permeating sweat is formed as a layer that draws a predetermined pattern) is the adhesive layer of (A) above, and Since it is an adhesive layer of (B), it is preferable.

(Through hole)
When the film dressing is affixed to the skin surface, the through-hole exposes the skin surface at the required drug administration interval, and has an opening of a size preferable for puncture of the injection needle and transdermal administration. What is necessary is just to have. In particular, as described in the description of the background art, conventionally, in order to inject a botulinum toxin preparation intradermally, a time-consuming pretreatment is necessary for the skin surface. Therefore, the through-hole provided in the present invention is preferably provided so as to be suitable for puncture of an injection needle for intradermal injection of a botulinum toxin preparation.
In the first aspect of the present invention, as shown in FIG. 1 (a), the through hole H penetrates the film dressing body A and the liquid absorbent sheet 3. For example, in FIG. 1A, the through hole H of the film body 1 and the through hole H of the liquid-absorbent sheet are separately formed in the through hole H. Even though the opening of the liquid absorbent sheet 3 is larger than the opening of the through hole H, the through hole H penetrates the film dressing body and the liquid absorbent sheet. Can be considered to be.
The size and arrangement pattern of the openings important for the user for positioning and drug administration are the main surface 1b on the outer side of the film body 1 in FIGS. 1 (a) and 1 (b) (hereinafter referred to as “the back surface of the film body”). It is preferable that the lower layer such as the liquid absorbent sheet 3 does not protrude into the through hole H.
The same applies to the case of the second aspect of the present invention, and the through-hole H penetrates from the film dressing body A to the second pressure-sensitive adhesive layer 4, but in FIGS. 1 (b) and 4 (b). As shown, the second pressure-sensitive adhesive layer 4 is formed so as to avoid the through-hole H (the opening of the through-hole H of the second pressure-sensitive adhesive layer rather than the opening of the through-hole H of the film body 1). Even if the structure is larger, the through hole H can be regarded as penetrating from the film dressing body A to the second pressure-sensitive adhesive layer 4.
Further, in the first aspect of the present invention, as shown in FIG. 4A, when the second pressure-sensitive adhesive layer 4 is further provided, the through-hole H is formed as a film dressing as in the second aspect. It can be regarded as penetrating from the main body A to the second pressure-sensitive adhesive layer 4.

The arrangement pattern and the arrangement interval of the through-holes H depend on the administration interval of a drug necessary for medical treatment, for example, the puncture interval appropriate for intradermal injection of a botulinum toxin preparation for the treatment of hyperhidrosis. Just decide.
As a preferable arrangement pattern of the through holes H, as shown in FIG. 6A, the through holes H are formed at intersections (each vertex of the equilateral triangle) of an equilateral triangle network (a mesh pattern having the equilateral triangle as a minimum structural unit of the mesh). And a pattern in which the through holes H are arranged at the intersections (each vertex of the square) of a square lattice (a mesh pattern having a square as the smallest structural unit of the mesh) as shown in FIG. 6B. .
Among these, the pattern in which the through holes H are arranged at the intersections of the equilateral triangle network as shown in FIG. 6A is between one through hole and through holes located adjacent to each other in the six directions around the through hole. Since the center-to-center distance P1 and the center-to-center distance P1 between the surrounding through-holes are also equal, this is a more preferable pattern in that the drug is administered at even intervals.

  6A and 6B, in the pattern in which the through holes H are arranged at the intersections of the equilateral triangle network and the square lattice, the distance between the centers between the through holes (the length of one side of the equilateral triangle or the square). A) P1 is preferably 4 to 20 mm, more preferably 8 to 16 mm.

The opening shape of the through hole H is not particularly limited. For example, a circular shape as shown in FIGS. 6A and 6B, an elliptical shape as shown in FIG. 7A, and a circular shape as shown in FIG. Such oval shapes, squares, rectangles, rhombuses, and the like.
The size of the opening of the through hole varies depending on the type of drug and the administration method, but when the opening shape is circular, for example, in order to inject a botulinum toxin preparation intradermally for the treatment of hyperhidrosis, the diameter About 2-20 mm is preferable and about 4-10 mm in diameter is more preferable.
In the case of intracutaneous injection, when puncturing with the needle sufficiently laid on the skin surface, not only the state of the puncture point but also the state of the injection needle that has entered the skin is observed through swelling of the skin surface, etc. Some size may be required with respect to the puncture direction. In such a case, if the oval shape, the oval shape, or the elongate rectangle shape as shown in FIGS. 7A and 7B is used, more skin surfaces are provided in the puncture direction without increasing the opening area of the through hole. Can be exposed, which is preferable. The dimension in the longitudinal direction of such an ellipse, oval, and elongated rectangle is preferably about 4 to 20 mm, and the dimension in the width direction (short axis direction, short side direction) is shorter than the dimension in the longitudinal direction. The circular diameter may be selected as appropriate.

The number of through-holes H differs depending on the site to which the film dressing is to be applied, the type and manner of administration of the drug, the arrangement pattern of the above-described through-holes, and the outer shape of the film body. In the case of 10000 mm ² , the number of through holes formed in the film dressing is preferably about 10 to 150. More specifically, as an auxiliary tool when the botulinum toxin preparation is intradermally injected into the axilla for the treatment of hyperhidrosis, when the area of the back surface of the film body is 4000 to 7000 mm ² , the number of through holes is About 30-100 is preferable.

  The method for forming the through hole is not particularly limited, and examples thereof include a method of punching with a punch blade (spring spring, Thomson blade), a forming method using a die cut roll, and a forming method by laser processing.

(Peeling sheet)
The film dressing is provided with a release sheet (also referred to as a release liner) that covers at least the pressure-sensitive adhesive surface and can be peeled off at the time of use, in the same manner as conventionally known film dressings and adhesive tapes.
In the first aspect of the present invention, the release sheet covers the pressure-sensitive adhesive surface 2a of the first pressure-sensitive adhesive layer 2 and the outer surface 3a of the liquid-absorbent sheet 3 shown in FIG. Further, in the first embodiment, as shown in FIG. 4A, when the second pressure-sensitive adhesive layer 4 is further provided partially, the release sheet is the pressure-sensitive adhesive of the first pressure-sensitive adhesive layer 2. The surface, the outer surface of the liquid-absorbent sheet 3, and the adhesive surface of the second adhesive layer 4 are covered. Although not shown in the drawing, in the first embodiment, when the second pressure-sensitive adhesive layer is provided on the entire outer surface of the liquid-absorbent sheet, the release sheet is bonded to the first pressure-sensitive adhesive layer. Cover the surface and the adhesive surface of the second adhesive layer.
In the second aspect of the present invention, the release sheet covers the adhesive surface 4a of the second adhesive layer 4 and the outer surface 3a of the liquid-absorbent sheet 3 shown in FIG. In the second embodiment, when the second pressure-sensitive adhesive layer 4 is provided on the entire outer surface of the liquid-absorbent sheet 3 as shown in FIG. The adhesive surface of the adhesive layer 4 is covered.

Examples of the sheet-like material used as the sheet body of the release sheet include plastic films (for example, polyethylene, polypropylene, polyethylene terephthalate, and laminated composites thereof), paper (for example, fine paper, craft paper, glassine paper, etc.), Or these laminated films etc. are mentioned, Paper (for example, quality paper, kraft paper, etc.) is mentioned as a preferable sheet-like material.
A release sheet can be obtained by subjecting the surface of these sheet materials to a release treatment such as a silicone resin treatment or a fluororesin treatment.
The thickness of the release sheet is not particularly limited, but is preferably 10 to 250 μm, more preferably 25 to 200 μm, and particularly preferably 50 to 100 μm.

(Lining sheet)
The film dressing is provided with a backing sheet that covers the back surface of the film main body in a peelable manner, similarly to a conventionally known film dressing. Before using the film dressing, the backing sheet prevents the back of the film body from being scratched or broken, and is too thin and flexible to lack self-supporting properties (so-called waistline) No) Even if it is a film body, it is a layer that allows the film dressing to be applied to the skin surface so as not to cause wrinkles, etc., and is peeled off after being applied to the skin surface It is.

Examples of the sheet-like material used as the sheet body of the backing sheet include sheet-like materials such as plastic films (for example, polyethylene, polypropylene, polyester, or laminated composites thereof), paper (for example, high-quality paper, kraft paper, etc.). Preferably, a biaxially stretched polypropylene film or a polyester film that hardly causes expansion and contraction is used. By applying a resin treatment such as polyester or polyolefin to the surface of these sheet-like materials, it is possible to obtain a backing sheet that can be peeled even if it is brought into close contact with the back surface of the film body.
The thickness of the backing sheet is not particularly limited, but is preferably 15 to 200 μm, and more preferably about 20 to 100 μm.

As a method for applying the backing sheet to the film dressing, it may be formed by a known laminating method such as extrusion molding or thermocompression bonding on one side of the peelable backing sheet. After preparing the film body with the backing sheet laminated on the back surface in this way, the first pressure-sensitive adhesive layer is applied and formed on the opposite surface of the film body, and the liquid-absorbent sheet and the release sheet are sequentially bonded together. The procedure is mentioned.
Further, when forming the second pressure-sensitive adhesive layer, the second pressure-sensitive adhesive layer is coated on the release sheet by a known method, and the second pressure-sensitive adhesive layer is absorbed together with the release sheet. The procedure of pasting to the adhesive sheet is mentioned.

  After obtaining the film dressing having the backing sheet obtained as described above, in the present invention, the liquid-absorbent sheet is laminated so as to cover a part of the pressure-sensitive adhesive layer surface, and further, the penetration from the film to the liquid-absorbent sheet The film dressing according to the present invention can be obtained by forming a plurality of holes.

FIG. 8 is a view showing an example in which a release sheet and a backing sheet having preferable handling properties are added to the first embodiment of the present invention shown in FIG.
In the example of the figure, the release sheet is divided into two parts 51 and 52 at the center so that the user can easily peel off the release sheet 5. And in the parting part, the sheet | seat of both parts 51 and 52 is extended | stretched, and it has become the handle parts 51a and 52a. Since the actual release sheet is sufficiently thin, the handle portion 52a is sharply folded, and the handle portion 51a rides on the top without overlapping.
In addition, a sheet-like handle portion 6a is joined to the backing sheet 6 covering the entire back surface of the film body so that the film dressing is applied to the skin surface and then the backing sheet is easily peeled off. In the embodiment shown in the figure, through-holes H are also provided in the backing sheet 6 because of the procedure for through-hole processing.
With the configuration of FIG. 8, the release sheet is quickly peeled off, the film dressing is affixed to the target site with favorable handleability, the backing sheet is quickly peeled off to conform to the unevenness of the skin surface, and sweating is caused by changes in the liquid absorbent sheet It is possible to easily identify the site and perform intradermal injection of the botulinum toxic preparation at regular intervals through the through-hole in this state.

  As described above, the film dressing can be identified as a sweat site and positioned for drug administration simply by being attached to a treatment target site. Therefore, there is no need to specify the sweating site in the conventional treatment, and the positioning marking to administer the drug at regular intervals to the specified sweating site (especially intradermal injection), thereby suppressing sweating. It becomes a preferable auxiliary tool when performing.

DESCRIPTION OF SYMBOLS 1 Film main body 1a One main surface of a film main body 1b The other main surface (back surface) of a film main body
2 First adhesive layer 2a Adhesive surface of the first adhesive layer 3 Liquid absorbent sheet 3a External surface of the liquid absorbent sheet 4 Second adhesive layer A Film dressing body H Through-hole

Claims (11)

A film body having a film body and a first pressure-sensitive adhesive layer provided on one main surface of the film body;
A part of the adhesive surface of the first pressure-sensitive adhesive layer is provided with a liquid-absorbent sheet that changes the light transmittance or light reflectivity by permeating sweat, and the permeation of the sweat can be visually recognized. The remaining area of the adhesive surface is an adhesive surface for adhering to the skin surface of a living body,
A plurality of through-holes penetrating the film dressing body and the liquid-absorbent sheet are formed, and when the film dressing body is attached to the skin surface of a living body together with the liquid-absorbent sheet, the skin is placed in the through-hole. The surface is exposed,
Film dressing with sweat perception and through holes. A film body having a film body and a first pressure-sensitive adhesive layer provided on one main surface of the film body;
The entire pressure-sensitive adhesive surface of the first pressure-sensitive adhesive layer is provided with a liquid-absorbent sheet that allows light permeation or light reflectance to change due to permeation of sweat, so that the permeation of perspiration can be visually recognized,
A part or all of the outer surface of the liquid-absorbent sheet is provided with a second adhesive material layer for adhering to the skin surface of the living body, and the second adhesive material layer adheres to the skin surface. In this state, it is a layer formed so that sweat secreted from the skin surface can reach the liquid-absorbent sheet,
A plurality of through-holes penetrating from the film dressing body to the second adhesive material layer are formed, and when the film dressing body is attached to the skin surface of a living body together with the liquid-absorbent sheet, The skin surface is exposed,
Film dressing with sweat perception and through holes. A part or all of the outer surface of the liquid-absorbent sheet is further provided with a second adhesive material layer for adhering to the skin surface of the living body,
The second pressure-sensitive adhesive layer is a layer formed so that sweat secreted from the skin surface can reach the liquid-absorbent sheet in a state of being adhered to the skin surface,
A plurality of through-holes penetrating from the film dressing body to the second adhesive material layer are formed, and when the film dressing body is attached to the skin surface of a living body together with the liquid-absorbent sheet, The film dressing according to claim 1, wherein the skin surface is exposed.   The film dressing of Claim 1 or 3 with which the liquid absorbing sheet is provided covering the center area | region except the outer periphery part of the adhesion surface of a 1st adhesive layer.   The film dressing according to any one of claims 1 to 4, wherein the liquid-absorbent sheet is a degreased paper or a porous sheet that can be used as a degreased paper. The film dressing of Claim 2 or 3 whose 2nd adhesive layer is an adhesive layer of the following (A) or (B).
(A) An adhesive is provided on the outer surface of the liquid-absorbent sheet so as to draw a predetermined pattern, the outer surface is exposed between the patterns, and the exposed portion is secreted from the skin surface of the living body. A second pressure-sensitive adhesive layer that allows the sweat to reach the liquid-absorbent sheet.
(B) The 2nd adhesive layer which has a porous structure which can permeate | transmit sweat.   The film according to claim 6, wherein the second pressure-sensitive adhesive layer having the porous structure (B) is a pressure-sensitive adhesive layer having a fibrous structure in which the pressure-sensitive adhesive is deposited in a fibrous form by spray coating. dressing. The area of the main surface of the film body a 2000～10000Mm ^2, the number of through-holes formed in the film dressing is 10 to 150, a film dressing according to any one of claims 1-7.   The film dressing according to any one of claims 1 to 8, wherein an opening shape of the through hole is a circle having a diameter of 4 to 20 mm.   The film dressing according to any one of claims 1 to 9, wherein the through-hole is for passing an injection needle for intradermal injection of the botulinum toxin preparation.   Furthermore, it has a peelable backing sheet provided to cover the other main surface of the film body, and a release sheet provided to cover at least the adhesive surface of the film dressing. The film dressing according to item 1.

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