HK40033260A - Medical adhesive material using elastic pad - Google Patents

Description

Medical adhesive material using stretchable pad

Technical Field

The present invention relates to an adhesive material suitable for a skin wound site, and more particularly to a medical adhesive material having both good adhesion and low skin irritation at a bent site such as an elbow or a knee.

Background

A medical adhesive material, particularly an emergency adhesive bandage, is required to be capable of protecting a wound site from the outside, and to have flexibility, followability, stretchability, and the like capable of following a curved surface of the skin and joint movement.

The first aid band-aid is generally composed of an adhesive tape and a pad, and most of the pads have a structure combined by a nonwoven fabric capable of absorbing exudate from the wound part and a net for preventing the nonwoven fabric from being fixed to the wound part.

In conventional products, the net for preventing the sticking is generally made of a polyethylene material, but a mat formed by combining a nonwoven fabric and a polyethylene net has almost no stretchability. Therefore, when the first aid adhesive bandage using such a pad is applied to a wound site, if the pad is once stretched due to joint movement or the like, the pad will have a stretched shape without returning to its original size, causing the pad to lift from the site of application, even the adhesive bandage to peel off, or the like. Further, since the pad positioned at the center of the first aid band-aid does not have stretchability, the irritation to the skin around the tape increases.

As a proposal that the stretchability of the pad has been studied so far, for example, patent document 1 proposes a stretchable adhesive bandage made of a nonwoven fabric composed of a stretchable base fabric and highly crimped cotton and a stretchable covering (knitted fabric).

Patent document 2 proposes a first aid adhesive bandage in which the pad portion can follow the shape of the human body, and the modulus of elongation and the elongation recovery rate of both the support body film and the pad are studied.

Patent document 3 proposes, as a pad for a wound surface having adhesiveness and stretchability and being less likely to adhere to a wound surface of the skin, a pad for a wound surface having a liquid absorbent layer having stretchability and a resin layer having openings, and having a strength at elongation of 50% limited in one direction.

Documents of the prior art

Patent document

Patent document 1: japanese laid-open patent publication No. 9-154871

Patent document 2: japanese patent laid-open publication No. 2007-117513

Patent document 3: japanese patent laid-open No. 2012 and 081045

Summary of The Invention

Problems to be solved by the invention

When the first aid adhesive bandage is attached to a curved portion of the body and the joints are flexed and extended, the first aid adhesive bandage may have a small size, so that the first aid adhesive bandage may have a small uncomfortable feeling at the attached portion and may have a small influence on the flexibility of the pad. However, when the size of the first aid adhesive bandage is large, if the pad has low stretchability, discomfort at the site of attachment, leakage of blood and exudates due to the pad lifting, increase in skin irritation, and the like may occur, and even peeling of the adhesive bandage may occur.

However, in the proposals of the wound dressings and the like in which the pad stretchability has been studied so far, there is no report on the adhesiveness and skin irritation at the time of application to a region having a large bending and stretching motion (such as an elbow, a knee, and the like), nor on the detailed study of the size of the support body or pad and the shape of the wound dressing in the first-aid wound dressing capable of covering this portion.

In view of the above problems, an object of the present invention is to provide a medical adhesive material which has stretchability enabling follow-up movement even in a large application area, has good adhesiveness, and causes little irritation to the skin, in a curved portion where a joint is repeatedly flexed and extended.

Means for solving the problems

In order to solve the above problems, the present inventors have conducted intensive studies and found that, in a medical adhesive material having a large adhesive area, the value of the elongation recovery rate after repeated stretching of the adhesive material is one of factors for achieving good adhesiveness and low skin irritation.

In addition, in such a pasting material, the shape of the tape, the area of the tape and the pad, and the arrangement are important.

Namely, the present invention provides the following embodiment (1).

(1) The present invention relates to a medical adhesive material including a support, an adhesive layer covering a surface of the support, and a pad disposed on the adhesive layer, characterized in that:

the support has an area of 4,700～13,000mm²，

The pad has an area of 1,500 to 4,500mm²，

In the overlapping portions of the support, the adhesive layer and the pad,

the continuous elongation recovery rate A (forward path) when the sheet is stretched 20 times under a load of 15N is 90% or more, the continuous elongation recovery rate B (return path) is 70% or more, and the ratio B/A of these elongation recovery rates is 0.5 or more.

According to the present invention, the following embodiments (2) to (9) are further provided.

(2) The medical adhesive material is characterized in that the pad has a laminated structure of a polyester nonwoven fabric layer and an extensible mesh layer.

(3) The medical adhesive material is characterized in that the gram weight of the polyester non-woven fabric layer in the pad is 50-150 g/m²。

(4) The medical adhesive material is characterized in that the support body is a polyurethane film or a polyurethane non-woven fabric.

(5) The medical adhesive material is characterized in that the area ratio of the support body to the pad is 3: 1-2: 1.

(6) The medical adhesive material is characterized in that the area ratio of the support body to the pad is 3: 1-2.5: 1.

(7) The medical adhesive material has a 30% tensile load (MD) of 5 to 50N/25mm and a 30% tensile load (CD) of 3 to 50N/25mm in an overlapping portion of the support, the adhesive layer, and the pad.

(8) The medical adhesive material is characterized in that the support body has a substantially square or substantially quadrangular shape, and has recesses at four corners of the substantially square or substantially quadrangular shape, and the shortest distance between the recesses and the pad is 10-25 mm.

(9) The medical adhesive material is an adhesive material for joints.

Effects of the invention

The medical adhesive material of the present invention satisfies a predetermined value of elongation recovery after repeated stretching, and thus provides an adhesive material which has good adhesion even when a large-area adhesive material is applied to a repeatedly flexed and stretched part and which is less irritating to the skin.

In the case of a patch (band-aid) using a pad having no or insufficient stretchability, which has been conventionally found in commercially available products, the difference in stretchability between the pad and the tape, which is not problematic in a patch having a small area, gradually affects the shape of the patch (and the pad). The stress applied to the periphery (edge portion) of the adhesive tape increases as the distance from the center of the adhesive material increases, and here, if the stretchability of the pad and the adhesive tape differs, the difference in stretchability increases as the distance from the center increases, the stress generated increases, and the risk of skin irritation increases.

In contrast, the medical adhesive material of the present invention has the above-described stretchability, that is, the stretchability of not only the tape portion composed of the support and the adhesive layer but also the pad portion, and therefore, the above-described stress can be alleviated. Therefore, it is possible to provide an adhesive material that can reduce the risk of skin irritation even when applied to a large area.

Further, since the medical adhesive material of the present invention has a structure with a high continuous elongation recovery rate, the medical adhesive material of the present invention has a low deformation rate of the tape or pad even when subjected to a plurality of bending and stretching operations, and the medical adhesive material of the present invention can easily maintain its original shape. Therefore, the medical adhesive material of the present invention is less likely to cause warpage or looseness due to deformation, can be expected to improve comfort during adhesion, and can easily maintain a high adhesion rate even with a low adhesion force.

As described above, in the adhesive material to be attached to a curved portion such as an elbow or a knee, when the shape thereof is enlarged, the stress applied to the periphery (edge portion) increases as the distance from the center portion of the adhesive material increases, and skin irritation or peeling is likely to occur due to the movement of the elbow or the knee.

In the medical adhesive material of the present invention, particularly in the substantially square or substantially square adhesive material, the recessed portions are provided at the four corners, and the shortest distance between the recessed portions and the pad provided on the tape (adhesive layer) is set to a predetermined value, whereby the stress applied to the periphery (edge portion) is further alleviated.

Drawings

Fig. 1 is a view (sectional view) showing one embodiment of the medical adhesive material of the present invention.

Fig. 2 is a view (sectional view) showing another embodiment of the medical adhesive material of the present invention.

Fig. 3 is a view (front view) showing an embodiment of the medical adhesive material of the present invention.

Fig. 4 is a view (front view) showing another embodiment of the medical adhesive material of the present invention.

Fig. 5 is a view (front view) showing another embodiment of the medical adhesive material of the present invention.

Fig. 6 is a view (front view) showing another embodiment of the medical adhesive material of the present invention.

Fig. 7 is a view (front view) showing another embodiment of the medical adhesive material of the present invention.

Detailed Description

[ medical adhesive Material ]

The medical adhesive material of the present invention has an adhesive layer covering the surface of the support and a pad disposed on the adhesive layer, and has a form of a so-called band-aid.

The medical adhesive material of the present invention is characterized in that the size of the adhesive material itself has a larger area than that of a conventional product (band-aid), that is, the area of the support is 4,700 to 13,000mm²In addition, the area of the pad is 1,500-4,500 mm²。

In the medical patch according to the present invention, the support, the adhesive layer, and the pad are laminated on each other, and the medical patch has a high elongation recovery rate, which will be described later.

< recovery from elongation >

The elongation recovery specified in the present invention means a continuous elongation recovery a (forward path) and a continuous elongation recovery B (return path) when a subject is stretched 20 times with a load of 15N, which are measured by the procedure based on JIS L1096 fabric and knitted fabric test method.

Specifically, first, a test piece is set on a tensile testing machine or a device having the same performance as the tensile testing machine.

An initial load (e.g., a load corresponding to a gravity corresponding to a length of 1m in the width of the test piece) was applied to the test piece, and at this time, the length (inter-chuck distance) of the test piece at the time of applying the 1 st initial load (advancing path) was measured (initial load variation point in the advancing path of the 1 st cycle: L)_1a’)。

Next, the test piece was pulled until a load of 15N was applied, and immediately thereafter, the load was removed (load 0N) and returned to the original position. Thereafter, the test piece was stretched by the application (15N) and removal (0N) of the load by repeating 20 times (20 cycles) in total. At the time of the 20 th application of the load, the test piece length at the time of the application of the initial load (advancing path) (initial load variation point in the advancing path of the 20 th cycle: L) was measured_20a') test piece length when a load of 15N was applied (upper limit variation point when the 20 th cycle reached a predetermined load: l is₂₀) And the length of the test piece when the load was removed and the initial load was reached (return path) (initial load variation point in the return path of the 20 th cycle: l is_20b’)。

From these measured values, the continuous elongation recovery rate a when a load is applied (forward path) and the continuous elongation recovery rate B when the load is removed (return path) are defined as follows.

[ solution 1]

L₂₀: in the first placeUpper limit variation point when 20 cycles reached a specified load (distance between chucks when 15N load was applied at 20 th cycle)

L_1a’: initial load variation point in advancing path of 1 st cycle (distance between chucks when 1 st initial load is applied)

L_20a’: initial load variation point in the advancing path of the 20 th cycle (distance between chucks when initial load is applied (when load is applied) at the 20 th cycle)

L_20b’: initial load variation point in return path of 20 th cycle (distance between chucks when initial load is reached (when load is removed) at 20 th cycle)

The present invention is characterized in that, in the overlapping portion of the support, the adhesive layer, and the pad of the medical patch, the continuous elongation recovery rate a (advancing path) is 90% or more, the continuous elongation recovery rate B (returning path) is 70% or more, and the ratio B/a of these elongation recovery rates is 0.5 or more.

In the present invention, the continuous elongation recovery rate in the overlapping portion (medical adhesive material) in at least one of the length (MD) direction and the width (CD) direction of the overlapping portion has a value of: the continuous elongation recovery rate a may be 90% or more, the continuous elongation recovery rate B may be 70% or more, and the ratio B/a of the continuous elongation recovery rates may be 0.5 or more. Further, it is particularly preferable that the values of the continuous elongation recovery rate a, the continuous elongation recovery rate B, and B/a are satisfied in each of the MD and CD directions.

The present invention will be further described below.

< support >

In the case of constituting the medical adhesive material described below, the material, form, and structure of the support constituting the medical adhesive material of the present invention are not particularly limited as long as the support has stretchability which can achieve a predetermined elongation recovery rate.

The area of the support body is 4,700-13,000 mm²The size of the application portion (wound site) can be appropriately determined according to the area of the application portion.

The shape of the support (i.e., the medical adhesive material) is not particularly limited, and may be a square (square, rectangle, etc.), a quadrangle (trapezoid, rhombus, etc.), a polygon, a circle, an ellipse, a semicircle, a triangle, a crescent, a combination thereof, or the like, and various shapes may be selected depending on the portion to be adhered. Further, when the shape is a shape having corners, such as a square, a quadrangle, a polygon, or the like, by providing the chamfer R at the corners (when the entire surface of the support is provided with the adhesive), it can be suppressed from peeling from the adhering portion.

As an example of a preferable mode, the shape of a substantially square or substantially quadrangular shape may be based on a square or quadrangular shape.

Examples of the support include those having flexibility such as 2 or more kinds of laminates including films, foams, nonwoven fabrics, knitted fabrics, woven fabrics, and laminated composites of nonwoven fabrics and films.

Examples of the material of these supports include: polyethylene, polypropylene, polyethylene terephthalate, polybutylene terephthalate, polyethylene naphthalate, polystyrene, nylon, rayon acetate, rayon, a rayon/polyethylene terephthalate composite, polyacrylonitrile, polyvinyl alcohol, acrylic urethane, ester urethane, ether urethane, a styrene-isoprene-styrene copolymer, a styrene-butadiene-styrene copolymer, a styrene-ethylene-propylene-styrene copolymer, a styrene-butadiene rubber, an ethylene-vinyl acetate copolymer, cellophane, and the like.

Among them, as preferable materials, films, foams, nonwoven fabrics, woven fabrics, knitted fabrics, and the like, which are made of polyester, polyurethane, polyethylene, polypropylene, polyamide, acrylic resin, or the like, can be used.

Among them, a material which can be closely attached to the skin, has flexibility capable of following the movement of the skin and the joints, and can suppress the occurrence of rash or the like on the skin after being attached for a long time is preferable in addition to the aforementioned stretchability, and a film or a nonwoven fabric made of polyurethane is preferable in terms of excellent followability to the movement of the skin surface to be attached and stretchability capable of following the flexion and extension of the joints.

In addition, in order to make the medical adhesive material inconspicuous at the time of application, the support body is colored in a color tone such as skin color with a coloring agent such as a pigment, an organic pigment, a natural pigment, or the like, so that the difference in color with the skin at the time of application can be reduced. In addition, a plastic film having excellent transparency can be used from the viewpoint of easily showing the color tone of the skin to be stuck.

The thickness of the support is appropriately selected in consideration of physical properties such as elongation, tensile strength, and handling properties, touch feeling at the time of application, adhesiveness to the affected part, and the like, and is usually about 5 μm to 1 mm. When the thickness of the support is as thin as about 5 to 30 μm, a support film described later may be provided on the surface opposite to the surface of the support on which the pressure-sensitive adhesive layer is provided (hereinafter referred to as the other surface).

When the support is a cloth such as a nonwoven fabric, the thickness thereof is preferably 50 μm to 1mm, more preferably 70 μm to 800 μm, and still more preferably 100 μm to 700 μm.

When the support is a plastic film, the thickness thereof is preferably 10 to 300. mu.m, more preferably 12 to 200. mu.m, and still more preferably 15 to 150. mu.m. When the support is a film, the support may be subjected to a treatment such as a blast treatment or a corona treatment on one surface or the other surface or both surfaces thereof in order to improve the anchoring property between the adhesive layer and the support.

When the thickness of the support is less than 5 μm, the strength and handling properties of the support itself are lowered, and the support is not easily stuck to the skin, and is damaged by contact with other members or the like, or peeled off from the skin in a short time by contact with water such as bathing. Further, when the thickness of the support is too large (more than 1mm), the adhesive material is difficult to follow the movement of the skin and is likely to be peeled from the edge portion of the adhesive material, and therefore, the adhesive material may be peeled from the skin in a short time or may increase the uncomfortable feeling at the time of adhesion.

Wherein, when a nonwoven fabric is used as the support, the grammage thereof is usually 10g/m²～100g/m²From improving the medical use of the adhesiveFrom the viewpoint of moisture permeability of the patch material and maintaining strength for easy attachment to the skin, 15g/m is preferable²～80g/m²More preferably 20g/m²～70g/m². When the gram weight of the non-woven fabric is less than 10g/m²In this case, the stretchability of the nonwoven fabric becomes too high, which may deteriorate the handleability of the medical adhesive material, and the adhesive may bleed out to the other surface of the support (nonwoven fabric). In addition, when the gram weight exceeds 100g/m²In the case where the stretchability of the nonwoven fabric is too small, the handleability is deteriorated, the moisture permeability of the medical adhesive material is reduced, the skin irritation may be increased, and further, the skin may be uncomfortable when the medical adhesive material is adhered.

Among these supports, the moisture permeability measured in JIS Z0208, 40 ℃, 90% RH is preferably 1,000g/m²24h, more preferably 2,000g/m²24h or more, particularly preferably 3,000g/m²24h or more. By setting the moisture permeability to 1,000g/m²More than 24 hours, the patch has less stuffiness and dampness when being stuck on the skin, and is not easy to generate skin irritation and pruritus when being stuck. The higher the moisture permeability is, the more preferable the upper limit of the moisture permeability is, but not particularly limited, and it is usually 30,000g/m²24h or less.

As the carrier film that can be provided on the other surface of the support, a known carrier film can be used, and for example, the carrier film is preferably formed of various films made of various thermoplastic resins such as polyurethane, polyethylene, polypropylene, ionomer, polyamide, polyvinyl chloride, polyvinylidene chloride, ethylene-vinyl acetate copolymer, thermoplastic polyester, polytetrafluoroethylene, and the like. Further, as the various films, films laminated on paper may be used.

The support film formed of these various films and the like is preferably made of a thick or tough material. The thickness of the support film may be appropriately set, and is usually 10 μm or more, preferably 20 μm or more, and its upper limit value is about 500 μm.

Since the carrier film is a film that is peeled from the support after the medical adhesive material of the present invention is adhered to a predetermined portion, the carrier film may be half-cut or provided with a portion (pre-lift portion) that does not closely adhere to the surface of the support, or a peel tape for easily holding the carrier film may be provided in the vicinity of the half-cut or pre-lift portion, in order to facilitate the peeling.

The support may contain additives such as antistatic agents and ultraviolet screening agents without impairing the effects of the present invention. Examples of the antistatic agent include surfactants (anionic surfactants, cationic surfactants, nonionic surfactants, and amphoteric surfactants). By the antistatic agent, the anchor property of the support and the process defects can be eliminated.

< adhesive layer >

The pressure-sensitive adhesive layer may be composed of a single pressure-sensitive adhesive layer or may be composed of a plurality of pressure-sensitive adhesive layers stacked on each other. When the pressure-sensitive adhesive layer is formed by laminating a plurality of pressure-sensitive adhesive layers, the pressure-sensitive adhesive layers may be formed by laminating different types of pressure-sensitive adhesive layers.

The pressure-sensitive adhesive layer is formed so as to cover the surface of one side of the support, and is preferably formed over the entire surface. When the adhesive layer is partially formed, any form such as a lattice, a net, a granule, and a vine pattern can be selected. By forming the pressure-sensitive adhesive layer partially in this manner, the air permeability, moisture permeability, and the like of the tape (the laminate of the support and the pressure-sensitive adhesive layer) can be further improved, and further, the irritation at the time of peeling from the skin can be adjusted (reduced).

In the present invention, the pressure-sensitive adhesive forming the pressure-sensitive adhesive layer is preferably at least one pressure-sensitive adhesive selected from the group consisting of acrylic pressure-sensitive adhesives, rubber pressure-sensitive adhesives, polyurethane pressure-sensitive adhesives, and silicone pressure-sensitive adhesives. These binders may be used alone or in combination of two or more. Among them, acrylic adhesives and polyurethane adhesives are preferable from the viewpoint of having sufficient adhesiveness to the skin surface, causing little irritation to the skin, and having high moisture permeability.

Examples of the acrylic pressure-sensitive adhesive include those containing: homopolymers of alkyl (meth) acrylate monomers such as butyl acrylate, 2-ethylhexyl acrylate and isononyl acrylate, or copolymers of these monomers, and copolymers of other monomers copolymerizable with the alkyl (meth) acrylate monomers, such as (meth) acrylic acid, hydroxyalkyl (meth) acrylates, vinyl acetate, styrene, vinyl pyrrolidone, (meth) acrylamide and alkoxyalkyl (meth) acrylates.

Examples of the polyurethane-based adhesive include adhesives composed of polyurethane resins obtained by reacting polyols with polyisocyanate compounds. The polyol may be, for example, a polyether polyol, a polyester polyol, a polycarbonate polyol, a polycaprolactone polyol, or the like. The polyisocyanate compound may be, for example, diphenylmethane diisocyanate, toluene diisocyanate, hexamethylene diisocyanate, or the like.

The molar ratio of NCO/OH of the polyol to the polyisocyanate compound used in the reaction is preferably 0.70/1.00 to 1.00/1.00 to suppress gelation in the reaction and to increase the adhesive force.

For example, a general method such as a bulk polymerization (solid state reaction) method in which a reaction is performed in a molten state, a solution polymerization method, or the like can be used for producing the polyurethane-based adhesive. The solvent used in the solution polymerization method may be, specifically, a ketone solvent such as methyl ethyl ketone, methyl isobutyl ketone or cyclohexanone, an ester solvent such as ethyl acetate or butyl acetate, an ether solvent such as dioxane or tetrahydrofuran, a glycol ether solvent such as cellosolve or carbitol, an acetate glycol ether solvent such as cellosolve acetate, an amide solvent such as dimethylacetamide or dimethylformamide, an aromatic hydrocarbon solvent such as toluene or xylene, an alcohol solvent such as methanol, ethanol or isopropanol, or a mixture thereof.

When producing the polyurethane adhesive, a catalyst, an additive, and the like may be used as needed. The catalyst may be a general urethanization catalyst such as a nitrogen-containing compound such as triethylamine or triethylenediamine, or an organic metal compound such as dibutyltin dilaurate, tin octylate, or tin stearate. Examples of the additive include an ultraviolet absorber such as a substituted benzotriazole, an antioxidant such as a phenol derivative, and a hydrolysis inhibitor.

In order to improve the adhesion of the polyurethane adhesive and to avoid problems such as adhesive residue, a chain extender may be used in the production of the polyurethane adhesive. Further, the polyurethane adhesive may be used in combination with a polyisocyanate curing agent to change the adhesive properties. The improvement of the binding power caused by the polyisocyanate curing agent can effectively improve the unfavorable conditions of viscose residue and the like. As the polyisocyanate used as the curing agent, the polyisocyanate used in the above reaction may be used, and polyol adducts of these isocyanates obtained by reacting with 2-or more functional polyols are preferably used, and further, polymeric polyisocyanates, isocyanurate modifications, and carbodiimide modifications are also preferable. Specifically, CORONATE L, CORONATE HL, CORONATE 3041, CORONATE 2030, CORONATE 2031, CORONATE HX, MillipateMTL, Millipate MR, etc. may be used.

The pressure-sensitive adhesive layer may contain, as optional components, additives that can be usually blended with the pressure-sensitive adhesive layer, such as a tackifier, a crosslinking agent, a softener (plasticizer), a pH adjuster, an antioxidant (antioxidant, preservative), a filler, an ultraviolet absorber, a colorant, and a perfume.

The thickness of the pressure-sensitive adhesive layer may be usually 10 to 200. mu.m, preferably 20 to 100. mu.m.

< pad >

The pad (also referred to as a stretchable pad) constituting the medical patch of the present invention is not particularly limited in material, form, and structure as long as it has stretchability capable of achieving a predetermined elongation recovery rate when constituting a medical patch described later.

The area of the pad is 1,500-4,500 mm²The size can be appropriately determined according to the area of the application portion (wound site) or the like.

As the pad, a special woven fabric, a gauze, a net, a nonwoven fabric, a laminate thereof, or the like can be used, and among them, a pad (stretchable pad) having a laminate structure in which a stretchable web layer (a contact layer with an application surface) is bonded to a stretchable nonwoven fabric layer having excellent liquid absorption properties is preferably used. The nonwoven fabric layer and the stretch web layer may be bonded (joined) by, for example, thermal fusion (using a gravure roll).

When the mat is composed of a nonwoven fabric layer and an extensible web layer, the mat is disposed so that the adhesive layer is in contact with the nonwoven fabric layer.

The stretchable nonwoven fabric layer is made of, for example, polyester, rayon, polyolefin, or the like, and may contain crimped fibers.

The stretchable web layer may be made of, for example, a polystyrene elastomer, a polyolefin, a vinyl chloride, a polyurethane, a polyester, a polyamide, or a polybutadiene resin.

The shape of the pad is not particularly limited, and may be a square (square, rectangle, etc.), a quadrangle (trapezoid, rhombus, etc.), a polygon, a circle, an ellipse, a semicircle, a triangle, a crescent, a combination thereof, or the like, and various shapes can be selected depending on the portion to be attached.

In the pad, the nonwoven fabric layer may have a basis weight of 50 to 150g/m²Preferably 70 to 140g/m²For example, it may be 80 to 120g/m². By setting the grammage to 50g/m²As described above, the water absorption can be adjusted to be suitable, and the water absorption can be set to 150g/m²Hereinafter, the possibility of falling off can be reduced even when the mat contains moisture due to bathing, water-related work, or the like.

In addition, in the stretchable pad having a laminated structure of a nonwoven fabric layer/a stretchable web layer, the thickness thereof may be 0.5 to 2.0mm, preferably 0.7 to 1.5 mm.

Alternatively, the pad may be sterilized by impregnating the pad with a sterilizing agent in advance, or may be sterilized after being formed into a finished product (medical adhesive material).

< Release liner >

The medical adhesive material of the present invention may be provided with a release liner (also referred to as a release layer or release paper) for protecting the pressure-sensitive adhesive layer or the pad until the time of use, and the medical adhesive material of the present invention may include a form provided with the release liner.

The release liner can be a product conventionally used in the field of adhesive tape and patch technology. For example, plastic films such as polyester (polyethylene terephthalate, polybutylene terephthalate, polyethylene naphthalate, and the like), polypropylene (unstretched, stretched, and the like), polyethylene, polyurethane, polyvinyl chloride, and polystyrene; high-quality paper, translucent paper, parchment paper, kraft paper and other paper or synthetic paper; release-treated paper obtained by coating the plastic film, paper, synthetic fiber, or the like with a release agent having a release property such as silicone resin or fluororesin; aluminum foil; a laminated paper obtained by laminating these films and sheets in various ways, and a colorless or colored sheet such as a laminated release paper coated with a release agent. Alternatively, the release liner may be provided with irregularities to facilitate removal from the packaging material.

The thickness of these release liners is not particularly limited, but is usually 10 μm to 1mm, for example, 20 μm to 500 μm, and preferably 40 μm to 200 μm.

The release liner may be square, rectangular, circular, etc., and may be formed into a rounded shape at the corners as desired. The size of the support member may be the same as or slightly larger than the size of the support member in the medical adhesive material. The release liner may be formed of one sheet or divided into a plurality of sheets, and the dividing line may be formed of a straight line, a wavy line, a perforated line, or may be formed such that the release liners are partially overlapped with each other.

< production method >

The method for producing the medical adhesive material to which the present invention is applied is not particularly limited, and the medical adhesive material can be produced by following the conventional method for producing a band-aid or adhesive material. For example, a medical adhesive material can be manufactured by first laminating a support and an adhesive layer to prepare an adhesive tape and disposing a pad on the adhesive layer of the adhesive tape.

Specifically, for example, a solution or emulsion of an adhesive (synthetic resin) is applied to casting paper coated with a silicone-based release agent or the like to form an adhesive layer, and then the adhesive layer is laminated with a support to produce an adhesive tape. The casting paper is a general term for a product that does not remain in the product, and the films and the papers exemplified in the < release liner > can be used herein. If necessary, the adhesive layer may be foamed after application of the adhesive to form a preferably foamed adhesive layer having air permeability containing a synthetic resin.

Next, the casting paper of the tape is peeled off to expose the adhesive layer, and here, a pad cut to an appropriate size is disposed at a predetermined position (for example, a position substantially at the center of the adhesive material in the case of a medical adhesive material), and usually, after a release liner is disposed so as to cover the adhesive layer and the pad, the release liner is cut into a predetermined shape, whereby a medical adhesive material having a laminated structure of a support/adhesive layer/pad/release liner can be obtained. In addition, when a support is provided with a carrier film on the surface opposite to the pressure-sensitive adhesive layer, a patch having a laminated structure of carrier film/support/pressure-sensitive adhesive layer/mat/release liner can be produced.

In general, a medical adhesive material is sealed in a wrapping paper made of paper, a plastic film, or a composite material thereof at room temperature in a subsequent process to produce a product. In this case, a sterilization treatment or the like may be performed as necessary.

The present invention will be further described below with reference to the accompanying drawings showing preferred embodiments of the present invention.

Fig. 1 and 2 are views (sectional views) showing one embodiment of the medical adhesive material of the present invention.

As shown in fig. 1, a medical adhesive material 1 of the present invention includes a support 2, an adhesive layer 3 covering the surface of the support 2, and a pad 4 disposed on the adhesive layer 3. In the present embodiment, the adhesive layer 3 is formed over the entire support 2, and thus has the form of a tape 7.

The mat 4 has a laminated structure of a nonwoven fabric layer 41 and an expandable mesh layer 42, and the nonwoven fabric layer 41 is in contact with the adhesive layer 3.

Fig. 2 is a view showing an embodiment further including a release liner 5 and a carrier film 6 in the embodiment of fig. 1.

As shown in fig. 2, the release liner 5 is disposed so as to cover the pressure-sensitive adhesive layer 3 and the stretchable mesh layer 42 of the pad 4. In fig. 2, the release liner is composed of a plurality of sheets (2 sheets).

Further, the support film 6 is provided on the other surface of the support 2 from the surface on which the adhesive layer 3 is formed.

Fig. 3 to 7 are views showing other embodiments of the medical adhesive material 1 of the present invention. These drawings correspond to the front view of the medical adhesive sheet 1 shown in fig. 1.

As shown in fig. 3 to 7, the medical adhesive material 1 of the present invention has a rectangular pad 4 disposed substantially at the center of a substantially rectangular support 2 (which forms an adhesive tape 7 together with an adhesive layer 3).

In the embodiment shown in fig. 3, the substantially rectangular support body 2 has recesses 21 provided toward the inside of the support body 2 at four corners thereof. Due to the presence of the concave portion 21, the distances between the four corners of the pad 4 and the four corners of the support body 2 can be shortened as compared with the case where the concave portion 21 is not present.

As described above, the stress applied to the periphery (edge portion) increases as the distance from the center portion of the adhesive material increases, and therefore, the stress applied to the periphery (edge portion) can be reduced by the presence of the recessed portion 21.

However, the shape (size) of the recess 21 should not impair the adhesiveness of the medical adhesive material 1, but the size of the medical adhesive material of the present invention (support area: 4,700 to 13,000 mm) is considered²The area of the pad is 1,500-4,500 mm²) In this case, the shortest distance C between the concave portion 21 and the pad 4 is preferably set_LIs set to be 10-25 mm. The shape of the recess 21 is not particularly limited, but is preferably a shape having a chamfer R in consideration of difficulty in peeling from the bonded portion.

In the embodiment shown in fig. 3, the support body 2 is provided with recesses 22 facing the inside in the longitudinal direction thereof in order to disperse stress applied to the periphery (edge portion) of the medical adhesive material 1. By providing the recess 22 in the longitudinal direction, stable adhesion can be ensured regardless of the size of the adhering portion (wound site) and the adhering position (adhering direction).

In the embodiment shown in fig. 5 to 7, the recess 21 shown in fig. 3 is not provided in the substantially rectangular support 2, but the recess 22 is provided at one position in the embodiment of fig. 5 and 7 and at two positions in the embodiment of fig. 6 toward the inner side in the longitudinal direction of the support. As described above, by providing the recess 22 in the longitudinal direction, stable adhesion can be ensured regardless of the size of the adhering portion (wound site) and the adhering position (adhering direction).

[ examples ]

The present invention will be specifically described below by way of examples and comparative examples, but the present invention is not limited to these examples.

The pads used in the medical adhesive materials of examples 1 to 4 below had a laminated structure of a nonwoven fabric layer and an extensible mesh layer, in which a polystyrene elastomer mesh constituting the extensible layer was bonded to a crimped polyester-based nonwoven fabric layer by thermal fusion bonding (grammage of nonwoven fabric layer: 90 g/m)²)。

Examples 1 to 3: production of medical adhesive Material (1)

< preparation of adhesive tape Using acrylic pressure-sensitive adhesive >

An acrylic pressure-sensitive adhesive (obtained by reacting 100 parts by mass of 2-ethylhexyl acrylate/vinyl acetate/acrylic acid (mass ratio 87/10/3) with 0.03 part by mass of an epoxy crosslinking agent (TETRAD X, manufactured by Mitsubishi gas chemical corporation)) was applied to silicone-treated casting paper so that the dry film thickness was 40g/m². As the air permeability treatment, distilled water was sprayed on the undried adhesive-coated surface, and then heated at 130 ℃ to form fine pores, thereby forming an adhesive layer made of an acrylic adhesive having air permeability.

A polyurethane elastic fiber nonwoven fabric (thickness 200 μm, grammage 65 g/m) as a support was bonded to the pressure-sensitive adhesive layer²) To manufacture the adhesive tape.

< preparation of medical adhesive plaster (1) >

The casting paper was peeled from the tape to expose the adhesive layer made of the acrylic resin having air permeability. The mat cut to a prescribed size is placed on the adhesive layer so that the adhesive layer of the tape is opposite to the nonwoven layer of the mat.

Then, a silicone-treated release liner was attached to cover the tape and the pad.

Thereafter, the medical adhesive material of each example was obtained by punching out the medical adhesive material in a predetermined size and shape so that the pad was located at the substantial center. The medical adhesive materials of examples 1, 3 and 4 have the shapes shown in fig. 3, and the medical adhesive material of example 2 has the shapes shown in fig. 4.

Example 4: production of medical adhesive Material (2)

< preparation of adhesive tape Using polyurethane adhesive >

A polyurethane adhesive (polyether) was uniformly mixed with 2 parts by mass of a crosslinking agent (CORONATE L, tokyo co., ltd.) and defoamed, and the mixture was applied to a polyester film (casting paper, thickness 50 μm) subjected to a peeling treatment using a blade coater so that the dry film thickness was 25 μm, followed by curing and drying at 120 ℃ for 3 minutes to form an adhesive layer.

On the obtained pressure-sensitive adhesive layer, a laminate of a support and a support film (support: film base of ether urethane resin having a thickness of 20 μm (moisture permeability: 3, 300 g/m)²Day), carrier film: polypropylene film of thickness 40 μm). Then, the resultant was stored in a hot air dryer at 50 ℃ for 5 days to complete the crosslinking reaction of the adhesive, thereby producing an adhesive tape having a carrier film adhered to casting paper.

< preparation of medical adhesive sheet (2) >

The casting paper was peeled off, the cushion layer was placed on an adhesive tape, the silicone-treated release liner was attached so as to cover the adhesive tape and the cushion layer, and the adhesive material for medical use of example 4 was obtained by punching out in a predetermined size and shape according to the same procedure as in example 1. The medical adhesive material of example 4 had a shape as shown in fig. 3.

Comparative example 1

In comparative example 1, the product name was used as the medical adhesive material: FC one-touch pads (pad size: 40X 60mm, tape size: 60X 100mm, manufactured by white cross Co., Ltd.).

Comparative example 2

In comparative example 2, the product name was used as the medical adhesive material: FC waterproof one-touch pad (white cross, pad size: 45X 90mm, tape size: 80X 130 mm).

Comparative example 3

A tape using the acrylic adhesive used in example 1 was bonded with a nonwoven fabric (grammage: 120 g/m)²Rayon, polyester, polyolefin) and a polyethylene mesh, and the medical adhesive material of comparative example 3 was obtained in the same manner as in example 1, except that the pad had a laminated structure. The medical adhesive material of comparative example 3 had a shape as shown in fig. 4.

Comparative example 4

A tape using the polyurethane adhesive used in example 4 was bonded with a nonwoven fabric (grammage: 120 g/m)²Rayon, polyester, polyolefin) and a polyethylene mesh, and the medical adhesive material of comparative example 4 was obtained in the same manner as in example 4, except that the pad had a laminated structure. The medical adhesive material of comparative example 4 had a shape as shown in fig. 4.

The sizes and shapes of the medical adhesive materials of the examples and comparative examples are shown in table 1. In Table 1, W in examples 1 to 4 and comparative examples 3 to 4_S、L_S、C_L、W_PAnd L_PCorresponding to the symbols shown in FIGS. 3 and 4, respectively, i.e. W_SIndicates the width L of the support 2 (adhesive material)_SIndicates the length of the support 2 (adhesive material), C_LRepresents the shortest distance, W, of the recess 21 from the pad 4_PIndicates the width, L, of the pad 4_PIndicating the length of the pad 4.

[ Table 1]

[ tensile test ]

The medical adhesive materials of examples 1 to 4 and comparative examples 1 to 4 were subjected to a tensile test in accordance with JIS Z0237(2009) tape/adhesive sheet test method, and the tensile load at 30% was measured. The 30% tensile load is a stress at which the object to be stretched is stretched to 130% when the entire length of the object to be stretched is 100%.

Each medical adhesive material was cut into short strips each having a width of 25mm and a length of 50mm in the width (CD) direction and the length (MD) direction, and the strips were used as test pieces. The test piece is an overlapping portion of the support, the adhesive layer, and the pad (including no release liner or carrier film).

The test piece was mounted on a Tensilon universal tester with a chuck spacing of 30mm, and subjected to 3 times of tensile measurement under a load of 100N in an environment of 23 ℃ and 50% relative humidity. The average of the 3 measurements was defined as the 30% tensile load in CD and MD, respectively.

In addition, in the medical adhesive material (the overlapped part of the support body, the adhesive agent layer and the pad), the 30% tensile load (MD) is preferably 5 to 50N/25mm, the 30% tensile load (CD) is preferably 3 to 50N/25mm, and in a more preferred mode, the 30% tensile load (MD) is 5 to 15N/25mm, and the 30% tensile load (CD) is 3 to 10N/25 mm.

The results obtained are shown in table 2.

[ BA-SUS plate adhesive force ]

The adhesive strength to BA-SUS board of the medical adhesive materials of examples 1 to 4 and comparative examples 1 to 4 was measured by a 180-degree peel test according to JIS Z0237.

Each medical adhesive material was cut into a short strip having a width of 12mm × a length of 30 to 150mm in the longitudinal (MD) direction to prepare a test piece. In addition, the test piece for BA-SUS plate adhesion was an overlapping portion of the support and the adhesive layer (not including a pad, a release liner, and a carrier film). The test piece was stuck to a BA-SUS plate in an atmosphere of 23 ℃ and 50% RH, and a 1kg rubber roller was brought into contact with the BA-SUS plate 2 times in a reciprocating manner at a speed of 600. + -. 30 mm/min. The peel force was measured under conditions of a peel angle of 180 degrees and a peel speed of 300. + -. 20mm/min within 1 minute after the press-bonding, and the adhesive force to BA-SUS plate of the test piece was determined. The measurement was conducted 3 times, and the average value thereof was taken as the adhesive force (unit: N/12mm) to BA-SUS board of the pasting material.

[ elongation recovery ]

The medical adhesive materials of examples 1 to 4 and comparative examples 1 to 4 were subjected to repeated tensile measurements to measure the elongation recovery.

Each medical adhesive material was cut into short strips each having a width of 30mm and a length of 50mm in the width (CD) direction and the length (MD) direction, and the strips were used as test pieces. The test piece is an overlapping portion of the support, the adhesive layer, and the pad (including no release liner or carrier film).

The test piece was fixed by upper and lower clamps in such a manner that the distance between the chucks was 30mm, and was mounted on a Tensilon universal tester. A predetermined load (upper limit point: 15N) was applied to the specimen at a tensile rate of 300. + -.20 mm/min under an atmosphere of a temperature of 23 ℃ and a relative humidity of 50%, and when the predetermined load was reached, the specimen was returned to the initial position (load: 0N) at the same rate, and the process was repeated 20 times (20 cycles).

The initial load was 0.0001N, the distance between chucks (the length of the test piece) at this time was the initial load variation point, and the initial load variation point in the 1 st advancing path (when the load was applied) was L_1a', the initial load variation point of the 20 th advancing path (when a load is applied) is L_20a', the initial load variation point of the 20 th return path (when the load is removed) is L_20b’。

The distance between chucks (the length of the test piece) when the specified load (15N) was reached was defined as the upper limit variation point, and the upper limit variation point when the specified load was reached at the 20 th time was defined as L₂₀。

From these measured values, the continuous elongation recovery a (%) and the continuous elongation recovery B (%) were calculated using the following equations.

One sample was subjected to 3 measurements (3 test pieces were measured), and the average value of the 3 measurements was obtained as the continuous elongation recovery rate (%) and the ratio B/a of the values was calculated.

The results obtained are shown in table 2.

[ solution 2]

L₂₀: upper limit variation point at the time when the specified load was reached at the 20 th cycle (distance between chucks at the time when 15N load was applied at the 20 th cycle)

L_1a’: initial load variation point in advancing path of 1 st cycle (distance between chucks when initial load is applied 1 st time)

L_20a’: initial load variation point in the advancing path of the 20 th cycle (distance between chucks when initial load is applied (when load is applied) at the 20 th cycle)

L_20b’: initial load variation point in return path of 20 th cycle (distance between chucks when initial load is reached (when load is removed) at 20 th cycle)

The elongation recovery rates a (%) and (B) at the 1 st cycle (1 st cycle) are shown in table 2 as reference values. In the above equation, the initial load variation point in the forward path of the 20 th cycle: l is_20a' replacement as initial load variation point L of advancing path (when load is applied) in 1 st cycle_1a', initial load variation point in the return path of the 20 th cycle: l is_20b' replace with initial load change point of return path (when load is removed) in 1 st cycle: l is_1b', upper limit variation point when the specified load is reached at the 20 th cycle: l is₂₀Replacement is performed at the upper limit variation point when the specified load (15N) is reached at the 1 st time: l is₁And separately calculates them.

[ practical evaluation ]

The medical adhesive materials of examples 1 to 4 and comparative examples 1 to 4 were adhered to the elbows of 10 to 30 adult male and female subjects for 24 hours.

Regarding the sticking to the elbow, each subject stuck after bathing, and remained stuck for 24 hours after bathing the next day. In addition, in a state where the elbow (arm) is stretched, the adhesive bandage is attached so that the longitudinal direction of each adhesive bandage is the elbow bending direction (the longitudinal direction of the arm).

After 24 hours of pasting, the adhesiveness before peeling was evaluated according to the following evaluation criteria (score: 1 to 6), and the average score of all the subjects (10 to 30) was calculated.

After the medical adhesive material was peeled off, the adhered part was visually observed after 1 hour and 24 hours of peeling, the skin condition was evaluated according to the following evaluation criteria (score: 1 to 6), and the average score of all the subjects (10 to 30) was calculated.

The following scores were evaluated as "good" when the average score was 4 or more, and "poor" when the average score was less than 4.

< adhesion before peeling >

6: all adhered well to the elbow

5: peeling only at the edge (peeling of about 5 to 15% of the total area of the medical adhesive material)

4: although the peeling occurred, the pad portion did not rise (peeling of about 15 to 30% of the entire area of the medical adhesive material)

3: a part of the adhesive tape is peeled/raised (about 30 to 50% of the entire area of the adhesive tape for medical use is peeled)

2: half to half of the adhesive tape is peeled/raised (more than 50% of the entire area of the adhesive tape for medical use is peeled)

1: peeled/peeled

< skin reaction >

6: the skin does not turn red

5: slight reddening of the skin (slight redness)

4: skin reddening (obvious reddening)

3: red swelling and pain

2: causing skin problems (eruption/blisters, etc.)

1: causing skin problems (eruption/large blisters, etc.)

[ Table 2]

As shown in tables 1 and 2, the medical adhesive materials of examples 1 to 4 satisfy the conditions that the continuous elongation recovery rate a is 90% or more and the continuous elongation recovery rate is 70% or more, and the medical adhesive materials are excellent in adhesion before peeling, and weak in skin reaction after peeling for 1 hour and 24 hours, and suppressed in skin irritation.

On the other hand, the continuous elongation recovery rate B of the adhesive materials of comparative examples 1 and 2 was 37 to 40%, which was inferior to that of the examples, and the adhesive materials were poor in adhesiveness. In addition, comparative example 1 was a relatively small preparation and therefore had less skin irritation, but comparative example 2, which had the same size as the patch of the example, was confirmed to be a patch having a large skin reaction and strong skin irritation.

Description of reference numerals:

1 medical adhesive material

2 support body

21 concave part

22 recess

3 adhesive layer

4 pad

41 non-woven fabric layer

42 expansion net layer

5 Release liner

6 bearing film

7 adhesive tape

Claims (9)

1. A medical adhesive material comprising a support, an adhesive layer covering the surface of the support, and a pad disposed on the adhesive layer,

the area of the support body is 4,700-13,000 mm²，

The pad has an area of 1,500 to 4,500mm²，

In the overlapping portions of the support, the adhesive layer and the pad,

the continuous elongation recovery rate A (forward path) when the sheet is stretched 20 times under a load of 15N is 90% or more, the continuous elongation recovery rate B (return path) is 70% or more, and the ratio B/A of these elongation recovery rates is 0.5 or more.

2. The medical adhesive material according to claim 1, wherein the pad has a laminate structure of a polyester nonwoven fabric layer and an expandable mesh layer.

3. The medical adhesive material according to claim 1 or 2, wherein the polyester nonwoven fabric layer in the pad has a grammage of 50 to 150g/m²。

4. The medical adhesive material according to any one of claims 1 to 3, wherein the support is a polyurethane film or a polyurethane nonwoven fabric.

5. The medical adhesive material according to any one of claims 1 to 4, wherein the area ratio of the support body to the pad is 3:1 to 2: 1.

6. The medical adhesive material according to claim 5, wherein the area ratio of the support to the pad is 3:1 to 2.5: 1.

7. The medical adhesive material according to any one of claims 1 to 6, wherein in an overlapping portion of the support, the adhesive layer and the pad,

the 30% tensile load (MD) is 5 to 50N/25mm, and the 30% tensile load (CD) is 3 to 50N/25 mm.

8. The medical adhesive material according to any one of claims 1 to 7,

the support body has a substantially square or substantially quadrangular shape, and has recesses at four corners of the substantially square or substantially quadrangular shape,

the shortest distance between the concave part and the pad is 10-25 mm.

9. The medical adhesive material according to any one of claims 1 to 8,

the medical adhesive material is an adhesive material for joints.