JPH07112021A - Antimicrobial dressing for surgery - Google Patents

Abstract

PURPOSE:To prevent infection by infiltration of moisture and bacteria and to prevent the infection to a wound without the need for exchange at the time a patient takes a bath or shower. CONSTITUTION:This antimicrobial dressing for surgery consists of films consisting of two-layered structures laminated with an adhesive layer on one surface of a thermoplastic polyurethane elastomer film and contains an antimicrobial compsn. which is clad on a core material and consists of an alumino silicate contg. metal ions having an antimicrobial effect in at least either of the thermoplastic polyurethane elastomer film and adhesive layer.

Description

Detailed Description of the Invention

[0001]

FIELD OF THE INVENTION This invention relates to antimicrobial surgical dressings.

[0002]

2. Description of the Related Art Conventionally, gauze, absorbent cotton, etc. have been used to protect the wound surface. However, since these absorb the exudate promptly, they have a defect that the wound surface becomes dehydrated and causes bleeding when peeled off, which causes pain to the patient. Further, if the exudate leaks to the surface through gauze or the like, there is a drawback that bacteria are likely to invade the wound and become infected.

Generally, as an adhesive dressing, 1)
Good operability, 2) Sterilized until use, 3) Adhesion on the entire surface, 4) No sticking to the wound surface, 5) Raw materials are easily available, easy and inexpensive to manufacture It is desirable to meet the requirements such as As an alternative to conventional gauze and absorbent cotton that meet these requirements, a dressing combining a spongy pad made of a hygroscopic pad and a non-adhesive film and a waterproof adhesive plaster (Airstrip [Airstrip] (registered trademark); Smith and Nephew Limited [Smi
Th & Nephew Limited] company) or an adhesive dressing (opsite [Op-si] that consists of a polyurethane film having high moisture vapor permeability and an adhesive layer).
te] (registered trademark); Smith and Nephew Limited [Smith & Nephew Limite
d] manufactured by Bio Crucive [Bioclusive]
(Registered trademark); Johnson and Johnson [Jo
Honson & Johnson] and Tegaderm (registered trademark) 3M) are commercially available.

However, among these, dressing using a hygroscopic pad or the like has a multi-layered structure,
Since it becomes bulky, water and bacteria may enter from the side. Polyurethane film with high water vapor permeability is excellent in water vapor permeability and stretchability, but it has poor liquid permeability, so even if it covers the wound surface, exudate from the wound surface will not be absorbed between the dressing and the wound surface. It has also been pointed out that there is a risk of reabsorption of exudate to the wound surface and infection, etc. Since infection is likely to occur at the wound surface and the sutured part of the wound, a cream base containing an antibacterial agent is used to prevent infection. However, when the antibacterial agent is applied to the gauze, about 57% of the gauze dressing permeates with the exudate and only about 21% reaches the wound surface. In addition, the operation of the cream base is troublesome, such as applying it to the wound surface on a daily basis.

That is, a wound dressing material used for a sutured part after surgery, a dressing for a wound, etc. can be easily operated, and even after sticking, bending and stretching of the joints of the hands and feet are easy and the patient can When bathing or taking a shower, it is not necessary to replace the bath and it is necessary to prevent infection of the wound. Therefore, it has been desired to develop a surgical dressing which is permeable to air and water vapor but is suitable for surgery and which can prevent invasion of water and infection by bacteria. As a dressing satisfying these requirements, the present inventors previously proposed in Japanese Patent Application No. 4-86848 an antibacterial surgical dressing in which at least one of a thermoplastic polyurethane elastomer film and an adhesive layer contains an antibacterial zeolite. did. However, although this dressing was sufficient in performance, it was poor in stability over time during use, coloring occurred, and if the wound surface was infected with bacteria, discoloration of the dressing due to infection was difficult to distinguish. Becomes
Further, there is a possibility that the antibacterial property may be lowered due to the precipitation of metal ions, and the value as a product is affected.

[0006]

SUMMARY OF THE INVENTION It is, therefore, an object of the present invention to provide an antibacterial surgical dressing having excellent stability over time. Another object of the present invention is to provide antibacterial surgery that is permeable to air and water vapor but has antibacterial properties suitable for surgery that can prevent invasion of water and infection by bacteria and is stable over time. To provide dressing.

[0007]

The above object is achieved by an antibacterial surgical dressing having the following constitution.

(1) A film having a base material layer and an adhesive layer laminated on one surface of the base material layer, the film being a core material and a metal ion having an antibacterial action coated on the core material. And an antibacterial composition comprising an aluminosilicate having:

(2) The antibacterial surgical dressing according to the above (1), wherein the base material layer is made of a thermoplastic polyurethane elastomer.

(3) The thermoplastic polyurethane elastomer is a dense polyurethane film having a thickness of 5 to 10
The antibacterial surgical dressing according to (2) above, which has a thickness of 0 μm.

(4) The thermoplastic polyurethane elastomer is a microporous polyurethane foam having an average pore diameter of 0.01 to 10 μm and a film thickness of 20 μm to 5 in the closest packing diameter portion.
The antimicrobial surgical dressing according to (2) above, which has a size of mm.

(5) A dense polyurethane film in which the thermoplastic polyurethane elastomer has a film thickness of 5 to 15 μm, and the average pore diameter of the most dense pore diameter portion is 0.01 to 100 μm.
The antibacterial surgical dressing according to (2) above, which is obtained by compounding microporous polyurethane foam having a thickness of m and a film thickness of 20 μm to 5 mm.

(6) The water vapor permeability of the base material layer is 500 to
The antibacterial surgical dressing according to the above (1) to (5), which has a dose of 10000 g / m ² · 24 h.

(7) The antibacterial surgical dressing according to any of (1) to (6) above, wherein the adhesive is a one-component heat-crosslinking acrylic adhesive.

The antibacterial surgical dressing of the present invention comprises a core material and an aluminosilicate having a metal ion having an antibacterial effect, which is coated on the core material, particularly when external infection or the skin is contaminated with bacteria. Infection can be prevented by containing the antibacterial composition.

The aluminosilicate having a metal ion having an antibacterial effect used in the present invention may be crystalline or amorphous, or both may be present together. The thickness and composition of the aluminosilicate coating are based on the physical properties and amount of core material used,
It can be adjusted by the alkali concentration, the amount of aluminosilicate added, the reaction temperature, the reaction time, and the like. In both crystalline and amorphous cases, the SiO ₂ / Al ₂ O ₃ molar ratio is preferably in the range of 1.4-40. Typically, a SiO ₂ / Al ₂ O ₃ molar ratio of 1.4-2.4 A-type zeolite, 2-3 X-type zeolite, 3-6 Y-type zeolite and 1.4-30 non-zeolite. Crystalline aluminosilicates or mixtures of crystalline and amorphous aluminosilicates are used.

Zeolite is particularly preferable as the aluminosilicate having an antibacterial effect used in the present invention. Zeolites are alkali or alkaline earth metal aluminosilicates having a three-dimensionally developed skeleton structure. Its general formula is XM _a · O · Al ₂ O ₃ · ySiO ₂ · zH.
It is represented by ₂ O (M = metal ion, X = coefficient of metal oxide, a = 2Xn ⁻¹ (n = valence of metal), y = coefficient of silica, z = molecular weight of bound water).

The antibacterial zeolite used in the present invention is an antibacterial metal ion-containing zeolite in which the cation exchange ability of zeolite is utilized to retain antibacterial metal ions in the zeolite matrix. Antibacterial metal ions include silver, copper,
There is zinc, and when it is used as a surgical dressing, it is preferable to use silver, but it is more preferable to use a plurality of metals including zinc and copper. Zeolite matrix and antibacterial metal (copper, zinc) compounds are recognized as food additives by the US Food and Drug Administration (FDA). Further, since the antibacterial metal ion is retained in the zeolite matrix, the minute amount of the antibacterial metal ion that is eluted can be continuously released for a long time by diffusion.

The core material used in the present invention may be any as long as it can be coated with an aluminosilicate, but it is desirable that it is transparent or has little coloration, and particularly it has excellent adhesiveness with an aluminosilicate. Silica gel is preferred. The antibacterial composition of the present invention has a content of antibacterial metal ions such as silver, copper and zinc, compared with antibacterial zirconia phosphate, antibacterial zeolite, antibacterial apatite and the like which are currently commercially available antibacterial substances. There is little, but at least the same effect can be exhibited. That is, by selectively disposing an aluminosilicate having a metal ion having an antibacterial action on a surface having a large effect or a portion close to the surface, a core material is provided inside the composition, and a structure containing no metal ion is used. The amount of aluminosilicate used is reduced, and accordingly, the amount of antibacterial metal ion used is reduced, the antibacterial composition is sufficiently effective, and coloring due to oxidation of silver ions is greatly suppressed. This allows
The stability of the antimicrobial surgical dressing of the present invention over time is obtained.

In the present invention, as the material of the base material layer, a silicone type elastomer, a polyester type elastomer, a polyolefin type elastomer or the like can be used. Thermoplastic polyurethane elastomers are preferred from the viewpoints of flexibility and water vapor permeability. Thermoplastic polyurethane elastomers allow gas molecules (water vapor van der Waals diameter 3.48 angstroms) to pass through at intervals of several angstroms generated by the thermal motion of polymer chains, but staphylococci and viruses can pass through them. It has the property of not doing. Further, the base layer has an average pore size of 1
Dense polyurethane film having a thickness of 10 to 10 angstroms and a thickness of 5 to 15 μm, and having high water vapor permeability and air permeability, an average pore diameter of 0.01 to 100 μm (preferably 0.01 to 10 μm), and a thickness of 20 μm A multi-layered structure of a microporous polyurethane foam having a thickness of 5 mm (preferably 20 to 200 μm) is preferable because both protection of the wound from external pressure and bacterium impermeability are achieved.

The above-mentioned thermoplastic polyurethane elastomer is a segmented polyurethane comprising a hard segment, a soft segment, and a chain extender, and is a polyurethane which is generally used for medical purposes and has water vapor permeability. . As the hard segment, diisocyanate, for example, ethylene diisocyanate, hexamethylene diisocyanate, toluylene diisocyanate, phenylene diisocyanate, dimethyldiphenylmethane diisocyanate, isophorone diisocyanate, 4-4 'diphenylmethane diisocyanate And the like, and preferably 4-4 ′ diphenylmethane diisocyanate is used. Examples of the soft segment include polyols such as polyalkylene polyols, polyether polyols, polycaprolactams and polycarbonates, and preferably polyether polyols are used. Examples of the chain extender include ethylene glycol, propylene glycol, 1,4-butanediol, butanediol and the like. Generally, a thermoplastic polyurethane elastomer used for medical purposes uses a hydrophilic polyol as a soft segment polyol in order to obtain high water vapor permeability, but the thermoplastic polyurethane elastomer used in the present invention should be a microporous polyurethane foam. Therefore, it has a particularly high water vapor permeability. The water vapor transmission rate of this microporous polyurethane foam is 30.
00 to 10000 g / m ² · 24 h, preferably 50
It is from 00 to 8000 g / m ² · 24 h. The water vapor transmission rate of the antibacterial surgical dressing of the present invention is 5
It is preferably from 00 to 2000 g / m ² · 24 h.

As the adhesive used in the present invention, an acrylic acid ester copolymer such as acrylic acid, 2-ethylhexyl acrylate or butyl acrylate is generally used for medical purposes. It has good adhesiveness with the polyurethane film, does not peel off from the polyurethane film during use, does not adversely affect the skin due to direct contact with the skin, and easily peels off from the skin at the end of use or replacement. In view of the need for the above, a one-component heat-crosslinking acrylic adhesive is preferable. The thickness of the adhesive layer is 5 to 50 μm, preferably 20 to 30 μm.

The surgical dressing of the present invention is manufactured, for example, as follows. First, the polyurethane emulsion solution is placed on a release paper, for example, a silicone-based release paper,
Apply using a precision layering tool (applicator) to layer to a uniform thickness. After coating, it is 60-1 with a dryer
It is dried at 00 ° C. and cured there for 2-3 hours to obtain a polyurethane film. Next, a one-component heat-crosslinking acrylic adhesive in which an antibacterial composition obtained by coating an aluminosilicate having an antibacterial metal ion with silica gel as a core material is dispersed in this polyurethane film is applied using an applicator, The surgical dressing of the present invention can be obtained by forming an adhesive layer having a thickness of 30 μm. Further, by using a polyurethane emulsion solution in which an aluminosilicate having an antibacterial metal ion is dispersed, a polyurethane film is obtained by the same method, and a one-component heat-crosslinking acrylic adhesive is applied to the obtained polyurethane film. You can also get Less than,
The present invention will be described in detail with reference to examples.

[0024]

【Example】

(Example 1) Polyurethane emulsion solution 30 (w /
v%) (Himlen X-3040, manufactured by Dainichiseika Co., Ltd.) was applied on a silicone-based release paper using a precision layering tool (applicator) to form a layer having a uniform thickness. After coating, it was dried at 60 to 100 ° C. using a dryer and cured there for 2 to 3 hours to obtain a polyurethane film (a) having a thickness of 30 μm. Next, Bactenone AZ with silica gel as core material and coated with antibacterial zeolite
Adhesion by mixing 0.05 g (manufactured by Gel Technology Co., Ltd.) and 50 g of one-component heat-crosslinking type acrylic adhesive 60 (w / v%) (Cybinol AT-H04, manufactured by Saiden Chemical Co., Ltd.) The agent was applied to the polyurethane film (a) using a precision layering tool (applicator) so as to have a thickness of 20 μm to obtain a dressing (1). The water vapor transmission rate of the obtained dressing (1) is 1500 g / m.
It was ² · 24h. Even if it was left in the room for 1 week or longer, the appearance hardly changed in color.

Example 2 0.01 g of Bactenone AZ (manufactured by Gel Technology Co., Ltd.) was dispersed in 100 g of polyurethane emulsion solution 30 (w / v%) (Heimlen X-3040, manufactured by Dainichiseika Co., Ltd.). The above solution was applied onto a silicone-based release paper using a precision layering tool (applicator) to form a layer having a uniform thickness. After coating, it was dried at 60 to 100 ° C. using a dryer and cured there for 2 to 3 hours to obtain a polyurethane film (b) having a thickness of 30 μm. Next, 50 g of one-component heat-crosslinking acrylic adhesive 60 (w / v%) (AV-6200, manufactured by Showa Highpolymer Co., Ltd.) was applied to release paper to a thickness of 20 μm using a precision layering tool (applicator). And apply 1
It was dried at 00 ° C. for 5 hours. A film made of this adhesive is transferred to the polyurethane film (b) to dress (2)
Got The water vapor transmission rate of the obtained dressing (2) was 1000 g / m ² · 24 h. The appearance was hardly changed even when left at room temperature for 1 week or longer.

Comparative Example The polyurethane film (a) produced in Example 1 was obtained. Next, 0.05 g of Bactekiller (antibacterial zeolite, manufactured by Nichimen Co., Ltd.) and one-component heat-crosslinking acrylic adhesive 60 (w / v%) (Cybinol A
An adhesive obtained by mixing T-H04 and 50 g of Saiden Kagaku Co., Ltd. was applied to the above polyurethane (a) using a precision layering tool (applicator) to a thickness of 20 μm, and the dressing (3) was applied. Obtained. Water vapor permeability of the obtained dressing (3) is 1500 g / m ² · 24 h
Met. When left at room temperature for 1 week or longer, the entire dressing turned brown.

(Test Example) The dressings prepared in Examples 1 and 2 and Comparative Example were applied to human skin (upper arm) and peeled off after 24 hours. No swelling was seen. In addition, no appearance of water invading between the skin and the dressing was observed even after bathing. However, in the comparative example, the dressing became dark brown and the state of the wound surface could not be observed.

[0028]

The antibacterial surgical dressing of the present invention comprises:
An antibacterial composition composed of a base material layer having good water vapor permeability and a hypoallergenic adhesive layer, and at least one of which is coated with a core material and made of an aluminosilicate having a metal ion having an antibacterial action. As a result, air and water vapor can be transmitted, but it is possible to prevent the invasion of water and infection by bacteria, and further prevent the wound from being infected without the need to replace the patient when taking a bath or taking a shower. It has excellent stability over time.

Claims (1)

[Claims] 1. A film having a base material layer and an adhesive layer laminated on one surface of the base material layer, the film comprising a core material and a metal ion having an antibacterial action coated on the core material. An antibacterial surgical dressing containing an antibacterial composition comprising an aluminosilicate having