The dressing on the wound

 

The invention relates to medicine and can be used as dressings for wounds. The bandage includes a layer of the device, one side covered with an adhesive elastomer. The layer of the device is made in the form of a laminate, which consists of a plastic film and a material having an irregular surface structure. The technical result consists in the reduction of the area of the elastomeric layer remaining on the skin when removing dressings. 4 C.p. f-crystals, 1 tab., 2 Il.

The present invention relates to a bandage on the wound or attached tape for use on the skin and which includes a layer of the device, covered on one side with an adhesive elastomer.

Thin adhesive dressings for wounds, made of plastic film, permeable to water vapor, such as OpSiTE(Smith&Nephew, UK) or Tegaderm(3M, USA), include adhesive acrylate type or adhesive having such properties. For repeated application and removal of such adhesives are prone to destruction with them part of the upper skin layer (Horny layer) and a bandage of this type can cause damage to the skin. the binding.

In this area also known gauze bandage, with the name of Mepitelwhich is attached to the skin through very soft adhesive silicone elastomer. Silicone elastomer has a skin friendly adhesive properties and is much softer to the skin than the above-mentioned adhesives. He has no tendency to tear off part of the corneal layer when it is deleted. The person wearing this bandage will not experience discomfort or pain when removing dressings. The stickiness of the silicone elastomer is not disturbed when removing the bandage, and thus the bandage can be removed and replaced several times.

Therefore, it would be advantageous if it were possible to replace the adhesives used for plastic films, adhesive elastomer having adhesive characteristics similar to the characteristics of the silicone elastomers used for Mepitelespecially when the bandage is placed on the sensitive skin. One serious problem in this respect is that such elastomers, as has been established, stick to the skin with the same adhesive strength with which they stick to plastic is e when you try to remove the bandages.

One object of the present invention is to solve this problem and create a functional film dressings, which includes a layer of soft adhesive elastomer.

The solution to this problem according to the invention is a bandage on the wound or attached tape for use on the skin, which includes the layer of the device, covered on one side with a soft adhesive elastomer, and which differs in that the layer of the device is a layered material consisting of a plastic film and a material with an irregular surface structure. Because soft adhesive elastomer is attached to the plastic film by using a material with an irregular surface structure, the elastomer will be attached to the film more firmly than otherwise, thereby removing the risk that the elastomer will remain on the skin when removing dressings.

In one embodiment of the invention the material with an irregular surface structure is a nonwoven material, and a soft adhesive elastomer comprises silicone elastomer.

Hereinafter the invention will be described in more detail with reference to the accompanying drawings, in which: Fig. 1 is a schematic view in Pastavy object to determine softness.

Plastic film bandage on the wound, as shown in Fig.1, includes a layer 1 of a plastic film, a thin layer 2 of non-woven material, repressivnogo to the plastic film, and a layer 3 of silicon elastomer.

The plastic film preferably consists of polyurethane film, which is permeable to water vapor, although it is also possible to use other materials plastic films. Nonwoven layer bonded to the plastic film by thermal calendering any other suitable way. The elastomer layer 3 is obtained by applying the above laminate 1,2 silicone-elastomer mixture so that the nonwoven layer facing up, this mixture is applied in a quantity sufficient to fill completely the fibrous structure of the specified non-woven material, and so that the excess elastomeric mixture will form a soft, uniform surface on the upper part of the layered material. Then layered material with a layer of elastomeric mixture is heated up until the elastomer mixture is solidified with the formation of the elastomer. Because silicone elastomer included in the free space between the fibers of the nonwoven material, the elastomer will be otdelnyh layer, from the foregoing it should be understood that the silicone elastomer penetrates the fibrous structure layer 2 up to layer plastic film 1.

Silicone elastomer is preferably an elastomer, available in the retail trade under the name of Silgel 612, which is produced by Wacker Chemie GmbH, Germany. You can also use other soft adhesive silicone elastomers. Although silicone elastomers are preferred because of the good properties of silicone at the wound care can also use other soft adhesive elastomers that are favorable to the skin, such as hydrogels or soft adhesive glue.

As mentioned above, the fibrous structure of the nonwoven material provides an effective attachment of the elastomer and is preferred as a pinning layer. However, other materials having irregular surface structure, such as a dense mesh material, the textile material with an open structure, a thin foam material having open pores, and other relevant materials, can provide sufficiently effective pinning of the elastomer.

By definition, the plastic film has a thickness of 5-100 mm, and kerepesi the g/m2to ensure that the layered material consisting of a plastic film and the pinned layer, will have the desired flexibility.

Of course, the bandage on the wound may be perforated, especially if it includes visibilium strip of absorbent material.

You may also be sterilized using a number of conventional sterilization methods, such as b-sterilization, steam sterilization, or sterilization with ethylene oxide.

The expression "skin friendly adhesion" is used herein to characterize a particular form of attachment shown soft adhesive elastomers suitable for use in this invention.

Typically, adhesive bandages and surgical plasters of different types use different types of pressure-sensitive adhesives that have relatively similar properties. The common characteristic of these commonly used adhesives is that they stick to the extreme layer of dead skin cells (Horny layer) with such strength that the number of layers of these cells will come off the glue from the skin when removing adhesive bandages. Currently used adhesives are mostly adhesives acrylate type, although it is also commonly used for heaven is the dimension of softness, will lie in the range of 7-20 mm, whereas the corresponding values for those adhesives that are typically used with an adhesive bandages, is less than 3 mm, the Depth of penetration is measured by the method based on the method of ASTM D 937 and D 51580. Carried out certain modifications. Used equipment is a penetrometer PNR10, Sommer&Runge KG, Germany. The test object, a weight of 62.5 g, representing a cone weighing 15 g and the reference product number 18-0122 and rod weight of 47.5 g and the reference product number 18-0042, was placed vertically in the penetrometer on top of a cylindrical Cup containing the test material, so that the uppermost part of the cone touches the surface of the test material. Then, the test object was given the opportunity to fall freely down into the cylindrical Cup. The degree to which a test object penetrates into the test material was measured with a gradient time of 5 seconds. Cylindrical Cup had a diameter of 50 mm and a height of 30 mm, the Cup was filled with the test material up to 25 mm

Used according to the present invention a soft elastomer having a skin friendly adhesive properties had significantly weaker adhesive bond with the skin rather than adhesives that are typically used with the biting leave intact Horny layer, when dressing containing such elastomers, peel off or tear. Despite the lower adhesive bond, elastomers nevertheless provide a reliable and positive bonding, i.e., there is a small risk of self-disconnection bandages due to the fact that the softness of the elastomer causes the flow to the skin and thus provides a wide effective contact surface. The softness of the elastomer also leads to increased amounts of energy in the elastomer and its carrier when removing the dressing, which also leads to more positive adhesion to the skin.

To measure the effectiveness of the peel, which is the degree to which the surface of the bandage becomes covered by cells as a result of tearing of the bandage, we conducted an experiment on 10 volunteers. Used four different types of plasters/bandages, namely: Duoderm, OpSite,Leukoporeand the elastomer coated (200 g/m2) non-woven tape. Soft elastomer having a skin friendly adhesive properties, represented the silicone elastomer type. Three testerment peel through the selective staining toluidine cells of the cornified layer, present on the surface remote bandages, followed by determination of the percentage of the surface covered with cells.

The results are evident from the table given at the end of the description.

In order to be a "skin friendly glue, adhesive bandage must have the effectiveness of the peel as a maximum of 10% in the case of normal skin.

Because the bandage, which includes skin friendly adhesive elastomer, to carry only a very limited number of cells of the cornified layer when removing the dressing, the surface automerge layer will be relatively unchanged after removal of the dressing. This gives the possibility of re-applying bandages such as its stickiness does not deteriorate in any appreciable degree. The adhesive surface of the bandage, which otdiraet cells of the cornified layer of the skin, is essentially covered by the cells after removal. This means that the dressing of this kind will not stick to the skin when you try re-applying bandages. Duoderm, OpSiteand Leukoporelose from 70 to 100% of its stickiness, then astir effectively functioned, the force with which it sticks to the skin, must exceed the load, which the bandage or plaster are subjected in normal use. It was found that the adhesion force, which is usually required in this regard that exceeds 0.5 N, measured at the break or OTDELENIE from skin belt width 25 mm at an angle of 135oso that the risk of self-disconnection headbands will not be unacceptably high. The adhesion strength is preferably will exceed 0.8 N/25 mm

The adhesion force for the Duoderm, OpSiteand Leukoporewas measured as 1.2, 2.2 and 0.8 N/25 mm, respectively, while the tape was applied on the back of healthy test and was left for 24 hours. Silicone tape used in the above test OTDELENIE had adhesive strength to skin, comprising 1.5 N/25 mm

Claims

1. The dressing on the wound or attached tape for use on the skin, containing a layer of the device, covered on one side with an adhesive elastomer, which has a skin friendly adhesive properties, characterized in that the layer of the medium p. the RNA structure surface, and the adhesive elastomer deposited on the layer side of the carrier containing material with an irregular surface structure.

2. The dressing on the wound under item 1, characterized in that the material with an irregular surface structure is a so-called non-woven material.

3. Dressing for a wound according to any one of paragraphs.1-2, characterized in that the adhesive elastomer is a silicone elastomer.

4. Dressing for a wound according to any one of paragraphs.1-3. characterized in that the bandage is perforated.

5. The dressing on the wound under item 4, characterized in that the dressing comprises a pad of absorbent material located on the side of the layer of media containing plastic film.

 

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