Multilayer medical film

 

The invention relates to medicine, specifically to polymer the bandages used in surgery for the treatment of wounds, burns, skin injuries of varying severity. Medical tape can be used for the manufacture of atraumatic dressings for damaged skin with high gas and vapor permeability, good biocompatibility, elasticity and transparency. Film made of a biocompatible polymer and consists of an inner layer based on biodegradable sobolifera and two outer layers of a thickness of 5-30 μm, made of biorastvorimym polymer. The inner layer of a thickness of 30-100 μm has an asymmetric structure, which on the one hand non-porous, monolithic, and with the other hand on its surface contains pores and long channels. While the internal pores of the biodegradable layer is filled to a depth h equal 3-30 μm, the polymer material of the outer biorastvorimym layer. Medical film containing biodegradable internal layer of sobolifera may contain medicinal substances of various types: analgesics, antibiotics, asepsis. Medical film has improved adhesion layers, and prevents delamination of the layers. 2 C.p. f-crystals, 1 and evasioni materials used in surgery for the treatment of wounds, burns, skin injuries of varying severity. The invention can be used for the manufacture of atraumatic dressings for damaged skin with high gas and vapor permeability, good biocompatibility.

Known adherent film made of three-ply [U.S. Patent No. 4517173, NCI 424-16, publ. 1985], one of its layers, adjacent to the wound, made of water-soluble cellulose derivatives and contains a medicinal substance, and the second and third layers are made of cellulose derivatives having a low solubility in water and low gas and vapor permeability.

The disadvantage is that this film is only for prolonged drug in the oral cavity, therefore, does not provide a high hygienic properties, requirements for bandages to treat wounds and burns, and it is desired combination detention liquid and high gas and vapor. In addition, the duration of excretion of drugs does not exceed 10 hours, which is insufficient for the treatment of wounds and burns.

Known three-layer bandage [U.S. Patent No. 4759354, NCI 424-13, publ. 1988], which includes the inner layer is about - and vapor-permeable layer.

However, the use of collagen in the inner layer does not provide good adhesion of the dressing to the wound by absorbing moisture and swelling and does not allows you to quickly enter a medicinal substance locally in the affected area (antiseptics, anesthetics) that can only be achieved through dissolution in the exudation of water-soluble polymer. When using collagen difficult to regulate the speed of biodegradation and is only possible due to the structure of the material in a small range.

The closest analogue is a medical armband [RF Patent №2125859, MKI6A 61 L 13/02, publ. 10.02.99,] performed three-layer and adjacent to the wound layer is made of a water-soluble polymer, a second layer of biodestruction material is a copolymer of glycolide and lactide, taken in the ratio of 70:301:100, and as a third layer using oxygen - and vapor-permeable membrane.

The disadvantages of the coating can be attributed to:

- the complexity of the design, consisting of three layers of different types, including manufacturing complexity;

- the possibility of delamination of the water-soluble layer and an inner layer, as in technical operations for the production of coatings, the rhenium.

- excessively rapid dissolution of antiseptics and analgesics;

- the opacity of the coating, due to the opacity of the use of the protective membranes, used as the outer layer.

The present invention solves the problem of improvement of sanitary and hygienic properties of the films due to the use of biodegradable porous structure layer, which also allows to simplify the design of the film due to the exclusion of the outer membrane layer. Besides the claimed design multilayer films can reduce the cost of manufacture due to the use of biodegradable porous structure layer and the same two outer layers of the water-soluble polymer, and also to improve adhesion of the layers and prevent delamination of the layers.

This object is achieved in that the multilayer medical film of biocompatible polymers, consisting of the inner layer on the basis of biodegradable sobolifera and two outer layers of a thickness of 5-30 μm, made of biorastvorimym polymer inner layer of a thickness of 30-100 μm has an asymmetrical structure, which on the one hand, non-porous, monolithic, and with the other hand on its surface contains pores and long channels. If this is about biorastvorimym layer.

To improve the healing properties of medical film biodegradable internal layer of sobolifera and external, adjacent to the wound layer water-soluble polymer may contain medicinal substances of various types: analgesics, antibiotics, antiseptics such as trimekain, gentamicin sulfate, kanamycin, Miramistin, chlorhexidine, dioxidine, etc.

The drawing shows the design of the multilayer medical film.

Multilayer medical film consists of a first outer non-porous layer 1 adjacent to the wound and made of biorastvorimym polymer of a thickness of 5-30 μm. The second, inner, layer 2 with a thickness of 30-100 μm, made of biodegradable sobolifera has an asymmetric structure, with large pores with one side filled with a polymer material of the first outer biorastvorimym layer to a depth h equal 3-30 microns; and on the opposite non-porous monolithic side 3 of the inner layer 2 deposited third layer biorastvorimym polymer 3 with a thickness of 10-15 μm.

The claimed design multilayer medical film allows to provide the necessary sanitary-hygienic requirements to the films for healing wounds and burns, namely when uproshenia, good adhesion to the damaged surface due to moisture absorption and swelling while maintaining flexibility and transparency. Due to partial penetration of water-soluble polymer in the pores of the inner layer improves the adhesion layer, and dissolving facing the wound layer water-soluble polymer is without stratification. The claimed design also allows you to provide her with different morphology, namely depending on the purpose and type of wounds to construct a medical film with different thickness of the biodegradable layer, porosity, average pore size, different drugs. The outer and inner layers collectively perform the role of protecting the wound from pathogenic microorganisms throughout the wound-healing process, and at the same time provides a relatively high permeability of oxygen to the wound, at least 20-25 l/m2hour.

The claimed design multilayer medical film, primarily characterized by the asymmetric structure of the biodegradable layer of sobolifera with different sizes of pores in the layer thickness to guarantee fill with water-soluble material layer. Execution biodegradable layer casinosee 100 μm significantly increased the period of biodegradation of the coating, beyond the healing of wounds that are not profitable, and also reduces the elasticity of medical films.

Execution of the outer layers of biorastvorimym polymer, such as polyvinyl alcohol, less than 5 μm on the technological level is complicated and does not allow for penetration of the polymer into the pores of the inner biodegradable layer to a depth of 3 to 30 μm, and the execution of the outer layers of a thickness exceeding 30 μm increases the time of their dissolution and respectively wound healing. The use of water-soluble PVA layer penetrating into the pores and channels of biodegradable inner layer of sobolifera, helps to ensure the transparency of the porous coating, which is one of the main requirements of such coatings.

The claimed design multilayer medical film and the ratio of the layers as provide the germination of epithelial cells in the large pores of the biodegradable polymer after complete washout of them biorastvorimym polymer that promotes rapid healing of wounds.

The claimed design multilayer medical film obtained as follows.

As the outer layers of the multilayer medical film used biorastvorimy polymer is polyvinyl alcohol which those leading to a smooth liquid film. Cast film is dried at a temperature of 90-95C for 20-40 minutes. The thickness of the PVA layer is 5-30 μm, depending on the purpose of the film is controlled by varying the gap between the polished surface of the substrate and "knife" Spinneret.

For the preparation of molding solution sobolifera in a glass flask with a capacity of 250 ml with a stirrer download soporific in the amount of 15 g, pour the methylene chloride and include mixing. Dissolution of lead for 30-40 minutes at a temperature of 30-40And atmospheric pressure to obtain a transparent homogeneous solution. Later in the flask add the required amount of the mixture of ethyl alcohol and distilled water, which is a precipitant for the polymer, the stirring is continued until a homogeneous solution, and then with continuous stirring to the flask add the plasticizer is glycerin. However, depending on the ratio of components forming the solution layer of the copolymer may have a different porosity, average pore size, and hence, different mechanical strength, elasticity, speed of biodegradation.

Then the obtained PVA film also using a Spinneret is applied Faure the project for him asymmetric patterns, then douchivaetsia at a temperature of 30-40C for 20-40 minutes to remove the solvent. The thickness of 30-100 μm.

Next, on the obtained two-layer coating using also Spinneret light type is applied to an aqueous solution of PVA. After drying of the third layer at a temperature of 90-95C for 20-40 minutes (the thickness of the third layer of 5-30 μm) of the multilayer film is removed from the polished substrate and is directed to the study of the properties, cutting, vacuum degassing, sterilization and packaging.

The obtained multilayer medical coating had a smooth surface without cracks and defects, sufficient mechanical strength, are transparent and elastic.

The claimed design multilayer medical film provides an effective germination of epithelial cells in the large pores of the biodegradable polymer after complete washout of them biorastvorimym polymer that promotes rapid healing of wounds.

Claims

1. Multilayer medical film of biocompatible polymers, consisting of the inner layer on the basis of biodegradable sobolifera, namely copolymer glycolide and lactide is tricou structure, on the one hand is non-porous, monolithic, and on the other hand, the surface pores are present and the long canals filled biorastvorimym polymer of the outer layer to a depth h equal 3-30 μm, while on the opposite non-porous monolithic side of the inner layer third layer biorastvorimym polymer.

2. Multilayer medical film under item 1, characterized in that the thickness of the outer layer is 5-30 μm, and as biorastvorimym polymer for the outer layers of the use of polyvinyl alcohol.

3. Multilayer medical film for PP.1 and 2, characterized in that the inner biodegradable layer sobolifera and/or external adjacent to the wound layer contains a drug.

 

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Patch // 2180857
The invention relates to outdoor applications, namely the patches used for exposure of the skin and smash of deep tissue (internationa and dermatitises), and can be used in medicine as a means of local action, cosmetics, and sports practice

FIELD: medicine.

SUBSTANCE: material has two layers - the first one and the second one. The first one has staple viscose fibers. The second one is manufactured from staple easily fusible thermoplastic synthetic fibers. Both layers are joined to each other under water jet treatment. The second layer fibers partially penetrate into the first layer and fixed therein. The second layer surface is melted and turned outward. It becomes smooth under temperature and pressure treatment. The non-woven material has high absorbing capacity.

EFFECT: low risk of traumatic complications.

5 cl, 2 dwg

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