RU139960U1 - MEDICAL FOAM POLYURETHANE COATING AND DEVICE FOR ITS APPLICATION (OPTIONS) - Google Patents

Abstract

1. Medical polyurethane foam coating for the treatment of burns, wounds or other skin injuries, formed from a mixture of the starting components directly on the damaged skin surface to obtain a voluminous foam structure with a cured outer layer and with an elastic inner layer, characterized in that the foam structure is made mainly with open-cell porosity, and the inner coating layer in contact with the skin contains two zones: an adhesive zone in contact with intact skin, and low adhesion hydrochloric zone enriched polyurea contacting the surface of the damaged skin (wound), wherein as the mixture of starting components a mixture based on a polyol and an isocyanate component in a ratio of (3.0-3.5): 1.2. Medical polyurethane foam coating according to claim 1, characterized in that it is made with a surface density of (0.10-0.20) g / cm. 3. Medical polyurethane foam coating according to claim 1, characterized in that it is made with open-cell porosity, which is up to 98 vol.% And with a moisture capacity of up to 100% .4. The medical polyurethane foam coating according to claim 1, characterized in that the adhesive characteristic value in the adhesive coating zone is at least 60.0 N / m. Medical polyurethane foam coating according to claim 1, characterized in that the composition of the following composition is used as a polyol as one component, parts by weight: 6. The medical polyurethane foam coating according to claim 1, characterized in that a composition with the content of isocyanate groups of 26.0-32 wt.% Is used as an isocyanate component. Medical polyurethane foam according to claim 1, characterized by

Description

The utility model relates to medicine, in particular to polymer-based dressings. Medical polyurethane foam coating is intended for closing wounds, burns or other skin injuries with self-help and mutual assistance, mainly prior to primary surgical treatment, since it protects wounds from external contamination, secondary microbial contamination, adverse environmental influences and trauma. And after the initial surgical treatment, the coating can be used at the hospital stage for the further treatment of wounds, burns, trophic ulcers, pressure sores, etc.

Known biomedical product developed by Bayer (DE), disclosed in the patent application RU 2008143908 (A61L 5/26) published 05/20/2010. A biomedical foam structure consists of a porous material with a partially present open pore structure. The specified biomedical product with a foam structure is obtained in the form of a coating by spraying the liquid composition directly on the skin, in particular on the wound, and curing it from the liquid phase into a solid product with a foam structure in no more than five minutes. The composition includes an ionic polymer dispersion or emulsion, as well as a coagulant. In this case, the ionic polymer dispersion or emulsion is selected from aqueous polyurethane dispersions, aliphatic polyurethane dispersions and polyurethane hybrid emulsions. The disadvantage of a biomedical product is that the urethane formation reaction is carried out previously before the manufacture of the polymer dispersion. And in the process of applying to the skin in the composition of the composition, pre-prepared and dispersed polyurethane foam introduced into the secondary foam carrier is used. This technology does not ensure self-sterilization of the coating material at the time of coating, disinfection of the wound surface and the adjacent surface of the skin, which can cause complications in the treatment process.

The closest analogue of the claimed utility model is a gel-like polyurethane foam dressing for closing wounds of various etiologies, known from the RF patent for the invention RU 2379060 (A61L 5/26, A61F 13/15), published on 01/20/2010. A gel-like polyurethane foam dressing is obtained and applied to the wound directly in the application process, which ensures sterile closure of the wound, both in clinical and in extreme field conditions. The dressing has an open-cell porous structure, which ensures the absorption properties of the dressing and allows you to remove wound. This dressing can be applied to the entire surface of the wound, regardless of its configuration and size.

The specified gel-like dressing made of flexible polyurethane foam was obtained by mixing a polyol as one component, including a high molecular weight simple oligoester polyol based on propylene oxide and ethylene oxide, water, an urethane forming activator, and an isocyanate component including a mixture of diphenylmethane diisocyanate isomers, an activator of a polyurethane extender, consisting of and foam hardener. Moreover, a blowing agent is additionally introduced into the activation additive, and a mixture of tertiary amines and organotin compounds is used as activator at a ratio of 1: 1 (parts by weight). When mixing these components receive a composition of the following composition, parts by weight:

high molecular weight oligoester polyol one hundred; water 2.0-4.0; blowing agent 2.0-4.0;

urethane-forming activator (a mixture of tertiary amines and organotin compounds at a ratio of 1: 1 (parts by weight)) 0.05-0.4;

chain extension 0.2-1.5; foamer 0.2-1.5; foam hardener 0.2-1.5;

the isocyanate component 30-60 when the content of isocyanate groups of 26.0-32 wt.%.

The disadvantage of the gel-like polyurethane foam dressing known from the RF patent for the invention RU 2379060 is the insufficient study of the requirements for the structure and properties of the finished product - medical polyurethane foam coating, as well as the lack of convenient means for applying medical polyurethane foam coating in the field and during hospital treatment in a hospital.

For the application of medical polyurethane foam coatings, both disposable and reusable devices for emergency medicine and for the use of coatings for treatment in stationary conditions are currently required.

A flexible packaging container is known from the prior art that can be used both for separate storage of chemical components and for the production of medical polyurethane foam coatings. The container is mainly intended for use as containers for packaging, separate placement and long-term storage of several components of a complex composition with the possibility of obtaining this composition by mixing the components directly in the same container. (See patent RU 2457992, 08/10/2012, B65D 81/32). The flexible packaging container contains at least two sealed sections, made with the possibility of communication between them by removing the septum, as well as means for outputting the finished composition. The container contains a buffer zone, in the form of an additional section in which an adapter for mixing the components is placed, these sealed sections are connected to the buffer zone with removable partitions, the possibility of communication of the sealed sections with each other is provided through the buffer zone by sequential elimination of the partitions, and the end faces of the container are rounded . The specified invention relates to packaging for separate placement and long-term storage of several, including liquid, components of a complex composition with the possibility of obtaining this composition in the same container in which they were stored. Packaging is intended for use in the chemical industry, in pharmaceuticals, in the food industry and in other industries.

This packaging container can also be used to obtain a medical polyurethane foam coating, however, the presence of a buffer zone and adapters complicates the use of this device when applying coating to treatment objects. In addition, the known packaging container is a disposable device that is not suitable for applying a medical coating to large areas of the damaged skin surface. To close extensive skin lesions, the doctor has to apply 3-4 or more disposable packs, and preparation for the use of each of them requires time and physical effort, which is inconvenient, especially in emergency conditions for first aid.

To cover extensive damage, it would be more convenient to apply a medical coating from a large container, for example, from an aerosol can, which can be made in a wide range of sizes, and can also be used repeatedly provided that it is equipped with disposable means (nozzles) to bring out the finished coating composition. However, prior art aerosol can designs for applying a two-component medical polyurethane foam coating are not known.

Utility Model Essence

The claimed utility model is aimed at optimizing the treatment of various types of burns and wounds, as well as other skin injuries using medical in situ polyurethane foam coating and at creating convenient reusable and disposable devices for applying medical polyurethane foam coating.

The utility model solves the problem of developing the optimal structure of a medical polyurethane foam coating that protects wounds from external contamination, secondary microbial contamination, adverse environmental influences, as well as trauma, does not cause pain when changing dressings or damage to the epithelium of the newly formed tissue.

The technical result of the utility model is to increase the effectiveness of the treatment of burns, wounds and other skin injuries when using a medical polyurethane foam coating of improved structure, which provides the creation and control of an optimal wound healing environment, using the claimed devices, which provide the possibility of more rapid medical care in extreme conditions and more effective treatment in a medical facility.

To solve this problem, a medical polyurethane foam coating has been declared for treatment, burns, wounds or other skin injuries, formed from a mixture of the starting components directly on the damaged skin surface to obtain a voluminous foam-like structure with a cured outer layer and with an elastic inner layer. In this case, the foam-like structure of the coating is made mainly with the open-cell structure of the pores of the inner layer, and the coating layer in contact with the skin contains at least two zones: an adhesive zone in contact with intact skin and a low adhesion zone enriched in polyurea in contact with a moist surface damaged skin (wounds). As a mixture of the starting components, a mixture based on the polyol and isocyanate components is used in the ratio (3.0-3.5): 1.

The medical polyurethane foam coating should preferably be made with a surface density (0.1 ÷ 0.2) g / cm ³ and the open-cell pore structure of the pores of the inner coating layer should preferably be up to 98% by volume. The developed medical polyurethane foam coating has a high moisture capacity, up to 100% vol.

The adhesive characteristics of the medical polyurethane foam coating in the adhesive zone is at least 60.0 N / m.

In the claimed medical polyurethane foam coating, as a starting polyol as one component, the composition of the following composition was used in parts by weight:

high molecular weight polyol foam control one hundred; water 2.0-4.0; blowing agent 2.0-4.0; urethane activator 0.05-0.4; chain extension 0.2-1.5; foamer 0.2-1.5; foam hardener 0.2-1.5.

As the initial isocyanate component in the claimed medical polyurethane foam coating, a composition was used with a content of isocyanate groups of 26.0-32 wt.%.

Medical polyurethane foam coating in the claimed range of the content of the starting components provides the temperature on the inner surface of the coating in contact with the skin during the formation of foam in the range of 36-43 ° C.

In the mixture of the starting components of the medical polyurethane foam coating, additives and / or fillers can be additionally added to match the specific application of the coating to optimize the healing properties.

For example, the claimed medical polyurethane foam coating in the composition of the initial composition may additionally contain additives and fillers selected from the group consisting of carbon (powdered activated carbon), boehmite (powder), chitosan, colloidal silver or other sources of silver ions, antibiotics, drug additives for special purposes , dyes (in a minimal amount). Additives and fillers can be introduced into the initial coating composition in an amount of not more than 0.1-20 wt.% By weight of the polyol as one component.

The introduction of dyes into the initial polyol as one component allows you to visually index specific coating compositions in the range of their practical application, while the dye will be included in the inert (insoluble) polymerization product, that is, it will not affect the skin when applying the coating.

Staining the proposed medical polyurethane foam coating in different colors allows us to identify compositions in the process of their application that differ from each other in the ratio of the input components. The choice of the ratio of the components within the stated limits allows us to specialize the obtained compositions according to the optimality of their physicochemical properties for specific types of medical use, for example, the optimal coating properties for treating burns differ from the optimal coating properties for treating purulent wounds.

In particular, the introduction of a carbon additive (powdered activated carbon) colors the coating black. Medical polyurethane foam coating with a carbon additive has a high absorption and is intended primarily for the treatment of purulent wounds.

For the treatment of burns, a medical polyurethane foam coating with a lower reaction temperature of urethane formation, preferably equal to 36 ° C, is required. To identify the composition in the practical application of the coating for this purpose, it is tinted in blue.

To stop bleeding and bactericidal treatment of the wound, a medical polyurethane foam coating with an increased reaction temperature of urethane formation, preferably equal to 43 ° C, is required. To identify the composition in the practical application of the coating for this purpose, it is tinted in orange.

Similarly, coatings for veterinary use are tinted green, and coatings intended for the treatment of children are painted bright red or yellow.

Another advantage of medical polyurethane foam coating is that it self-sterilizes at the time of mixing the starting components.

After mixing the starting components, the medical polyurethane foam coating meets the following time criteria:

- the time from the beginning of the mixing of the components to the formation of a white mixture - (16 ÷ 24) sec.,

- coating lifting time - foam formation process - (120 ÷ 150) sec.,

- polymerization time - curing process of the coating (15 ÷ 25) min.

Medical polyurethane foam coating can be applied using a disposable or reusable device.

A disposable device for applying a medical polyurethane foam coating from a mixture of the starting components is made in the form of a flexible container containing at least two sealed sections, one of which contains the polyol as one source component, and the other isocyanate source component in the ratio (3.0-3, 5): 1, while these sections are separated by a partition made with the possibility of eliminating at least part of the specified partition, as well as means for outputting the mixture of the original components nt foamy structure with obtaining a coating for closing wounds, burns or other skin lesions.

In a disposable device for applying medical polyurethane foam coating, the partition is made in the form of a weld of a given strength, which is revealed (by delamination) with increasing pressure in at least one of the sections.

A disposable device for applying a medical polyurethane foam coating may contain an additional section, while the sealed sections for accommodating the initial components are connected to the additional section with removable partitions, and the possibility of communicating the sealed sections to each other is provided through the additional section by sequential elimination of the partitions. An additional section allows you to enter various additives into the composition of the medical polyurethane foam coating provided for by its formulation.

The additional section may be made in the form of one or more intermediate sections arranged in parallel. The additional section can be made in the form of several intermediate sections arranged in series.

A disposable device for applying a medical polyurethane foam coating can be made composite of separately manufactured sections made of various polymer or multilayer composite materials, in particular, combined multilayer materials. At least one of the container sections is made of a multilayer metal-polymer material, in particular a three-layer material with an inner layer of aluminum foil and with outer layers of polyethylene and / or polypropylene. Moreover, another section of the container is made of a transparent polymeric material, in particular, of a polyethylene film 200-300 microns thick.

In another embodiment, in a disposable device for applying a medical polyurethane foam coating, one or more of its flexible sections can be made of a barrier polymer film or a fluoropolymer-containing polymer film.

The single-use device for applying medical polyurethane foam coating has a tubular shape and is formed of at least one strip of polymeric material by welding (heat welding or ultrasonic welding), and its end side is closed with a 1.5–3 cm wide weld that opens when pressure increases inside the container, acting as a means of outputting the finished composition.

The outward means of the mixture of the initial components of the foam-like structure can be made in the form of a plug-sleeve, or in the form of an injector, or in the form of a metering device, or in the form of a pipette, or in the form of a sprayer. In another embodiment, the means for outputting the mixture of the initial components of the foam structure to the outside can be made in the form of a notch on the external weld.

As mentioned above, a single-use device for applying a medical polyurethane foam coating may contain a notch on an external weld as a means for outputting a mixture of the initial components of the foam-like structure, while in the notch zone the seam has a curved shape with a protrusion located opposite the notch.

The device may further comprise a backup zone in the form of an empty section adjacent to the end face of the container.

In an optimal embodiment, a disposable device for applying a medical polyurethane foam coating from a mixture of starting components is made in the form of a flexible container containing at least two sealed sections, one of which contains a polyol as one source component, and the other isocyanate source component in the ratio (3.0 -3.5): 1, while these sections are separated by a partition made with the possibility of eliminating at least part of the specified partition, as well as means for outputting a mixture of the initial components of the foam-like structure to obtain a coating for closing wounds, burns or other skin lesions, which is made with open porosity, and the inner coating layer in contact with the skin contains two zones: a peripheral adhesive zone in contact with intact skin, and a low adhesion zone, enriched with polyurea in contact with the moist surface of damaged skin (wounds).

A device for applying medical polyurethane foam coating can be made with the possibility of reusable use, for example in the form of an aerosol can or cartridge-syringe.

A reusable device for applying a medical polyurethane foam coating comprises a housing, a mixing chamber with an opening for expelling from the mixing chamber a mixture of the initial components of the foam-like structure to obtain a coating. In this case, the housing contains at least two sealed sections, one of which contains a polyol as one, and the other isocyanate component in the ratio (3.0-3.5): 1, these sections are equipped with tubes for outputting the initial components through the valve into the mixing chamber , as well as a means for displacing the starting components from these sections into the mixing chamber.

The casing of this device can be made in the form of an aerosol can, with at least two flexible polymer containers placed under pressure inside the can as airtight sections, one of which contains a polyol as one, and the other isocyanate component in the ratio (3.0-3 , 5): 1. These containers are equipped with tubes for outputting the starting components through a spray valve into the mixing chamber.

In another embodiment, the housing of a refillable device for applying a medical polyurethane foam coating can be made of at least two aerosol cans equipped with a common mixing chamber with an opening for removing from the mixing chamber a mixture of the initial components of the foam-like structure, while the inner cavity of each cylinder is a sealed section made with the possibility of placing in it under pressure one of the starting components, so that in at least one cylinder p a polyol as one is placed, and in the other a isocyanate component in the ratio (3.0-3.5): 1, these sections are equipped with tubes for discharging the initial component placed in them through the spray valve into the mixing chamber. Aerosol containers can be more than two, for example, in the case when, according to the formulation of the polymer coating, additives or fillers are introduced into its composition, which can be introduced into the mixing chamber from additional cans.

For the convenience of moving the device, aerosol cans can be interconnected (with a clamp, tube, etc.) and / or mounted on a common base.

In the claimed device, the polyol as one and the isocyanate components can be placed inside aerosol cans either poured into the body in contact with the propellant gas, or in flexible polymer containers isolated from the expelling gas (propellant).

In another embodiment, the manufacture of the inventive reusable device for applying medical polyurethane foam coating its body can be made in the form of a cylindrical cartridge-syringe containing at least two sequentially placed sealed sections separated by a movable piston gasket, while in one section there is a polyol and in the other, the isocyanate component in the ratio (3.0-3.5): 1. In the cartridge, the channels for outputting the initial components from each section are brought to one end of the housing, and a piston with a rod is installed from the opposite open end. The cartridge syringe rod, for ease of use, can be connected with a mechanical drive, made, for example, in the form of a metering gun. Channels for the output of the original components are displayed on the end of the housing (cartridge) in the form of two separate conclusions - fittings (spouts) or in the form of a single fitting separated by a partition.

A reusable device for applying a medical polyurethane foam coating may contain a housing that is made in the form of a double cartridge syringe containing two sealed sections made in the form of two separate cartridges, while a polyol as one and an isocyanate component are placed in one cartridge in the ratio ( 3.0-3.5): 1. Then, each cartridge at one end is made with a piston mounted on the rod, and at the other end with a channel with a fitting for removing the initial component, the outputs of these channels being detachably connected to the mixing nozzle, which serves to bring out the mixture of the initial components of the foam structure to obtain coverings. These cartridges can be mounted on a common tool tray and connected by a common piston drive mechanism.

Cartridges in the device can be installed adjacent and parallel and placed in a common tube, while the channels for outputting the initial components at the output are interconnected and removed from the tube in the form of one common fitting (spout).

The mixing chamber of a reusable device for applying medical polyurethane foam coating is made in the form of a replaceable (disposable) container with an outlet on one side, and on the other side it is mounted on the above device on aerosol cans with the possibility of detachable fixing it.

The mixing chamber may be provided with means for mixing the starting components, which is made in the form of a comb shaft, rotor blade or in the form of a static mixing nozzle.

The mixing nozzle (static) for a reusable device for applying medical polyurethane foam coating is a replaceable disposable accessory product and can be installed on the nozzle of the cartridge syringe or on the outlet of the mixing chamber. For this, in its design provides two options detachable connection. The mixing nozzle is made in the form of a tube, the inner surface of which is provided with combs from the partitions and / or the nozzle is provided with an internal axis with a comb made of partitions applied to it. The specified internal axis can be made to rotate from an external drive, for connection with which it is provided with a pin.

The utility model is illustrated by figures 1-14.

FIG. 1 in section shows the structure of the claimed medical polyurethane foam coating.

In FIG. 2 shows a disposable device for applying a medical polyurethane foam coating, which is made in the form of a flexible container.

In FIG. Figure 3 shows a sectional view of an aerosol can into which two flexible polymer containers are immersed, one with a polyol and one with isocyanate components.

In FIG. Figure 4 shows a sectional view of a refillable device made in the form of twin aerosol cans, in which the polyol and isocyanate components are filled into cans without polymer containers.

In FIG. 5 shows a refillable device containing dual aerosol cans into which the starting components are immersed in flexible polymer containers.

FIG. 6 shows a refillable device comprising a dual cartridge syringe, wherein the cartridge syringe chambers are provided with two separate nozzles for withdrawing coating components.

In FIG. 7 shows a refillable device comprising a dual cartridge syringe, wherein the cartridge syringe chambers are provided with one common nozzle for discharging a mixture of coating components.

In FIG. 8 shows a dual-chamber syringe cartridge with separate nozzles.

In FIG. 9 shows a two-chamber syringe cartridge with one joint spout for withdrawing two components.

In FIG. 10 shows a mixing chamber mounted on a twin aerosol can, with two aerosol valves located opposite each other for mixing the counter-sprayed components, and with a free exit of the polyurethane foam product through the outlet.

In FIG. 11 shows a mixing chamber equipped with a mixing nozzle with obstacles randomly located on the inner surface in the form of a comb of incomplete partitions, ridges, lintels, etc.

In FIG. 12 shows a mixing chamber equipped with a mixing nozzle made with an internal axis on which a comb of partitions is located.

In FIG. 13 shows a mixing chamber equipped with a mixing nozzle with an internal axis on which a comb of partitions is located, and for better mixing of the components, the internal axis is provided with a pin for interaction with an external rotation drive.

In FIG. 14 shows a mixing chamber equipped with a mixing nozzle with a comb on the inner surface of the output tube and an internal axis with a comb from partitions, as well as with a pin for interaction with an external rotation drive.

In FIG. 15 shows the steps of applying the claimed medical polyurethane foam coating in the treatment of a long-term non-healing wound on the outer surface of the foot, complicated by suppuration, in a patient with diabetes.

In FIG. 16 shows the use of the claimed medical polyurethane foam coating in the treatment of burn injuries of the hand.

The claimed medical polyurethane foam coating operates as follows.

In FIG. Figure 1 shows a sectional view of a medical polyurethane foam coating applied in laboratory conditions to a wound model (steel substrate with a drop of iodine solution). As shown in FIG. 1, the medical polyurethane foam coating has a voluminous foam structure with a cured outer layer 1 of a thickness of 1-2 mm. The cured outer layer 1 of the medical polyurethane foam coating is tough and acts as a “shell” that protects the wound from all external influences, from trauma, from external pollution, from secondary microbial pollution and other adverse environmental influences. The outer layer 1 of the coating is low porosity and finely porous. Medical polyurethane foam, in a preferred embodiment, has a surface density (0.1 ÷ 0.2) g / cm ³ .

In this case, the inner layer 2 of the medical polyurethane foam coating is flexible and large-pore. The inner layer 2, which penetrates the wound, has sorption and heat-shielding properties. The foam-like sponge structure of the coating layer 2 is made mainly with an open-cell pore structure, which is 90-98 vol.%. The open-cell pore structure of the claimed medical polyurethane foam coating provides it with high moisture capacity, which is very important, for example, for the treatment of burns. The moisture content of the coating is up to 100 vol.%.

The skin contact layer contains at least two zones: an adhesive zone 3 in contact with intact skin and a low adhesion zone 4 enriched with polyurea in contact with the moist surface of the damaged skin (wound). The value of the adhesive characteristics of the medical polyurethane foam coating in the adhesive zone 3 is not less than 60.0 N / m Low adhesion zone 4 is enriched with polyurea in the interaction of water from the native plasma with isocyanates. Thus, zone 4 has hydrophobic properties, and due to the boundary formation of polyurea during dressing, this zone contributes to the spontaneous separation of the polyurethane dressing from the wound surface, which provides a painless change of dressing without damaging the epithelium or newly formed tissue.

In FIG. 2 shows a disposable device for applying a medical polyurethane foam coating, which is made in the form of a flexible polymer container containing two sealed sections 5 and 6, one of which contains a polyol as one component, and the other as an isocyanate component in the ratio (3.0-3 , 5): 1. These sections 5 and 6 are separated by a partition 7 made with the possibility of eliminating at least a portion 8 of the partition. The partition 7 is made in the form of a weld of a given strength, revealed by delamination in the weakened section 8 of the weld with increasing pressure in at least one of the sections.

When separately placing the polyol as one of the isocyanate components, the device is stored for an expiration date. If you need to use the finished product, which is obtained by mixing the starting components, proceed to manually mix them directly in the device where they were stored. To do this, press with your hand on one of the sections in which the liquid polyol or isocyanate starting component is placed. As you know, the pressure produced by a liquid is transmitted to any point of the liquid or gas in the same way in all directions, including to the partition 7 and to the section 8 of weakened strength. Under pressure, section 8 is destroyed by delamination of the weld, while maintaining the integrity of the significantly stronger walls of the container and the external strong butt welds forming the container body. Then, the pressure is continued alternately by pressing by hand on sections 5 and 6. Thus, the components are mixed to obtain a gel-like foamed polyurethane composition, ready for output to the outside when removing the notch 9. After removing the notch 9, the gel-like foamed polyurethane composition is applied from this disposable device to the patient’s wound concentric movements from the center to the periphery to obtain the claimed medical polyurethane foam coating, which fill the entire surface of the wound and adjoining A portion of healthy skin that is adjacent to it is of sufficient width to fix the coating on the patient's body (1-2 cm).

Note that the means for bringing out the mixture of the starting components of the claimed coating to the outside can be in the form of a plug-sleeve, or in the form of an injector, or in the form of a metering device, or in the form of a pipette, or in the form of a sprayer. As shown in FIG. In the second embodiment, the means for bringing out the mixture of the starting components of the medical polyurethane foam coating is made in the form of a notch 9 on the external weld.

In FIG. 3 shows a sectional view of a reusable device for applying the claimed medical polyurethane foam coating from an aerosol can 10 filled with gas under pressure into which two polymer containers are immersed. The container 11 is filled with a polyol as one component, and the container 12 is filled with an isocyanate starting component. Containers 11 and 12 are connected through tubes 13 and 14 to a mixing chamber (not shown in the drawing) in which a urethane formation reaction occurs when the initial polyol and isocyanate components are mixed from containers 11 and 12.

In FIG. 4 shows a reusable device for applying a medical polyurethane foam coating in the case when its body is made of at least two aerosol cans 15 and 16, equipped with a common mixing chamber (figure 10). The internal cavity of each cylinder is a sealed section, made with the possibility of placing in it under pressure one of the source components. So, in the cylinder 16, the polyol as one component 17 is placed, and in the cylinder 15 the isocyanate component 18 is placed in the ratio (3.0-3.5): 1. The cylinders 15 and 16 are provided with tubes 19, 20 for outputting the initial component through the corresponding valve of the atomizer 21 and 22 into the mixing chamber. Polyol and isocyanate components are filled into cylinders without the use of polymer containers and are in contact with an inert displacing gas (propellant).

In FIG. 5 shows a refillable device containing twin aerosol cans 23 and 24 filled with gas under pressure, into which the original polyol and isocyanate components are immersed in flexible polymer containers 25 and 26 made of a barrier film, each of which is connected by a tube 27, 28 to a valve 29, 30 on the cap of each cylinder.

In Fig. 6, the claimed reusable device is shown, in the case when its body is made in the form of a double cartridge syringe. Cartridges 31 and 32 are placed adjacent and parallel to each other. A polyol as one component is placed in the chamber of the cartridge 32, and an isocyanate component is placed in the chamber of the cartridge 31, the chambers of the cartridge syringe having separate nozzles 33 and 34 for withdrawing said components. The means for displacing the coating components from the chambers of the cartridge-syringe are pistons 36, 36 connected to the drive by rods 37, 38.

In FIG. 7 shows a reusable device, in the case when its body is made in the form of a double cartridge-syringe, and the cartridges 39, 40 are installed adjacent and parallel to the common tube 41. A polyol component is placed in the chamber of the cartridge 39 and an isocyanate component in the chamber of the cartridge 40 component, while the channels 42 and 43 for removing the source components are interconnected and removed from the tube in the form of one common fitting 44.

In FIG. 8 shows the inventive reusable device, the housing of which is made in the form of a cartridge syringe. The cylindrical cartridge 45 of the device contains two sequentially placed sealed sections 46 and 47, separated by an intermediate piston 48, while in section 47 there is a polyol as one component, and in section 46 is an isocyanate component in the ratio (3.0-3.5): 1 . Channels 49 and 50 for outputting the initial components are brought to one end of the housing, and a piston 51 with a stem 52 made with a longitudinal groove is installed from the opposite open end.

In FIG. 9 shows a two-chamber syringe cartridge similar to that shown in FIG. 8, characterized in that it is made with one fitting 53 containing a dividing wall.

In FIG. 10 shows a mixing chamber that can be mounted on an aerosol can, for example, as shown in FIG. 3. When installing the mixing chamber on an aerosol can, the heads of the spray nozzles 55, 56 are oriented so that their nozzles are located opposite each other to mix the counter-sprayed components. After mixing in the volume of the mixing chamber, a urethane formation reaction takes place, and through the hole 57 a foamy gel-like reaction product is freely released to obtain the claimed medical polyurethane foam coating. To act on the spray valves in the claimed device provides a drive (mechanical, electrical or electromechanical, etc., not shown). A mechanical drive, in particular, can be made in the form of a bar acting immediately on two heads. At the same time, an opening is provided in the housing of the mixing chamber for withdrawing the rod interacting with the specified bar. A seal is installed between the stem and the walls of the indicated hole. In another embodiment, a jumper can be fixed on the inner surface of the wall of the mixing chamber, which automatically presses the spray valve heads 55, 56 when the mixing chamber is mounted on an aerosol can. The mixing chamber is a disposable component product with respect to the claimed device, therefore, the starting device variant in the form of a jumper or symmetrical protrusions automatically pressing the spray valve heads 55, 56 is preferred in emergency situations when using the device.

In FIG. 11 shows a mixing chamber 58 provided with a mixing nozzle 59 made in the form of a static mixer detachably connected to the output of the mixing chamber. The mixing nozzle 59 is made in the form of a tube, the inner surface of which is provided with combs from the partitions 61. The comb is randomly located obstacles in the form of incomplete partitions, ridges, jumpers, etc., placed on the inner surface of the nozzle.

In FIG. 12 shows a mixing chamber 62 provided with a mixing nozzle 63 made in the form of a static mixer detachably connected to the output of the mixing chamber. The mixing nozzle 63 is made in the form of a tube equipped with an internal axis 64 provided with combs from the partitions 65.

In FIG. 13 shows a mixing chamber 66 provided with a mixing nozzle 67 made in the form of a static mixer detachably connected to the output of the mixing chamber. The mixing nozzle 67 is made in the form of a tube equipped with an internal axis 68, on which combs from partitions 69 are located. Moreover, the internal axis of the static mixer is made to rotate from an external drive by connecting with the rod 69.

In FIG. 14 shows a mixing chamber 70 provided with a mixing nozzle 71 made in the form of a static mixer detachably connected to the output of the mixing chamber. The mixing nozzle 71 is made in the form of a tube, on the inner walls of which combs 72 are located. The mixing nozzle 71 is provided with an internal axis 73, on which combs from partitions 74 are located. Moreover, the internal axis of the static mixer is rotatable from an external drive by connecting to the rod 75.

The utility model is illustrated by the following examples.

Example 1

The claimed medical polyurethane foam coating was used to treat a 6x4 cm long non-healing wound on the outer surface of the foot, complicated by suppuration, in a patient with diabetes. (Fig. 15A). The medical polyurethane foam coating was applied using the reusable device shown in FIG. 3 made in the form of an aerosol can 10 filled with gas under pressure. In the housing of the cylinder 10 placed two polymer containers. The container 11 is filled with a polyol as one component, and the container 12 is filled with an isocyanate component in a ratio of 3: 1. As the polyol as one component used the composition of the following composition in parts by weight:

a foam regulator containing a high molecular weight polyol, one hundred; water 3.0; blowing agent 3.0; urethane activator 0.25; chain extension 1.0; foamer 1.0; foam hardener 1,0.

As the initial isocyanate component in the claimed medical polyurethane foam coating, a composition based on phenylmethanediisocyanate with an isocyanate group content of 30 wt.% Was used.

The initial components of the indicated composition are mixed with each other by their counter spraying in the mixing chamber. When the spray valve heads 76 and 77 are pressed, the initial components of the above composition are pressurized from containers 11 and 12 through tubes 13 and 14 in the direction of the mixing chamber, which is shown in FIG. 12. The mixing chamber is detachably mounted on the lid of the aerosol can 10. For pressing the heads of the spray valves, a mechanical drive is used in the form of a strap fixed to a rod inserted through a side hole into the housing of the mixing chamber and equipped with a handle. The heads 76 and 77 of the spray valves are oriented with nozzles towards each other. After clicking on the indicated heads 76 and 77, the spray valves open and spraying and primary mixing of the starting components takes place in the mixing chamber 62. As a result of mixing the opposite flows of the polyol and isocyanate components coming under pressure from the containers 11 and 12 of the aerosol can, an urethane formation reaction is actively taking place, accompanied by foaming. At the outlet of the mixing chamber, a mixing nozzle 63 is additionally installed to improve mixing of the coating components and grinding the foam structure, which improves the physicomechanical properties of the coating material. Through the open end of the static mixer, gelled foam is applied directly to the wound (Fig. 15B). The result is a voluminous foam-like coating structure with a cured outer layer (curing time 16 min) and with an elastic inner layer that has open-cell porosity. In this case, the inner coating layer in contact with the skin contains two zones: an adhesive zone in contact with intact skin and a low adhesion zone enriched with polyurea in contact with the wound surface. Polyurea is formed due to the interaction of water contained in the native plasma with isocyanates. Despite the hydrophobic properties of the polyurea layer, wound is transported through it into the elastic spongy inner layer of the coating due to micropores associated with the Plateau-Gibbs channels. The application of the claimed coating shows the effect of inhibiting the colonization of the microbial flora by 1.5-2 times, which is associated with the bactericidal action of the residual epoxy groups formed in the polyol as one component of the polymerization reaction, which ultimately self-sterilize the polyurethane foam composition of the claimed coating.

In the example, we used a coating composition that provides a temperature on the skin surface during application of 42 ° C to improve the effect of bactericidal treatment. The coating height was 20 mm, the surface density was 15 g / cm ³ , and the moisture capacity was 100%. Replacement of the coating was carried out once a week. Change of coverage is painless, because peeling of the coating from the wound surface due to swelling took place. On the 24th day after the start of treatment, the wound completely healed (Fig. 15C).

Example 2

A medical polyurethane foam coating was used to treat a burn of the hand, which makes up 15% of the body surface.

For coating, the device shown in FIG. 7. This is a refillable device, the case of which is made in the form of a double cartridge-syringe, and the cartridges 39, 40 are adjacent and parallel to the common tube 41. In the chamber of the cartridge 39 there is a polyol component, and in the chamber of the cartridge 40 is an isocyanate component in the ratio of 3 5: 1. At the same time, the channels 42 and 43 for removing the initial components are interconnected in an expanded section and removed from the tube in the form of one common fitting 44. A mixing nozzle (static mixer) is installed on the fitting 44, made in the form of a tube, the inner surface of which is provided with combs. In addition, in the nozzle cavity there is a central axis, the surface of which is also provided with combs from the partitions. During the operation of the device, the piston rods of the cartridge-syringe interact with a mechanical drive in the form of a metering gun, and the polyol and isocyanate components are displaced from the cartridges 39, 40 through channels 42, 43, 44 into the cavity of the mixing nozzle, where swirling and mixing flows , as a result of the mixing of the components, a urethane formation reaction proceeds to produce a foamed gel-like material of a medical polyurethane foam coating. Foamed material was applied to the burned hand to obtain a glove-shaped coating (See FIG. 16).

The surface of the wound is not infected. For treatment, a single application of a polyurethane foam coating was enough. The coating composition was used to ensure the temperature on the skin surface during the application of 36 ° C, to exclude thermal effects on the burn surface.

In accordance with examples, the utility model discloses a new effective dressing based on polyurethane foam. The resulting medical polyurethane foam coating is applicable for closing wounds, burns and other skin lesions (trophic ulcers, pressure sores, etc.) both in emergency conditions and during hospitalization. It perfectly protects wounds from external pollution, secondary microbial contamination, adverse environmental influences and traumatization. In addition, the use of the claimed utility model allows to optimize the treatment of various types of burns and wounds. Convenient reusable and disposable devices for applying medical polyurethane foam coating have been created. The problem of optimizing the structure of a medical polyurethane foam coating, performed directly on the wound in situ from the starting components, has been solved. Change and coating does not cause pain, and the change of coating proceeds without damage to the epithelium of the newly formed tissue.

Improving the structure of the medical polyurethane foam coating provides optimal wound healing moisture for healing while maintaining the minimum possible amount of wound exudate on the wound surface.

The use of the claimed disposable and reusable devices provides the ability to more quickly provide medical care in extreme conditions and more effective treatment in a medical facility.

Claims (45)

1. Medical polyurethane foam coating for the treatment of burns, wounds or other skin injuries, formed from a mixture of the starting components directly on the damaged skin surface to obtain a voluminous foam structure with a cured outer layer and with an elastic inner layer, characterized in that the foam structure is made mainly with open-cell porosity, and the inner coating layer in contact with the skin contains two zones: an adhesive zone in contact with intact skin, and low adhesion hydrochloric zone enriched polyurea contacting the surface of the damaged skin (wound), wherein as the mixture of starting components a mixture based on a polyol and an isocyanate component in a ratio of (3.0-3.5): 1. 2. Medical polyurethane foam coating according to claim 1, characterized in that it is made with a surface density (0.10-0.20) g / cm ³ . 3. Medical polyurethane foam coating according to claim 1, characterized in that it is made with open-cell porosity, which is up to 98 vol.% And with a moisture capacity of up to 100%. 4. The medical polyurethane foam coating according to claim 1, characterized in that the value of the adhesive characteristic in the adhesive zone of the coating is at least 60.0 N / m. 5. Medical polyurethane foam coating according to claim 1, characterized in that the composition of the following composition is used as a polyol as one component, parts by weight: high molecular weight polyol foam control one hundred water 2.0-4.0 blowing agent 2.0-4.0 urethane activator 0.05-0.4 chain extension 0.2-1.5 foamer 0.2-1.5 foam hardener 0.2-1.5 6. Medical polyurethane foam coating according to claim 1, characterized in that the composition with the content of isocyanate groups of 26.0-32 wt.% Is used as an isocyanate component. 7. Medical polyurethane foam coating according to claim 1, characterized in that it self-sterilizes at the time of mixing of the starting components. 8. Medical polyurethane foam coating according to claim 1, characterized in that it provides a temperature on the surface of the coating during the formation of foam in the range of 36-43 ° C. 9. The medical polyurethane foam coating according to claim 5, characterized in that it additionally contains additives and / or fillers selected from the group consisting of carbon, boehmite, chitosan, silver ion sources, antibiotics and dyes. 10. The medical polyurethane foam coating according to claim 9, characterized in that, as an additive containing carbon, activated carbon powder is introduced to improve the absorption properties of the coating mainly in the treatment of purulent wounds. 11. The medical polyurethane foam coating according to claim 9, characterized in that for the treatment of burns it is made with a reduced reaction temperature of urethane formation, preferably equal to 36 ° C, and a dye of blue or blue color will be introduced into the polyol as one component. 12. The medical polyurethane foam coating according to claim 9, characterized in that to stop the bleeding and bactericidal treatment of the wound, it is made with an increased reaction temperature of urethane formation, preferably equal to 42-43 ° C, and an orange dye is introduced into the polyol as one component. 13. Medical polyurethane foam coating according to claim 9, characterized in that for the identification of the coating when it is used in veterinary medicine, a green dye is introduced into the polyol as one component. 14. Medical polyurethane foam coating according to claim 1, characterized in that after mixing the starting components, it meets the following time criteria: but. - the time from the beginning of the mixing of the components to the formation of a white mixture is 16-24 s; b. - the rise time of the coating during the formation of foam is 120-150 s; c. - the curing time of the coating in the polymerization process is 15-25 minutes 15. Medical polyurethane foam coating according to claim 1, characterized in that it is applied using a disposable or reusable device. 16. A disposable device for applying medical polyurethane foam coating, characterized in that the device is made in the form of a flexible container containing at least two sealed sections, one of which contains a polyol as one and the other isocyanate component in the ratio (3.0-3 , 5): 1, while these sections are separated by a partition made with the possibility of eliminating at least part of the specified partition, as well as means for outputting the mixture of the initial components of the foam structure urs to form a coating. 17. The device according to p. 16, characterized in that the partition is made in the form of a weld of a given strength, revealing separation by increasing pressure in at least one of the sections. 18. The device of claim 16, wherein the container contains an additional section, wherein the sealed sections for accommodating the initial components are connected to the additional section by removable partitions, and the possibility of communicating the sealed sections to each other is provided through the additional section by sequential elimination of the partitions. 19. The device according to p. 16, characterized in that it is made up of separately manufactured sections made of different in composition polymer or multilayer composite materials, in particular from combined multilayer materials. 20. The device according to p. 16, characterized in that the container is made of a multilayer metal-polymer material, in particular of a three-layer material with an inner layer of aluminum foil and with outer layers of polyethylene and / or polypropylene. 21. The device according to p. 16, characterized in that at least one of the sections of the container is made of a transparent polymeric material, in particular of a polyethylene film 200-300 microns thick. 22. The device according to p. 16, characterized in that its sections are made of a barrier polymer film or a fluoropolymer-containing polymer film. 23. The device according to p. 16, characterized in that the container has a tubular shape and is formed from a strip of polymer material by welding. 24. The device according to p. 16, characterized in that its end side is closed with a weld seam 1.5-3 cm wide, which opens when the pressure inside the container rises, performing the function of a means to bring out the finished composition. 25. The device according to p. 16, characterized in that the means of outputting the mixture of the initial components of the foam structure is made in the form of a nozzle or tube - sleeve, or in the form of an injector, or in the form of a metering device, or in the form of a pipette, or in the form of a sprayer. 26. The device according to p. 16, characterized in that the means for outputting the mixture of the initial components of the foam structure to the outside is made in the form of a notch on the external weld. 27. The device according to p. 16, characterized in that the container further comprises a backup zone in the form of an empty section adjacent to the end of the container. 28. A reusable device for applying a medical polyurethane foam coating, characterized in that it comprises a housing, a mixing chamber and a channel for expelling from the mixing chamber a mixture of the initial components of the foam-like structure to obtain a coating, the housing comprising at least two sealed sections, in one of which contains a polyol as one, and in the other isocyanate component in the ratio (3.0-3.5): 1, these sections are equipped with tubes for outputting the initial components through the valve to the mixing th camera, and means for displacing the starting components into the mixing chamber. 29. The device according to p. 28, characterized in that the mixing chamber is made in the form of a removable (disposable) container with an outlet installed on the housing of the said device with the possibility of detachable fixing it. 30. The device according to p. 29, characterized in that the mixing chamber is equipped with a means for mixing the starting components, which is made in the form of a comb shaft, rotor blade or in the form of a static mixing nozzle. 31. The device according to p. 28, characterized in that its body is made in the form of an aerosol container, while at least two flexible polymer containers are placed under pressure inside the container as pressurized sections, one of which contains a polyol container and the other is isocyanate component in the ratio (3.0-3.5): 1, these containers are equipped with tubes for outputting the starting components through the spray valve into the mixing chamber. 32. The device according to p. 28, characterized in that its body is made of at least two aerosol cans equipped with a common mixing chamber with an opening for removing from the mixing chamber a mixture of the initial components of the foam-like structure, while the internal cavity of each cylinder is a sealed section made with the possibility of placing in it under pressure one of the starting components, so that at least one cylinder contains a polyol as one, and the other isocyanate component in the ratio (3.0-3.5): 1, those indicated section provided with tubes for outputting the original component through the spray gun valve in the mixing chamber. 33. The device according to p. 32, characterized in that the aerosol cans are interconnected and / or installed on a common basis. 34. The device according to p. 32, characterized in that the polyol asic and isocyanate components are placed inside aerosol cans in flexible polymer containers. 35. The device according to p. 28, characterized in that its body is made in the form of a cylindrical cartridge-syringe containing at least two sequentially placed sealed sections, separated by a movable piston gasket, while in one section is placed polyol, and in the other - isocyanate component in the ratio (3.0-3.5): 1, and the channels for outputting the starting components are brought out to one end of the housing, and a piston with a rod is installed from the opposite open end. 36. The device according to p. 35, characterized in that the rod of the cartridge-syringe is connected with a mechanical drive made in the form of a metering gun. 37. The device according to p. 35, characterized in that the channels for the output of the initial components are brought to the end of the case in the form of two separate conclusions - fittings (spouts). 38. The device according to p. 35, characterized in that the channels for the output of the original components have a common output to the end of the housing, made in the form of a single fitting with a dividing wall. 39. A reusable device for applying medical polyurethane foam coating, characterized in that it contains a housing and a mixing nozzle, the housing is made in the form of a double cartridge syringe containing two sealed sections, made in the form of separate cartridges, while a polyol is placed in one cartridge, and in the other, an isocyanate component in the ratio (3.0-3.5): 1, each cartridge on one end is made with a piston mounted on the rod, and on the other end is a channel for removing the initial component, and the passages of these channels are detachably connected to the mixing nozzle, which serves to bring out the mixture of the initial components of the foam-like structure to obtain a coating. 40. The device according to p. 39, characterized in that the cartridges are mounted on a common lodgement and connected by a common mechanism for driving pistons. 41. The device according to p. 39, characterized in that the outputs of the channels for removing the source components are made in the form of two fittings (spouts). 42. The device according to p. 39, characterized in that the cartridges are installed adjacent and parallel to the common tube, while the channels for removing the original components are interconnected and removed from the tube in the form of one common fitting (nose). 43. A mixing nozzle for a reusable device for applying a medical polyurethane foam coating, characterized in that it is made in the form of a tube, the inner surface of which is provided with combs from the partitions and / or the nozzle is made with an internal axis equipped with combs from the partitions, while the nozzle is installed with the possibility of detachable connection with the output of the mixing chamber according to p. 28 or with the output of the cartridge syringe according to p. 37. 44. The mixing nozzle according to claim 43, wherein the inner axis is rotatable. 45. The mixing nozzle according to claim 44, characterized in that the inner axis is connected to a pin associated with the rotation drive.

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