RU2827960C1 - Haemostatic solution, haemostatic product and method for obtaining thereof - Google Patents

Abstract

FIELD: chemistry; medicine.

SUBSTANCE: group of inventions relates to a haemostatic article comprising a nonwoven material on which a haemostatic solution containing a haemostatic composition, a plasticiser, a solvent is applied, with the following ratio of components to the weight of the solution, wt.%: haemostatic composition 3–20; plasticiser 2–15; solvent 70–95, such that the nonwoven material is impregnated with said solution, wherein the linear density of the application of the haemostatic composition on the nonwoven material is 0.2–2.0 g/m, where the haemostatic composition used is a haemostatic clay material and a binder selected from a sodium and/or calcium salt of alginic acid, plasticizer used is water-soluble polymers and/or copolymers of alcohols and/or ethers, and/or polyatomic alcohols, and / or water-soluble organic derivatives of polyatomic alcohols, and/or polyols, purified water is used as a solvent, and also relates to a method for making a haemostatic article, according to which a haemostatic composition, a plasticiser, a solvent are mixed with the following ratio of components to the weight of the solution, wt.%: haemostatic composition 3–20; plasticiser 2–15; solvent 70–95, where the haemostatic composition used is a haemostatic clay material and a binder selected from a sodium and/or calcium salt of alginic acid, plasticiser used is water-soluble polymers and/or copolymers of alcohols and/or ethers, and/or polyatomic alcohols, and/or water-soluble organic derivatives of polyatomic alcohols, and/or polyols, purified water is used as a solvent; mixture of haemostatic composition, plasticiser, solvent is applied to nonwoven material so that it is impregnated in said mixture; drying the nonwoven material impregnated with the mixture of the haemostatic composition, a plasticiser, a solvent by blowing it through the rollers; placing the dried nonwoven material impregnated with a mixture of the haemostatic composition, a plasticiser, a solvent in a vacuum foil package; material placed in vacuum foil package is sterilized.

EFFECT: group of inventions provides higher stimulation of blood coagulation with increased area of contact of the haemostatic product with the wound surface.

19 cl, 3 tbl, 11 ex

Description

Field of technology

[1] The present invention relates to the field of medicine, in particular to medical products intended to stop external bleeding of varying intensity, and can be used in hospital, field, and domestic conditions to provide first medical and emergency aid.

State of the art

[2] One of the main causes of death after injuries and wounds, for example, during natural and man-made disasters, is profuse bleeding, often accompanied by pronounced hemodynamic disturbances that develop through a pathophysiological cascade. The basis of this cascade is a sharp decrease in the volume of circulating blood in the body of an animal or a person. Without timely intervention, this process inevitably leads to a life-threatening condition such as hypovolemic shock. In this regard, special attention of researchers and practitioners is directed to the search for and creation of the most powerful, maximally safe means with a pronounced hemostatic effect to ensure timely stopping of profuse bleeding.

[3] Recently, a new generation of modern hemostatic materials has appeared for emergency stopping of bleeding, which form clots as a result of a physical or chemical reaction upon contact with blood. The following requirements are put forward for hemostatic materials: it is necessary that they allow for a complete stop of bleeding in the shortest possible time; fit tightly to the wound surface; prevent resumption of bleeding; have high adhesive capacity; do not irritate the tissues surrounding the hemostatic material; are non-toxic; and are also convenient to use for providing first medical and emergency aid, have a minimal risk of embolization of blood vessels, and are easily removed from the wound. However, the known technical solutions concerning hemostatic materials have a number of disadvantages.

[4] Thus, patent RU2599033C2 (published 10.10.2016; IPC: A61L 15/16, A61L 15/28, A61L 15/18, A61L 15/44, A61L 15/46) describes an invention related to means and devices for ensuring hemostasis, in particular, to hemostatic bandages and wound dressings. The technical result of the analogue consists in stimulating blood clotting and wound healing. The analogue describes a hemostatic device for stimulating blood coagulation, including a substrate, such as gauze, fabric, sponge, spongy matrix, one or more threads, etc., a hemostatic material placed on the substrate, such as kaolin clay, and a binder, such as cross-linked calcium alginate with a high molar content of guluronic monomer, located on the substrate to retain the hemostatic material. The first disadvantage of the analogue is that the hemostatic composition contains cross-linked calcium alginate with a high content of guluronic acid, which reduces the strength of the hemostatic device of the analogue. Another disadvantage of the analogue is the need for long-term compression on the wound area after using the hemostatic device. The next disadvantage of the analogue is the low stability of the thrombus formed at the site of vascular injury during mechanical movement of the limbs, a high frequency of recurrent bleeding. Another disadvantage of the analogue is the high blood clotting time, which varies from 106 s to 250 s. The listed disadvantages reduce the effectiveness of first aid and emergency care when using the hemostatic device of the analogue. The next disadvantage of the analogue is the lack of information on the linear density of the hemostatic composition applied to the substrate, since the density of the hemostatic composition affects the blood clotting rate and, accordingly, the effectiveness of first aid and emergency care. Another disadvantage of the analogue is the lack of information on the linear density of the plasticizer applied to the substrate, since the density of the plasticizer applied affects the elasticity and plasticity of the hemostatic device and, accordingly, the possibility of its modeling according to the shape of the wound surface.

[5] Patent RU135921U1 (published 27.12.2013; IPC: A61L 15/22, A61K 31/722) describes a utility model related to medical devices, including topical hemostatic materials intended to stop external bleeding of varying intensity in surgery, including general surgery, abdominal surgery, military field surgery, cardiac surgery, combustiology, neurosurgery, plastic surgery, resuscitation, thoracic surgery, traumatology, maxillofacial surgery, endocrine surgery. The technical result of the analogue consists in expanding the range of hemostatic agents and their functional capabilities; in the ability to model a hemostatic medical device according to the shape of a wound surface; in the ease of extraction of the hemostatic medical product from the wound; in obtaining resource-saving and environmentally safe production of the hemostatic medical product; in the availability and reproducibility of raw materials intended for the production of the hemostatic medical product. The analogue describes a hemostatic medical product, which is made in the form of a one-sided or two-sided multilayer dressing and which consists of at least a substrate and an active layer of non-woven material based on chitosan nanofibers, characterized in that the active hemostatic layer is placed on the surface of the substrate, at least on one side, which is a non-woven material with a specific gravity of no more than 15 g / m, consisting of at least chitosan nanofibers, with a diameter of from 80 nm to 350 nm, obtained by electrospinning, the substrate consists of one or more layers and contains at least one process and / or contact layer, wherein each contact layer is placed in close proximity to the active layer and is represented by a non-woven material with a specific gravity of no more than 50 g / m, consisting of at least aliphatic polyamide nanofibers with an average diameter of from 80 nm to 450 nm, obtained by electrospinning, the technological layer is made of cellulose or synthetic material, and, if necessary, a gel-forming layer is placed between the contact and active layers, which is a non-woven material with a specific gravity of no more than 35 g / m, consisting of at least carboxymethyl cellulose nanofibers with an average diameter of 80 nm to 300 nm, obtained by electrospinning. The first disadvantage of the analogue is the use of chitosan in a hemostatic medical product as a component of the active substance, since its use causes the development of an allergic reaction to a foreign protein contained in chitosan. Also, when using products in which particles or granules of chitosan are applied to any base (substrate), shedding of these particles or granules of the hemostatic medical product is noted, regardless of the method of their application, and after contact with blood, such products lose their softness and flexibility. Deterioration of the softness and flexibility of the hemostatic medical product reduces its contact area with the wound surface, especially in the presence of pockets or a deep wound channel, which leads to a decrease in the effectiveness of first aid and emergency care. Another disadvantage of the analogue is the use of chitosan nanofibers obtained by electrospinning in the hemostatic medical product, since the existing technologies for electrospinning chitosan nanofibers use highly toxic solvents and a large number of process additives, which significantly worsens the biocompatibility of the hemostatic medical product analogue with human tissues. Another disadvantage of the analogue is its low efficiency, since after applying the hemostatic medical product to the source of bleeding, manual compression must be performed for 2 - 3 minutes. This leads to low efficiency of first aid and emergency care in the event of bleeding. The next disadvantage of the analogue is the lack of information on the linear density of application of the active substance, which is chitosan, to the non-woven material, since the density of application of the active substance affects the rate of blood clotting and, accordingly, the effectiveness of first aid and emergency care. Another disadvantage of the analogue is the lack of a plasticizer in the hemostatic medical product, since its presence increases the elasticity and plasticity of the hemostatic product and, accordingly, allows for its improved modeling according to the shape of the wound surface to stop bleeding.

[6] Patent RU2743425C1 (published 18.02.2021; IPC: A61K 9/70, A61L 15/22, A61K 31/722) describes an invention related to the field of medicine, namely to means for stopping external bleeding of varying intensity, including from large blood vessels, and can be used in hospital, field, and domestic conditions to provide first and medical aid for wounds and injuries as a local hemostatic agent, including for bleeding in which massive blood loss is the leading cause of death. The technical result of the analogue is to increase the efficiency of using a hemostatic agent. The analogue describes a chitosan-based hemostatic agent, characterized in that nonwoven material with a surface density of 20 g/ ^m2 to 105 g/ ^m2 impregnated with chitosan aerogel is used for its production. The analogue also describes a method for producing a chitosan-based hemostatic agent, which consists in preparing a chitosan solution followed by supercritical drying, characterized in that a carrier made of nonwoven material is poured with a prepared chitosan solution with a concentration of 1 mol/l to 4 mol/l to form a chitosan gel for at least 6 hours, after which the agent is washed to a neutral pH and the solvent is replaced with a step-by-step increase in the solvent concentration of 10 - 50 - 70 - 90 - 100 - 100 - 100% by weight and then drying the hemostatic agent using the supercritical drying process. The disadvantage of the analogue is the use of chitosan as the active substance of the hemostatic agent, since its use causes the development of an allergic reaction to the foreign protein contained in chitosan. The next disadvantage of the analogue is the lack of information on the linear density of application of the active substance, which is chitosan, to the non-woven material, since its density of application affects the rate of blood clotting and, accordingly, the effectiveness of first aid and emergency care. Another disadvantage of the analogue is the lack of a plasticizer in the hemostatic agent, since its presence increases the elasticity and plasticity of the hemostatic agent and, accordingly, allows for improved modeling of the shape of the wound surface during use. The next disadvantage of the analogue is that a ready-made chitosan solution with a concentration of 1 mol/l to 4 mol/l is poured into a carrier made of non-woven material to form a chitosan gel for at least 6 hours, after which the agent is washed to a neutral pH and the solvent is replaced with a step-by-step increase in the solvent concentration of 10 - 50 - 70 - 90 - 100 - 100 - 100% by weight and subsequent drying of the hemostatic agent using the supercritical drying process. This complicates the technological process of manufacturing the hemostatic agent of the analogue.

[7] Application WO2016176186A1 (published 03.11.2016; IPC: A61L 26/00, A61F 13/00, A61K 31/70) describes an invention related to a hemostatic composition that contains biologically absorbable ingredients. The technical result of the analogue consists in providing a stimulating effect on regenerative processes in a wound, which is expressed in accelerating the growth of granulation tissue, stimulating marginal and insular epithelialization, creating favorable conditions for the migration of epithelial cells, vascular invasion and wound healing without scars. The analogue describes a hemostatic composition that includes calcium alginate, chitosan, epsilon-aminocaproic acid, an acid selected from aminomethylbenzoic acid and tranexamic acid, and tannin. The analogue also describes a method for preparing a hemostatic composition, which includes mixing one or more polysaccharide bases, tannin, a fibrinolysis inhibitor, colloidal silver and a solvent to form a mixture and drying the mixture at a temperature of 25°C to 80°C to a residual moisture content of approximately 15 - 20%. A disadvantage of the analogue is the use of chitosan as a component of the active substance of the hemostatic composition, since its use causes the development of an allergic reaction to the foreign protein contained in chitosan. Another disadvantage of the analogue is the manufacture of the hemostatic agent in the form of powder, granules or paste. The use of a hemostatic agent in the specified form in the analogue leads to the washout of the agent with the blood flow flowing from the wound (especially with profuse bleeding). In addition, hemostatic granules, powder or paste are difficult to extract from the wound due to tight adhesion to the wound surface and wound edges, which can lead to thrombus detachment and renewed bleeding. It is worth noting that the presence of hemostatic granules, powder or paste in the wound can change the local blood circulation of the tissues of the wound cavity (wound channel), this is manifested in a change in their color and the occurrence of edema after the extraction of the hemostatic agent from the wound.

[8] Application WO2020226602A1 (published 12.11.2020; IPC: A61L 15/44, A61L 15/54, A61P 7/04) describes a utility model related to the field of medicine, in particular, to surgery, and can be used to quickly stop profuse bleeding during surgical interventions, during first aid in case of wounds and external bleeding, in hemophilia as a hemostatic combination agent created using an enzyme activator of the blood coagulation system, non-covalently immobilized on activated fibrous carbon material and spunlace fabric (medical material). The technical result of the analogue is to obtain an effective and widely available hemostatic combination agent for stopping bleeding. The analogue describes a hemostatic combined agent for stopping bleeding, containing an adsorption element and a hemostatic composition applied to it, in which a non-woven fabric made of viscose and polyester (spunlace) is used as the adsorption element, and the hemostatic composition contains the following components: locust bean gum 1 - 5%, tannin 5 - 10%, glycerin 5 - 20%, aminocaproic acid 1 - 5%, kaolin 5 - 20%, barium sulfate 5 - 10%, distilled water - the rest. A disadvantage of the analogue is drying the non-woven material impregnated with the hemostatic composition in a thermal cabinet, which leads to uneven distribution of the hemostatic composition over the non-woven material. The next disadvantage of the analogue is the lack of information on the linear density of application of the components of the hemostatic composition to the non-woven material, since the density of application of the components of the hemostatic composition affects the rate of blood clotting and, accordingly, the effectiveness of first aid and emergency care. Another disadvantage of the analogue is the lack of information on the specific gravity of the non-woven material used, since the specific gravity of the non-woven material affects the strength of the hemostatic agent. Another disadvantage of the analogue is the lack of a plasticizer in the hemostatic agent, since its presence increases the elasticity and plasticity of the hemostatic agent and, accordingly, allows for improved modeling of it according to the shape of the wound surface to stop bleeding.

[9] Patent RU2636240C2 (published on 21.11.2017; IPC: A61L 26/00, A61L 15/32, A61K 9/14, A61K 9/19) describes an invention related to a dry composition and a method for producing it, where the composition, upon addition of an aqueous medium, forms an essentially homogeneous paste suitable for use in hemostatic procedures. In addition, the invention relates to a method for using the said dry composition and to a hemostatic kit. The proposed composition of the analogue is used for medical purposes and in surgical interventions. The technical result of the analogue is to ensure rapid readiness of the drug for use, as well as to eliminate possible personnel errors at the stage of mixing and moving the powder and liquid when obtaining a paste of the required consistency for applying it to the wound area, which ultimately improves safety for the patient. The analogue describes a method for producing a dry composition suitable for use in hemostatic procedures and wound healing, comprising the following successive stages: a) obtaining a cross-linked biocompatible polymer in powder form, one or more polyols selected from sugar alcohols and sugars, and an aqueous medium; b) mixing the biocompatible polymer, one or more polyols and an aqueous medium to obtain a paste; and c) freeze-drying the paste, wherein the dry composition contains from 10 wt.% to 60 wt.% of one or more polyols. The main disadvantage of the analogue is the production of a hemostatic agent in the form of a paste. The use of a hemostatic agent in this form in the analogue leads to the agent being washed out with the blood flow flowing from the wound (especially in case of profuse bleeding). In addition, hemostatic paste is quite difficult to extract from the wound due to its tight adhesion to the wound surface and wound edges, this can lead to the detachment of a thrombus and the resumption of bleeding. In addition, the presence of hemostatic paste in the wound leads to a change in local blood circulation of the tissues of the wound cavity (wound channel), this is manifested in a change in their color and the appearance of edema after the extraction of the hemostatic agent.

The essence of the invention

[10] The objective of the present invention is to develop a hemostatic solution, a hemostatic product and a method for its manufacture that ensure the effective provision of first medical and emergency aid.

[11] The specified task is achieved due to such a technical result as ensuring an increase in stimulation of blood coagulation with an increase in the area of contact of the hemostatic product with the wound surface. The specified task is achieved, including, but not limited to:

[12] the presence of a hemostatic composition, plasticizer, solvent, and modifying additives in the hemostatic solution;

[13] the acidity index of the hemostatic solution, which is not less than 6;

[14] the use of a hemostatic composition in the form of a finely dispersed powder;

[15] linear density of application of the hemostatic composition onto non-woven material, amounting to 0.2 – 2 g/m;

[16] linear density of application of plasticizer on non-woven material, amounting to 0.1 – 0.9 g/m;

[17] using non-woven material with a density of 20–50 g/ ^m2 ;

[18] using non-woven material with a thickness of 0.15 – 0.5 mm;

[19] drying non-woven material impregnated with a hemostatic solution by blowing air through it while passing it through rollers.

[20] More fully, the technical result is achieved by a hemostatic solution for application to a non-woven material, containing a hemostatic composition, a plasticizer, a solvent, modifying additives, with the following ratio of components to the mass of the solution, wt.%: hemostatic composition 3 – 20; plasticizer 2 – 15; solvent 70 – 95; modifying additives – the rest. Moreover, the acidity index of the hemostatic solution is not less than 6.

[21] Application of a hemostatic solution to a non-woven material allows for the production of a hemostatic medical product that is easily removed from the wound and does not alter local blood circulation in the tissues of the wound cavity. The non-woven material, in turn, has a high degree of absorption of liquid substances, which allows the use of this material in cases of heavy bleeding to provide first medical and emergency aid.

[22] The hemostatic composition in the hemostatic solution not only helps stop bleeding in direct contact with damaged body tissues, but also allows the composition of the said solution to be retained on a non-woven material. The hemostatic composition also helps increase the stability of the thrombus formed at the site of vessel damage. Thus, the presence of the hemostatic composition in the present solution improves the effectiveness of first medical and emergency aid.

[23] The presence of a plasticizer in the hemostatic solution, on the one hand, prevents dehydration upon contact with damaged tissues of the body. On the other hand, the presence of a plasticizer in the solution increases the elasticity and plasticity of the non-woven material to which the real hemostatic solution is applied. This allows the said non-woven material to be modeled according to the shape of the wound surface to increase the area of its contact with the wound surface, improving the effectiveness of first medical and emergency aid.

[24] Modifying additives in the hemostatic solution help stabilize the said solution on the non-woven material, including helping stabilize the hemostatic composition on the non-woven material, which increases the ability of the hemostatic solution to retain its physicochemical properties and pharmacological activity during its shelf life. Modifying additives also help reduce the peeling of the hemostatic composition from the substrate (non-woven material). A crosslinking agent and/or a thickening component can be used as modifying additives.

[25] The solvent is added to the mixture of the hemostatic composition, plasticizer, or to the mixture of the hemostatic composition, plasticizer, and modifying additives to produce a liquid homogeneous system, which is applied to the nonwoven material.

[26] The specified combination of components and their ratio in the hemostatic solution allow for increased stimulation of blood clotting, improved elasticity and plasticity of the non-woven material onto which the solution is applied, and increased stability of the thrombus formed at the site of vascular injury. Increased stimulation of blood clotting leads to a reduction in the time required to stop bleeding; increased elasticity and plasticity of the non-woven material allows for the said material to be modeled according to the shape of the wound surface to increase the area of its contact with the wound surface. Thus, the above ensures improved efficiency in providing first medical and emergency aid.

[27] At the same time, the acidity index of the real hemostatic solution, which is not less than 6, increases the stimulation of blood clotting, increases the stability of the thrombus formed at the site of vascular damage, ensuring an improvement in the effectiveness of first medical and emergency care.

[28] The hemostatic composition may contain a hemostatic clay material, a binder in the following ratio of components to the weight of the composition, wt.%: hemostatic clay material 40 - 85; binder 15 - 60. The hemostatic clay material helps stop bleeding upon contact with damaged body tissues. The use of a binder is necessary to hold the composition of the hemostatic solution on the non-woven material. The specified combination and number of components of the hemostatic composition allow for increased stimulation of blood clotting, improved stability of the thrombus formed at the site of vascular injury, and also help to hold the composition of the hemostatic solution on the non-woven material, thereby improving the effectiveness of first medical and emergency aid.

[29] Alginic acid salt containing guluronic acid in an amount of 20–50 wt.% can be used as a binder. The use of alginic acid salt containing guluronic acid in an amount of 20–50 wt.% increases the ability of the binder to retain the composition of the hemostatic solution on the non-woven material, which improves the effectiveness of first medical and emergency aid.

[30] A hemostatic composition in the form of a finely dispersed powder with a particle size of 0.5–30 μm can be used. This improves the homogeneity of the hemostatic solution mixture, one of the components of which is the said hemostatic composition, ensuring uniform application of the solution to the non-woven material, which in turn improves the effectiveness of first medical and emergency aid.

[31] Water-soluble polymers and/or copolymers of alcohols and/or ethers, and/or polyhydric alcohols, and/or water-soluble organic derivatives of polyhydric alcohols, and/or polyols can be used as a plasticizer; this increases the elasticity and plasticity of the non-woven material onto which the hemostatic solution is applied, and prevents dehydration upon contact with damaged body tissues. The specified plasticizer also has antiseptic properties, is biologically compatible with body tissues, and promotes wound healing. This improves the effectiveness of first aid and emergency care.

[32] Purified water can be used as a solvent. When a mixture of a hemostatic composition, a plasticizer or a mixture of a hemostatic composition, a plasticizer, and modifying additives interacts with purified water, the hemostatic composition is hydrogenated by water, which increases the safety of using the nonwoven material onto which the resulting hemostatic solution is applied when providing first medical and emergency aid, since the possibility of a burn to the wound surface is eliminated when using it.

[33] The technical result is also achieved by a hemostatic article comprising a non-woven material onto which a hemostatic solution is applied, containing a hemostatic composition, a plasticizer, a solvent, and modifying additives, with the following ratio of components to the mass of the solution, wt.%: hemostatic composition 3–20; plasticizer 2–15; solvent 70–95; modifying additives – the rest, such that the non-woven material is impregnated with the said solution. In this case, the linear density of the application of the hemostatic composition to the non-woven material is 0.2–2 g/m.

[34] Application of a hemostatic solution to a non-woven material allows for the production of a hemostatic medical product that is easily removed from the wound and does not alter the local blood circulation of the tissues of the wound cavity. The main advantage of using non-woven material to produce a hemostatic product is its high absorption rate of liquid substances, which allows the use of this hemostatic product in cases of heavy bleeding to provide first aid and emergency care.

[35] A hemostatic solution containing a hemostatic composition, a plasticizer, modifying additives and a solvent is applied to the non-woven material in the following ratio of components to the mass of the solution, wt.%: hemostatic composition 3 – 20; plasticizer 2 – 15; solvent 70 – 95; modifying additives – the rest.

[36] The hemostatic composition in the hemostatic solution, firstly, helps stop bleeding upon direct contact with damaged tissues of the body; secondly, it helps increase the stability of the thrombus formed at the site of vessel damage; thirdly, it allows the composition of the said solution to be held on a non-woven material. This improves the effectiveness of first medical and emergency aid.

[37] The plasticizer in the hemostatic solution prevents dehydration of damaged tissues of the body upon contact with them. Also, the presence of a plasticizer in the hemostatic solution, which is applied to the non-woven material, increases the elasticity and plasticity of the said material. This allows the said non-woven material to be modeled according to the shape of the wound surface to increase the area of its contact with the wound surface, improving the effectiveness of first medical and emergency aid.

[38] Modifying additives in the hemostatic solution help stabilize the said solution on the non-woven material, including helping stabilize the hemostatic composition on the non-woven material, which increases the ability of the hemostatic solution to retain its physicochemical properties and pharmacological activity during its shelf life. Modifying additives also help reduce the peeling of the hemostatic composition from the substrate (non-woven material).

[39] The solvent is added to the mixture of the hemostatic composition, plasticizer, or to the mixture of the hemostatic composition, plasticizer, and modifying additives to produce a liquid homogeneous system used to impregnate the nonwoven material.

[40] The specified combination of components and their ratio in the hemostatic solution, which is applied to the non-woven material, allow for increased stimulation of blood clotting, improved stability of the thrombus formed at the site of vascular injury, and increased elasticity and plasticity of the non-woven material to which the solution is applied. As stated earlier, increased stimulation of blood clotting leads to a reduction in the time required to stop bleeding; increased elasticity and plasticity of the non-woven material allows for the said material to be modeled according to the shape of the wound surface to increase the area of its contact with the wound surface. Thus, the above ensures improved efficiency in providing first medical and emergency aid.

[41] Impregnation of nonwoven material with a hemostatic solution for the production of a hemostatic product ensures uniform distribution of the solution components on the material.

[42] In this case, the linear density of application of the hemostatic composition to the non-woven material is 0.2 – 2 g/m. The specified linear density of application of the hemostatic composition allows for an increase in the rate of blood clotting while maintaining the elastic and plastic properties of the non-woven material, ensuring an improvement in the effectiveness of first medical and emergency aid.

[43] The linear density of the plasticizer applied to the non-woven material can be 0.1 – 0.9 g/m. This improves the elasticity and plasticity of the non-woven material onto which the real hemostatic solution is applied for the manufacture of a hemostatic medical product. This makes it easy to model the manufactured hemostatic medical product according to the shape of the wound surface to increase the area of its contact with the wound surface, improving the effectiveness of first medical and emergency aid.

[44] The nonwoven material may contain viscose and polyester in the following ratio of components, wt.%: viscose 60–90; polyester – the rest. The use of the described nonwoven material allows for the production of a flexible hemostatic product that has a high degree of absorption of liquid substances, which allows the use of this hemostatic product to stop heavy bleeding when providing first medical and emergency aid.

[45] The surface density of non-woven material can be 20–50 g/ ^m2 , which increases the strength of the hemostatic product used to provide first medical and emergency aid.

[46] The thickness of the non-woven material can be 0.15 – 0.5 mm. This thickness of the material allows for easy placement of the non-woven material in the wound cavity to increase the area of contact of the hemostatic product with the wound surface. This improves the effectiveness of first medical and emergency aid.

[47] The technical result is also achieved by the method for manufacturing a hemostatic article described above, according to which the hemostatic composition, plasticizer, and solvent are first mixed; then the mixture of the hemostatic composition, plasticizer, and solvent is applied to the nonwoven material in such a way that it is impregnated in the said mixture; then, the nonwoven material impregnated with the mixture of the hemostatic composition, plasticizer, and solvent is dried by blowing air over it while passing it through rollers; then, the dried nonwoven material impregnated with the mixture of the hemostatic composition, plasticizer, and solvent is placed in a vacuum foil package; next, the material placed in the vacuum foil package is sterilized.

First, the hemostatic composition, plasticizer, and solvent are mixed. The hemostatic composition in the mixture helps stop bleeding, allows the composition of the said solution to be retained on the non-woven material, and helps increase the stability of the thrombus forming at the site of vessel damage. The plasticizer in the mixture prevents dehydration upon contact with damaged body tissues, increases the elasticity and plasticity of the non-woven material onto which the said mixture of components is applied, which allows the said non-woven material to be modeled according to the shape of the wound surface to increase the area of its contact with the wound surface. The solvent is used to make a liquid mixture. Mixing the components allows obtaining a liquid homogeneous system, which is then applied to the non-woven material. The hemostatic composition, plasticizer, and solvent can be mixed at a temperature of 15–50°C.

[48] Then, the mixture of the hemostatic composition, plasticizer, and solvent is applied to the nonwoven material in such a way that it is impregnated in the said mixture to produce a hemostatic product. Application of the said mixture, which is a hemostatic solution, to the nonwoven material allows for the production of a hemostatic medical product that is easily removed from the wound and does not change the local blood circulation of the tissues of the wound cavity. The nonwoven material, in turn, has a high degree of absorption of liquid substances, which allows the use of the said material in case of heavy bleeding to provide first medical and emergency aid. Impregnation of the nonwoven material with a hemostatic solution ensures uniform distribution of the components of the solution on the material.

[49] Then, the nonwoven material impregnated with a mixture of the hemostatic composition, plasticizer, and solvent is dried by blowing air through it while passing it through rollers. The speed of passing the nonwoven material through the rollers can be 1–15 m/min, and the air flow speed can vary from 5 m/s to 40 m/s. The air flow temperature can be 70–250°C. The described drying allows not only to dry the hemostatic product to a residual moisture content of no more than 10%, but also ensures uniform distribution of the components of the said mixture over the nonwoven material by passing it through the rollers.

[50] Then the dried non-woven material, impregnated with a mixture of the hemostatic composition, plasticizer, and solvent, is placed in a vacuum foil package. The use of packaging allows for mechanical protection during transportation and storage of the hemostatic product, and allows for protection of the product from environmental influences.

[51] Next, the material placed in the vacuum foil packaging is sterilized to destroy pathogenic microorganisms. The material placed in the vacuum foil packaging can be sterilized using an electron beam method, where the energy of the sterilizing dose can be 1 - 5 Mrad for each side of the material.

[52] Modifying additives may be additionally used to produce a hemostatic solution, which is applied to the non-woven material. A cross-linking agent and/or a thickening component may be used as modifying additives. The thickening component may be added to the mixture of the hemostatic composition, plasticizer, and solvent during mixing. The cross-linking agent may be sprayed onto the non-woven material impregnated with the mixture of the hemostatic composition, plasticizer, and solvent before drying it. The use of modifying additives helps stabilize the said solution on the non-woven material, including helping stabilize the hemostatic composition on the non-woven material, which increases the ability of the hemostatic solution to retain its physicochemical properties and pharmacological activity during its shelf life. Modifying additives also help reduce peeling of the hemostatic composition from the substrate (non-woven material).

Detailed description

[53] In the following detailed description of the embodiment of the invention, numerous implementation details are provided in order to provide a clear understanding of the present invention. However, it will be obvious to one skilled in the art how the present invention can be used with or without these implementation details. In other instances, well-known methods, procedures, and components have not been described in detail in order not to unnecessarily obscure the features of the present invention.

[54] Furthermore, it is clear from the above presentation that the invention is not limited to the given implementation. Numerous possible modifications, changes, variations and substitutions, preserving the essence and form of the present invention, are obvious to specialists skilled in the subject matter.

[55] Local hemostatic agents are biosurgical materials that have a hemostatic effect in direct contact with damaged tissues of the body. To improve the effectiveness of first medical and emergency aid, it is necessary that hemostatic agents allow bleeding to be completely stopped in the shortest possible time, prevent resumption of bleeding, and adhere tightly to the wound surface. Hemostatic agents must have high adhesive capacity to the thrombus forming at the site of vascular injury, be easily removed from the wound, not have an irritating effect on the tissues surrounding the agent, do not affect the hemostatic function in general bleeding, and be easy to use to provide first medical and emergency aid. Hemostatic agents can be presented in the form of powder, paste, solution, sponge, bandage, etc.

[56] This technical solution relates to a hemostatic solution for application to a non-woven material. Application of a hemostatic solution to a non-woven material allows for the production of a hemostatic medical device that can be easily removed from a wound without damaging surrounding tissues and that does not alter local blood circulation in the tissues of the wound cavity. The wound cavity is a space limited by the bottom and walls of the wound. It should be noted that the non-woven material has a high degree of absorption of liquid substances, such as blood, which allows the use of this material in cases of heavy bleeding to provide first aid and emergency care.

[57] The hemostatic solution contains a hemostatic composition, a plasticizer, a solvent, and modifying additives in the following ratio of components to the mass of the solution, wt.%: hemostatic composition 3–20; plasticizer 2–15; solvent 70–95; modifying additives – the rest.

[58] The hemostatic composition in the hemostatic solution not only helps stop bleeding upon direct contact with damaged body tissues, but also allows the composition of the said solution to be retained on a non-woven material. The hemostatic composition also helps increase the stability of the thrombus formed at the site of vessel damage. Thus, the presence of the hemostatic composition in the present solution improves the effectiveness of first medical and emergency aid.

[59] The presence of a plasticizer in the hemostatic solution, on the one hand, prevents dehydration upon contact with damaged tissues of the body. On the other hand, the presence of a plasticizer in the solution increases the elasticity and plasticity of the non-woven material to which the real hemostatic solution is applied. This allows the said non-woven material to be modeled according to the shape of the wound surface to increase the area of its contact with the wound surface, improving the effectiveness of first medical and emergency aid.

[60] Modifying additives in the hemostatic solution help stabilize the said solution on the non-woven material, including helping stabilize the hemostatic composition on the non-woven material, which increases the ability of the hemostatic solution to retain its physicochemical properties and pharmacological activity during its shelf life. Modifying additives also help reduce the peeling of the hemostatic composition from the substrate (non-woven material).

[61] The solvent is added to the mixture of the hemostatic composition, plasticizer, or to the mixture of the hemostatic composition, plasticizer, and modifying additives to produce a liquid homogeneous system, which is applied to the nonwoven material.

[62] The specified combination of components and their ratio to the mass of the solution, wt.%: hemostatic composition 3 – 20 wt.%; plasticizer 2 – 15 wt.%; solvent 70 – 95 wt.%; modifying additives – the rest, allow to increase the stimulation of blood clotting, improve the stability of the thrombus forming at the site of vascular injury, and increase the elasticity and plasticity of the non-woven material to which the solution is applied. At the same time, the specified amount of solution components allows to increase the rate of blood clotting, eliminating peeling of the hemostatic composition from the non-woven material to which the hemostatic solution is applied, accordingly, the hemostatic composition does not penetrate the bloodstream, which can cause vascular embolization. Increased stimulation of blood clotting leads to a reduction in the time required to stop bleeding; increased elasticity and plasticity of the non-woven material allows to model the specified material according to the shape of the wound surface in order to increase the area of its contact with the wound surface. Thus, the above ensures improved efficiency in providing first medical and emergency care.

[63] In this case, the acidity index of the hemostatic solution is not less than 6. Increased activation of blood coagulation is observed at a pH (acidity index) of the hemostatic solution, which is not less than 6, this is due to a number of factors such as inactivation of antithrombins, the release of procoagulants from erythrocytes and platelets, faster polymerization of fibrin, etc. Thus, the specified acidity index of the hemostatic solution increases the stimulation of blood coagulation, and also increases the stability of the thrombus formed at the site of vascular injury, ensuring improved efficiency of first medical and emergency care.

[64] The hemostatic composition may contain a hemostatic agent and a binding substance. It is necessary that the hemostatic agent and the binding substance be biologically compatible with the body tissues and do not require toxic chemicals for their processing.

[65] The hemostatic agent may contain clay materials or other silicon-based substances that, when in contact with a bleeding wound, promote blood clotting. It is preferable to use kaolin clay material. Kaolin (kaolin clay material) does not contain plant proteins or animal or human proteins, as well as thrombin and chitosan, and therefore will not cause allergic reactions when used in a hemostatic solution. When kaolin comes into contact with blood, the blood clotting process is initiated by activating blood factor XII (clotting).

[66] It is necessary that the binder allows the composition of the hemostatic solution to be retained on the non-woven material, reduces the adhesion of the non-woven material to which the hemostatic solution is applied to the wound surface. This will allow the said non-woven material to be extracted from the wound and/or removed from the wound practically without damaging the surface of the formed crust and/or without destroying the formed clot of coagulated blood. An alginic acid salt can be used as a binder. It is preferable to use an alginic acid salt containing guluronic acid in an amount of 20 - 50 wt.% as a binder. The use of an alginic acid salt that contains guluronic acid in an amount of 20 - 50 wt.% of the weight of alginic acid increases the ability of the binder to retain the composition of the hemostatic solution on the non-woven material, which improves the effectiveness of first aid and emergency care. It is preferable to use a divalent or trivalent metal alginate, since this ensures cross-linking of the alginate molecules, which improves the retention of the hemostatic solution composition on the non-woven material. For example, calcium alginate can be used as a divalent or trivalent metal alginate. The use of calcium alginate is due to the fact that it is biocompatible with human or animal tissues, plastic, promotes blood clotting, and when modifying additives are added to it, such as sodium salts, its binding properties are improved, which, in turn, increases the effectiveness of first medical and emergency aid. Additionally, sodium alginate can be used as a binder, preferably in combination with calcium alginate.

[67] Preferably, the hemostatic composition contains a hemostatic clay material, a binder in the following ratio of components to the weight of the composition, wt.%: hemostatic clay material 40 - 85; binder 15 - 60. If the hemostatic clay material is less than 40 wt.% and, accordingly, the binder is greater than 60 wt.%, then the blood clotting rate decreases when using a non-woven material impregnated with the present hemostatic solution. If the hemostatic clay material is greater than 85 wt.% and, accordingly, the binder is less than 15 wt.%, then when using a non-woven material impregnated with the present hemostatic solution, the hemostatic clay material enters the bloodstream, which causes a side effect in the form of embolization of vessels and organs. The specified preferred amount of components of the hemostatic composition allows for increased stimulation of blood clotting, improved stability of the thrombus formed at the site of vessel damage, and also promotes retention of the hemostatic solution composition on the non-woven material, thus improving the effectiveness of providing first medical and emergency aid.

[68] A hemostatic composition in the form of a finely dispersed powder may be used. Preferably, the particle size of the finely dispersed powder is 0.5 - 30 μm. This improves the homogeneity of the mixture of the hemostatic solution, one of the components of which is the said hemostatic composition, ensuring uniform application of the hemostatic solution to the non-woven material, which, in turn, improves the effectiveness of first medical and emergency aid.

[69] Preferably, water-soluble polymers and/or copolymers of alcohols and/or ethers, and/or polyhydric alcohols, and/or water-soluble organic derivatives of polyhydric alcohols, and/or polyols are used as a plasticizer. This increases the elasticity and plasticity of the non-woven material onto which the hemostatic solution containing the said plasticizer is applied, which allows the said non-woven material to be modeled according to the shape of the wound surface to increase the area of its contact with the wound surface. The presence of the said plasticizer in the hemostatic solution, which is applied to the non-woven material, prevents dehydration upon contact with damaged tissues of the body, has antiseptic properties and a softening effect, is biologically compatible with body tissues, and promotes wound healing. This improves the effectiveness of first aid and emergency care. For example, glycerin can be used as a plasticizer.

[70] Purified water is preferably used as a solvent. When a mixture of a hemostatic composition, a plasticizer or a mixture of a hemostatic composition, a plasticizer, and modifying additives interacts with purified water, the hemostatic composition is hydrogenated by water, which ensures its safe use, since the possibility of a burn to the wound surface during its use is excluded. The use of purified water as a solvent is due to the fact that it does not contain foreign inclusions and also minimizes the growth of secondary microflora in the hemostatic solution, which ensures control of potential negative effects on the human body; purified water is biologically compatible with body tissues. The use of purified water as a solvent improves the effectiveness of first aid and emergency care.

[71] A crosslinking agent and/or a thickening component can be used as modifying additives. It is preferable to use calcium chloride, soluble calcium salts as a crosslinking agent, and sodium carbonate, soluble salts of alginic acid, and salts of high-molecular compounds as a thickening component. For example, calcium chloride is used to convert sodium alginate into an insoluble form - calcium alginate; sodium carbonate is used to convert insoluble calcium alginate into soluble sodium alginate. This allows for crosslinking of the molecules of the binder, for example, an alginic acid salt, thus fixing it on the non-woven material, increasing its adhesion to the non-woven material and improving its bond with the hemostatic clay material; this minimizes the risks of peeling of the hemostatic clay material from the non-woven material during operation, storage and transportation of the hemostatic product. The specified modifying additives increase the ability of the hemostatic solution to retain its physicochemical properties and pharmacological activity during its shelf life, improving the effectiveness of first medical and emergency care.

[72] For a better understanding of the present invention, the following examples and Table 1 describe the components used, their ratio in the composition of the hemostatic composition, hemostatic solution, which illustrate, but do not limit, the proposed invention.

[73] Example 1. A hemostatic composition, plasticizer, and solvent are used to produce a hemostatic solution. The hemostatic composition contains a hemostatic clay material and a binder. The ratio of the components of the hemostatic composition to the mass of the composition, as well as the ratio of the components of the hemostatic solution to the mass of the solution are given in Table 1.

[74] Example 2. A hemostatic composition, plasticizer, and solvent are used to produce a hemostatic solution. The hemostatic composition contains a hemostatic clay material, a binder, where the binder consists of a mixture of calcium alginate and sodium alginate. The ratio of the components of the hemostatic composition to the mass of the composition, as well as the ratio of the components of the hemostatic solution to the mass of the solution are given in Table 1.

[75] Example 3. A hemostatic composition, plasticizer, solvent, and modifying additive are used to produce a hemostatic solution, where the thickening component, sodium carbonate, is used as a modifying additive. The hemostatic composition contains a hemostatic clay material and a binder. The ratio of the components of the hemostatic composition to the mass of the composition, as well as the ratio of the components of the hemostatic solution to the mass of the solution are given in Table 1.

[76] Example 4. A hemostatic composition, a plasticizer, a solvent, and a modifying additive are used to produce a hemostatic solution, where a crosslinking agent, calcium chloride, is used as the modifying additive. The hemostatic composition contains a hemostatic clay material, a binder, where the binder consists of a mixture of calcium alginate and sodium alginate. The ratio of the components of the hemostatic composition to the mass of the composition, as well as the ratio of the components of the hemostatic solution to the mass of the solution are given in Table 1.

Table 1

Composition and quantity of components of the hemostatic solution

Example number Hemostatic composition Plasticizer Solvent Modifying additives Name Quantity, wt.% Name Quantity, wt.% Name Quantity, wt.% Name Quantity, wt.% Hemostatic clay material Binder 20 Glycerol 10 Purified water 70 - - Name Quantity*, wt.% Name Quantity*, wt.% 1 Kaolin 50 Calcium alginate 50 2 Kaolin 50 Calcium alginate 45 20 Glycerol 10 Purified water 70 - - Sodium alginate 5 3 Kaolin 83 Calcium alginate 17 12 Glycerol 10 Purified water 77.7 Sodium carbonate 0.3 4 Kaolin 47 Calcium alginate 37 19 Glycerol 10 Purified water 70 Calcium chloride 1 Sodium alginate 16

*Note: quantity*, wt.% – indicates the quantity of components of the hemostatic composition to the mass of the composition; quantity, wt.% – indicates the quantity of components of the hemostatic solution to the mass of the solution.

[77] Table 2 contains information on the acidity index of the hemostatic solution, the composition and quantity of components of which are described in examples 1–4 and are given in Table 1. Table 2 also contains information on the effect on blood clotting time of the acidity index of the hemostatic solution applied to the non-woven material, which is used as a hemostatic agent.

Table 2

Effect of the acidity index of a hemostatic solution applied to a non-woven material on blood clotting time

Example number Acidity index of hemostatic solution Blood clotting time, sec 1 6 94±14 2 7.2 104±23 3 8 42±16 4 8.6 70±22

[78] Thus, the present hemostatic solution for application to non-woven material provides an increase in the stimulation of blood clotting, since the blood clotting time for the compositions obtained according to examples 1 - 4, which illustrate, but do not limit the proposed invention, is 26 - 127 s.

[79] The present technical solution also relates to a hemostatic product comprising a non-woven material onto which a hemostatic solution is applied. Application of a hemostatic solution onto a non-woven material makes it possible to obtain a hemostatic medical product that is easily removed from a wound without damaging the surrounding tissues and that does not change the local blood circulation of the tissues of the wound cavity when used. The use of a non-woven material for the manufacture of a hemostatic product is due to its high degree of absorption of liquid substances, such as blood, which makes it possible to use the present hemostatic product in the event of heavy bleeding to provide first medical and emergency aid.

[80] A hemostatic solution is applied to the non-woven material, which contains a hemostatic composition, a plasticizer, modifying additives and a solvent in the following ratio of components to the mass of the solution, wt.%: hemostatic composition 3 – 20; plasticizer 2 – 15; solvent 70 – 95; modifying additives – the rest.

[81] The hemostatic composition in the hemostatic solution helps stop bleeding upon direct contact with damaged tissues of the body, and also helps increase the stability of the blood clot formed at the site of vessel damage; in addition, the said composition allows the hemostatic solution to be retained on a non-woven material. This improves the effectiveness of first aid and emergency care.

[82] On the one hand, the plasticizer in the hemostatic solution prevents dehydration of damaged body tissues upon contact with them. On the other hand, the presence of a plasticizer in the hemostatic solution, which is applied to a non-woven material, increases the elasticity and plasticity of the said material. This allows the said non-woven material to be modeled according to the shape of the wound surface to increase the area of its contact with the wound surface, improving the effectiveness of first medical and emergency aid.

[83] Modifying additives in the hemostatic solution help stabilize the said solution on the non-woven material, including helping stabilize the hemostatic composition on the non-woven material, which increases the ability of the hemostatic solution to retain its physicochemical properties and pharmacological activity during its shelf life. Modifying additives reduce the peeling of the hemostatic composition from the substrate (non-woven material). For example, a crosslinking agent and/or a thickening component can be used as modifying additives.

[84] The solvent is added to the mixture of the hemostatic composition, plasticizer, or to the mixture of the hemostatic composition, plasticizer, and modifying additives to produce a liquid homogeneous system used to impregnate the nonwoven material.

[85] The specified combination of components and their ratio in the hemostatic solution, which is applied to the non-woven material, provide increased stimulation of blood clotting, improve the stability of the blood clot formed at the site of vessel injury, and increase the elasticity and plasticity of the non-woven material. As indicated earlier, increased stimulation of blood clotting leads to a reduction in the time required to stop bleeding; increased elasticity and plasticity of the non-woven material allows the specified material to be modeled according to the shape of the wound surface to increase the area of its contact with the wound surface. Thus, the above provides improved efficiency in providing first medical and emergency aid.

[86] In this case, the hemostatic solution is applied to the non-woven material in such a way that the said material is impregnated with the hemostatic solution. Impregnation of the non-woven material with the hemostatic solution for the manufacture of a hemostatic medical product ensures uniform distribution of the components of the solution on the material.

[87] Moreover, the linear density of application of the hemostatic composition to the non-woven material is 0.2 - 2.0 g / m. If the linear density of application of the hemostatic composition to the non-woven material is less than 0.2 g / m, then the blood clotting rate decreases. If the linear density of application of the hemostatic composition to the non-woven material is more than 2.0 g / m, then the hemostatic composition peels off from the non-woven material and enters the bloodstream, which causes a side effect in the form of embolization of vessels and organs. The specified linear density of application of the hemostatic composition, which is 0.2 - 2.0 g / m, allows to increase the blood clotting rate while maintaining the elastic and plastic properties of the non-woven material, ensuring an improvement in the effectiveness of first aid and emergency care.

[88] Preferably, the linear density of the plasticizer application on the non-woven material is 0.1 - 0.9 g / m. If the linear density of the plasticizer application on the non-woven material is less than 0.1 g / m, then the hemostatic product is not flexible and does not take the shape of the wound cavity, accordingly, not the entire surface of the wound is in contact with the hemostatic product. If the linear density of the plasticizer application on the non-woven material is greater than 0.9 g / m, then the access of the hemostatic clay material to the source of bleeding is impaired, this, accordingly, leads to a deterioration in the effect of the hemostatic clay material aimed at increasing the stimulation of blood clotting, also the linear density of the plasticizer application on the non-woven material, greater than 0.9 g / m, leads to the fact that the hemostatic product becomes tactilely unpleasant for work, which makes the product unsuitable for its intended use - stopping bleeding. The said preferred linear density of application of the plasticizer to the non-woven material allows to improve the elasticity and plasticity of the non-woven material to which the present hemostatic solution is applied. This allows to model the said non-woven material according to the shape of the wound surface to increase the area of its contact with the wound surface, improving the efficiency of first medical and emergency aid.

[89] For a better understanding of the present invention, the examples below and Table 3 describe the linear density of application of the hemostatic composition, plasticizer on the non-woven material in the manufacture of a hemostatic medical product, and also describe the effect of the linear density of application of the hemostatic composition on the blood clotting time when using the present product, which illustrate, but do not limit, the proposed invention.

[90] Example 5. To manufacture a hemostatic product, a hemostatic solution is used, manufactured according to Example 1, with which a non-woven material is impregnated. The characteristics of the hemostatic product are given in Table 3.

[91] Example 6. To manufacture a hemostatic product, a hemostatic solution is used, prepared according to Example 2, with which a non-woven material is impregnated. The characteristics of the hemostatic product are given in Table 3.

[92] Example 7. To manufacture a hemostatic product, a hemostatic solution is used, prepared according to example 3, with which a non-woven material is impregnated. The characteristics of the hemostatic product are given in Table 3.

[93] Example 8. To manufacture a hemostatic product, a hemostatic solution is used, prepared according to Example 4, with which a non-woven material is impregnated. The characteristics of the hemostatic product are given in Table 3.

Table 3

Characteristics of a hemostatic product

Example number Linear density of application of hemostatic composition, g/m Linear density of plasticizer application, g/m Blood clotting time, sec 5 0.2 0.5 101±23 6 1 0.5 70±16 7 1.5 0.5 50±12 8 2 0.5 55±15

[94] According to the data in Table 3, when using the present hemostatic product, the stimulation of blood clotting is increased, since the blood clotting time according to examples 5-8, which illustrate but do not limit the proposed invention, is 38-124 s. In this regard, the present hemostatic product increases the stimulation of blood clotting, ensuring a reduction in the time required to stop bleeding. Thus, the above characteristics of the present hemostatic product ensure an improvement in the effectiveness of first medical and emergency aid.

[95] The nonwoven material used to manufacture the hemostatic product has the ability to gather into folds, due to which it is possible to give various shapes to the present hemostatic product, accordingly, this increases the area of contact of the said product with the wound surface. The nonwoven material preferably contains viscose, polyester in the following ratio of components, wt.%: viscose 60 - 90, polyester - the rest. The use of a nonwoven material containing polyester, viscose in the said preferred ratio of components in a hemostatic product has a number of advantages: the said material has high strength and tear resistance; it has a lint-free structure, this eliminates the shedding of lint and other elements of the material and, accordingly, their ingress into the wound and the circulatory system; also, the said material is non-toxic and biocompatible with the tissues of the human body. Thus, the use of the said material in a hemostatic product allows for the production of a flexible medical product that has a high degree of absorption of liquid substances, such as blood, which in turn allows the use of this hemostatic product in the event of heavy bleeding. The said advantages of using a non-woven material, which preferably contains viscose, polyester in the following ratio of components, wt.%: viscose 60 - 90, polyester - the rest, lead to an improvement in the efficiency of providing first medical and emergency aid when using this hemostatic product. The surface density of the non-woven material is preferably 20 - 50 g / m ² , this increases the strength of this hemostatic product.

[96] The thickness of the non-woven material is preferably 0.15 - 0.5 mm. If the thickness of the non-woven material is less than 0.15 mm, the material has low strength. If the thickness of the non-woven material is more than 0.5 mm, the material has low flexibility, which complicates the process of modeling it according to the shape of the wound surface. The specified preferred thickness of the material allows the non-woven material to be placed in the wound cavity to increase the contact area of the hemostatic product with the wound surface. This improves the effectiveness of first aid and emergency care when using this hemostatic product.

[97] This technical solution relates to a method for manufacturing a hemostatic article, including a non-woven material, onto which a hemostatic solution is applied. First, according to the manufacturing method, a hemostatic composition, a plasticizer, and a solvent are mixed to obtain a hemostatic solution. The hemostatic composition in the mixture helps stop bleeding, allows the composition of the said solution to be retained on the non-woven material, and also helps increase the stability of the blood clot formed at the site of the vessel injury. The plasticizer in the mixture, upon contact with damaged body tissues, prevents their dehydration, increases the elasticity and plasticity of the non-woven material onto which the mixture of the said components is applied, which allows the said non-woven material to be modeled according to the shape of the wound surface to increase the area of its contact with the wound surface. The solvent is used to manufacture a liquid system. Mixing the components allows obtaining a liquid homogeneous system, which is subsequently applied to the non-woven material. The hemostatic composition, plasticizer, and solvent can be mixed at a temperature of 15–70°C, but it is preferable to mix the components at a temperature of 15°C to 50°C. The preferred temperature range at which the components of the solution are mixed is due to the fact that at a temperature below 15°C the plasticizer and hemostatic composition are not evenly distributed in the solvent, a mixture with unstable physicochemical properties is formed, and mixing the components at a temperature above 50°C is not an optimal solution from the point of view of the technological process for preparing the hemostatic solution.

[98] Then, the mixture of the hemostatic composition, plasticizer, and solvent is applied to the nonwoven material in such a way that it is impregnated in the said mixture to produce a hemostatic product. Application of the said mixture, which is a hemostatic solution, to the nonwoven material allows for the production of a hemostatic medical product that is easily removed from the wound without damaging the surrounding tissues and that does not change the local blood circulation of the tissues of the wound cavity. The nonwoven material, in turn, has a high degree of absorption of liquid substances, such as blood, which allows the use of the said material in cases of heavy bleeding to provide first medical and emergency aid. Impregnation of the nonwoven material with a hemostatic solution ensures uniform distribution of the components of the solution on the material.

[99] Then, the nonwoven material impregnated with the mixture of the hemostatic composition, plasticizer, and solvent is dried by blowing air over it while passing it through rollers. The speed of passing the nonwoven material impregnated with the hemostatic solution through the rollers can be 1–15 m/min, and the air flow speed can vary from 5 m/s to 40 m/s. The air flow temperature can be 70–250°C. The described drying allows not only to dry the hemostatic product to a residual moisture content of no more than 10%, but also ensures uniform distribution of the components of the specified mixture over the nonwoven material by passing it through rollers. After drying, it is preferable to roll the hemostatic product in layers in a Z-shape before placing it in the package; this allows the hemostatic product to be unfolded more quickly and placed in the wound.

[100] Then the dried non-woven material impregnated with a mixture of the hemostatic composition, plasticizer, and solvent is placed in a vacuum foil package. The use of packaging allows for mechanical protection during transportation and storage of the hemostatic product, and protects the product from environmental influences.

[101] Next, the material placed in the vacuum foil package is sterilized to destroy pathogenic microorganisms. The material placed in the vacuum foil package can be sterilized using an electron beam method, where the energy of the sterilizing dose is preferably 1 - 5 Mrad for each side of the material. If the energy of the sterilizing dose is less than 1 Mrad, then the pathogenic microorganisms are not destroyed, and if the energy of the sterilizing dose is more than 5 Mrad, then the hemostatic medical product is destroyed.

[102] For a better understanding of the present invention, the following examples 9 - 11 describe embodiments of the method for manufacturing a hemostatic medical product. The information provided illustrates, but does not limit, the proposed invention.

[103] Example 9. First, the hemostatic composition, plasticizer, and solvent are mixed at a temperature of 15–50°C using a high-speed mixer with a rotation speed of up to 1000 rpm. The ratio of the said components and the acidity index of the solution being prepared are given in Examples 1 and 2, Tables 1 and 2. Then, the mixture of the hemostatic composition, plasticizer, and solvent is applied to the nonwoven material in such a way that it is impregnated in the said mixture to produce a hemostatic article. In this case, the linear density of application of the hemostatic composition and the linear density of application of the plasticizer to the nonwoven material are given in Table 3 and correspond to Examples 5 and 6. Then, the nonwoven material impregnated with the mixture of the hemostatic composition, plasticizer, and solvent is dried by blowing air through it while passing it through rollers. The speed of passing the nonwoven material through the rollers is 1-15 m/min, and the air flow speed is 5-40 m/s. The air flow temperature reaches 100°C. Then, the dried nonwoven material impregnated with a mixture of a hemostatic composition, a plasticizer, a solvent is rolled up in Z-shaped layers, after which the said material is placed in a vacuum foil package. Then, the material placed in the vacuum foil package is sterilized by an electron beam method, where the energy of the sterilizing dose is 5 Mrad for each side of the material.

[104] Modifying additives may be additionally used to manufacture a hemostatic product. Modifying additives in the hemostatic solution help stabilize the solution on the nonwoven material, including helping stabilize the hemostatic composition on the nonwoven material, which increases the ability of the hemostatic solution to retain its physicochemical properties and pharmacological activity during its shelf life. Modifying additives also help reduce the peeling of the hemostatic composition from the substrate (nonwoven material).

[105] A crosslinking agent and/or a thickening component may be used as modifying additives. The thickening component may be added to the mixture of the hemostatic composition, plasticizer, solvent during mixing, for example, sodium carbonate, soluble salts of alginic acid, salts of high-molecular compounds may be used as a thickening component. The crosslinking agent may be sprayed onto the nonwoven material impregnated with the hemostatic solution before drying, for example, calcium chloride, soluble calcium salts may be used as a crosslinking agent. Spraying the crosslinking agent onto the nonwoven material impregnated with the hemostatic solution allows for less substance to be applied to the volume, and, therefore, this allows for maintaining the elasticity and plasticity of the nonwoven material impregnated with the hemostatic solution. Pneumatic spray guns, including those using an electrostatic field, may be used to spray the crosslinking agent.

[106] Example 10. First, the hemostatic composition, plasticizer, solvent, and modifying additive are mixed at a temperature of 15–50°C using a high-speed mixer with a rotation speed of up to 1000 rpm. A thickening component, sodium carbonate, is used as a modifying additive. The ratio of the said components and the acidity index of the solution being prepared are given in Example 3, Tables 1 and 2. Then, the mixture of the hemostatic composition, plasticizer, solvent, and modifying additive is applied to the nonwoven material in such a way that it is impregnated in the said mixture to produce a hemostatic product. In this case, the linear density of application of the hemostatic composition, the linear density of application of the plasticizer on the non-woven material are indicated in Table 3 and correspond to Example 7. Then, the non-woven material impregnated with the mixture of the hemostatic composition, plasticizer, solvent, modifying additive is dried by blowing it with air while passing it through the rollers. The speed of passing the non-woven material through the rollers is 1 - 15 m / min, and the air flow speed is 5 - 40 m / s. The air flow temperature reaches 150 ° C. Then, the dried non-woven material impregnated with the mixture of the hemostatic composition, plasticizer, solvent, modifying additive is rolled up in Z-shaped layers, after which, the said material is placed in a vacuum foil package. Next, the material placed in the vacuum foil package is sterilized by an electron beam method, where the energy of the sterilizing dose is 2.5 Mrad for each side of the material.

[107] Example 11. A hemostatic composition, plasticizer, solvent, modifying additive are used to manufacture a hemostatic product. The ratio of the said components and the acidity index of the solution being manufactured are given in Example 4, Tables 1 and 2. First, the hemostatic composition, plasticizer, and solvent are mixed at a temperature of 15–50°C using a high-speed mixer with a rotation speed of up to 1000 rpm. Then, the mixture of the hemostatic composition, plasticizer, and solvent is applied to the nonwoven material in such a way that it is impregnated in the said mixture to manufacture the hemostatic product. In this case, the linear density of application of the hemostatic composition and the linear density of application of the plasticizer to the nonwoven material are given in Table 3 and correspond to Example 8. Next, a modifying additive, which is a crosslinking agent – calcium chloride – is sprayed onto the nonwoven material impregnated with the hemostatic solution. Afterwards, the material is dried by blowing air through the rollers. The speed of passing the nonwoven material through the rollers is 1-15 m/min, and the air flow speed is 5-40 m/s. The air flow temperature reaches 70°C. Then, the dried nonwoven material is folded in layers in a Z-shape, after which the said material is placed in a vacuum foil package. Next, the material placed in the vacuum foil package is sterilized by an electron beam method, where the energy of the sterilizing dose is 1 Mrad for each side of the material.

[108] Thus, the present hemostatic solution, hemostatic product and method of its manufacture provide an improvement in the effectiveness of first medical and emergency aid by increasing the stimulation of blood clotting while increasing the area of contact of the hemostatic product with the wound surface.

[109] The present application materials present a preferred disclosure of the implementation of the claimed technical solution, which should not be used as limiting other, particular embodiments of its implementation that do not go beyond the requested scope of legal protection and are obvious to specialists in the relevant field of technology.

Claims (37)

1. A hemostatic product comprising a non-woven material onto which a hemostatic solution is applied, containing a hemostatic composition, a plasticizer, a solvent, in the following ratio of components to the mass of the solution, wt. %: • hemostatic composition 3–20; • plasticizer 2–15; • solvent 70–95, in such a way that the non-woven material is impregnated with the said solution, while the linear density of the application of the hemostatic composition to the non-woven material is 0.2–2.0 g/m, where a hemostatic clay material and a binder selected from sodium and/or calcium salt of alginic acid are used as a hemostatic composition, water-soluble polymers and/or copolymers of alcohols and/or esters, and/or polyhydric alcohols, and/or water-soluble organic derivatives of polyhydric alcohols, and/or polyols are used as a plasticizer, and purified water is used as a solvent. 2. A hemostatic product according to paragraph 1, characterized in that the hemostatic solution additionally contains modifying additives, which are a cross-linking agent and/or a thickening component. 3. A hemostatic product according to item 1, characterized in that the hemostatic composition contains a hemostatic clay material, a binder in the following ratio of components to the weight of the composition, wt. %: • hemostatic clay material 40–85; • binder 15–60. 4. A hemostatic product according to paragraph 3, characterized in that an alginic acid salt with a guluronic acid content of 20–50 wt.% is used as a binder. 5. A hemostatic product according to paragraph 1, characterized in that the hemostatic composition is used in the form of a finely dispersed powder with a particle size of 0.5–30 μm. 6. A hemostatic product according to item 1, characterized in that the linear density of the application of the plasticizer to the non-woven material is 0.1–0.9 g/m. 7. A hemostatic product according to item 1, characterized in that the nonwoven material contains viscose and polyester in the following ratio of components, wt. %: • viscose 60–90; • polyester – the rest. 8. A hemostatic product according to item 1, characterized in that the surface density of the nonwoven material is 20–50 g/ ^m2 . 9. A hemostatic product according to item 1, characterized in that the thickness of the nonwoven material is 0.15–0.5 mm. 10. A method for manufacturing a hemostatic product, according to which: • mix the hemostatic composition, plasticizer, and solvent in the following ratio of components to the mass of the solution, wt. %: - hemostatic composition 3–20; - plasticizer 2–15; - solvent 70–95, wherein a hemostatic clay material and a binder selected from sodium and/or calcium salt of alginic acid are used as the hemostatic composition, water-soluble polymers and/or copolymers of alcohols and/or esters, and/or polyhydric alcohols, and/or water-soluble organic derivatives of polyhydric alcohols, and/or polyols are used as the plasticizer, and purified water is used as the solvent; • a mixture of a hemostatic composition, a plasticizer, and a solvent is applied to a non-woven material in such a way that it is impregnated in the specified mixture; • dry the non-woven material impregnated with a mixture of a hemostatic composition, plasticizer, and solvent by blowing air through it while passing it through rollers; • place the dried non-woven material, impregnated with a mixture of a hemostatic composition, plasticizer, and solvent, in a vacuum foil package; • sterilize the material placed in a vacuum foil package. 11. The method according to item 10, characterized in that the hemostatic composition, plasticizer, and solvent are mixed at a temperature of 15–50°C. 12. The method according to item 10, characterized in that modifying additives are additionally used, which include a crosslinking agent and/or a thickening component. 13. The method according to item 12, characterized in that a thickening component is added to the mixture of the hemostatic composition, plasticizer, and solvent during the mixing process. 14. The method according to item 12, characterized in that the crosslinking agent is sprayed onto the nonwoven material impregnated with a mixture of a hemostatic composition, plasticizer, and solvent before drying it. 15. The method according to item 10, characterized in that the speed of passing the nonwoven material through the rollers is 1–15 m/min. 16. The method according to item 10, characterized in that the air flow rate is 5–40 m/s. 17. The method according to item 10, characterized in that the temperature of the air flow is 70–250°C. 18. The method according to paragraph 10, characterized in that the material placed in the vacuum foil packaging is sterilized using an electron beam method. 19. The method according to item 18, characterized in that the energy of the sterilizing dose is 1–5 Mrad for each side of the material.