Haemostatic medical bandage

Abstract

The invention relates to a haemostatic medical device, and more particularly to a haemostatic medical bandage, and can be used on open wounds in order to quickly stopping bleeding, for example, when providing first aid under field or combat conditions. The present haemostatic medical bandage comprises the following components in the proportions as indicated: 56.1-58.3 wt% non-woven fabric; 3.2-9.5 wt% kaolin; 19.8-20.3 wt% glycerin; 7.4-8.8 wt% water; 3.1-13.5 wt% X-ray contrast thread. The kaolin used may be pharmaceutical-grade kaolin. The kaolin may comprise particles having a size of 0.05-0.2 µm. The kaolin may have an iron purity of not more than 0.06% per gram of the fraction. The non-woven material may comprise viscose and polyester. The non-woven material may comprise viscose, polyester, and regenerated lignocellulosic fibre having an antibacterial effect. The X-ray contrast thread may comprise barium sulphate, polypropylene, and polyester. The haemostatic medical bandage may be z-folded or rolled. The technical result of the claimed invention consists in improving the effectiveness and also the hygroscopicity and elasticity of a haemostatic medical bandage.

Description

[0001] Medical hemostatic bandage

[0002] Field of technology

[0003] The invention relates to a medical hemostatic agent, in particular to a medical hemostatic bandage, and can be used on open wounds to quickly stop bleeding, for example, when providing emergency care in field or combat conditions.

[0004] State of the art

[0005] A hemostatic device for stimulating blood clotting is known (RU Patent No. 2599033, published October 10, 2016, IPC A61L15 / 00). The device comprises a substrate, such as gauze, fabric, sponge, spongy matrix, one or more threads, etc., a hemostatic material, such as kaolin clay, placed on the substrate, and a binder, such as cross-linked calcium alginate with a high molar content of hyaluronate monomer, placed on the substrate to retain the hemostatic material. The device is used to treat a bleeding wound; at least part of the clay material comes into contact with the blood and accelerates its clotting. Upon contact with blood, the binder has low solubility and retains most of the clay material on the gauze. A dressing that can be applied to a bleeding wound to promote blood clotting includes a flexible substrate and a gauze substrate applied to it.

[0006] The disadvantages of this technical solution include the labor-intensive nature of its manufacture, since the device has a specific configuration and includes a synthetic product with a complex structure based on hyaluronic acid. Also known is a hemostatic medical device (RU Patent No. 135921, published on December 27, 2013, IPC A61L15 / 22), made in the form of a single-sided or double-sided multilayer dressing and consisting of at least a substrate and an active layer of non-woven material based on chitosan nanofibers. The active hemostatic layer is located on the surface of the substrate, on at least one side, and is a non-woven material with a specific gravity of no more than 15 g / m2, consisting of at least chitosan nanofibers with a diameter of 80 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 located in immediate proximity to the active layer and is represented by a non-woven material with a specific weight of no more than 50 g / m2, consisting of at least aliphatic polyamide nanofibers with an average diameter of 80 to 450 nm, obtained by electrospinning. The process layer is made of a cellulose or synthetic material, and, if necessary, a gelling layer is placed between the contact and active layers, which is a non-woven material with a specific weight of no more than 35 g / m2, consisting of at least carboxymethyl cellulose nanofibers with an average diameter of 80 to 300 nm, obtained by electrospinning.

[0007] The known multilayer product is low-effective, labor-intensive to manufacture, has a base of nanofibers of a certain diameter, and must be applied to the wound with a specific side.

[0008] A solution that is closest in essence to the claimed medical hemostatic bandage (prototype) has not been identified.

[0009] There is a need for a highly effective medical hemostatic bandage that can quickly and reliably stop bleeding, including in field and combat conditions, and that does not require extensive labor costs for its production.

[0010] Disclosure of invention

[0011] The technical result of the claimed invention is to increase the effectiveness of the medical hemostatic bandage, as well as its hygroscopicity and elasticity.

[0012] The stated technical result is achieved by the fact that the medical hemostatic bandage includes a non-woven material, kaolin, glycerin, water and radiopaque thread, in the following ratio of components, mass%:

[0013] non-woven material 56.1 - 58.3;

[0014] kaolin 3.2 - 9.5;

[0015] glycerin 19.8 - 20.3;

[0016] water 7.4 - 8.8;

[0017] radiopaque thread 3.1 - 13.5.

[0018] In this case, pharmacopoeial kaolin can be used as kaolin.

[0019] Kaolin with a particle size of 0.05–0.2 µm can be used. Kaolin may have an iron purity of no more than 0.06% per gram of fraction.

[0020] Non-woven material may include viscose and polyester.

[0021] Non-woven fabric may contain 60% viscose and 40% polyester. Non-woven fabric may also include viscose, polyester, and regenerated wood pulp fiber, which has antibacterial properties.

[0022] Non-woven material may contain 50% viscose, 30% polyester and 20% regenerated wood pulp fiber.

[0023] Radiopaque thread may include barium sulfate, polypropylene, and polyester.

[0024] The medical hemostatic bandage may have a z-fold or may be laid in the form of a roll.

[0025] The effectiveness of a medical hemostatic bandage is increased by quickly stopping bleeding, including when tamponing wounds of complex configurations.

[0026] The increased elasticity of the claimed medical hemostatic bandage is achieved due to the plasticity of kaolin included in the composition of the bandage, in contrast to chitosan, which is part of known bandages, which are subject to destruction under the conditions of tamponade of wounds of complex configuration.

[0027] The increase in hygroscopicity of the declared medical hemostatic bandage is achieved by increasing its absorption capacity, achieved through the declared ratio of all components of the bandage.

[0028] The declared medical hemostatic bandage can be used to stop bleeding from cut, lacerated and abrasive wounds, as well as for temporary use to control severe bleeding from surgical wounds (surgical, postoperative, dermatological, etc.) and traumatic injuries during plastic surgery on blood vessels, stenting, catheter angiography and other operations.

[0029] The main active ingredient in the claimed invention is kaolin, a natural clay mineral with the chemical composition Al2Si2O5(OH)4. Kaolin does not contain plant or animal proteins, chitosan, thrombin, or other synthetic substances, and is therefore non-toxic, inert, and non-allergenic. Kaolin also has an enveloping and absorbent effect. Kaolin enhances the body's natural blood clotting properties and stimulates platelet adhesion at the wound site.

[0030] Kaolin's action is such that upon contact with blood, the thrombus formation process begins immediately due to the activation of factor XII. This reaction leads to the transformation of factor XII into its activated form, XIa, i.e., the conversion of prekallekrein (also known as Fletcher factor) into kallekrein. The activation of factors XII and XIa initiates the subsequent blood clotting mechanism. Thanks to kaolin, the prekallekrein activation reaction proceeds much more rapidly and efficiently.

[0031] Also, kaolin, being a natural mineral, has the properties of clay materials, which makes it quite easy to process and obtain a hemostatic composition.

[0032] It is precisely due to the stated ratio of components in the proposed solution—non-woven material, kaolin, glycerin, water, and radiopaque thread—that the maximum effectiveness of the medical hemostatic bandage is achieved.

[0033] The inclusion of kaolin in the composition of a medical hemostatic bandage reduces overall blood loss, eliminates the occurrence of allergic and burn skin reactions, exergonic reactions, and also ensures the possibility of leaving the bandage directly on the wound for more than 24 hours.

[0034] The use of pharmacopoeial kaolin enhances the enveloping and absorbent (absorbing) pharmacological action of the medical hemostatic bandage.

[0035] The use of kaolin with a particle size of 0.05 - 0.2 µm increases the viscosity and reduces the flowability of the composition obtained by mixing kaolin with glycerin and water. The use of a nonwoven fabric made of viscose and polyester helps retain residual moisture and ensures the material's flexibility for easy packing in any wound location. For this nonwoven material, the optimal content is 60% viscose and 40% polyester.

[0036] The use of a nonwoven fabric made of viscose, polyester, and regenerated wood pulp fiber, which has antibacterial properties, reduces the potential for wound infection, even in challenging field conditions. The optimal composition for this nonwoven material is 50% viscose, 30% polyester, and 20% regenerated wood pulp fiber.

[0037] The inclusion of a radiopaque thread embedded in a non-woven material in a medical hemostatic bandage allows for quick detection of the bandage within the wound cavity. The radiopaque thread can be made of barium sulfate, polypropylene, or polyester. The optimal composition is 55% barium sulfate, 33% polypropylene, and 12% polyester.

[0038] A medical hemostatic bandage can have a Z-pattern, which allows for the most convenient tamponade of the wound.

[0039] A medical hemostatic bandage can be laid out in the form of a roll, which allows for bandaging, including of limbs in case of amputation (medical or traumatic).

[0040] To make a medical hemostatic bandage, kaolin is mixed with glycerin and water in specific ratios. The mixture is mixed in a blender using a rotary mixer for 30 minutes, while water and glycerin are sprayed directly into the blender.

[0041] To achieve maximum effectiveness of the medical hemostatic bandage, kaolin with a particle size of 0.05 - 0.2 µm is used, which is obtained by sifting kaolin particles through a set of sieves with different diameters to obtain fractions with the required particle size.

[0042] The resulting composition must have the following indicators, which are also provided for by TU 21.20.24-001-47062474-2023:

[0043] - density not less than 30 g / m2.

[0044] - capillarity not less than 0.05 cm.

[0045] - sorption capacity - not less than 40 g of saline solution, while the absorption rate of the product must be not less than 12 g of saline solution / s.

[0046] - wetting time no more than 5 sec.

[0047] A strip of appropriate size, for example 7.5 cm x 370 cm, is cut from a non-woven material, such as viscose or polyester, with a radiopaque thread sewn into it.

[0048] The radiopaque thread must be visible in the structure of the bandage during fluoroscopy and can be made, for example, from barium sulfate, polypropylene and polyester, and have a blue / blue color (pigment).

[0049] Next, the resulting mixture, based on kaolin, glycerin, and water, is applied to the nonwoven material, laid out in a single layer, and allowed to dry completely. Apply 2-3 layers of the mixture until the entire surface of the nonwoven material is visually evenly coated.

[0050] To verify that the components of a medical hemostatic bandage comply with the stated requirements, a corresponding analysis is conducted to determine their percentage content (weight %). The resulting medical hemostatic bandage is then assembled into a specific configuration for more compact packaging and use, such as a Z-fold or roll.

[0051] The obtained and appropriately laid medical hemostatic bandage is packaged in individual packaging, which has an outer layer made of two-layer biaxially oriented nylon, polyethylene glycol terephthalate, polyvinylidene chloride (PVDC), and an inner layer in the form of two-layer biaxially oriented nylon, linear low-density polyethylene (LLDPE), which is welded and subjected to radiation sterilization.

[0052] Next, they carry out weight control and a random test for sterility of the medical hemostatic bandage.

[0053] The resulting medical hemostatic bandage must meet the following requirements, which are also provided for in TU 21.20.24-001-47062474-2023:

[0054] - density - (1.45 - 1.52) g / m2;

[0055] - tensile strength at break: in the longitudinal direction - not less than 45.0 MPa, in the transverse direction - not less than 42.0 MPa;

[0056] - material thickness - not less than 98 microns;

[0057] - tensile strength: in the longitudinal direction - not less than 111.8 N / 15 mm, in the transverse direction - not less than 103.0 N / 15 mm;

[0058] - oxygen permeability - not less than 11.0 cm3 / (m2 x day x atm.); - vapor permeability - not less than 3.8 g / m2 / day;

[0059] - crushing strength - not less than 14.71 N.

[0060] Implementation of the invention

[0061] The methods for using the claimed medical hemostatic bandage are described below. The medical hemostatic bandage can be applied (depending on the nature of the wound) by applying it as a tight bandage to the wound or by placing it directly into the wound.

[0062] When using a bandage as a dressing, it is necessary to wrap the bandage in several layers over the wound and secure it.

[0063] For penetrating wounds, the bandage can be placed directly into the wound channel, pressing the bandage with your hand directly over the source of bleeding. More than one bandage can be applied to the wound. Press the bandage with your hand for 3-5 minutes or until the bleeding stops.

[0064] Typically, hemostasis is achieved within 3 minutes of applying the bandage to the wound or securing it in place. However, if necessary, the bandage can be left in place for a longer period.

[0065] After completing the above steps, if necessary, prepare the victim for transportation.

[0066] The bandage can be left in place for up to 24 hours. Then, carefully remove the bandage. If it is difficult to remove, moisten it with sterile saline. After removal, thoroughly clean the wound. For greater patient comfort and easier removal, irrigation (washing with water) is possible.

[0067] A comparative analysis of the claimed kaolin-based bandage with known chitosan-based bandages showed that the claimed bandage is not inferior to known bandages in terms of hemostatic effectiveness, and in some parameters even surpasses them (Table 1).

[0068] Table 1. Comparison of the results of the effectiveness of the hemostatic action of the declared bandage with known bandages. Indicator

[0069] Name Temporary Primary Secondary

[0070] bandage Survival hemostasis after temporary temporary

[0071] after 3 hours marching hemostasis hemostasis

[0072] samples preserved Gemoflex 63% 100% 63% 80% Gemospas Bio 75% 88% 63% 80%

[0073] Geomed 50% 75% 75% 100% Declared

[0074] bandage (on

[0075] 63% 100% 88% 81% based

[0076]

[0077] kaolin)

[0078] Below are examples of the use of medical hemostatic bandages with different component compositions.

[0079] Example 1.

[0080] The medical hemostatic bandage was manufactured using the above method to obtain the following ratio of the declared components, mass%:

[0081] non-woven material - 57.5;

[0082] kaolin - 2.8;

[0083] glycerin - 19.8;

[0084] water - 8.0;

[0085] radiopaque thread - 11.9.

[0086] As a result of experimental use of the resulting bandage, it was found that the reaction rate was reduced and the blood clotting time was increased. Example 2.

[0087] The medical hemostatic bandage was manufactured using the above method to obtain the following ratio of the declared components, mass%:

[0088] non-woven material - 58.1;

[0089] kaolin - 10.7;

[0090] glycerin - 19.9;

[0091] water - 7.8;

[0092] radiopaque thread - 3.5.

[0093] As a result of experimental use of the resulting bandage, it was found that the elasticity of the bandage decreased and the possibility of effective tamponade worsened.

[0094] Example 3.

[0095] The medical hemostatic bandage was manufactured using the above method to obtain the following ratio of the declared components, mass%:

[0096] non-woven material - 54.9;

[0097] kaolin - 3.2;

[0098] glycerin - 22.5;

[0099] water - 6.2;

[0100] radiopaque thread - 13.2.

[0101] As a result of experimental use of the resulting bandage, it was found that the elasticity of the bandage decreased.

[0102] Example 4.

[0103] The medical hemostatic bandage was manufactured using the above method to obtain the following ratio of the declared components, mass%:

[0104] non-woven material - 59.7;

[0105] kaolin - 4.2; glycerin - 17.9;

[0106] water - 10.2;

[0107] radiopaque thread - 8.0.

[0108] As a result of experimental use of the resulting bandage, it was found that the frost resistance of the bandage had deteriorated, which is especially important when using the bandage in conditions of low ambient temperatures.

[0109] Example 5.

[0110] The medical hemostatic bandage was manufactured using the above method to obtain the following ratio of the declared components, mass%:

[0111] non-woven material - 57.9;

[0112] kaolin - 6.5;

[0113] glycerin - 20.2;

[0114] water - 8.2;

[0115] radiopaque thread - 7.2.

[0116] As a result of experimental use of the resulting bandage, it was found that this bandage has a pronounced hemostatic activity in relation to arterial bleeding, allowing for a reduction in overall blood loss due to the rapid and reliable stopping of bleeding, i.e., it has an effective hemostatic effect.

[0117] From the above examples it follows that only the use of the stated ratio of components allows one to obtain a medical hemostatic bandage with the required physicochemical properties.

[0118] Thus, it can be concluded that the declared bandage is characterized by increased efficiency, hygroscopicity and elasticity, and also has a highly effective hemostatic effect, and can be used in various climatic and extreme conditions.

Claims

Invention formula 1. A medical hemostatic bandage comprising non-woven material, kaolin, glycerin, water and radiopaque thread in the following ratio of components, wt.%: non-woven material 56.1 - 58.3; kaolin 3.2 - 9.5 glycerin 19.8 - 20.3 water 7.4 - 8.8 radiopaque thread 3.1 - 13.

5.

2. A medical hemostatic bandage according to paragraph 1, characterized in that pharmacopoeial kaolin is used as kaolin.

3. A medical hemostatic bandage according to paragraph 1, characterized in that kaolin with a particle size of 0.05 - 0.2 µm is used.

4. A medical hemostatic bandage according to paragraph 1, characterized in that the kaolin has an iron purity index of no more than 0.06% per 1 gram of fraction.

5. A medical hemostatic bandage according to paragraph 1, characterized in that the non-woven material includes viscose and polyester.

6. A medical hemostatic bandage according to paragraph 5, characterized in that the non-woven material contains 60% viscose and 40% polyester.

7. A medical hemostatic bandage according to paragraph 1, characterized in that the non-woven material includes viscose, polyester and regenerated wood-cellulose fiber, which has an antibacterial effect.

8. A medical hemostatic bandage according to claim 7, characterized in that the non-woven material contains 50% viscose, 30% polyester and 20% regenerated wood cellulose fiber.

9. A medical hemostatic bandage according to claim 1, characterized in that the radiopaque thread includes barium sulfate, polypropylene and polyester.

10. A medical hemostatic bandage according to paragraph 1, characterized in that it has a Z-fold or is laid in the form of a roll.

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