UA105516U - Method for bleeding arrest from blood vessels of various types - Google Patents

Abstract

The method for bleeding arrest from the blood vessels of various types provides for application of chitosan-containing hemostatic material onto the site of vascular defect followed by impression of the bandage onto the wound surface. Chitosan is used in a form of a gel with a concentration of an active ingredient from 0.5 % to 5 % and molecular weight of chitosan from 100 to 900 kDa. The multilayer bandage is shaped with thickness from 0.5 to 5 cm by applying chitosan gel on a base, such as gauze, cellulose, collagen followed by drying or freeze-gelation. Following the pressure onto the multilayer bandage for at least 5 minutes, the tight dressing is provided with extra pressure until the complete arrest of bleeding.

Description

The useful model belongs to the field of medicine, in particular to local hemostatic materials that allow you to stop bleeding from vessels of various diameters, both in the case of wounds in wartime or emergency situations, and during planned surgical interventions in surgery, traumatology, obstetrics and gynecology.

There is a known method of stopping bleeding using the topical agent "OtsiksSioi", which contains as an active substance the mineral component zeolite, which allows you to quickly absorb the liquid part of the blood and concentrate the formed elements of the blood around the lesion (US patent. 7595429 B2., О0520040939687, 20040913 Ab1К33/ 00, 2009.09.29).

But this method is not convenient for practical use and is characterized by the presence of complications in the form of an increase in local temperature due to an exothermic reaction during sorption, which can lead to burns of wound tissues. In addition, the drug does not affect the thrombus-forming activity of formed blood elements.

There is also a known method of stopping bleeding using the drug Kaprofer, which contains iron trichloride, epsilon-aminocaproic acid and physiological solution. Bleeding is stopped by applying a bandage moistened with the drug Kaprofer. Hemostasis is carried out due to coagulation of blood proteins and activation of the hemostasis system (Gulunyan Z.A., Lalaev K.V.

Method of stopping bleeding with the drug "Kaprofer". Method. river - Yerevan, 1982. - 8 p.)

But this method is characterized by the use of a procoagulant - epsilon-aminocaproic acid, which can cause the development of disseminated intravascular coagulation (DIC) and iron trichloride, which can cause a chemical burn and necrosis of the soft tissues of the wound.

There is a well-known method of stopping bleeding with the use of a local agent, "SeYoch dace", which is a woven base in the form of a multilayer bandage or bandage with a hemostatic layer applied to it, which includes chitosan microgranules. This material is applied by application to the wound with subsequent pressure from 3 minutes until the bleeding stops completely (kKbkzai O ei ai, Tyzhivp ./ oi ashta apa etegdepsu zygdegu. - 2011. -17(3) 199- 204).

The above-mentioned method is the closest in terms of technical essence and result that can be achieved, so it was chosen as a prototype.

Ko) But this method has the following disadvantages. Thus, gradual application to a bandage or multilayer bandage is an energy-consuming process, and a local increase in body temperature at the site of application is also possible. In addition, the production of chitosan microgranules is carried out by a technologically complex method, which increases the cost of the materials themselves.

The use of the method itself is possible only in emergency situations and in military field conditions at the stage of providing first aid.

The basis of a useful model is the task of improving the existing method using such a form of chitosan, which, when applied to a base made of woven or non-woven material, would facilitate its convenient use and lead to the rapid formation of a thrombus at the site of injury, would not cause the development of systemic complications in the patient, would have low cost for serial production and could be used both at the stage of first aid and in the operating room for planned surgical interventions.

The problem is solved by the fact that in a known method of stopping bleeding by applying a local agent to the site of a vascular defect, namely a hemostatic material that includes chitosan, the formation of a multilayer bandage followed by the addition of pressure to it when the bandage is pressed against the surface of the wound, according to a useful model, chitosan, which is used as a hemostatic material, is used in the form of a gel with a concentration of the active substance from 0.5 95 to 595 and a molecular weight from 100 to 900 kDa, a multilayer bandage is formed with a thickness of 0.5 to 5 .0 cm, by applying chitosan gel to the base, in particular gauze, cellulose, collagen, followed by drying it, or using the sol-gel method, stimulated by freezing (Igeee-deiyatsop), and after applying pressure to the multilayer bandage during its pressing against the wound for at least five minutes, fixing it by applying a tight bandaging, or continuing the constant pressing of a multi-layer bandage and until the bleeding stops completely.

Drying of the multilayer bandage is carried out at a temperature of 420 to 460 "C for 24-48 hours.

In addition, the method of freeze-drying, which is carried out at a temperature from -60 to 160 "C after preliminary cooling and freezing of a multilayer bandage at a temperature of -30 ... -50 "C for a day, can be used to dry a multilayer bandage, or it is used quick freezing at a temperature of -100 ... -19070 because immediately before freeze-drying.

The sol-gel method, stimulated by freezing (tGeee-deiyatsyop), is carried out by moderate freezing of a multilayer bandage at a temperature from -5 to -20 "C for a day, followed by treatment of the frozen material with a mixture of 12 95 sodium hydroxide solution and 96 95 ethyl alcohol ( 171), which is cooled to the freezing temperature of a multilayer bandage for 3-7 days.

The use of the claimed method, with all essential features, including excellent ones, allows to eliminate the effect of the hemostatic material on the surrounding tissues when bleeding is stopped, to prevent the development of systemic complications. In addition, carrying out the method taking into account the listed operations allows the liquid part of the blood to be quickly absorbed, which leads to the concentration of formed elements of the blood, in particular erythrocytes and platelets at the site of bleeding with subsequent adhesion of erythrocytes and platelets to the surface of the material and the rapid formation of a thrombus at the site of injury and as result until the complete stop of bleeding. The form of the hemostatic material within the framework of this method is convenient to use, has a low production cost, which allows it to be used not only at the stage of first aid, but also in the conditions of operative interventions.

The method is carried out as follows.

In the conditions of providing first aid when external bleeding is detected as a result of mechanical injury, gunshot wound, etc., a multilayer monolayer is prepared, which can be twisted into a roll or a bandage (further bandage), the basis of which is gauze, cellulose, collagen. Chitosan in the form of a gel is applied to this base, while the thickness of this bandage is from 0.5 to 5 cm. The molecular weight of the chitosan gel is from 100 to 900 kDa, and the concentration of the active substance is from 0.595 to 595. The bandage is dried in thermostat at a temperature from 20 C to -O0 C within 24-48 hours. It is possible to use lyophilic drying, for which the bandage is pre-cooled and frozen in a special refrigerating chamber at a temperature of -30 "C to -50 "C during the day, or quick freezing is used at a temperature of -100 "C to -190 "C immediately before drying At the same time, the freeze-drying process is carried out at a temperature from -60 to 160 "C. In addition, it is possible for a multilayer bandage to use the sol-gel method, stimulated by freezing (ieege-deiyaop), which is carried out by moderately freezing the bandage in a special refrigerator chamber at a temperature of -57C to -20C for a day, followed by treatment of the frozen material with a mixture of 12 95 sodium hydroxide solution and 96 96 ethyl alcohol (171), cooled to a temperature from 5 "C to -20 "C for 3-7 days. Carry out applying this bandage to the surface of the wound with a traumatized vessel, applying pressure to its outer side with the help of, for example, fingers or the palm, for at least 5 minutes. If necessary, the time of pressing on the surface of the wound can be extended, for example, up to 10 minutes.

After visual confirmation that the bleeding has stopped, the bandage is fixed by tightly bandaging the affected area or the bandage is constantly pressed against the wound until the patient receives specialized medical care.

Experimental studies were conducted on 26 animals, 21 of which are white laboratory rats weighing 200-250 g, and 5 are Chinchilla rabbits weighing 4.5-5 kg.

Example 1

An anesthetized white laboratory rat is laid on its back. After preliminary shaving of the hair, access is made to the femoral vascular-nerve bundle, the skin, subcutaneous tissue, and superficial fascia are dissected layer by layer for 0.8-1.0 cm. The elements of the bundle are bluntly separated, the femoral artery is freed from the edge of 1/2 of its circumference. Immediately after the bleeding begins, an application is carried out with a multilayer chitosan bandage, for the preparation of which gauze, cellulose and collagen are used as a basis with chitosan applied to it in the form of a gel with a molecular weight of 200 kDa and a concentration of the active substance of 2 95 µl, which is previously dried in a thermostat at a temperature of 425 "С for 25 hours. The thickness of the chitosan bandage is 0.5 cm. The bandage is pressed to the wound and finger pressure is applied to it for 5 minutes. Then the fixation of the bandage was continued for 2.5 minutes, it is observed rapid formation of a thrombus at the site of the injury and as a result complete stoppage of bleeding. After the end of the exposure, the bandage was removed from the wound, the bleeding did not resume, no effect on the surrounding tissues was observed.

Example 2

An anesthetized rabbit is placed on its back. After preliminary shaving of the hair, access to the abdominal cavity is carried out, the internal organs are removed to the top, the parietal peritoneum is dissected in the projection of the spinal column, the aorta is bluntly isolated from the level of the departure of the renal arteries to the bifurcation of the aorta. In the middle of this area, the wall of the aorta is dissected up to 1/2 of its circumference. because Immediately after the start of bleeding, a multilayer chitosan bandage is applied,

for the preparation of which gauze, cellulose and collagen with applied chitosan in the form of a gel with a molecular weight of 200 kDa and a concentration of the active substance of 2 95 are used as a basis. For a multilayer bandage, freeze-drying is carried out at a temperature from -60 "C to 160 " C for 30 hours after preliminary cooling and freezing, which is carried out in a special refrigerating chamber at a temperature of -30C for a day, it is possible to use quick freezing at a temperature of -100"C immediately before drying. Apply pressure to the bandage for 5 minutes and fix it on wounds, applying finger pressure until the bleeding stopped completely, which did not exceed 10 minutes, due to the rapid formation of a thrombus at the site of the injury. After the end of the exposure, the bandage is removed, the bleeding does not resume, the impact on the surrounding tissues was not observed.

Example C

All actions are carried out as in example 2, only after the formation of a multi-layered chitosan bandage, the sol-gel method stimulated by freezing is used for it (Igeeedeiacyop). The material is frozen in a special refrigerating chamber at a temperature of -570 for a day, then the frozen material is treated with a mixture of 12 95 sodium hydroxide solution and 96 95 ethyl alcohol in a ratio of 1:1, and this mixture is cooled to a temperature of -5 "C for 3 days. Then apply pressure on the bandage for 5 minutes and fix it on the wound by tight bandaging for another 5 minutes. After the exposure, the bandage is removed, the bleeding does not resume, due to the rapid formation of a thrombus at the site of the injury, no effect on the surrounding tissues was observed.

Data on the complete stopping of bleeding without the effect of the claimed method on the surrounding tissues and the absence of systemic manifestations in animals are shown in the table.

Table

Indicators of stopping bleeding when performing the method

Laboratory animal | Traumatic vessel | The cross-sectional area of the blood vessels of St

Laboratory animal Injured vessel Cross-sectional area of the vessel: bleeding min.

Ш7 11 / Femoral artery with diameter.//://ЗГ/| b 9 shyayush.

Thigh 111 /Femoral artery With |Complete occlusion/:/ | 6

THY4 1 /Femoral artery |Complete occlusion/:/ | 9

SHIELD 5 0 /Femoral artery |Complete occlusion/:/ | 8

THY7 11 /Femoral artery |Complete occlusion/:/ | 8 and

SHIELD 0 /Femoral artery |Complete occlusion/:/ | 6

SHIELD 0 /Femoral artery |Complete occlusion/:/ | 6 of which 0 /Femoral artery |Complete crossing/:/ | 6

KZ 11111111 / Stegyu artery | Full intersection/:/ | 6

KB 77777111 dAorta 0 |Complete occlusion/.:/ | 9 -- 8 2 2juzh;i«

Designation: Sh - shur, K - rabbit.

As can be seen from the data in the table, bleeding was stopped quickly in all laboratory animals. After hemostasis, physiological blood flow was restored in the damaged vessel.

Thus, the use of the method made it possible to completely stop bleeding due to the rapid formation of a thrombus at the site of injury, without affecting the surrounding tissues and the absence of systemic manifestations, which has a positive effect not only in case of damage to large vessels, but also diffuse bleeding from soft tissues or parenchymal organs in the conditions of operational actions.

Claims (5)

USEFUL MODEL FORMULA 1. The method of stopping bleeding from vessels of various types by applying a local agent to the site of a vascular defect, namely a hemostatic material that includes chitosan, by forming a multilayer bandage followed by adding pressure to it when the bandage is pressed against the surface of the wound, which differs the fact that chitosan, which is used as a hemostatic material, is used in the form of a gel with a concentration of the active substance from 0.5 95 to 5 95 and a molecular weight of chitosan from 100 to 900 kDa, and a multilayer bandage is formed with a thickness of 0.5 to 5 cm, by applying chitosan gel to the base, in particular gauze, cellulose, collagen, followed by drying it, or using the sol-gel method, stimulated by freezing (Igteele-deiacyop), and after applying pressure to the multilayer bandage while pressing it to wounds for at least five minutes, fix it by tightly bandaging it, or continue to constantly press the multilayer bandage to the full stoppage of bleeding. 2. The method of stopping bleeding from vessels of various types according to claim 71, which is characterized by the fact that the drying of the multilayer bandage is carried out at a temperature of 4207 to 460 "C for 24-48 hours. 3. The method of stopping bleeding from vessels of various types according to claim 1, which differs in that the method of lyophilic drying can be used to dry the multilayer bandage. 4. The method of stopping bleeding from blood vessels of various types according to claims 1, 3, which differs in that lyophilization is carried out at a temperature from -60 "C to -60 "C after preliminary cooling and freezing of a multilayer bandage at a temperature from -30 C to -507C for a day or use quick freezing at a temperature from -100 "C to -190 "C immediately before freeze-drying. 5. The method of stopping bleeding from vessels of different types according to claim 1, which differs in that the sol-gel method, stimulated by freezing (ShGeele-deiyaop), is carried out by moderate freezing of a multilayer bandage at a temperature from -5 "C to -20 " C for a day, followed by treatment of the frozen material with a mixture of 12 95 sodium hydroxide solution and 96 95 ethyl alcohol in a ratio of 1:11, which is cooled to the freezing temperature of a multilayer bandage for 3-7 days.