UA141355U - HEMOSTATIC COMPOSITE MATERIAL - Google Patents

Abstract

The hemostatic composite material contains a matrix-base, a sorbent and additional substances. As a matrix-base contains polyurethane foam or woven or non-woven natural or synthetic fabric. As a sorbent contains nanosized silica and / or pyrogenic alumina. As additional substances it contains at least one substance selected from the group consisting of: aminocaproic acid, carboxymethylcellulose, sodium alginate, polyvinyl alcohol, gelatin, polyacrylic acid, boric acid, furacillin, decamethoxine, benzalkonium chloride, procaine hydrochloride.

Description

A useful model belongs to dressings or absorbent pads for physiological fluids and can be applied in emergency medical care and surgery to stop bleeding.

In case of wounds in the conditions of hostilities, emergencies, natural disasters, etc., it is necessary to stop the bleeding as soon as possible, to prevent dirt and infection from entering the wound. At the same time, the time of pre-medical care can last for hours, and sometimes even a day.

Various hemostatic materials are known in the form of bandages, napkins, plasters, rubber bands, etc., which contain hemostatic substances of synthetic or natural origin, including aminocaproic acid, polyvinyl alcohol, oxidized cellulose, collagen, gelatin, fibrinogen and other substances (1). These materials mostly have a unidirectional (hemostatic) effect and do not have antimicrobial or protein-absorbing properties. A significant drawback of the well-known hemostatic bandage "Se|oh M", the active substance of which is chitosan, is its high cost and, accordingly, low availability. In addition, chitosan residues, which are difficult to remove from the wound, can cause tissue necrosis.

Hemostatic properties of nanosized silica are known, which are caused by adsorption with subsequent activation of the blood plasma protein - the Hageman factor responsible for blood coagulation (2, C). In addition, nanosized silica has high water-absorbing properties and sorption capacity in relation to pathogenic proteins and microorganisms, and therefore it is advisable to use it for the primary treatment of a wound. However, silica has a powder form, which creates certain inconveniences when used in field conditions, during mass damage and disasters, in particular, it is impossible to achieve accurate dosage, it interferes with dust formation.

The closest to the declared useful model is a bandage for wounds, containing a gauze base and nano-sized silica as a sorbent, which are pressed using a press under a certain pressure I4). The bandage has the shape of a disk 3-4 mm thick, 4 cm in diameter, which is applied to the wound and fixed in any acceptable way. The bandage is characterized by hemostatic, water-absorbing and adsorption properties, but its disadvantages are fragility, as well as the lack of antimicrobial action.

The task of a useful model is to create a hemostatic composite material that has water-absorbing (dehydrating) properties, provides antimicrobial action, protein sorption,

Zo reduces blood loss.

The task is solved by the fact that the hemostatic composite material containing the matrix-base, sorbent and additional substances, according to a useful model, as the matrix-base contains polyurethane foam or woven or non-woven natural or synthetic fabric; as a sorbent containing nanosized silica and/or pyrogenic aluminum oxide; as additional substances contains at least one substance selected from aminocaproic acid, carboxymethylcellulose, sodium alginate, polyvinyl alcohol, gelatin, polyacrylic acid, boric acid, furacilin, decamethoxine, benzalkonium chloride, procaine hydrochloride, lidocaine, etc., according to this ratio of components, mass . 9o: matrix-base 10-50 nano-sized silica and/or 25-50 pyrogenic aluminum oxide, additional functional up to 15 substances

The material has the form of a 2-fold folded bandage or a 3-7 mm thick plate of a certain geometric shape and size, which is packed in a sterile film package. For cases of massive bleeding, the product is equipped with a pillow with mechanical air pumping with a means of fixation (as an option - "Velcro"), which ensures effective pressing of the material to the area of bleeding.

A woven or non-woven natural or synthetic fabric, polyurethane foam serves as the matrix-base of the hemostatic composite material.

The sorbents used in the proposed hemostatic composite material include silica or aluminum oxide, which have hemostatic and adsorption properties. Additional functional substances: carboxymethylcellulose, sodium alginate, polyvinyl alcohol, gelatin, etc. - in addition to the known hemostatic effect, perform the function of a binder and belong to water-soluble high molecular weight compounds.

The declared hemostatic composite material is formed in the form of a 2-fold folded bandage or tape of woven (medical gauze) or non-woven (for example, spunlace) material, impregnated with a silica-based composition with fillers, or polyurethane foam of a certain geometric shape and size (for example, a square with a side of about 5 cm and 0.5 cm thick), which is filled with a silica-based composition with additional functional substances.

The proposed hemostatic composite material is demonstrated by the following examples.

Example Mo 1. Cut a medical bandage of sufficient length. In the container by intensive mechanical stirring for 15 min. prepare a suspension of nanosized silica (aerosil A-300) with polyvinyl alcohol in water, which contains 10 wt. 95 silica and 1 wt. 95 polyvinyl alcohol. Impregnation of the bandage is performed by immersing it in the suspension followed by free draining of the remaining suspension. After impregnation, the bandage is dried at a temperature of 60 "С.

Example Mo 2. Cut a strip of spunlace material of sufficient length. In the container by intensive mechanical stirring for 15 min. prepare a suspension of nanosized silica with sodium alginate in water, which contains 5 wt. 95 of silica and 0.5 wt. 96 sodium alginate. Impregnation of the tape is performed by immersing it in the suspension followed by free draining of the remaining suspension. After impregnation, the bandage is dried at a temperature of 60 "С.

Example Mo 3. From the ready-made polyurethane foam material with a thickness of 5 mm, cut a sufficient number of blanks of the base of a square shape measuring 5x5 cm. In a container by intensive mechanical mixing for 15 minutes. prepare a suspension of nanosized silica with carboxymethyl cellulose (CMC) in water, which contains 5 wt. 95 of silica and 0.5 wt. 95 KMC.

Impregnation of polyurethane foam blanks is carried out by immersing them in a suspension followed by squeezing and unzipping. After impregnation, the blanks are dried at a temperature of 60 s.

Example Mo 4. From polyurethane foam material with a thickness of 5 mm, cut a sufficient number of blanks of the base of a square shape with a size of 5x5 cm. In a container by intensive mechanical mixing for 15 minutes. prepare a suspension of pyrogenic aluminum oxide with sodium alginate in water, which contains 5 wt. 95 aluminum oxide and 0.5 wt. 95 sodium alginate.

Impregnation of polyurethane foam blanks is carried out by immersing them in a suspension followed by squeezing and unzipping. After impregnation, the workpieces are dried at room temperature

From 60 p.

Example Mo 5. From polyurethane foam material with a thickness of 5 mm, cut a sufficient number of blanks of the base of a square shape with a size of 5x5 cm. In a container by intensive mechanical mixing for 15 minutes. prepare a suspension containing 2.5 mg. Fo of nanosized silica, 2.5 wt. 9% of pyrogenic aluminum oxide and 0.5 wt. 95 KMC.

Impregnation of polyurethane foam blanks is carried out by immersing them in a suspension followed by squeezing and unzipping. After impregnation, the blanks are dried at a temperature of 60 s.

Example Mo 6. Production of a composite with a polyurethane foam base, nanosized silica filler (aerosil A-300). Composite synthesis is carried out in two stages.

At the first stage, a polyurethane prepolymer with isocyanate (MSO) end groups is obtained: 5 g of isophorone diisocyanate and 0.02 g of DBDLO (tin dibutyldilaurenate) (0.195 by weight of the components) are loaded into a reactor with a capacity of 0.1 l, then dropwise add 10 g of polyester (polyoxypropylene glycol, laprol-3002, laprol-5003, ester of adipic acid and diethylene glycol) (with a molecular weight from 1000 to 5000 g/mol) with intensive stirring of the reaction mixture until the theoretical content of MSO groups reaches 12 - 14 95. The content of MSO (95) is determined by the titrimetric method.

At the second stage, 20.5 wt.% of polyurethane prepolymer is added to 59 wt.9%. of distilled water as a foaming agent, 10 wt. 95 glycerol as a crosslinking agent and 10 wt. 95 of Aerosil A-300 as a sorbent. All components are thoroughly and intensively mixed for 10 minutes. at 2000 rpm The mixture is poured into a mold of a certain configuration (square, rectangle, disc, etc.) and kept at a temperature of 35 "C until complete foaming and hardening of the composite.

Example Me 7. Production of a composite with a polyurethane foam base, nanosized silica fillers (aerosil A-300) and sodium alginate. Composite synthesis is carried out in two stages.

The first stage - see example Mo 6.

At the second stage, 20.5 wt.% of polyurethane prepolymer is added to 58.5 wt.9%. of distilled water as a foaming agent, 10 wt. 956 glycerin as a crosslinking agent, 0.5 mabs. 95 sodium alginate as a filler and 10 wt. 95 of Aerosil A-300 as a sorbent. All components are thoroughly and intensively mixed for 10 minutes. at 2000 rpm The mixture is poured into a mold of a certain configuration (square, rectangle, circle, etc.) and kept at a temperature of 35 °C until complete foaming and hardening of the composite.

Example Me 8. Production of a composite with a polyurethane foam base, nanosized silica fillers (aerosil A-300) and furacilin). Composite synthesis is carried out in two stages. 7 Similarly to example 8, various medicinal substances were administered depending on their pharmacological action: boric acid, decamethoxine, benzalkonium chloride, procaine hydrochloride, lidocaine, etc.

The first stage - see example Mo 6.

At the second stage, 20.5 wt.% of polyurethane prepolymer is added to 58.5 wt.9%. of distilled water as a foaming agent, 10 wt. 956 glycerin as a crosslinking agent, 0.5 mabs. 95 furacilin as a filler and 10 wt. 95 of Aerosil A-300 as a sorbent. All components are thoroughly and intensively mixed for 10 minutes. at 2000 rpm The mixture is poured into a mold of a certain configuration (square, rectangle, disk, etc.) and kept at a temperature of 35 "C until complete foaming and hardening of the composite.

Examples MoMo 1-8 demonstrate the production of laboratory samples of hemostatic composite material. In the case of industrial production of the composite as a finished medical product, it is additionally subjected to sterilization, for example, gas or radiation, and packed in a disposable package.

A comparative study of 1) water absorption was carried out; 2) sorption of protein - gelatins (5) and 3) the index of total blood loss over a certain period of time on the model of parenchymal bleeding from the liver of the I6|Y rat by the well-known hemostatic material "Seioch"M, the well-known wound dressing (prototype) and the claimed composite material made according to MoMeo examples 1-8.

The results are shown in the table. As can be seen from the given data, the claimed material is superior to the well-known tool "Seoch "M" and is not inferior to the prototype in terms of the studied parameters.

A comparative analysis of the proposed hemostatic composite material and the prototype shows that the composite material differs from the silica dressing by the presence of structuring and binding substances and substances 3 with antimicrobial and/or local anesthetic properties. From other known hemostatic materials declared

The solution is distinguished by the use of a sorbent (silica or aluminum oxide), which has hemostatic and adsorption properties and exerts a multidirectional effect on the wound, does not form a crust (thick scab) on the wound surface, and does not overdry the wound surface. The declared hemostatic material provides effective hemostasis, and also has antimicrobial and/or local anesthetic properties due to the medicinal substances included in its composition (boric acid, furacilin, decamethoxine, benzalkonium chloride, procaine hydrochloride, lidocaine, etc.). The proposed material is quickly applied, accurate dosing of the sorbent is ensured, there is no dust formation, which is essential when providing medical aid in field conditions.

Table

Comparison of the effectiveness of the declared hemostatic composite material, the known hemostatic agent "Se|oh"" and the known wound dressing

Bandage p" tm" | FOR wounds

KOELENYA EN Sl st type)

Water absorption through | 540 At 1063 | 1447 907 507 1007 345 420 xHV., because

Gelatin sorption, 127 284 176 123 135 mg/g

Blood loss, g, through 15 | 0.42 | 0.20 0.32 0.17 0.25 0.33 0.28 0.42 1.1 0.45 min. 7 swelling in 0.9 95 Massi solution after 180 min.; ") the average value of 10 observations; blood loss without the use of a hemostatic agent is 2.2 g

Sources:

PI Theory and practice of local treatment of purulent wounds / Ed. Prof. B.M. Datsenko. - K.:

Health, 1995. - 384 p. 5 (2 Magoiiv.). Tne enesi oi soPoidai! viisa op Biooi soadiyaop //A!yvi. U. Ehr. Vio! Honey. September 5, 1961. - Mine. 39. - R. 249-258.

ИЗ| Medicinal chemistry and clinical application of silicon dioxide /ed. Acad. A.A.

Chuyko - K.: Science. Dumka, 2003. - 413 p.

I) Bandage for wounds L.I. Gerashchenko, S.V. Sander, O.I. Bondarchuk, V.I. Bogomaz, O.O. Chuyko //Patent of Ukraine No. 153084A, publ. 30.06.97, Bull. Mo 3. - prototype.

I5Y Preclinical study of interosorbents. Methodical recommendations /V.G. Mykolaiv,

N.T. Kartel, E.A. Posohova and others - K.: Gos. Expert Center of Ministry of Health 3 Ukraine!, 2010. - 56 p.

IEI Hemostatic material of local action on the basis of oxidized cellulose / A.R.

Tarkova, A.M. Chernyavskyi, S.V. Morozov et al. / Siberian scientific medical journal. - 2015. - T. 35, Mo. 2. - P. 11-15.

Claims (1)

USEFUL MODEL FORMULA Hemostatic composite material containing matrix-base, sorbent and additional substances, which differs in that it contains polyurethane foam or woven or non-woven natural or synthetic cloth as a matrix-base; as a sorbent containing nanosized silica and/or pyrogenic aluminum oxide; as additional substances contains at least one substance selected from the following: aminocaproic acid, carboxymethylcellulose, sodium alginate, polyvinyl alcohol, gelatin, polyacrylic acid, boric acid, furacilin, decamethoxine, benzalkonium chloride, procaine hydrochloride, lidocaine, etc., according to this ratio of components, mass . 90: matrix-base 10-50 nanosized silica and/or 25-BO pyrogenic aluminum oxide additional functional substances up to 15.