RU2331443C2 - Haemostatic compressing bandage and haemostatic medicinal composition - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: haemostatic compressing bandage represents appliance, having guide rail with fixed on it one-piece spiked clamping plates (one of them is still, another is moving) and rotating drum with ratchet gear. Between the still plate and cylinder drum, which is fixed on guide rail, armoured belt made of non-hygroscopic air-penetrable material is set with movable hygroscopic swab/bolster. The haemostatic compressing bandage is impregnated with new original haemostatic medicinal composition, including ingredients as follows (by weight): N-(β-oxymethyl)-4,6-dimethyl-dihydropirimidone-2 (xymedone) - 20.0-22.0%, phenylephrine (mesatone) - 2.0-2.5%, decilate - 1.0-1.2%, boric acid - 9.5-10.0%, aqueous 50% glycerol solution.

EFFECT: increase in efficiency of external hemorrhage arresting.

3 cl, 7 dwg

Description

The invention relates to medicine, namely to hemostatic agents used to stop external bleeding.

Temporary artificial mechanical stop of external bleeding is carried out by various known methods:

- imposing a standard, impromptu tourniquet or twist;

- finger compression of the main arterial trunks during the pressure dressing;

- maximum limb flexion in the joint;

- pressing the vessel with fingers directly in the wound;

- overlay clamp on the vessel.

The above methods have known disadvantages, although they are in the vast majority of cases a saving measure for external bleeding.

Particularly severe, sometimes irreparable complications are given by a circular pulling of a limb with a tourniquet with turning off a wide area of tissues, including intact, from the blood circulation. The duration of hemostasis should not exceed 2 hours. The removal of the tourniquet is often accompanied by the development of a turnstile shock (Syromyatnikova A.V., Brookman M.S. Guide to practical exercises in surgery. M: Medicine, 1983; Burykh M.P. General principles of the technology of surgical operations. Rostov-on-Don: Publishing house "Phoenix", 1999).

Dressings, as a means of therapeutic effect on the pathological process by using various materials and substances and keeping them on the patient’s body, can be of various types:

- by the method of fixation: bandage, adhesive plasters, gypsum, starch, gelatin, glass, celluloid, elastic, kerchief, sling-like, aerosol, adhesive (glue, well);

- by mechanical properties: soft, hard or motionless (tire and hardening) for immobilization, with traction;

- on the effects on the biophysical and chemical processes occurring in the affected area: protective dry aseptic, therapeutic antiseptic (bactericidal or bacteriostatic) dry and wet-drying, hypertonic, oil-balsamic, hemostatic, radioactive;

- by air permeability: non-hermetic ("breathing") and occlusal (hermetic with complete obstruction of air access to the wound).

Hemostatic dressings are used mainly if necessary:

- cause compression of bleeding vessels (pressure bandages);

- neutralize the effect of excess exogenous heparin using protamine and sulfate;

- inhibit fibrinolysis (acid epsilon - aminocaproic, ambenom);

- provide the necessary drugs to accelerate the formation of a blood clot: fibrinogen, calcium-containing substances, thrombin, antiseptic sponge with kanamycin (gelatin, kanamycin, sulfate, furatsilin, CaCl ₂ ), isogenic fibrin film (impregnated with glycerin), collagen hemostatic sponge (2% solution , furatsilin and boric acid), zhelplastan (dried blood plasma of cattle, kanamycin monosulfate and edible gelatin), hydrogen peroxide, decylate, nettle leaves, yarrow grass, intoxicating lagoholis, viburnum bark, Arnica flowers, grass of the mountaineer, stamen, etc.

A close analogue to the claimed invention is a wound adaptive reposition apparatus that allows for pre-surgical stopping of external bleeding (AS No. 1165376, MKI A61V 17/10. A device for reducing the edges of a wound (G. A. Izmaylov, E. S. Zelenov, RR Garaev, A. A. Kilkinov. Publish. 1985.07.07, BI No. 25), taken as a prototype. The device consists of a gear rack with pressure plates, ratchet mechanism with a handle. Prefabricated plates, their sections have spikes installed in cylindrical grooves. The prototype has a big drawback, which, First of all, it consists in the absence of simultaneous closure of the wound with an aseptic dressing that prevents secondary infection and protects against external influences - mechanical and physical. Moreover, stapling the plates after the edges of the wound come closer is a weak link, due to insufficient reliability of fixation - the release of the bracket from the holes the inevitable divergence of the edges of the wound and the resumption of bleeding.Lack of stability of the plates, their possible eversion and detachment of sections can also ty to weaken tissue compression and relapse of bleeding.

Various means are used for local chemical and biological stopping of bleeding: hemostatic collagen sponge, aminocaproic acid, isogenic fibrin film, zhelplastin, thrombin, calcium preparations (gluconate, chloride, lactate, etc.). These analogues, although they have a hemostatic effect, but have an action specifically directed, for example, thrombin is useful for Werlgaf’s disease, fibrinogen for hypofibrinogenemia, etc. Of the disadvantages, in addition to the selectivity of the action, a slowly developing therapeutic effect with the formation of a surface, easily rejected thromboplastic layer is essential. In practice, topical application is limited only by capillary bleeding, and hemostasis in arterial bleeding is excluded. Often there is a genesis of severe allergic reactions (anaphylactic shock, rash, itching, etc.), which are especially dangerous for victims at the prehospital stage.

Of the hemostatic agents, the most effective are adrenaline, norepinephrine, and serotonin, which cause a vasoconstrictor effect, especially in case of injuries of vessels of the muscle type. However, the onset of vasoconstriction is short-lived and their use is fraught with the occurrence of pronounced side effects: increased blood pressure, headaches, tremors, slowing heart activity, possibly impairing the supply of oxygen to the myocardium. Serotonin causes bright tissue edema (Mashkovsky M.D. Medicines. M.: New Wave LLC. Publisher S.B.Divov, 2002; 1-2). These drugs are unstable, quickly lose their therapeutic activity.

In clinical practice, as a hemostatic agent, a composition is used that impregnates a hemostatic collagen sponge prepared from a mass of collagen, 2% collagen solution with the addition of furatsilin and boric acid (Mashkovsky M.D. Medicines. M. 2002; 1: 472). The known hemostatic dry porous mass in the form of plates, soft elastic consistency is accompanied by significant disadvantages:

- devoid of vasoconstrictor effect;

- contraindicated in case of hypersensitivity to furatsilin and other nitrofurans;

- Genesis of an allergic reaction to collagen is possible;

- delayed thrombosis;

- low disinfecting ability of furatsilin, a solution of which is currently not used in clinical practice only for mechanical antiseptics;

- there is no highly effective component aimed at enhancing regenerative processes in damaged tissues;

- low solubility of collagen in water and alcohols.

The objective of the invention is a new hemostatic compressing dressing to stop external bleeding and a medicinal hemostatic composition for its impregnation.

The technical result of the claimed invention is to increase the reliability of hemostasis and the prevention of secondary contamination of the wound.

The technical result is achieved by the claimed device is a bandage and a new hemostatic composition.

The hemostatic composition (Hemoxyphenyldecibor) contains N- (β-hydroxyethyl) -4,6-dimethyldihydropyrimidone-2 (Xymedon), phenylephrine (mesatone), boric acid and an aqueous glycerol solution with the content of the components, respectively, wt.%:

N- (β-hydroxymethyl) -4,6-dimethyl- dihydropyrimidone-2 (xymedon) 20.0-22.0 Phenylephrine (mesatone) 2.0-2.5 Decylate 1.0-1.2 Boric acid 9.5-10.0 50% aqueous glycerol solution rest

The proposed hemostatic composition - hemoxyphenyldecibor (the abbreviated name means a combination of the initial letters of the main purpose and the active ingredients of the composition) contains highly effective chemical pharmacological agents that provide quick and reliable hemostatic compressive wound cover, preservation, protects it from secondary invasion of pathogenic microbes, and also provides direct anti-inflammatory, antibacterial and regenerative effects. All of these constituent components of the composition are authorized by orders of the Ministry of Health of the USSR and the Russian Federation and are included in the Register of Medicines Allowed for Medical Practice and Production.

The use of lower than declared concentrations of the components leads to a worse hemostatic effect. The use of higher concentrations increases the cost of the composition without increasing the hemostatic effect.

The manufacturing process of the proposed hemostatic composition - Hemoxyphenyl decibor. produced according to the accepted methods of the State Pharmacopoeia by simple mixing of the ingredients (Pharmacist's Handbook edited by A.I. Tenzova. - M.: Medicine, 1973. - 584 p.).

Xymedon is known as a medicinal product (AS No. 1685454, class A61K 31/505, publ. 10/23/1991) and is used in the clinic. It has a multivalent effect, including regenerative, antibacterial, desensitizing (Ksimedon / Ed. G.A. Izmaylova. Kazan: Publishing House of the Institute of Fine Arts named after A.E. Arbuzov, 1986; 114). Xymedon in the claimed composition was first used in concentrations of 20-22% in an aqueous solution of glycerol (1: 1). According to clinical observations, such a solution far exceeded its healing local properties. No complications were noted. The application of the drug to the wound was painless with a pronounced dehydrating effect in the first phase of the wound process.

Glycerin, which in high concentrations has a bacteriostatic property (TG Kazachenok Pharmaceutical Dictionary (Latin-Russian, Russian-Latin), Minsk, Vysshaya Shkola, 1977; 464), was taken as a form-forming agent - Remedium constituens.

The introduction of the composition of the composition of a 50% aqueous solution of glycerol (1: 1) potentiates the disinfecting property of other components, prevents the dressing from drying out completely, while maintaining its elasticity and ease of displacement of the cushion roll along the base fabric hardened tape.

Mesatone, unlike adrenaline and norepinephrine, is not catecholamine. In this regard, it is more resistant, has a longer vasoconstrictor effect, being a stimulator of α-adrenoreceptors of blood vessels. In addition, the drug, in comparison with adrenaline and norepinephrine, does not have a pronounced pressor property, as evidenced by the literature data (Mashkovsky M.D. Medicines. Moscow: Novaya Volna LLC, publisher S.B.Divov 2002; 1: 233-234).

Boric acid is included as an antiseptic with high antibacterial activity against the vast majority of pathogenic microflora. The drug was dissolved in glycerol, so it is taken as a filler in the composition. A solution of boric acid 10% in glycyrine, as an external antiseptic, has a drying effect (Mazmanyan Ts.G. Reference for pharmacotherapy of genitourinary diseases. Tashkent: Publishing House "Medicine" of the Uzbek SSR, 1977).

Decylate (thrombovar, fibro-vein, varicol, sotradecol, obeitrol, etc.) is a venosclerosing drug with surface-active properties, used for conservative injection-sclerosing treatment with initial and uncomplicated forms of varicose veins. The drug causes a moderate reaction from the tissues, which helps to accelerate the formation of a blood clot and close fairly strong connection with them formed a blood clot. Strengthening the bonding of a blood clot with damaged bleeding tissues is an extremely important point in hemostasis, especially in people with blood diseases (hemophilia, Verlhof disease, etc.).

The inventive composition is prepared as follows.

The components are mixed sequentially - xymedon, boric acid, an aqueous solution of glycerol, and after sterilization of the solution thus obtained under aseptic conditions, phenylephrine and decylate are added in the form of a pharmacopeia powder or an ampouled 1% solution.

Figure 1 shows the inventive hemostatic compression dressing (General view), which is a device;

figure 2 is one of the variants of the bringing together mechanism;

figure 3 - location of the dressing at the initial stage of application, side view;

figure 4-5 bandage at the initial and final stages of use, respectively, section aa in figure 1;

figure 6 - pinch roller;

Fig.7 - the place of the possible establishment of the dressing (wounds 12 are marked by solid lines).

The device comprises two parallel mounted fixed 1 and movable 2 pressure plates on a guide rail 3, on which a tension mechanism is also mobile mounted, consisting of a cylindrical drum 4, a ratchet wheel 5, a latch 6, a fixing disk 7 and a handle 8 located on the drum 4 and intended for its rotation. The pressure plates 1, 2 contain spikes 9 for gripping tissues. On the inner sides of the fixed pressure plate 1 and drum 4 along their entire length, a reinforced dry cloth tape 10 is fixed with a movable cushion roller 11 impregnated with a hemostatic and bactericidal composition. Moreover, the tape 10 is made of a non-hygroscopic material with low sorption properties and serves as an external protective layer of a "breathing" dressing, having the property of filtering air from bacteria and dust. In addition to the protective role against secondary microbial contamination of the wound 12, the tape 10 is designed to constrain damaged tissues and fix the dressing. The displaceable dressing material in the form of a cushion roll 11 is made of a hygroscopic material with high sorption qualities. The proposed design of the claimed dressing with the properties of a multifunctional multilayer medical dressing meets the traditional understanding of strict adherence to the principles of asepsis and antiseptics at all stages of the treatment of fresh wounds.

Prepared sterilized device is immersed in hemoxyphenylborne, for example, the following composition, wt.%:

N- (β-hydroxymethyl) -4,6-dimethyl- dihydropyrimidone-2 (xymedon) 20.0-22.0 Phenylephrine (mesatone) 2.0-2.5 Decylate 1.0-1.2 Boric acid 9.5-10.0 50% aqueous glycerol solution rest

for 30 minutes at room temperature to soak the cloth hygroscopic part, dried in a thermostat at a temperature of 36-38 ° C and placed in a sterile hermetically sealed plastic bag. Store in a dark place.

A hemostatic dressing is used as follows.

1. The bandage is removed from the sterile package in an extended position, installed on the wound so that the sharp ends of the spikes 9 are 3-4 cm from each edge of the wound 12 (Fig.3). By rotating the handle 8, the pressure plates 1, 2, moderately pressed to the skin, are brought together by winding the tape 10 onto the drum, while shifting the plate.

2. Bring plates 1, 2 to a complete stop of bleeding, after which the line of connection of damaged tissues is closed by a pad-roller 11 displaced along the tape 10 (Fig. 5).

The practical use of the dressing of the proposed design for off-wound paravular arterial arrest of external bleeding acquires the following obvious significant structural and qualitative differences and advantages over the prototype:

- prevents the entry into the wound of a secondary infection;

- creates sufficient hemostatic compression of blood vessels with minimal shutdown of intact tissues from the blood circulation;

- the victim can move independently, due to reliable duplicate fixation of the adjacent edges of the wound due to jamming of the movable jaw on the rail and the ratchet wheel with a latch;

- a cushion sliding along the tape - the roller puts additional pressure on the vessels, thereby enhancing the hemostatic effect of the components that make up the drug composition.

The dressing design is devoid of any additional devices that regulate the degree of tissue tension when the edges of the wound come closer, since the turgor of the skin-subcutaneous and deeper tissue layers with fresh wounds is almost the same for all people. The criterion for evaluating the effectiveness of the compression effect is a complete stop of bleeding. As shown by the application of the proposed dressing in clinical practice, it increases the reliability of hemostasis, simplifies manipulation, expands the boundaries of use, prevents excessive trauma, "preservation" and further contamination of the wound at the stages of medical evacuation, as well as in places of self-help and mutual assistance, to postpone the primary surgical treatment with the implementation of the final stop of bleeding. The expediency of the widespread use of such a bandage is due to the need to improve technologies for stopping external bleeding by including military field hospitals in the set of surgical instruments, equipping medical posts of the regiment, battalion, paramedics and orderlies with such single-use bandages.

The reasons for the revision of the technical methods of hemostasis are the features of modern combat trauma and the consequences of peacetime accidents with an increase in the number of wounded in a short time, the limited means and forces of the medical service, and adverse conditions for stage evacuation.

The application of the proposed dressing is especially advisable in conditions when there are few trained medical personnel on long-distance expeditions and wintering, on ships. The use of such dressings by specialized units of the Ministry of Emergencies will significantly improve the quality of pre-medical medical care for victims.

Claims (3)

1. Hemostatic drug composition containing, wt.%: N- (β-hydroxymethyl) -4,6-dimethyl- dihydropyrimidone-2 (xymedon) 20.0-22.0 Phenylephrine (mesatone) 2.0-2.5 Decylate 1.0-1.2 Boric acid 9.5-10.0 50% aqueous glycerol solution rest 2. A hemostatic compressing dressing containing a guide rail with clamping movable and fixed plates having spikes, a ratchet mechanism and a handle, characterized in that the clamping plates are made integral and a cylindrical drum is additionally movably mounted on the guide rail, and the wound edges are drawn together by a reinforced tape mounted on a fixed clamping plate and a cylindrical rotating drum, moreover, a cushion roll is movably fixed on the tape to close the lines x the edges of the wound, and the tape and cushion roller are impregnated with the hemostatic drug composition according to claim 1. 3. The hemostatic compression dressing according to claim 2, characterized in that the tape is made of non-hygroscopic breathable, and the cushion roller is made of absorbent material.

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