RU58353U1 - ADAPTATION AND COMPRESSION HEMOSTATIC BANDAGE - Google Patents

Abstract

The utility model relates to medical equipment and can be used in surgery. The dressing is a bandage, in the form of a tape with two head-rollers, made of hygroscopic matter with different extensibility of the edges in length and constant in width. The dressing is impregnated with a medicinal composition containing the following components taken in a ratio of wt.%:

Xymedon - 0.5-0.7

Thrombin - 1.25-1.28

Dimexide -50.0-51.2

Sodium chloride - 0.85-0.9

Distilled water - the rest.

The dressing provides an effective application to the wound with crossed bilateral descending (from the center to the periphery) spiral strokes with controlled local mechanical pressure on the tissue, rolling the rollers towards each other, eliminating circular turns throughout the formation of the dressing.

Description

The utility model relates to medical equipment and can be used in surgery to increase the hemostatic effect, expand functionality when closing a wound and prevent complications.

Currently, a variety of methods are used to temporarily stop bleeding, which are analogues of our proposal. The choice of methods for stopping bleeding depends on the type of damaged vessel, the location and size of the wound. Mandatory immobilization of the injured area of the body is provided. They mainly use mechanical methods aimed at compressing damaged vessels directly in the wound (tamponade, applying a clamp to a bleeding vessel, etc.) or proximal to it (tourniquet, finger pressing, maximum flexion or elevated position of the limb, etc.). [A.S. USSR No. 1110446, MKI A 61 B 17/00, publ. 08/30/1984; A.S. USSR No. 1232251, MKI A 61 F 13/00, publ. 05/23/1986; Izmailov S.G. and other Technical aspects of the treatment of varicose veins. N. Novgorod: Publishing House of the NGMA 2005, 216; Petrov S.V. General surgery. St. Petersburg: Publishing House "Lan", 1999, 672]. However, for example, a spiral bandage without an inflection is unstable, prone to relaxation and slipping, and a spiral bandage with an inflection does not make it possible to achieve the necessary hemostatic compression of tissues.

Known hemostatic dressing for stopping capillary, diffuse and parenchymal bleeding, containing a hemostatic layer consisting of a textile carrier, from knitted or

non-woven materials with a sorption capacity for water of 9-20 g / g, a layer of polyethylene glycol with a mol. m. 200-1200 to a content on the surface of 0.2-0.3 g / cm ³ . The dressing contains an additional layer of perforated film or mesh of a hydrophobic polymer, for example polypropylene, located on the side of the wound surface.

As a hemostatic agent, the dressing contains iron gluconate or lactate with a content in the bandage in the range of 0.4-3.0 mg / cm ² and an antimicrobial preparation, for example, furagin in the range of 0.03-0.3 g / cm ² and / or local an anesthetic, for example lidocaine in the range of 0.1-0.6 mg / cm ² (US Pat. RU No. 2200583, publ. March 20, 2003).

A dressing is known that acts as a hemostatic agent and as a means for the safe and efficient delivery at a controlled speed of any of the many pharmaceutical preparations to the targeted tissue. The material contains a carrier in the form of fibers, suture materials, fabrics of rigid cross-linked foam materials or bandages. A pharmaceutical preparation in the form of solid microparticles bound to carrier fibers with the possibility of isolation from them and a lipid-auxiliary agent that promotes the binding of microparticles to fibers, as well as their action in the body (US Pat. RU No. 2176526, publ. 10.12.2001) .

Known dressing for the treatment of wounds, burns, ulcers, bedsores and first aid (Pat. RU No. 2143281, publ. 12/27/1999). The dressing is made of cotton viscose non-woven material, which is combined with a draining layer of textile fabric or fabric based on artificial fibers with a distribution of drugs in the amount of 0.01-20 wt.%. The dressing provides the possibility of using antimicrobial, local anesthetizing, hemostatic and / or therapeutic drugs and their prolonged action.

The dressing contains chlorhexidine bigluconate and / or ampholan and / or gentamicin and / or propolis and / or lidocaine as preparations.

However, in the given dressings, the effect is achieved due to the medicines contained in them, since in these cases they use the usual technique of applying them.

The prototype of the proposed utility model is a well-known pressure bandage used for moderate bleeding from small vessels, venous or capillary hemorrhage. To do this, several sterile wipes are placed on the wound, on which a pre-rolled fabric roller or a piece of foam is placed onto the wound to increase pressure on damaged tissues and this assembly is tightly bandaged (General Surgery, edited by P.N. Zubarev et al. St. Petersburg: SpecLit, 1999 , 472; Izmailov S.G. et al. Technique for applying soft dressings. N. Novgorod - Kazan: KSTU Publishing House 2004, 84). Such a dressing can be applied at the pre-hospital stage and in the clinic as an independent reception, or in combination with other methods.

However, the prototype has significant disadvantages:

- the use of a single-head bandage as a fixing means leads to the inevitable displacement of the pressure gauze roller in the direction of movement, rolling of the head;

- the magnitude of the lateral displacement of the edges of the wound progressively increases with each made next round of bandage, regardless of the type of dressing (circular, spiral, simple, spiral with an excess);

- unilateral uneven displacement of the edges of the wound is the basis of the essence of bandaging the dressing;

- in cases of significant wound length, the pressure distribution on the tissue due to the absence of a perfectly conical shape of the limb, when dressing is applied unevenly;

- the bandage can be used only in certain areas of the body with the localization of the wound with a close location of the bone base (“pressed” to something);

- a relatively sufficient tissue compression can be achieved only in the area of one (initially free end of the bandage) wound edge and completely inferior (in the rolled part of the bandage) with the contralateral one, without thereby obtaining reliable hemostasis;

- there is no proper adaptation of the edges of the wound, and their sharp deviation from the longitudinal midline of the latter leads to tissue diastasis, secondary infection and the possible formation of a disfiguring scar;

- in the process of application, marked soreness is noted, which persists for a long time even after application of the dressing, due to the pressure of the roller;

- by pulling the bandage behind the head, dangerous slipping of other deeply lying vital anatomical formations is possible with their possible damage and the development of traumatic neuritis, additional hemorrhages, necrosis.

In known dressings to enhance the hemostatic effect, various drugs or their compositions are used (US Pat. RU No. 2200583, 2176525, 2143281).

The technical result of the proposed utility model of adaptation-compression hemostatic dressing consists in local selective hemostasis and accurate bilateral matching of damaged tissues, creating optimal conditions for their sufficient immobilization and prevention of complications, as well as in enhancing regeneration and anti-inflammatory effect.

The technical result is achieved by the proposed adaptation-compression hemostatic dressing, which is a device comprising a double-headed bandage made of

hygroscopic tissue with a different extensibility coefficient of both its edges and impregnated with a pharmacological preparation. Such a bandage provides the original technology of bilateral bandaging. The latter, in turn, creates an instantaneous, reliable compression of the damaged soft edges of the tissue defect. Seamless connection allows you to stop bleeding, even in relatively large blood vessels. An unconventional, original technology for applying an adaptation-compression hemostatic dressing containing an active pharmacological, hemostatic, antimicrobial and regenerative drug can be used for external hemostasis not only on the evacuation routes of the wounded, but also in the clinical setting in the postoperative period.

As a pharmacological preparation for the impregnation of a dressing, a new drug composition was used.

The adaptation-compression hemostatic dressing consists of a double-headed bandage containing a fabric tape and two rolled head-rollers at both ends, the upper and lower edges of the tape having a different stretch ratio in length, which contributes to a more snug fit of the tape, especially on the conical part of the body, for example, on the thigh, lower leg, forearm. The bandage is impregnated with a medicinal composition, including the pyrimidine derivative - xymedon;

the natural component of the blood coagulation system is thrombin and dimexide (dimethyl sulfoxide-DMSO) - a chemical antiseptic and oxidizing agent. The composite ingredients of the presented composition - "Xitrodimex" are in the following content, wt.%:

Xymedon - 0.5-0.7

Thrombin - 1.25-1.28

Dimexide - 50.0-51.2

Sodium chloride - 0.85-0.9

Distilled water - the rest.

The optimal ratio of components due to their most pronounced therapeutic effect [Mashkovsky M.D. Medicines M .: "Medicine", 2005; Izmailov S.G. Xymedon in clinical practice. Nizhny Novgorod, 2001].

Xymedon is described as a multivalent therapeutic agent used internally and topically, primarily to stimulate regeneration processes. However, its recommended forms in the composition of hypertonic solutions in distilled water are applicable only for direct application of the agent to a wound (Izmailov S.G. et al. Xymedon in clinical practice. N. Novgorod: Publishing House of NGMA 2001, 188), which becomes unacceptable in cases of closed management of a fresh wound defect, lack of direct contact of the product with the wound surface.

If the use of hypertonic solutions of Xymedon granulating wound is advisable due to the created dehydrating effect, then it does not bring any benefit in the treatment of clean, especially closed wounds. Therefore, for the preparation of the therapeutic medicinal composition proposed by us, a physiological (isotonic) aqueous NaCl solution was reasonably taken with a solvent, which promotes more active resorption of xymedon by tissues. It is reliably proven that Xymedon leads to the normalization of the blood coagulation system.

Dimexide is successfully used in the complex treatment of purulent wounds and many inflammatory diseases. The drug mainly has bactericidal, antipiogestic, analgesic properties, and also facilitates the transportation of other drugs, potentiating their actions. The ability to penetrate into deep tissues (Kurbangaleev S.M. Purulent infection in surgery. M .: Medicine 1985. - 272) through cell membranes, capturing a contact pharmacological preparation with it, allows you to create high concentrations of it, in particular, xymedon, in damaged tissues thus reinforcing

regenerative properties of Xymedon, so it should be considered advisable to include it in our composition.

Thrombin - contains thrombin, a small amount of thromboplastin and calcium chloride. It is a corrector of the hemostatic system, which makes it extremely important (or causes) its use in patients suffering from increased bleeding. The activation of the action of thrombin was observed by us while its use with xymedon.

Thrombin in the form of an aqueous solution (in 0.3% NaCl) of at least 125 activity units is used only locally to stop bleeding from small capillaries and parenchymal organs. When bleeding from larger vessels, thrombin is not used due to its possible washing off while maintaining a significant blood flow velocity and relatively high blood pressure in the vessels (Mashkovsky M.D. Medicines. M .: Medicine, 2005). With our technique for applying a bandage, in the presence of other components of the composition, blood flow decreases sharply. The hemostatic ability of thrombin is potentiated by the presence of xymedon in the mixture.

It is known that xymedon has a pronounced regenerative ability, thrombin has a local hemostatic effect; dioxidine - an antiseptic, each individually bring a directed effect, which is much lower than the total. Due to the potentiation of the action of the components in a single composition, a greater therapeutic effect is achieved. This argued the proposed therapeutic composition - "Xitrodimex" (xymedon, thrombin, dimexide). All of the listed drugs are authorized by the Ministry of Health of the Russian Federation and are recommended for practical use (Izmailov S.G. et al. Xymedon in clinical practice. N. Novgorod, 2001, 188; Mashkovsky MD. Medicines. M .: "Medicine", 2005 )

Thus, the listed drugs individually do not have sufficient properties to achieve the goal. Only their inclusion in appropriate concentrations in the medicinal composition allows to obtain a higher necessary therapeutic effect: hemostasis, increased regeneration and anti-inflammatory effect. The composition is harmless, does not cause any side effects, which allows us to recommend it for wide clinical use.

The proposed ratio of the components used for dressing impregnation of the medicinal composition was found experimentally and is optimal, ensuring that the medicinal composition meets the requirements of Gosfarmokopey.

The technique of applying the adaptation-compression hemostatic dressing we have proposed is as follows:

The victim should be seated or laid down to create a comfortable position, which is determined by his general condition, nature and location of the damaged area. At the same time, it is desirable to place the area to be ligated at the height of the operator’s chest, it should be accessible to him, which ultimately contributes to a better implementation of the manipulation. Damaged parts of the body give rest with a moderate elevated position (preferably mid-physiological). The effectiveness of compression hemostasis is determined by the mandatory observance of the dressing technique. The bandage is grabbed by the head-rollers with two hands, slightly stretch the tape, holding it in such a position that the inner surface is facing the operator. Then, retreating 3-4 cm proximal from the horizontal line of the upper corner of the wound from its contralateral side, put the bandage tape on the skin and, constantly holding the bandage moderately stretched in length, make the first downward move by simultaneously rolling both roll heads in a descending spiral. After

fixing the initial position of the bandage, avoiding the traditional, fixing, circular tour central to the wound zone, subsequent oncoming turns of the bandage follow bilaterally in an oblique distal direction so that each new round covers the previous one or bandage width. Different degrees of stretching of the edges of the tape along the length with its constant width even on the cone-shaped area allow you to create uniform compression of tissues over their entire lesion and maintain the constancy of the width of the tape. The dressing is moved to the damaged area bilaterally with increasing pressure on the tissues, achieving a stop of bleeding with simultaneous adaptation of the edges of the wound. In this way, a state of local hemostasis is achieved by squeezing small arterial branches and veins only in damaged tissues and in the paravular zone, preventing tissue constriction, and not disrupting blood flow in the main blood vessels (exclude the effect of the tourniquet !;).

EFFECT: local selective hemostasis and exact bilateral comparison of damaged tissues with elimination of the open wound surface is achieved by gradually increasing compression with each new turn. The bandage tension and, accordingly, the necessary optimal pressure created by it should smoothly increase or decrease (if the arterial pulse disappears distal to the wound). In this case, a roll of bandage is untwisted in close proximity to the skin. After the wound and hemostasis are completely closed, the ends of the tape are knotted together or fixed on a healthy part of the body.

If there is a need to increase the effect, then in addition the second layer of the dressing is likewise formed. The direction of the sequence of bandage rounds - from a larger array of tissues to a smaller one (for example, on the lower leg), from the center to the periphery is argued for by a greater possibility of tissue displacement than vice versa. The criteria for assessing the correctness of applying a dressing are complete local hemostasis,

the precision of comparing the edges of the wound, the preservation of pulp in the main arteries distal to the wound.

An unusual technology for the formation of the proposed dressing prevents its relaxation and sliding (the final tour is done at the bottom of the bandage surface), especially during the transportation of the victim. The simultaneous closed management of the wound process meets the modern requirements of surgery, since additional contamination of the wound is excluded, and the therapeutic composition provides not only increased hemostasis, but also the preservation of the defect. In cases of a successful state of the wound (lack of suppuration, etc.), its uncomplicated healing, the initially applied adaptation-compression hemostatic dressing according to the proposed bilateral technique can be saved until the final formation of a strong scar. The use of the proposed adaptation-compression hemostatic dressing device has obvious undeniable advantages: bilateral traction applied to the edges of the wound is distributed to a significant array of tissues; there remains the possibility in some cases of additional discrete bilateral shear of the surface and deep tissue layers; there are no factors contributing to the destruction of the wound barrier and foreign bodies in the wound cavity and in the paravular zone.

Thus, the proposed device - the original adaptive-compression hemostatic dressing is a reliable external mechano-pharmacological hemostatic device that provides a simultaneous comparison of damaged soft and even hard tissues, creating optimal conditions for their sufficient immobilization, preventing or eliminating such common complications as traumatic shock, secondary infection, etc. The used medicinal composition prevents the development of wound microflora ora, accelerates hemostasis, helps accelerate processes

regeneration. The proposed method for applying a dressing has been tested in clinical practice; it surpasses all known similar methods in its therapeutic effect. Therefore, it can be used as an independent manual procedure for transport hemostasis and primary early closure (“canning”) of a wound along the evacuation paths of victims, especially during mass injuries (military operations, various disasters, etc.).

Claims (1)

Adaptation-compression hemostatic dressing containing a fixing part made of fabric absorbent tissue imprinted with medicinal substances, characterized in that the fixing part is made in the form of a tape with two roll heads, the tape has different extensibility of the edges along the length with a constant in width, and as Immigrant medicinal substances used the composition "Xitrodimex", including the following components, wt.%: Ximedon 0.5-0.7 Thrombin 1.25-1.28 Dimexide 50.0-51.2 Sodium chloride 0.85-0.9 Distilled water Rest