RU2082467C1 - Method and device for treating infected wounds with ultrasound - Google Patents

Abstract

FIELD: medicine. SUBSTANCE: method involves introducing medical preparations heated to 23-42 C into the infected wound cavity. To do it, water-proof chamber filled with the preparations is mounted on frame and low frequency ultrasonic treatment is carried out. 0.05-0.15 MPa excessive pressure condition is created in the chamber. The device has unclosed chamber with holes for introducing medical solution and ultrasonic wave guide. The chamber is mountable with its open end placed on the surface to be treated. Pressure gage for measuring pressure inside the chamber cavity and members for fastening the chamber on the patient body are mounted on the chamber. EFFECT: enhanced effectiveness of drug penetration into biological tissues. 2 cl, 3 dwg

Description

 The invention relates to medicine, specifically to ultrasound treatment of infected wounds.

 A known method of ultrasonic bactericidal treatment of infected tissues using various medicinal substances [1] The drug solution was supplied to the surface of the infected wound and was subjected to ultrasound due to the introduction of an ultrasonic instrument into the voiced medium. The processing was carried out at a vibration frequency of 26.6 kHz and an amplitude of displacement of the end of the instrument 55-60 μm, antibiotics were used as the voiced medium.

 The described method is not versatile. With relatively small wounds and the protrusion of the wound surface above the nearby part of the body, the drug solution is not retained in the wound, it is irretrievably lost without any therapeutic effect. In addition, modern strains of staphylococcal microflora are characterized by high antibiotic resistance, including with ultrasound exposure.

 The results of using low-quality ultrasound in the initial surgical treatment of infected wounds are known [2]. In the present case, the disadvantages of the previously described method for the rehabilitation of infected wounds remain, in addition, there is a relatively weak bactericidal effect of ultrasonic vibrations on Staphylococcus aureus.

 Famous work of Zakharova G.N. devoted to the use of low-frequency ultrasound in the prevention and treatment of purulent wounds [3] where the possibility of combining the effects of ultrasound and antiseptic solutions is shown. However, in this case, a bactericidal effect was not observed when exposed to staphylococcal microflora; Proteus and Pseudomonas aeruginosa were also quite resistant to low-frequency ultrasound.

The results of ultrasonic treatment of wounds are known [4] when both antibiotics (tetracycline) and antiseptics (furatsilin) were used as voiced media. It turns out that the bactericidal effect is manifested at relatively large temporary doses of ultrasonic exposure from 30 to 180 s / cm ² , which led to an increase in the inflammatory process, and at a dose of 180 s / cm ² muscle necrosis was noted.

The closest in essence to the proposed method for the treatment of infected wounds is a method that includes increasing the temperature of voiced drug solutions selected for the prototype [5]
It is known that increasing the temperature of voiced medicinal solutions promotes the intensification of the bactericidal ability of ultrasonic vibrations [5]. The paper describes experiments combining the action of ultrasound with antiseptic solutions of low concentration with an optimal increase in the temperature of the voiced solution. Sounding of wound microflora with a concentration of 40-42 • 10 ³ microbial bodies in 1 ml (mg / ml) of a solution with a volume of 50 ml was carried out with an operating frequency of 26.5 kHz and an oscillation amplitude of 50-60 microns. As disinfectants, solutions were used 0.1% H ₂ O ₂ , 0.1% HCOOH and 0.001% CMPO ₄ with a discrete change in the temperature of the voiced medium within 23-42 ^o C. The greatest bactericidal effect is manifested when joint action of ultrasound with feeding the wound heated to a temperature of 37 ^o C solution of hydrogen peroxide or potassium permanganate solution, thereby reducing the time suppressing bacterial microflora 1.5-2.0 times in comparison with the process of scoring microbial cells in an antiseptic solution at room evap e (at 23 ^o C). So, the necessary time for bactericidal treatment was reduced when voicing staphylococcal microflora from 14 to 9 minutes, solutions with a predominance of E. coli from 13 to 8, Pseudomonas aeruginosa from 12 to 7, Proteus from 10 to 6 minutes.

 The above research results show that the exposure time at which bactericidal treatment of biological tissues is ensured remains quite large and ranges from 6 to 9 minutes, depending on the type of bacterial microflora. In this case, the negative effect of ultrasound on healthy cells and the granulation layer of the wound is possible.

 In addition, in this method, the active penetration of a drug solution into all cavities and pockets of an infected wound is not guaranteed. The effectiveness of the method is significantly reduced with a small wound or protrusion of the wound surface, which does not allow the drug solution to accumulate reliably on voiced biological tissues.

 The problem the invention is aimed at enhancing the bactericidal ability of ultrasonic vibrations, creating favorable conditions for ultrasonic treatment of any wounds regardless of the size and condition of the wound surface, intensifying the penetration of drugs into biological tissues, reducing the time of sterilization of infected wounds and the healing process as a whole.

This problem is solved by the fact that the ultrasonic treatment of infected biological tissues is carried out in a sealed chamber filled with a heated drug solution under an external statistical pressure in the range of 0.05-0.15 MPa. The chamber in the form of a funnel is superimposed on the wound surface and fixed on it, completely covering the outer edges of the wound. A waveguide is introduced into the chamber to a depth of 10-15 mm, not touching any parts of the surface of the infected wound, after which a drug solution preheated to a temperature of 37-42 ^o C is fed into the chamber at a pressure of 0.05-0.15 MPa, the quality of which the antiseptics of the oxidizing group were initially tested.

 The heated antiseptic solution supplied to the chamber under pressure plays the role of a constantly present contact medium and contributes to the continuity of the process of voicing wounds of any shape and size. Excessive statistical pressure ensures reliable entry of antimicrobial agents into all cavities and pockets of an infected wound. The application of the optimal value of the external statistical pressure on the voiced medium leads to an increase in hydrostatic pressure, which in turn increases the rate of collapse of cavitation cavities (caverns), intensifies the effect of shock waves and enhances the cavitation process as a whole. In this case, the chemical (oxidative) action of ultrasound is activated with the formation of a large number of chemically active radicals in the solution, the permeability of cell membranes increases, the diffusion penetration of chemically active substances through the cell walls increases, which generally significantly reduces the necessary time for the rehabilitation of infected wounds.

So, with the combined action on the microflora (Staphylococcus aureus, Proteus, Escherichia coli and Pseudomonas aeruginosa with a concentration of 40-42 • 10 ³ mt / ml in a volume of 50 ml) of low-frequency ultrasound (frequency f = 26.5 kHz, the amplitude of the displacement of the end face of the concentrator A = 40 -45 μm), an antiseptic (0.1% hydrogen peroxide solution heated to a temperature of 37-42 ^o C and an external static pressure of 0.05-0.15 MPa), the sterilization time of the tested bacterial suspensions is reduced from 5.0 to 7.2 times compared to the conventional ultrasound process. Moreover, the greatest effect is achieved when external static pressure is applied to the medium. Only due to pressure, the time of bactericidal treatment is reduced by 1.8-2.0 times compared with the combined action of ultrasound and a heated solution of antiseptic. Moreover, the maximum necessary dosing time is in the range from 3 to 5 minutes, depending on the type of microbial association in the wound, which provides relatively harmless to the body the proposed method of bactericidal treatment of infected wounds. The inventive method differs from the prototype in that in addition to preheating the medicinal substance supplied to the voiced area, external static pressure is applied to the voiced wound medium, which determines the use of an overhead camera, in which ultrasonic treatment of the wound is carried out. These differences allow us to conclude that the proposed solution meets the criterion of "novelty."

 The constant presence of the drug medium in the chamber ensures the continuity of the process of ultrasound exposure and the possibility of ultrasound treatment of various types of wounds regardless of their shape and size at different stages of the wound process. On the other hand, the presence of an optimal value of external pressure enhances the bactericidal effect of ultrasonic vibrations, creates the conditions for reliable entry of a medicinal substance into all cavities and pockets of a wound, contributing to the spread of ultrasonic vibrations throughout the volume of a wound, intensifies the accumulation of medicinal substances in biological tissues, activates the cleaning and massage of wound surfaces from necrotic deposits, provides conditions for epithelialization of the wound and significantly reduces the healing time. Signs that distinguish the claimed method of treating infected wounds from the method described in the prototype, are not identified in other methods in the study of this and related fields of medicine and, therefore, provide the claimed solution with the criterion of "inventive step".

 To perform this method of treating infected wounds, a device has been developed for administering a drug to the body.

A device for introducing drugs into the body is known, which comprises a handle, a chamber with a membrane filled with medicinal fluid, an ultrasound applicator and a matching element in the form of a tampon adjacent to the applicator from the distal part of the device and connected to the camera. The tampon is elastic [6]
This device does not allow you to enter the medicinal fluid under a given excess static pressure, thereby not ensuring the reliable entry of antimicrobial agents into all cavities and pockets of an infected wound.

 The closest in technical essence to the proposed device for the treatment of infected wounds is a device for introducing drugs into the body [7] containing an open chamber with holes for introducing a drug solution and an ultrasonic waveguide, which is installed with an open end on the treatment surface.

 This device also does not allow you to enter the medicinal fluid under a given excess static pressure, thereby not ensuring the reliable entry of antimicrobial agents into all cavities and pockets of an infected wound.

 A comparative analysis showed that the claimed solution differs from the prototype by the presence of fastening elements of the device on the body, providing sealing, and a pressure sensor, which provides the criterion of the invention of "novelty."

 Signs that distinguish the claimed device from the prototype, are not identified in other analogues when receiving this and related fields of medicine and, therefore, provide the claimed solution with the criterion of "inventive step".

 In FIG. 1 shows a device for implementing the method of ultrasound treatment of infected wounds, top view; figure 2 General view of the device in section; figure 3 diagram of the treatment of an infected wound.

 The device consists of a housing (chamber) 1 with two holes 2 and 3 for injecting the drug solution and the waveguide through the sleeve 4 and nut 5, as well as a rotary valve 6 for regulating the flow of the solution into the chamber; a rubber seal 7 with a gasket 8 is provided at the end of the chamber a housing is integrated with a pressure sensor, consisting of a sleeve 9, a cylinder 10, a plunger 11, a screw 12 and an ottorirovanny spring 13. The device is equipped with a nut 14 with slots 15 18 for fastening the cable ties.

 A method of treating an infected wound is as follows.

 At the preliminary stage of the implementation of the method according to well-known methods, a clinical analysis of blood and urine is carried out, smears from the wound cavity to the flora are examined. Bacteriological studies establish the types of pathogenic microflora present in the wound, the predominant type of microorganisms, as well as the presence of microbial associations. Based on the research results, the main parameters of the ultrasonic processing process are selected. The patient is placed in a position in which the device is applied to the wound surface and fixed on it, completely covering the outer edges of the wound. The device is secured by tensioning the cable ties 19, the grips of which are included in the slots 15 18 of the nut 14. The degree of tension is determined by the sealing conditions, manually provided and fixed with a special clamp.

 The waveguide 20 is introduced into the device chamber through the hole 3 of the nut 5 and the sealing sleeve 4. The distance between the radiating end of the waveguide and the wound surface should not be less than 5-10 mm, which excludes thermomechanical destruction of wound tissues.

Through the opening 2 of valve 6, a drug solution preheated to a temperature of 37-42 ^° C is supplied into the internal cavity of the device, the choice of which is determined by the prevailing type of microflora in the wound. The supply of the solution is carried out using a medical syringe, the tip of which is inserted into the hole 2 until it stops in the valve roller 6. Due to the forced injection of the solution in the chamber, an overpressure is artificially created in the range 0.05-0.15 MPa. When the specified pressure is reached in the chamber, the valve 6 roll is turned 90 ^° by pressing the notched petal, which closes the hole for supplying the solution to the chamber.

In the process of bactericidal treatment, some joint depressurization and minor leakage of liquid from the chamber are allowed provided that the overpressure in it is within 0.05-0.15 MPa, which is achieved by periodically forcing the drug solution into the chamber. The source of low-frequency ultrasonic vibrations is turned on and the wound is treated at generally accepted optimal parameters for the process of scoring of biological tissues: the frequency of ultrasonic vibrations is 26.5 kHz; the oscillation amplitude of the radiating end of the waveguide tool 40-50 microns; the duration of ultrasonic exposure is 4-5 minutes, which corresponds to the intensity of scoring of 20-25 s / cm ² .

The physicochemical processes arising from this, initiated by increased solution temperature, static pressure, cavitation, acoustic flows, variable sound pressure, cause the spread of the drug solution throughout the wound, its penetration into all cavities and pockets. Moreover, in the zone of developed cavitation of the ultrasonic field, the permeability of cell membranes increases, chemically active radicals H ^• , OH ^• , HO appear in the voiced medium $\genfrac{}{}{0ex}{}{\text{•}}{\text{2}}$ chemically active substances penetrate through the membranes of bacterial cells, disrupt or stop the redox processes in microbial cells, and cause their death. Highly active primary and secondary products of sound chemical reactions are distributed throughout the treated wound cavity, deported to the surface layer of the wound, where the bulk of the pathogenic microorganisms accumulate. At the same time, the manifestation of the “reverse” ultrasonic capillary effect ensures the extraction of pathological contents and pathogenic microflora from the capillary-porous system of the wound surface, and the wound cavity is intensively cleaned. At the end of the processing of the infected wound, ultrasonic vibrations are turned off, the camera is removed, the wound is visually inspected, and a sterile dressing is applied.

 Repeated visual, and if necessary microbiological and pathological control is carried out periodically when changing the dressing. Based on the results of the control, a conclusion is drawn on the feasibility and timing of re-processing the wound. The number of treatment sessions of an infected wound by the proposed method is determined individually in each case, depending on the type and condition of the wound, the degree of its bacterial contamination, the microbial landscape of the wound, the condition of the patient’s body, the dynamics of the postoperative healing period. The total number of sessions for the entire course of treatment does not exceed five to seven.

 The developed method for treating infected wounds allows not only to provide effective suppression of bacterial microflora, regardless of the shape and size of the wounds at various stages of the wound process, but also to reduce the risk of infection metastasis from the purulent foci zone to the layers of biological tissues adjacent to the voiced area due to intensive cleaning of wound surfaces , active impregnation of drug solutions in them in excess of the minimum inhibitory concentration.

 1. Nikolaev G.A. Loshchilov V.I. Ultrasound technology in surgery. M. Medicine, 1980, p. 222.

 2. Goryachev A.N. et al. Low-frequency ultrasound during primary surgical treatment. Abstracts of the 2nd All-Union Conference "Wound and Wound Infection". M. 1986, p. 27.

 3. Zakharova G.N. etc. The use of low-frequency ultrasound in the prevention and treatment of purulent wounds. Abstracts of the II All-Union Conference "Wounds and wound infection". M. 1986.

 4. Infants P.I. and others. The use of cavitation ultrasound in the surgical treatment of wounds. Abstracts of the II-nd All-Union Conference. "Wounds and wound infection." M. 1986.

 5. Cherkashin VV and others. The influence of physico-chemical factors on the enhancement of the bactericidal action of ultrasound. Sat Ultrasound in physiology and medicine. - Abstracts of the III-rd All-Union Conference. Tashkent, 1980, p. 176.

 6. Auth. St. SU N 288873, class A 61 M 37/00, 1964.

 7. Auth. St. SU N 882528, class A 61 M 37/00, 1964.

Claims (2)

1. The method of ultrasonic treatment of infected wounds, including the introduction into the wound cavity of a medicinal solution heated to 23 42 ^o C, followed by ultrasonic treatment with low frequency, characterized in that the ultrasonic treatment of infected tissues is carried out in a hermetic chamber placed on a wound filled with heated medicinal solution, while creating an excess pressure of 0.05 to 0.15 MPa.  2. Device for ultrasonic treatment of infected wounds, containing an open chamber with holes for the introduction of a drug solution and an ultrasonic waveguide, made with the possibility of installing the open end on the treatment surface, characterized in that the chamber also has a pressure sensor in the chamber cavity and its mounting elements on the patient’s body.

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