RU2644290C2 - Method for treatment of nonspecific limited pleural empyema and device for its implementation - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: for treatment of nonspecific limited pleural empyema, basis therapy is performed according to the indications. Purulent contents are removed from the cavity through the injected needle and the cavity is sanitized with a drug solution by cycles until the "clean" solution is removed. At that, the sanitation is carried out by ultrasonic (US) treatment with a solution through a needle inserted into the puncture of the cavity wall after liquid removal from the cavity. US sanitation include cavity walls exposure to a cavitating "sounded" jet, augmented by cavitation ozonized medicinal solution in the cavity ensuring solution circulation inside without pressure increase. Sanitation procedures are carried out 3-4 times a day once a day, after 1-2 days with 3-9 procedures. The consumption of drug solution is 100-150 ml/minute. The exposure of the ultrasonic treatment cycle is 1-7 minutes. To remove liquid from the pleural cavity both a syringe and an aspiration system are used.

EFFECT: method provides acceleration and simplification of pleura sanitation while increasing comfort and safety of procedures and improved quality of sanitation including cleaning of bacterial films, removal of purulent, pathological plaque from the pleural cavity with minimal damage to the healthy tissue while reducing the drug load on the patient's body.

2 cl, 3 dwg, 1 ex

Description

The invention relates to medicine, in particular to ultrasound therapy in pulmonology, and relates to minimally invasive methods and devices for minimally invasive non-surgical local treatment of pleural empyema by intracavitary administration of drugs.

Pleural empyema is a pathological process characterized by accumulation of pus in the pleural cavity. Patients with pleural empyema are hospitalized in the purulent surgery department. Common therapeutic measures include the regimen (free) and high-calorie nutrition. Local treatment of pleural empyema is of utmost importance. Its purpose is the evacuation of pus, sanitation of the pleural cavity and the creation of conditions for the fastest expansion of the lung (see Mukonin, A.A. Purulent-destructive lung diseases: etiology, pathogenesis, diagnosis, treatment and prevention Text./A. A. Mukonin, I .V. Leshchenko, A.V. Ovsyankin, T.Sh. Benateli, K.V. Gaidul / A Manual for Doctors / - M .: ABOLmed, 2005. - 40 p.).

In recent years, due to the increased microflora resistance, the structure of the causes of pleural empyema has changed, the prerequisites for revising treatment tactics in chronic and especially in acute pleural empyema have been created, new possibilities have appeared in the treatment of empyema using modern immunological, bronchological, new antiseptic agents, and also using endoscopic techniques of treatment, laser and ultrasound. Treatment of pleural empyias to this day is a complex, multifaceted problem, as evidenced by the high mortality and chronicity rates that have occurred in empyemic treatment so far.

Draining treatment of acute pleural empyema is the predominant method and includes:

- adequate emptying of purulent cavities and their sanitation (puncture of the pleural cavity with its washing, closed drainage of the empyema cavity);

- sterilization of the pleural cavity with subsequent expansion of the lung (treatment and diagnostic thoracoscopy, expansion of a collapsed lung on the background of temporary occlusion of the bronchopleural fistula, closed ultrasound and drug lung decortication);

- antimicrobial therapy, taking into account the sensitivity of microflora to antimicrobials.

To cure a patient with pleural empyema, it is necessary to begin treatment of each empyema with active aspiration.

Puncture of the empyema cavity is both a medical and diagnostic method (the contents of the empyema cavity are evacuated, sanitation is performed by rinsing and administration of proteolytic, fibrinolytic drugs and antimicrobial agents, detecting hermetic lung tissue, clinical, laboratory, bacteriological and cytological studies of exudate).

The size of the puncture needle is selected depending on the nature of the pus (mainly a needle with an internal diameter of 2-3 mm). The needle is connected to the syringe with a rubber adapter, which is pinched during the evacuation of pus from the syringe to maintain the tightness of the cavity. Removal of purulent exudate at each puncture is maximum. After removal of pus, the empyema cavity is washed with antiseptic solutions up to pure “water”, the procedure ends with the introduction of proteolytic enzymes into the cavity. Punctures are performed daily or every other day. The pleural cavity is considered sanitized when the number of leukocytes does not exceed 20-25 in the field of view for 3-4 studies of washings.

Despite the development of the main method of sanitation of the pleural cavity (by washing from a syringe through an inserted needle), the quality of processing depends on the experience and skills of the doctor, who manually dispense a washing solution through portions of 50-100 ml (Luer syringes), which requires significant labor costs and time for 10-20 times the rearrangement of syringes and their subsequent processing, which additionally injures the patient.

The use of puncture as an independent method for the treatment of pleural empyema is advisable in patients with limited, “parietal” empyema. The lack of a therapeutic effect from pleural punctures is a direct indication for closed drainage of the pleural cavity. (see Tseymakh E.A., Levin A.V., Samuilenkov A.M., Ananko O.N., Chukanov I.V. “Pleural empyema. Clinic, diagnosis, treatment.” / Study guide / p. 1-47).

The method of drainage of the pleural cavity is based on the rules of puncture - adequate anesthesia of the site of puncture of the chest wall with a local anesthetic (novocaine 0.25% or 0.5% is most often used), prevention of injury to the intercostal neurovascular bundle. After preliminary puncture and obtaining pus in the area of the corresponding intercostal space, a skin incision of up to 1 cm is performed, the wound is stitched. Through the skin incision, the chest wall makes its way through the thoracar, the stylet is removed, making sure the tube is standing correctly, a drainage tube is passed through it into the pleural cavity. The tube is removed. Drainage is fixed to the skin. Active and passive aspiration (mainly alternation) is carried out, the empyema cavity is washed with antiseptic solutions, proteolytic enzymes are introduced. Recently, new minimally invasive treatment methods are being developed. One of them is medical diagnostic thoracoscopy.

The method consists in the following: under endotracheal anesthesia, a thoracoscope is inserted through the intercostal space into the empyema cavity, the contents are aspirated and the cavity is examined using the optical system (the size of the cavity is determined, the state of the visceral and parietal pleura, lung tissue, the presence of bronchopleural fistulas, a biopsy is performed, necrotic and fibrinosis are removed masses). The empyema cavity is washed with an antiseptic solution, and drainage is established. The possibilities of therapeutic thoracoscopy using ultrasonic sanitation methods are expanding. Thoracoscopy in combination with bronchoscopy: the contents of the cavity are aspirated, filled with an antiseptic solution, and a rotating ultrasound waveguide instrument is inserted through the tube of the thoracoscope. Ultrasonic treatment of all departments of the cavity is carried out under visual control. Processing takes about 10 minutes. Sound parameters: vibration frequency - 26.5 kHz, vibration intensity - 1.5 W / cm ² , vibration amplitude - 30-60 microns. Then the cavity is drained, drained or the wound is sutured tightly, then it is conducted at the punctures. Low-frequency ultrasound is used for closed lung decortication with the help of special jackets-waveguides; peeling of the leukocyte-necrotic layer of the empyema wall is performed.

However, the above treatment methods, including ultrasound treatment through a thoracoscope, are not always effective, because they do not allow for complete rehabilitation of patients due to the fact that they use mainly solutions of antiseptics or enzymes, not taking into account the development of an imbalance at the local level. All this dictates the need to search for new effective drugs and treatment methods (flushing, sanitation) that allow minimizing trauma to the patient with a high probability of stopping the inflammatory process, preventing recurrence and chronicity of the inflammatory process.

The objective of the invention is to develop a minimally invasive method of local treatment of pleural empyema, which allows to accelerate and simplify pleural sanitation, given the modern development of technology and technology to increase the effectiveness of therapy, with the goal of persistent relief of inflammation and reduce the treatment time for this pathology in order to prevent recurrence and chronicity of the inflammatory process, and also reducing inflammatory processes while increasing the effectiveness of treatment by providing high-quality cleaning-sanitation of the cavity from and customizing and necrotic tissues while increasing the comfort and safety of treatments using modern ultrasound equipment and domestic devices with minimal time and resources where possible to mechanize the process of readjustment.

The problem is solved in that the cavity is sanitized with an “voiced” ultrasound solution of the medicinal product with low-frequency ultrasound treatment of the cavity through a needle inserted into the puncture of the pleural cavity wall after preliminary removal of accumulated fluid from the cavity. Ultrasonic rehabilitation includes the action of a cavitating “voiced” stream on the walls of the pleural cavity, supplemented by cavitation bubbling of the drug solution in the cavity with the solution circulating inside without increasing the pressure in it, and for ultrasonic treatment of the cavity, a 0.05% aqueous solution of chlorhexidine is used, in this case, the procedures are carried out in 1-2 days with a treatment course of 3-10 procedures, and for carrying out the ultrasonic sanitation procedures, the ultrasound therapy apparatus AUZX-100- "FOTEK" of the company "FOTEK", Yekaterinburg, containing an ultrasound generator, an acoustic unit, a waveguide-instrument, the amplitude of which is 20-150 μm, the oscillation frequency is 23-25 kHz, with an internal irrigation channel with a diameter of 2 mm for supplying a medicinal solution and a protective casing 120 mm long with a transition cone for connecting to a needle inserted into the puncture of the wall of the cavity, an infusion system for supplying a drug solution.

An ultrasound device with a replaceable tip and a protective casing is connected to the needle through a switching valve, also used to remove fluid from the pleural cavity, and a three-way valve for infusion therapy and monitoring “Discofix” is used as a switching valve for ultrasonic treatment of the cavity and to remove liquid from the pleural cavity "Manufactured by" B. Braun "(Fig. 1 shows a table that discusses the principle of the use of this switch for sanitation of the cavity), and ultrasound treatment of the cavity is carried out at a flow rate ora 100-150 ml / min, exposure 1-7 min and infusion volume according to the volume of exudate removed, and for conducting ultrasound procedures, a “voiced" drug 0.05% aqueous solution of chlorhexidine with a temperature of 30-35 ° C is used, with a puncture the walls of the pleural cavity are carried out with a needle with a diameter of 2-2.5 mm, a length of 60-90 mm with a head of the Luer type. After the end of the cycle of ultrasound treatment of the cavity, the injected drug is removed and the next cycle of ultrasonic sanitation is carried out to “clean water”, while both the syringe and the aspiration system are used to remove fluid from the pleural cavity, after which the ultrasound apparatus is disconnected, the needle is removed and the puncture is closed with an antiseptic bandage.

The method provides the washing of bacterial films, the removal of purulent, pathological plaque from the cavity with minimal damage to healthy tissues, which provides an antimicrobial, antiseptic and anti-inflammatory effect, reduces the drug load on the patient's body and prevents the inflammatory process from chronizing.

Technically, the method consists in introducing into the pleural cavity after removal of the exudate through the inserted needle of the sanitizing ultrasound “voiced” solution from the ultrasonic waveguide tool (in the protective casing) through its internal irrigation channel with a diameter of 2 mm, through the distal end of the protective casing and switching the crane into the needle, which is in the patient.

Method parameters: the frequency of ultrasonic vibrations of the waveguide tool 23-25 kHz, the flow rate of the drug solution 100-150 ml / min, the exposure time is 1-5 minutes, the course of treatment is 3-10 procedures, the volume of the solution is at least 300 ml, the temperature of the solution, the drug, the amount antiseptic drug, treatment cycles are selected and substantiated empirically according to the results of experiments and laboratory experiments with photographing and video fixation.

The apparatus for implementing the proposed method of treatment AUZH-100- “FOTEK” (LLC “FOTEK”) includes: an ultrasonic generator, an acoustic unit, a waveguide tool with an internal irrigation channel with a diameter of 2 mm, a protective casing of a special shape 120 mm long and an infusion system for feeding drug solution.

The power consumption of the apparatus is 150 VA, the mass of the acoustic unit with the instrument is 0.4 kg. The device allows you to locally affect the endometrium and myometrium of the ultrasound with a “voiced” solution of the injected therapeutic drug, spraying it in bulk in the cavity in a predetermined quantity and effectively acting on the microbial agent and biological tissue at a distance of 3-10 cm.

Previously, such devices with waveguide instruments and protective casings were used for ultrasound treatment of open cavities and through natural channels in gynecology and obstetrics (see patent PM No. 125853, A61N 7/00 "Device for the local treatment of inflammatory diseases of the uterine cavity", publ. 20.03 .2013 and “Prevention and treatment of inflammatory diseases in obstetrics and gynecology using the method of ultrasonic cavitation of medicinal solutions”, Practical Guide for Doctors. Yekaterinburg. Publishing House - “VIP-Ural. 2014. 65 p.).

According to the proposed method, according to indications, after one or two days, patients undergo ultrasound treatment of the closed pleural cavity with a cavitated chlorhexidine solution through an inserted needle using the ultrasonic therapy apparatus AUZX-100-FOTEK with a waveguide tool and a protective casing for ultrasound intracavitary administration of the drug.

In FIG. 2 shows a diagram of the implementation of the proposed method with an attached needle for intracavitary ultrasound rehabilitation.

The scheme of the method for ultrasound rehabilitation of closed cavities includes:

1 - ultrasonic generator;

2 - acoustic unit;

3 - nozzle for supplying fluid to the acoustic unit;

4 - waveguide tool;

5 - internal irrigation channel of the waveguide tool;

6 - a protective casing of an acoustic unit with a cone by a waveguide connector with a needle;

7 - switch-connector (three-way valve) of the waveguide with a needle;

8 - needle (in the patient);

9 - a system for supplying a medicinal solution;

10 - flow rate regulator of the medicinal (sanitizing) solution.

The system consists of an ultrasonic generator 1, an acoustic unit 2 with a fluid supply fitting 3, an ultrasonic waveguide tool 4 with an internal irrigation channel 5 with a diameter of 2 mm, a protective casing 6 with a cone-connector, a switch-connector (in the form of a three-way valve) 7 for connecting a puncture needles of the Luer type 8, systems for supplying the drug solution 9 with a flow regulator 10. The cavitation process begins when the drug solution passes through the internal irrigation channel 5 of the waveguide tool and 4. cavitating fluid jet passes through the acoustic assembly 2, a waveguide 4-tool with a protective casing 6, a connector 7 and the switch, this field enters the needle 8 of the "Luer" (in the patient) and delivered to the pleural cavity tissue subject to remediation. This method of ultrasonic sanitation allows not to increase the pressure in the sanitized cavity above atmospheric pressure or to provide some discharge in the cavity if the container with the drug solution is lower or at the same level as the sanitized cavity.

The device allows you to produce:

- washing of tissues from bacterial films, purulent and pathological plaque due to irrigation with a directed cavitated stream and cavitation barborting of a solution in a sanitized cavity;

- finely dispersed cavitation spraying of solutions in order to deeply impregnate medicinal substances into the mucous membrane of the cavity;

- non-contact removal of necrotic tissue with minimal damage to healthy tissue.

To substantiate the proposed method in the first series of experiments examined and treated 8 patients aged 20 to 39 years.

Evaluation of the effectiveness of the application of the above method was based on improving the patient's condition, the rate of reduction of clinical manifestations, normalizing the level of leukocytes, CRP, IL and ultrasound control.

Thus, the proposed method of treatment allows you to quickly and persistently stop the inflammatory process, to prevent recurrence and chronicity of the inflammatory process with minimal additional costs due to the use of a 0.05% aqueous solution of chlorhexidine injected with an ultrasound device and a needle into the closed pleural cavity.

The novelty of the invention is the use for the sanitation of a closed pleural cavity of an ultrasound apparatus with nozzles for a new purpose - for treating pleural empyema by supplying a sanitizing solution of chlorhexidine through an ultrasonic apparatus working tool with a protective casing-connector, through a switch-valve into a needle inserted into the patient. This leads to an additional analgesic effect due to ultrasound treatment with adjustable continuous supply of flushing (sanitizing) composition to the cavity and allows to mechanize the process of rehabilitation, improve the quality of rehabilitation with a decrease in the total time spent on procedures, reducing the likelihood of aggravation of the inflammatory process and the need for subsequent surgical treatment, which allows you to recommend a method for implementation in medical institutions.

Clinical example No. 1

Central City Hospital No 7, Yekaterinburg - Department of Purulent Surgery and Department of Pulmonology.

Testing period: September 2014 - February 2015

Patients with pleurisy in the Central City Hospital No. 7. As a rule, patients with pleurisy are in the pulmonology department of the City Clinical Hospital No. 7 for 1.5-2 months, and the hospital has to spend a lot of money on their treatment. Although the use of thoracoscopy can reduce the time of treatment for pleurisy to 2-3 weeks, but not all hospitals have the equipment and trained personnel necessary for thoracoscopy. Therefore, most often patients are treated by puncture or by the method of trocar drainage of the pleural cavity. To wash the pleural cavity with this method, expensive broad-spectrum antiseptics (dioxidine) are used, which increases the total cost of treatment. Also, it is not always possible to immediately select an effective systemic antibiotic for a patient, as a result of which patients may have elevated body temperature and fever for a long time (up to 2-3 weeks), which requires the development and use of a method of stable high-quality sanitation of the pleural cavity at minimal cost .

The standard (control) technique of pleural puncture in the Central City Hospital No. 7 includes the following steps:

1. Ultrasound examination.

With the help of ultrasound, the place of accumulation of fluid in the pleural cavity is determined and a point for puncture is selected.

2. Puncture of the pleural cavity.

In the treatment room, a needle is made with a needle with an internal diameter of 2 mm, then a tube is attached to the needle, through which fluid is actively aspirated from the cavity.

3. Washing the pleural cavity with antiseptic solutions with a syringe.

After emptying the cavity, a solution of an antiseptic (chlorhexidine, dioxidine) is introduced into it using a Luer syringe with a volume of 50-100 ml. Next, the solution is removed with the same syringe. Thus, the pleural cavity is washed according to the generally accepted method with 0.5-1.5 liters of solution to “pure” waters (5-15 times connecting a syringe of 50-100 ml), which requires a lot of labor and time.

At the end of 2014, the doctors tested the technology of sanitation of the pleural cavity with the continuous supply of sanitizing ultrasound cavitated solutions according to the proposed method.

In FIG. 3 shows a photo of treatment of a patient according to the proposed method.

To the puncture needle through which the pleural cavity was washed, a flow switch and an output cone of the protective casing of the acoustic unit with the Luer connector at the distal end were attached (the casing was put on the site with the waveguide tool), and a cavitated 0.05% was introduced through the needle into the cavity aqueous chlorhexidine solution. Then, after sanitation, using a syringe connected to the switch, the solution was removed and the sanitation cycle was repeated. The number of cycles of ultrasonic rehabilitation according to indications.

In the process of ultrasound debridement, the fluid from the pleural cavity during treatment first came out cloudy, yellow, then became transparent, colorless, with feathers of fibrin. Clouding of the solution during sanitation indicated that the cavity was well cleaned. After the procedure, the needle was removed and the puncture was sealed with an antiseptic dressing.

After rehabilitation by cavitated solutions, patients returned to normal temperature faster (after 1-3 rehabilitation). The terms of treatment decreased by about 1.5 times. The cost of treatment decreased, since the cavitated chlorhexidine solution allowed to sanitize the pleural cavity faster and more efficiently, with a smaller volume of antiseptic, which made it possible to cancel the systematic antibiotic earlier.

After elimination of the purulent process using minimally invasive treatment methods in patients with pleural empyema in the long term, favorable dynamics of residual inflammatory phenomena is noted.

According to the proposed method, 8 patients were treated. At the control examination after 6 months, pathology was not detected.

The proposed technology for the rehabilitation of hard-to-reach closed cavities with cavitated ultrasound solutions can have good prospects. Testing should be continued and a study of the effectiveness of this method in various clinical applications should be recommended.

Claims (2)

1. A method of treating nonspecific limited pleural empyema, including conducting basic therapy according to indications, removing purulent contents from the cavity through the inserted needle, sanitizing the cavity with a drug solution in cycles until a “clean” solution is removed, characterized in that the cavity is sanitized by ultrasonic treatment with solutions through a needle inserted into the puncture of the wall of the patient’s cavity after removal of the fluid from the cavity, and ultrasonic sanitation includes exposure to the cavity walls with a cavitating “voiced” stream, additional by cavitation bubbling of the drug solution in the cavity with the solution circulating inside without increasing the pressure in it, while the ultrasound debridement procedure is carried out for 3-4 cycles once a day, after 1-2 days with the number of procedures 3-9, with the flow rate of the drug solution 100-150 ml / min and the exposure of the ultrasound treatment cycle for 1-7 minutes, while both a syringe and an aspiration system are used to remove fluid from the pleural cavity. 2. A method of treating nonspecific limited pleural empyema according to claim 1, characterized in that for conducting ultrasound sanitation procedures, a “voiced” 0.05% aqueous solution of chlorhexidine with a temperature of 30-35 ° C is used, and the cavity wall is punctured with an internal needle diameter 2-2.5 mm, length 60-90 mm with a head of the Luer type.

Images