RU168394U1 - Device for ultrasonic treatment of cavities with solutions - Google Patents

Abstract

The development relates to medicine, in particular to ultrasound therapy, and concerns minimally invasive methods and devices intended for conservative non-surgical local treatment, in particular, pleural empyema, by means of intracavitary sanitation due to the introduction of ultrasound-treated solutions and preparations. The essence of a useful model is that the protective the casing of the waveguide-tool ends with a tip for connection to a puncture needle inserted into the puncture of the wall of the cavity of the patient, ensuring the flow of the drug The ultrasonic treatment of the cavity through the needle is 100-150 ml / min and the infusion volume according to the volume of exudate removed, and for ultrasound “sounding” of the closed cavity ultrasonic sanitation solution, the ultrasonic therapy device AUZX-100- “FOTEK” of the company “FOTEK” with infusion is used system, with a frequency of ultrasonic vibrations of 23-25 kHz, an amplitude of vibrations of an ultrasonic waveguide tool of 20-150 microns, with an acoustic unit complete with an ultrasonic instrument with a length of 74.5 mm with an internal irrigation channel with a diameter of 2 mm and a replaceable protective cover of an inserted design 120 mm long with a narrow end diameter of the casing 2 mm, while for puncture of the patient’s cavity wall and the introduction of the “voiced” solution of the sanitizing drug, a puncture needle with an internal diameter of 2 mm 60-90 mm long with a Luer head is used.

Description

The development relates to medicine, in particular to ultrasound therapy, and relates to minimally invasive devices and methods intended for conservative non-surgical local treatment, in particular, pleural empyema, by means of intracavitary sanitation due to the introduction of ultrasound-treated “voiced” solutions and preparations.

Puncture of the empyema cavity is both therapeutic and diagnostic (the contents of the empyema cavity are evacuated, sanitation is performed by rinsing and administration of proteolytic, fibrinolytic drugs and antimicrobial agents, identification of hermetic lung tissue, clinical, laboratory, bacteriological and cytological studies of exudate). Despite the development of the main method of sanitation of the pleural cavity by manually washing from a syringe through an inserted needle, the quality of processing depends on the experience and skills of the doctor who manually delivers a washing solution in portions of 50-100 ml, which requires significant labor and time for 10-20- multiple permutation of syringes and their subsequent processing, which additionally injures the patient.

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. The use of puncture as an independent method for the treatment of pleural empyema is advisable in patients with limited "parietal" empyema.

Recently, the development of new minimally invasive treatment methods using ultrasonic rehabilitation devices is underway.

Known devices for ultrasonic treatment of cavities with solutions through natural channels with expanders or extenders.

Known, in particular, "A method for the treatment of inflammatory diseases of the vagina and vaginal part of the cervix and a device for its implementation" (see AS No. 1101239, A61N 31/02. Publ. 07.07.1984.), In which the exposure to ultrasonic energy oscillations are conducted through a liquid drug at an ultrasonic frequency of 26.5-44 kHz, an amplitude of 40-60 μm, a waveguide rotation speed of 30-60 rpm for 60-120 s, and then through a consistent drug by contact sounding at frequency 26-44 kHz, amplitude 20-40 microns for 10-15 s, in which the emitter and the waveguide-tool, introduced into the uterus, is equipped with a trellis expander with a centralizer sleeve mounted on it with the help of spokes, inside of which a Teflon ring is pressed in for free placement of the waveguide-tool in it. In this case, the waveguide tool has a beveled end at an angle of 45 ° -60 ° and the possibility of rotational and translational movement, and the waveguide tool has a concave bowl-shaped torus.

However, such devices are of limited use also because of the large size of the waveguide-tools requiring expansion of channels, and cannot be used for the rehabilitation of closed cavities, in addition, carrying out such a procedure is time-consuming, which creates difficulties for its widespread use in clinics with a large flow of patients.

One of the new directions of intracavitary ultrasound rehabilitation is the treatment and diagnostic thoracoscopy, which consists in the fact that under a local or general anesthesia a thoracoscope is inserted through the incision in the intercostal space into the empyema cavity, then the contents are aspirated and examined using an optical system (cavity size, visceral and parietal pleura, lung tissue, the presence of bronchopleural fistulas, a biopsy is performed, necrotic and fibrinous masses are removed). 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 is carried out by bubbling all parts of the cavity under visual control. Ultrasound treatment lasts about 10 minutes. Sound parameters: vibration frequency - 26.5 kHz, vibration intensity - 1.5 W / cm, 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, the leukocyte-necrotic layer of the empyema wall is peeled off (see Tseymakh E.A., Levin A.V., Samuilenkov AM, Ananko O.N., Chukanov I.V. "Pleural empyema. Clinic, diagnosis, treatment." / Study guide / p. 1-47).

With good results of treatment using a thoracoscope, an incision is required to process the cavity with subsequent suturing, which is already an operation and requires additional time and money.

Also known is a small-sized device, taken as a prototype, combining ultrasound treatment with the supply of a sanitizing solution into the cavity through natural channels without dilators, containing an ultrasound generator, an acoustic unit, a waveguide tool with a protective casing and cover, an infusion system for supplying a medicinal solution. Moreover, inside the acoustic unit and the waveguide-tool there is an irrigation channel, and the protective casing is made in the form of a stepped thin-walled metal tube with a sealed distal end with grooves on the distal end and with drainage holes, and the cover, worn on the narrow part of the protective casing, is made of fluoroplastic (see Patent PM No. 125853, A61N 7/00, Pub. March 20, 2013 “Device for the local treatment of inflammatory diseases of the uterine cavity”).

Ultrasound devices with such a device and with removable ultrasound instruments of various types - "horseshoe", "scapula", "ball" were effectively used for ultrasound treatment of open cavities through natural channels in gynecology and obstetrics using interchangeable protective covers 107-109 mm long (cm . "Prevention and treatment of inflammatory diseases in obstetrics and gynecology using the method of ultrasonic cavitation of medicinal solutions" Practical guide for doctors. Ekaterinburg. Publishing house. "VIP-Ural". 2014. 65 S.), which is somewhat They kept their application, restricting the access of ultrasonic treatment of cavities only through natural channels.

All this dictates the need to search and develop new devices or improve the known devices for ultrasound treatment (flushing, sanitation) of closed cavities, which, with minimal trauma to the patient, can most likely stop the inflammatory process, prevent recurrence and chronicity of the inflammatory process in the closed cavity.

The objective of the utility model is to develop an ultrasound device for implementing a minimally invasive (without incision and suturing) method of local treatment (sanitation) of closed cavities, in particular, pleural empyema, which allows to simplify and accelerate the process of delivering a “voiced” solution to the cavity for treatment by providing high-quality cleaning - sanitation cavities from infected and necrotic tissues while increasing the convenience and safety of procedures using modern ultrasound equipment, acoustic nodes and ultrasound instruments ntents of domestic production at the minimum cost of time and money, with a minimum of changes in the design of existing ultrasonic devices, components and tools while expanding their capabilities.

The problem is solved by the fact that it is proposed and developed a device that includes a change in the design of the protective casing of a removable ultrasonic instrument. In this case, the protective casing of the waveguide-tool is made in the form of a stepped thin-walled metal tube with a distal end ending in a hollow cone tip, which is necessary to connect to a standard Luer type puncture needle for sequential connection of the irrigation channels of the ultrasonic generator, the tip tool with the puncture a needle inserted into the puncture of the wall of the patient’s cavity for ultrasonic sanitation of closed cavities.

Ultrasound rehabilitation is carried out by an ultrasonic therapy device manufactured by FOTEK LLC, Yekaterinburg AUZH-100- FOTEK with a replaceable tool (tip), 74.5 mm long, with an internal irrigation channel with a diameter of 2 mm and a protective cover of the proposed design with a length of 120 mm, ensuring the flow rate of a medicinal solution is 100-150 ml / min at a frequency of ultrasonic vibrations of 23-25 kHz, an amplitude of vibrations of an ultrasonic waveguide tool of 20-150 μm and an infusion volume of the volume of exudate removed, and the cavity wall is punctured with an internal puncture needle they have a diameter of 2 mm with a head for connecting to Luer syringes. The final cone of the protective casing has a central channel with a diameter of 2 mm. The acoustic unit is used complete with an ultrasonic instrument with a length of 74.5 mm with an internal irrigation channel with a diameter of 2 mm and a replaceable protective cover of the proposed design with a length of 120 mm with a diameter of the narrow end of the casing of 2 mm, and for puncture of the wall of the patient’s cavity and the introduction of ultrasound “voiced” solution the drug uses a puncture needle with an inner diameter of 2 mm and a length of 60-90 mm with a Luer head.

The device with the proposed protective casing-connector provides non-contact ultrasound washing of bacterial films through a needle in a closed cavity, removing purulent pathological plaque from the cavity with minimal damage to healthy tissues, producing an antimicrobial, antiseptic and anti-inflammatory effect, reducing the drug load on the patient’s body and preventing the inflammatory process from chronizing .

Technically, the device creates a prefabricated serial uniform channel with a diameter of 2 mm for supplying an ultrasound flow to the pleural cavity, providing a sanitized (cavitated) drug solution of a predetermined adjustable volume from an ultrasonic instrument with an internal irrigation channel with a diameter of 2 mm through a removable protective casing connector ending in a cavity of the patient a Luer-type connecting cone with a channel with a diameter of 2 mm, and then through an inserted needle with an inner diameter of 2 mm.

The main elements of the device are in the form of an ultrasound instrument (tip), 74.5 mm long, with an internal irrigation channel with a diameter of 2 mm, a removable protective casing-connector with a conical connection to a needle with a Luer head with an internal irrigation channel with a diameter of 2 mm, a puncture needle with an inner diameter of 2 mm and a length of 60-90 mm is practically selected as providing a flow rate of a drug solution of 100-150 ml / min at a frequency of ultrasonic vibrations of 23-25 kHz and a solution volume of at least 300 ml at an exposure time of 3-5 min, and quantity and consumption pr parathyroid antiseptic selected and substantiated experimentally by the results of laboratory experiments and experiments with photographing and video fixation as to ensure stable operation of the device during ultrasonic sanitation, in particular the pleural cavity.

The novelty of the utility model is the use of the well-known ultrasound apparatus AUZX-100- “FOTEK” for a new purpose - with an additional removable protective casing-connector for intracavitary full-volume ultrasound rehabilitation of closed cavities through the inserted puncture needle with adjustable delivery of the washing ultrasound “voiced” solution, which allows for reducing the overall time spent on procedures to mechanize the process and improve the quality of rehabilitation, and this is also an unobvious effect of the proposed device for a minimally invasive method cheniya.

The ultrasonic cavitation apparatus AUZX-100- “FOTEK” (LLC “FOTEK”) contains: an ultrasonic generator, an acoustic unit, an ultrasonic instrument with an internal irrigation channel and a replaceable protective cover, and an infusion system for controlled delivery of a medical sanitizing 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 with the proposed removable protective casing-connector allows locally contactlessly acting on the endometrium and myometrium with the “voiced” solution of the injected therapeutic drug, spraying it in bulk in a closed cavity in a predetermined quantity and effectively exposing the microbial agent and biological tissue to a distance of up to 3-10 cm.

In FIG. 1 shows a diagram of an apparatus for introducing a cavitated solution from an ultrasound apparatus through an attached needle into a closed cavity in order to carry out rehabilitation.

Scheme with a device for the rehabilitation of closed body cavities, FIG. 1 includes:

1 - ultrasonic generator;

2 - acoustic unit;

3 - nozzle for supplying fluid to the acoustic unit;

4 - ultrasonic waveguide tool;

5 - internal irrigation channel of an ultrasonic instrument;

6 - replaceable protective casing-connector of the acoustic unit;

7 - a puncture needle (in a patient);

8 - infusion system for supplying a solution;

9 - flow regulator (sanitizing) solution.

Scheme consisting 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 (2 mm in diameter), a protective casing-connector 6 for attaching a puncture needle 7 (of the Luer type, length 60 -90 mm), a system for supplying a medicinal solution 8 with a flow regulator 9, works as follows.

The cavitation process begins with the passage of the drug solution from the infusion system 8 with the flow regulator 9 through the internal irrigation channel of the acoustic unit 2 connected to the ultrasonic generator 1, then the jet of cavitated liquid through the internal irrigation channel 5 of the ultrasonic tool 4 through the output of the protective casing-connector 6 enters puncture needle 8 located in the patient. Thus, the “voiced” sanitizing solution is delivered to the tissues in the body cavity to be sanitized. This method of non-contact ultrasonic sanitation with the proposed device allows not to increase the pressure in the sanitized cavity above atmospheric or to provide some discharge in the cavity if the container with the medicinal solution is lower or level with the sanitized cavity.

An ultrasound device with a device allows you to produce:

- Non-contact 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 closed cavity;

- Fine cavitation non-contact spraying of solutions with the aim of deep impregnation of drugs in the cavity;

- Non-contact ultrasound removal of necrotic tissue with minimal damage to healthy tissue. Both local and systemic drug treatment.

To justify the design of the proposed device in the first series of experiments, 8 patients aged 20 to 39 years were examined and treated.

The effectiveness of the proposed device 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.

The proposed device for treatment allows you to quickly and steadily stop the inflammatory process, prevent recurrence and chronicity of the inflammatory process with minimal additional costs due to the use of cavitated "voiced" solution, introduced using an ultrasound device into the closed pleural cavity, which leads to a significant reduction in treatment time, reduces the likelihood of aggravation of the inflammatory process and the need for subsequent surgical treatment and allows us to recommend a triad for implementation in medical institutions using ultrasound devices.

Clinical example No. 1. Central City Hospital No 7, Ekaterinburg - purulent surgery and pulmonology departments.

Testing period: September 2014 - February 2016

Patients with pleurisy in the Central City Hospital No. 7.

As a rule, patients with pleurisy are in the pulmonological department of the Central City Hospital No. 7 for 1.5-2 months. Among this group of patients there are often drug addicts, homeless people, and the hospital has to spend a lot of money on their treatment. Although the use of thoracoscopy allows you to reduce the treatment time for pleurisy to 2-3 weeks, but not all hospitals have the equipment and trained personnel necessary for thoracoscopy, therefore, most patients are treated with puncture or 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 (ultrasound).

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 puncture needle is made with a puncture needle with an internal diameter of 2 mm and a length of 60-90 mm. Then a tube is attached to the needle, through which the spent liquid is actively aspirated from the cavity.

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

After emptying the cavity, a solution of an antiseptic (chlorhexidine, dioxidine) is injected into it using a syringe with a volume of 50-100 ml. Next, the solution is removed with the same syringe. In this way, 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 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 using the proposed device.

In FIG. 2 shows a photo of ultrasound treatment of a patient using the proposed device.

To the puncture needle through which the pleural cavity was washed, the output cone of the protective casing-connector of the acoustic unit was attached (the casing was put on the assembly with a 74.5 mm-long instrument waveguide), and an ultrasound cavitated 0.05% chlorhexidine solution was introduced into the cavity through the needle . Then, using a syringe, the solution was removed. The number of cycles of ultrasonic rehabilitation according to indications.

The fluid from the pleural cavity during the ultrasound treatment first came out cloudy and yellow, then became transparent and colorless, with feathers of fibrin. Clouding of the solution during sanitation indicated that the cavity was well cleaned.

After sanitation, ultrasound cavitated solutions in patients the temperature normalizes faster (after 1-3 sanitation). Duration of treatment is reduced by about 1.5 times. The cost of treatment is reduced, since a cavitated aqueous solution of chlorhexidine made it possible to sanitize the pleural cavity more effectively, with a smaller volume of antiseptic, as well as earlier cancellation of the systemic antibiotic.

Ultrasound cavitation apparatus with the proposed device was treated 8 patients. At the control examination after 6 months, pathology was not detected.

After elimination of the purulent process using a minimally invasive treatment method in patients with pleural empyema in the distant period, favorable dynamics of residual inflammatory phenomena is noted.

The technology of ultrasonic rehabilitation of hard-to-reach closed cavities with cavitated solutions through the proposed device can have good prospects. The testing and study of the effectiveness of this method in various clinical applications should be continued.

At the same time, the procedure for the rehabilitation of the cavity with the proposed device has good tolerance, is comfortable and safe for patients, does not require large time and material costs for its implementation.

Claims (3)

1. Device for ultrasonic sanitation with solutions of closed cavities, containing an ultrasound generator, an acoustic unit with an irrigation channel, an instrument waveguide with an irrigation channel, an infusion system for supplying a medical sanitizing solution, a protective casing of the waveguide instrument in the form of a thin-walled metal tube, characterized in that the protective casing of the waveguide tool is made in the form of a stepped thin-walled metal tube with a distal end ending in a hollow cone tip for connecting eniya to the puncture needle introduced into the patient puncture the cavity wall, providing drug consumption sanitizing solution through needle 100-150 ml / min and volume infusions remote exudate volume during 3-5 minutes exposure. 2. A device for ultrasonic sanitation with solutions of closed cavities according to claim 1, characterized in that the protective casing of the waveguide tool ends with a tip in the form of a hollow cone with a central channel with a diameter of 2 mm for attaching a Luer-type puncture needle, and ultrasonic sanitation is carried out at a frequency ultrasonic vibrations 23-25 kHz, the amplitude of the ultrasonic waveguide tool 20-150 microns, with an acoustic unit complete with an ultrasonic instrument 74.5 mm long with an internal irrigation channel with a diameter of 2 mm and shifts 120 mm long protective casing of the proposed design with a 2 mm narrow end diameter of the casing. 3. A device for ultrasonic sanitation with solutions of closed cavities according to claim 1, characterized in that a puncture needle with an internal diameter of 2 mm and a length of 60-90 mm with a Luer head is used to puncture the patient’s cavity wall and administer a medicinal sanitizing solution.

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