RU2634984C2 - Method for irrigation therapy for inflammatory diseases of paranasal sinuses and device for its implementation - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: joint sealing of the nasal cavity, nasopharynx and paranasal sinuses is performed. Periodically, the pressure in the nasal cavity is measured with creation of negative and positive pressure. Drugs are introduced into the nasal cavity after creation of negative pressure. At that, the damaged sinus is saturated with a drug solution after creation of negative pressure through the opposite half of the nose in nasal sinus position opposite the drain one, when its fistula plane is in the uppermost position in relation to the opposite wall or to the place of front and back walls joint, for the maxillary sinuses. Evacuation is performed in drain situation, when the sinus fistula plane is in the lowest position towards the opposite wall or to the place of front and back walls joint, for the maxillary sinuses. After the damaged sinus is filled with a drug solution, a mechanical effect is provided on the biofilms located on its walls, due to disturbance of the liquid in it by means of an air-hydraulic impact, which is carried out by injecting air into the affected half of the nose before opening of the auditory tubes, which is accompanied by a sensation of a "push" in the ears, with the closed vestibule of the opposite half of the nose pressing the wing of the nose to the nasal septum and raising the soft palate in the drain position of the sinus, and also due to the liquid movement in the sinuses, resulting from the use of liquid inertia forces in the paranasal sinuses by mechanical movements of the head with a sudden stop not directed towards the affected sinus fistula. Then the liquid is evacuated from the sinuses using the negative pressure created in the nasal cavity in the drain position of the affected sinus along with biofilms pieces and bacterial plankton. The method is implemented by a device that includes a tripod, movable locking bar, cylinder for solutions or air injection into the nasal cavity, embodied in the tripod between the movable locking bar and the fixed left side wall of the tripod. The cylinder for vacuum creation in the nasal cavity, fixed on the tripod between the movable locking bar and the fixed right-side wall of the tripod and olives with channels that are attached by tubes to the said cylinders. At that, the movable locking bar is made with a possibility of movement in two directions to the fixed right and left side walls of the tripod through the upper and lower guides placed in slots for guides in the upper and lower lids of the tripod, and implementation of alternated compression of these cylinders. In the second embodiment, the device comprises a tripod with holes in the side walls, a syringe for vacuum creation in the nasal cavity. A syringe for solutions or air injection into the nasal cavity and olives with channels, attached by tubes to the said syringes. At that fixation of the syringe cylinders in the holes of the side walls of the tripod, impeding their displacement during operation is provided by cylinder stops, so that the cylinder stops of the syringe for vacuum creation in the nasal cavity are located on the inner surface the left side of the tripod, and the cylinder stops of the syringe for solutions or air injection into the nasal cavity are located on the outer surface of the right-side wall of the tripod. And the syringe cylinders are located in opposite directions to be controlled by both hands.

EFFECT: method allows to increase the effectiveness of treatment of paranasal sinuses due to mechanical influence on drug solution biofilms and evacuation of biofilm particles, microbial plankton from the sinuses with the used solutions.

3 cl, 5 dwg, 2 ex

Description

The invention relates to medicine and is used for the prevention of recurrence of sinusitis after surgical treatment with restoration of patency of the natural anastomoses of the paranasal sinuses in the late postoperative period, as well as for the treatment of sinusitis, while maintaining the patency of the natural anastomoses of the affected sinuses.

The main cause of recurrence of sinusitis after functional endoscopic rhinosurgery (FESS), restoration of patency of the natural anastomoses of the paranasal sinuses, is the persistence of infectious agents in the mucous membrane of the paranasal sinuses and the pathological biofilms formed on it.

“Chronic rhinosinusitis, according to modern concepts, is also a disease associated with biofilms. The latter are often found in the tissues of the paranasal sinuses (according to some observations, up to 72% of cases), in contrast to the absence of biofilms in patients in the control group without clinical manifestations of the disease. With the greatest frequency of chronic rhinosinusitis biofilms, researchers isolated Staphylococcus aureus (50%), Haemophilus influenzae (28%), Pseudomonas aeruginosa (22%) and mushrooms (22%). ” (A.V. Golub. Bacterial biofilms - a new goal of therapy? Clinical Microbiology and Antimicrobial Chemotherapy 2012, Volume 14, No. 1, pp. 23-29. Http://www.antibiotic.ru/cmac/2012/n1.shtml) .

“A serious problem in clinical practice is the widespread use of resistant forms of microorganisms, which reduces the effectiveness of the use of antibacterial drugs. Of particular difficulty is the increased drug resistance of bacteria in biofilms. " V.D. Georgian. "Communicative signals of bacteria." "Antibiotics and chemotherapy", 2003, 48 (10): 32-39.

http://www.antibiotic.ru/index.php?module=subjects&func=viewpage&pageid=109&pageno=1)

Recent studies have confirmed that 76.7% of patients with chronic rhinosinusitis after FESS had evidence of biofilm formation, which apparently plays an important role in the pathogenesis of the disease.

(Dlugaszewska J, Leszczynska M, Lenkowski M, Tatarska A, Pastusiak T, Szyfter W. The pathophysiological role of bacterial biofilms in chronic sinusitis. Eur Arch Otorhino-laryngol. 2015 May 30, http: //www.ncbi.nlm.nih .gov / pubmed / 26024693 et al. http://www.ncbi.nlm.nih.gov/pubmed/23880921#).

Several authors point to the resistance of microorganisms in biofilms to antibiotics (Pompilio A, De Nicola S, Crocetta V, Guarnieri S, Savini V, Carretto E, Di Bonaventura G. New insights in Staphylococcus pseudintermedius pathogenicity: antibiotic-resistant biofilm formation by a human wound -associated strain.

BMC Microbiol. 2015 May 21; 15: 109. doi: 10.1186 / s12866-015-0449-x.

http://www.ncbi.nlm.nih.gov/pubmed/25994406;

Drilling A, Coombs GW, Tan HL, Pearson JC, Boase S, Psaltis A, Speck P, Vreugde S, Wormald PJ. Cousins, siblings, or copies: the genomics of recurrent Staphylococcus aureus infections in chronic rhinosinusitis. Int Forum Allergy Rhinol. 2014

Dec; 4 (12): 953-60. doi: 10.1002 / alr. 21423. Epub 2014 Oct 1.

http://www.ncbi.nlm.nih.gov/pubmed/25271410 and others.

In the dissertation, Radzig M.A. it is noted that the ability of pathogenic bacteria to form biofilms is a big problem for medicine - bacterial communities attached to various surfaces and surrounded by a matrix consisting of extracellular polysaccharides, proteins, nucleic acids, and others. The resistance of bacteria that live in biofilms to drugs is significantly increased by compared with planktonic bacteria (Radtsig Marina Aleksandrovna. “INTERACTION OF BACTERIA CELLS WITH SILVER AND GOLD COMPOUNDS: INFLUENCE ON GROWTH, EDUCATION E Biofilm, mechanisms of action, biogenesis of nanoparticles. "Abstract of a dissertation for the degree of candidate of biological sciences. Moscow, 2013)

Preliminary destruction of biofilms is the basis for successful therapy (Shields RC. Mokhtar N, Ford M, Hall MJ, Burgess JG, ElBadawey MR, Jakubovics NS. Efficacy of a marine bacterial nuclease against biofilm forming microorganisms isolated from chronic rhinosinusitis. PLoS One. 2013; 8 (2): e55339.doi: 10.1371 / journal.pone.0055339.Epub 2013 Feb 18.

http://www.ncbi.nlm.nih.gov/pubmed/23441151#; ON. Ascension. Biofilms are a therapeutic target for chronic infections. Atmosphere. Pulmonology and Allergology No. 3 2008 p 43-44.

http://www.atmosphere-ph.ru/modules.php).

“In any case, it is now clear that traditional antibiotic therapy is not always able to solve a number of serious problems associated with infections, especially against the backdrop of a global increase in resistance of pathogens. That is why an active search for drugs with potential impact on biofilms continues throughout the world. In other cases, only mechanical cleaning, including biological surfaces, can guarantee the success of infection therapy. ”

(A.V. Golub. Bacterial biofilms - a new goal of therapy? Clinical microbiology and antimicrobial chemioter. 2012; 14 (1): 23-29

http://www.antibiotic.ru/cmac/2012/n1.shtml).

Thus, in view of the insufficient effectiveness of antimicrobial therapy of sinusitis associated with the formation of pathological biofilms, mechanical destruction and removal of biofilms is important, which presents certain difficulties due to the anatomical features of the paranasal sinuses.

A known method of irrigation therapy in the treatment of sinusitis is the method of "moving" solutions of drugs. After anemization of the mucous membrane and cleaning of the nasal cavity, the patient’s head is thrown backwards, turned 45 ° in the direction of the affected maxillary sinus. 6-8 ml of an antiseptic solution is injected into the half of the nose, to which the affected sinus is adjacent, so that a small amount of air remains in the vestibule of the nose, and this nostril is clamped (by pressing the wing of the nose to the septum). In the other half of the nose, an olive of a hand-compressed rubber balloon is introduced, the negative pressure of which should not exceed 12-15 mm Hg. When the patient utters the sound “cookie”, slowly and gradually release the balloon held in his hand; while the nasal cavity and its paranasal sinuses are released from the air and negative pressure is created in them. Then quickly take the olive, while opening the second nostril; this leads to equalization of pressure in the sinuses and the ingestion of a solution of the drug substance (see Multivolume Guide to Otorhinolaryngology edited by A.G. Likhachev vol. IV, pp. 152-153, MED-GIZ, 1963; Otorhinolaryngology: national manual edited by V.T. Palchun, Moscow: GEOTAR-Media, 2008, p. 262).

A known method of treating sinusitis using a device for the treatment of sinusitis, which is used to distinguish the nasal cavity from the external environment using inflatable balloons. Negative pressure is created in the nasal cavity, due to which pathological contents are evacuated from the paranasal sinuses. At the next stage of treatment, a solution of the drug is injected into the nasal cavity, which enters the sinus with increasing pressure in the nasal cavity (see AS No. 1768141, class A61B 17/12, 17/24, 1992; see also Otorhinolaryngology: national leadership edited by V.T. Palchun, Moscow: GEOTAR-Media, 2008, pp. 263-265).

A known method of treating paranasal sinusitis and a device for its implementation, including sealing the nasal cavity, periodically changing the pressure in the nasal cavity with the creation of negative and positive pressure and introducing drugs into the nasal cavity at the time of creating negative pressure in it (a.s. No. 1768142, class A61B 17/12, 17/24, 1992).

There is a method of treating rhinosinusitis with medicinal aerosols, in which the delimitation of the nasal cavity and nasopharynx from the oropharynx is carried out by taking a soft palate, after which a number of procedures are performed in the nasal cavity: sinus drainage (creating negative pressure in the nasal cavity in the drainage position for each paranasal sinus with the aim of evacuating the exudate), kavum-pita (cleaning the nasal cavity by applying a medicinal aerosol through one half of the vestibule of the nose and evacuating it through the other half), sinus njection (the introduction of medicinal aerosols into one of the half of the nasal cavity, after creating negative pressure in it through the other half), sinus aeration (pneumomassage) - short-term cycles of increasing and decreasing pressure in the nasal cavity (RF patent 2213530, CL АВВ 17/24 , 2003, publ. 10.10.2003. Bull. No. 28.). Prototype.

The disadvantages of the known methods is:

- insufficient mechanical effect of injected fluids on biofilms in the paranasal sinuses.

- with classical displacement treatment, negative pressure in the half of the nose to be treated, into which the drug solution is introduced, occurs after the solution has been evacuated through the nasopharynx and the opposite half of the nose, and only a small amount of the drug substance can enter the sinuses the next time it is introduced;

- the unregulated effect of negative pressure on the mucous membrane of the nasal cavity during the procedure can lead to edema, narrowing of the diameter of the natural anastomoses up to their complete closure and making it difficult to excrete exudate;

- when several paranasal sinuses are damaged before the procedure, it is practically difficult (in terms of the time spent by the medical staff) to consistently create the optimal position (facilitating the movement of exudate under the influence of gravity to the natural anastomoses) for each sinus separately (as a result, it is not possible to effectively drain the sinuses during the procedure , since in order to move the exudate into the nasal cavity, it is necessary to preliminary move it to the anastomosis, in the opposite case, the alignment of the negative occurs significant pressure in the nasal cavity and sinus and the drainage effect ceases);

- the need to use qualified medical personnel when using a sinus catheter;

- adverse effect of the sinus catheter on the mucous membrane of the nasal cavity and nasopharynx due to mechanical pressure;

- the need for local anesthesia when using a sinus catheter;

- as a rule, a single administration of drugs during the day due to the use of labor by medical staff;

- aerosols cannot have a mechanical effect on biofilms.

The objective of the proposed method of treatment is to reduce the recurrence rate of sinusitis after surgical treatment and treatment of sinusitis while maintaining patency of the anastomoses of the paranasal sinuses, which is achieved:

- due to mechanical effects on biofilms delivered to the paranasal sinuses with solutions of medicinal substances;

            - subsequent evacuation of the used solution with particles of biofilms from the paranasal sinuses;

- the use of short-term controlled negative pressure;

- the availability of the procedure for the patient with the possibility of its use several times during the day;

- by removing time limits for the patient to be in a drainage position before the procedure.

The tasks are carried out using a device that allows you to create an adjustable (calculated on the basis of the Boyle-Mariotte law) negative pressure in the nasal cavity and nasopharynx or positive pressure in these cavities; inject drugs into the nasal cavity, paranasal sinuses in the form of solutions that enter the sinuses when the pressure reduced in them is balanced with atmospheric pressure (in this case, negative pressure is created through one half of the nose, and drug solutions are injected through the affected half of the nasal cavity after creating it and paranasal sinuses of negative pressure); evacuate the contents of the paranasal sinuses and with special techniques that make it possible to seal the exit from the nasopharynx due to the soft palate; to ensure the movement of delivered solutions into the sinuses and their subsequent mechanical effect on biofilms; pneumohydraulic impact, contributing to the destruction of biofilms.

Sealing the exit from the nasopharynx is carried out using the following method: with a tightly closed oral cavity, the patient tries to exhale through the mouth. At the same time, the air pressure in the oropharynx and the underlying airways rises and the soft palate under its action reliably delimits the exit from the nasopharynx (MMP - the method of raising the soft palate).

The movement of the solution in the sinus with its effect on biofilms is carried out using head movements with a sharp stop of movement. Due to the inertia of the solution in the cavity of the paranasal sinuses, it moves after stopping movement and mechanically acts on biofilms. In this case, movements leading to the sinus in the drainage position are excluded. Sinus drainage position - this is the position when the plane of the anastomosis is in the lowest position relative to the opposite side of the sinus wall or the junction of the adjacent walls (for the maxillary sinus, the junction of the front and rear walls).

For the right maxillary sinus, this is the position of the head on the left side, and for the left maxillary sinus on the right side. For frontal sinuses, this is the vertical position of the head with an inclination of up to 45 ° in the opposite direction. For the main sinus, this is a face down position.

Purposeful saturation with solutions of the affected sinuses is carried out in positions opposite to the drainage, when the plane of the sinus anastomosis is in the highest position relative to the opposite wall of the sinus or the junction of the anterior and posterior walls for the maxillary sinus. For the right maxillary sinus, this is the position of the head on the right side, and for the left maxillary sinus on the left side. For frontal sinuses, this position of the head thrown back posterior in a prone position is possible with an inclination of up to 45 ° to the affected side for better sinus filling. For the main sinus, this is a face-up position.

Pneumohydraulic shock in the sinus to destroy biofilms is carried out after filling the affected sinus with a solution of a medicinal substance, giving the affected sinus a drainage position and simultaneously increasing the pressure in the nasal cavity. With passable anastomoses of the paranasal sinuses, above which the solution is located, this leads to disturbance of the fluid in the sinus and its movement and, consequently, to a mechanical effect on biofilms.

The regulation of the negative pressure level is carried out by calculation according to the Boyle-Mariotte law (pV = p ₁ V ₁ ) by evacuating from the nasal cavity and nasopharynx a certain amount of air (increasing the volume of the closed space). It is known that the volume of the nasal cavity and nasopharynx averages about 35 ml. (VV Suntsov. Selective synchronous inhalation and device for its implementation. "Bulletin of Otolaryngology" in 1999, No. 5, pp. 51-53). Therefore, the rapid evacuation of 10 ml of air from the nasal cavity (an increase in the volume of the sealed nasal and nasopharyngeal cavities will lead to a decrease in the standard atmospheric pressure (p = 101325 Pa) to 78808 Pa or by about 20% (0.2 atm).

p _{1 =} 101325 Pa * 35 ml / 45 ml = 78808.33 Pa.

Gradually, the pressure in the nasal cavity changes slightly due to alignment with pressure in the paranasal sinuses. If necessary, you can increase the volume of the middle nasopharynx and nasal cavity by 20 ml, respectively reducing the standard atmospheric pressure to 64479.54 Pa. However, this can cause some unpleasant sensations in the patient, therefore it is not recommended to increase the volume of the nasal cavity and nasopharynx by more than 15 ml (suction 15 ml of air) without special need.

The lower the negative pressure is created in the nasal cavity, the less time should be the period of its impact and more breaks between procedures. A decrease in atmospheric pressure in the nasal cavity leads to the predominance of hydrostatic pressure in the capillaries over hydrostatic pressure in the interstitial fluid. The result is an increase in swelling of the nasal mucosa. Limiting the time of exposure to negative pressure on the nasal mucosa and increasing the intervals between these effects (due to the availability of procedures to the patient himself) minimizes this negative effect due to fluid inertia in the capillary bed.

General features of the proposed method with the prototype:

- joint sealing of the nasal cavity, paranasal sinuses and nasopharynx;

- periodic changes in pressure in the nasal cavity with the creation of negative and positive pressure;

- the introduction of drugs into the nasal cavity at the time of creating negative pressure in it;

- sealing the nasal cavity and nasopharynx from the side of the oropharynx simultaneously with soft palate - by applying the method of raising the soft palate (exhaling into the mouth with the mouth closed) and from the side of the vestibule of the nose by introducing olives into both halves of the vestibule of the nose or by pressing the wings of the nose to the nasal septum fingers of the patient’s hands;

- a change in pressure in the nasal cavity and nasopharynx is carried out simultaneously in both halves of the nasal cavity and in the nasopharynx;

- and uncoupling of ways to create negative pressure and ways of supplying a solution of medicinal substances;

- negative pressure created in the nasal cavity and nasopharynx, act discretely and for a short time with the possibility of regulation.

New features of the proposed method with the prototype:

- the use of solutions of drugs instead of aerosols with the specified method of sealing the nasal cavity, nasopharynx and paranasal sinuses;

- the use of pneumohydraulic shock to destroy the biofilm;

- the use of the method of moving the solution in the sinus to destroy the biofilm due to the use of inertia of fluid movement in the sinuses;

- evacuation of destroyed biofilms together with a solution from the paranasal sinuses;

- the availability of the procedure for the patient without the use of sophisticated equipment with electronic control.

Common features of the claimed device with a prototype:

- source of vacuum,

- source of injection,

- connecting tubes,

- olives with canals

New features of the claimed device with a prototype:

- a tripod with two cylinders or syringes fixed, taking into account the possibility of manipulating them to create the necessary dilution in the nasal cavity and forcing the solution into the nasal cavity;

- a balloon or syringe to create a vacuum in the nasal cavity, which can be used to adjust the volume of increase in the sealed nasal cavity and nasopharynx (when using cylinders according to the marks on the tripod, to which the pressure bar is shifted, when using syringes according to the markings on the syringe barrel);

- the ability to use a balloon or syringe to pump the solution into the nasal cavity to pump air into the nasal cavity;

- a movable bar on a tripod, allowing alternately to exert pressure on both cylinders or the use of syringes mounted on a tripod horizontally in opposite directions, preventing their displacement during manipulation.

1. Saturation of the affected paranasal sinuses with medicinal solutions.

The goal of this stage is to fill the affected paranasal sinuses with medicinal solutions. Before the first procedure, anemization of the nasal mucosa is performed. The patient assumes a position in which the affected sinus is in the position opposite to the drainage. Then, without changing the position of the head, he performs the method of raising the soft palate (MAP), in this position holds his breath and creates a vacuum in the nasal cavity and nasopharynx through the olive to suck air from the nasal cavity. After that, the patient can breathe through the mouth (since negative pressure in the nasal cavity sucks a soft palate) or continue holding his breath for several seconds to complete the procedure. Depression can be performed in several modes, and the reduction of the negative effect of depression on the mucous membrane is achieved due to the short action of reduced pressure. With 1 mode, a vacuum is created in the nasal cavity and nasopharynx for about 2-3 seconds up to about 64 kPA (an increase in the volume of the nasal cavity and nasopharynx by 20 ml), with 2 modes, a vacuum is created up to about 70 kPa for 4-5 seconds (an increase in the volume of the nasal cavity and nasopharynx per 15 ml) and in mode 3 dilution to approximately 80 kPa for 6-8 seconds (increase in the volume of the nasal cavity and nasopharynx by 10 ml). After creating a vacuum in both nasal cavities and paranasal sinuses, 5-6 ml of the drug solution is injected into the affected half of the nose. The drug solution enters the sinuses, in which atmospheric pressure is reduced, primarily in the sinus, whose opening is in the position opposite to the drainage. After that, the pressure in the nasal cavity and nasopharynx is equalized with atmospheric by extracting olives from the vestibule of the nasal cavity and stopping the reception of raising the soft palate. After a break, the procedure is repeated until the volume of the medicinal solution is approximately equal to the volume of the affected sinus

2. Pneumohydraulic shock

The purpose of the stage is the destruction of biological films by perturbing a solution delivered earlier to the affected sinus.

After saturation of the affected sinus with a medicinal solution, the patient takes a drainage position for the affected sinus and immediately increases the atmospheric pressure in the nasal cavity and nasopharynx. This is achieved with the help of the PMTC and the injection of air into the affected half of the nose while the opposite half of the nose is closed by pressing the nose wing against the septum.

The signal to stop air compression in the nasal cavity is the opening of the auditory tubes (“push” in the ears).

The pressure in the nasal cavity rises and through the anastomosis acts on the solution filling the sinus anastomosis. There is a disturbance of the fluid in the sinus. The hydraulic wave reaches the walls of the sinus and mechanically acts on the biofilms tearing it.

3. The movement of medicinal solutions in the cavity and paranasal sinuses

After the procedure of pneumohydraulic shock, the affected sinus, if necessary, can be additionally saturated with a medicinal solution, after which the patient makes sudden head movements with a quick stop of movement. In this case, as a result of the inertia of the solution in the sinus cavity, a movement of this solution occurs, which contributes to the destruction of biofilms. Movement should not be directed so that the sinus does not assume a drainage position. So, with the defeat of the maxillary sinuses and the vertical position of the patient's body, head movements are made to the right and left from and to the midline, up and down, but not to the right shoulder for the left sinus and not to the left shoulder for the right sinus. Movements to the shoulder of the same name with a return to the midline are possible. In case of damage to the frontal sinuses in a horizontal position of the patient with his head bowed, movements are made to the right and left of the midline or to the right and left to the midline. With the defeat of the main sinuses in the horizontal position of the patient, movements to the right and left with a return to the midline.

4. Sinus drainage.

Purpose of the procedure: to evacuate the remains of a medicinal solution with detritus of biofilms and bacterial plankton from the affected sinus. The patient takes a drainage position for the affected sinus and inserts olives into the nasal cavity. Then he performs the technique of raising the soft palate and creates a rarefaction in the nasal cavity through any half of the vestibule of the nose. The drug solution with biofilm detritus and bacterial plankton under the influence of negative pressure enters the nasal cavity, from where it is removed by simple blowing or with the help of a nasal shower.

A device for implementing the method can be proposed in two versions.

The device in 1 embodiment is shown in FIG. 1-4 (Fig. 1 is a front view, Fig. 2 is a top view, Fig. 3 is a bottom view, Fig. 4 is a movable pressure plate, side view) and contains olive (1) for the introduction of drug solutions; channel (2) in olive (1) for the introduction of solutions of medicinal substances; olive (3) to create a vacuum in the nasal cavity; channel (4) in olive (3) to create a vacuum in the nasal cavity; the top cover (5) of the tripod; the handle (6) of the movable clamping plate of the tripod (9); the stationary left side wall of the tripod (7); a cylinder (8) for the introduction of solutions of medicinal substances; movable clamping plate of a tripod (9); the motionless right side wall of the tripod (10); balloon (11) to create a vacuum in the nasal cavity; the bottom cover of the tripod (12); a connecting tube (13) between the olive (3) to create a vacuum in the nasal cavity and a balloon to create a vacuum in the nasal cavity (11); a connecting tube (14) between the olive (1) for the introduction of solutions of medicinal substances and the cylinder (8) for the introduction of solutions of medicinal substances; slots (15) for the upper guides (17) of the movable clamp bar (9) in the upper cover (5) of the tripod; slots (16) for the lower guides (18) by moving the clamping bar (9) in the bottom cover of the tripod (12); upper guides (17) of the movable pressure bar (9); lower guides (18) of the movable pressure bar (9); a hole (19) in the upper cover (5) of the tripod for a tube (14) connecting the olive (1) for the introduction of drug solutions and a bottle (8) for the introduction of drug solutions; the hole (20) in the upper cover (5) of the tripod for a tube (13) connecting the olive to create a vacuum in the nasal cavity and a balloon (11) to create a vacuum in the nasal cavity; marking (21) in ml to determine the volume of displaced air from the balloon 11, which corresponds to the magnitude of the increase in the volume of the nasopharynx, paranasal sinuses and nasal cavity.

The device in the first embodiment works as follows.

1. Saturation of the affected paranasal sinuses with medicinal solutions.

Preparatory operations: the patient after instilling vasoconstrictor drops and cleaning the nasal cavity occupies a position opposite to the drainage for the affected sinus. The cylinder 8, and channel 2 of olive 1, and the connecting tube 14 are filled with a medicinal solution.

The patient takes the tripod with the device in his hands and by the handles 6 of the movable clamp bar 9 puts the movable clamp bar 9 of the tripod into the right position in accordance with the marking 21, which determines the desired volume of exhaust air, while the cylinder 11 is squeezed between the fixed right side wall of the tripod 10 and the movable pressure bar 9, as a result, air leaves the cylinder 11 through the connecting tube 13 and channel 4 into the atmosphere.

Then the patient injects olive 1 in the vestibule of the nasal cavity on the side in which it is supposed to affect the affected sinus, olive 3, it introduces into the opposite vestibule of the nasal cavity. The following actions of the patient are: the reception of raising the soft palate, the translation of the movable pressure bar 9 in the middle position. At the same time, negative pressure is created in the nasal cavity and paranasal sinuses due to the filling of the balloon 11 with air from the nose.

The patient moves the movable pressure bar 9 towards the fixed left side wall of the tripod 7, while the balloon 8 is filled with a solution of the drug, and it enters the corresponding half of the nasal cavity and paranasal sinuses in which negative pressure was created (primarily in that sinus, which is in the optimal position for the receipt of the solution).

Olives 1 and 3 are extracted from the vestibule of the nasal cavity.

2. Pneumohydraulic shock.

For the procedure, balloon 8 and olive 1 with channel 2 are used after removing the drug solution from them.

Olive 1 is placed in the vestibule of the nasal cavity, on the side on which the affected sinus is located and presses the wing of the nose on the opposite side to the septum until the vestibule of the nose is sealed. The patient performs a method of raising the soft palate and dramatically changes the position of the head to the drainage for the affected sinus (while the solution in the sinus moves to the anastomosis). Then he moves the movable clamping bar 9 towards the stationary left side wall 7 of the tripod. In this case, air from the pressed balloon 8 through the channel 2 of olive 1 enters the nasal cavity. The pressure in the nasal cavity rises, including at the interface between the air and the solution in the anastomosis of the affected sinus, previously filled with the solution, there is a disturbance of the liquid in the sinus, which mechanically affects the biofilms.

3. The movement of medicinal solutions in the cavities of the paranasal sinuses due to fluid inertia in the sinus cavity during head movements is performed after saturation of the affected sinuses with a solution without using a device.

4. Sinus drainage.

The patient picks up a tripod and moves the handle 6 of the tripod 9 by the handles 6 towards the fixed right side wall of the tripod 10 in accordance with the marking 21, which determines the desired amount of discharged air. In this case, the air leaves the balloon to create a vacuum in the nasal cavity 11. The patient takes a drainage position for the affected sinus and inserts olive 1 in the vestibule of the nose from the affected sinus and presses the wing of the opposite half of the nose to the septum. After that, it performs the technique of raising the soft palate and returns the movable clamping bar of the tripod 9 to the middle position, while due to air from the nasal cavity through olive 3, its channel 4 into the balloon 11, a vacuum is created in the nasal cavity. The solution from the sinus cavity with biofilm detritus, held in the area of the sinus anastomosis by surface tension, enters the lumen of the nasal cavity and through olive 3, its channel 4 into the balloon 11. The remaining solution with biofilm detritus from the nasal cavity is removed by simple blowing or, if necessary, nasal shower .

The device in embodiment 2 is shown in FIG. 5 and contains olive for the introduction of solutions of medicinal substances (1); channel (2) in olive (1) for the introduction of solutions of medicinal substances; olive (3) to create a vacuum in the nasal cavity; channel (4) in olive (3) to create a vacuum in the nasal cavity; tripod (5); tubes (6) connecting olives (1) for the introduction of solutions of medicinal substances and the cylinder (18) of the syringe supplying the drug solution to the nasal cavity; tubes (7) connecting olives (3) to create a vacuum in the nasal cavity and the cylinder (13) of the syringe to create a vacuum in the nasal cavity; the hole (8) for the cylinder (13) of the syringe, which creates a vacuum in the nasal cavity, in the right side wall of the tripod; the hole (9) for the cylinder (13) of the syringe, which creates a vacuum in the nasal cavity, in the left side wall of the tripod; stops (10) of the cylinder (13) of the syringe creating a vacuum in the nasal cavity, which are installed on the inner side of the left side wall of the tripod (5) at the hole (9) for the cylinder (13) of the syringe creating a vacuum in the nasal cavity; emphasis (11) of the rod (12) of the syringe, which creates a vacuum in the nasal cavity; the rod (12) of the syringe creating a vacuum in the nasal cavity; a cylinder (13) of a syringe creating a rarefaction in the nasal cavity, a piston (14) of a cylinder (13) of a syringe creating a rarefaction in the nasal cavity; stops (15) of the cylinder (18) of the syringe supplying the drug solution to the nasal cavity; an emphasis (16) of the rod (22) of the cylinder (18) of the syringe supplying the drug solution to the nasal cavity; an opening (17) for the cylinder (18) of the syringe supplying the drug solution to the nasal cavity in the right side wall of the tripod (5); a cylinder (18) of a syringe supplying a drug solution to the nasal cavity, an opening (19) for a cylinder (18) of a syringe supplying a drug solution to the nasal cavity in the left side wall of the tripod (5); the piston (20) of the cylinder (18) of the syringe supplying the drug solution to the nasal cavity; the rod (21) of the syringe supplying the drug solution to the nasal cavity, the hole (22) for the tube of the connecting (6) olive (1) for the introduction of solutions of drugs and the cylinder (18) of the syringe for the introduction of solutions of drugs; an opening (23) for a tube of connecting (7) olive (3) to create a vacuum in the nasal cavity and a cylinder (13) of a syringe to create a vacuum in the nasal cavity; hole (24) for the connecting pipe 6; hole (25) for the connecting pipe (7).

The device in the second embodiment works as follows:

1. Saturation of the affected paranasal sinuses with medicinal solutions.

Filling of the barrel 18 of the syringe delivering the drug solution with the drug solution is done through olive 1 through the channel 2 and the connecting tube 6. The field of immersion of olive 1 into the solution of the drug substance, the patient pulls the piston 19 by stopping the rod 16 of the syringe 21 until the cylinder 18 of the syringe feeding the drug solution .

Preparatory operations: the patient after instilling vasoconstrictor drops and cleaning the nasal cavity occupies a position opposite to the drainage for the affected sinus.

The patient takes a tripod with the device in his hands and inserts olive 1 in the vestibule of the nasal cavity on the side in which it is supposed to affect the affected sinus, olive 3 it introduces into the opposite vestibule of the nasal cavity. The following actions of the patient are: after the reception of raising the soft palate, the piston rod 12 and the piston 14 are pulled by the stop of the syringe rod 11 to the desired mark on the cylinder 13 of the syringe. The stops 10 of the syringe cylinder 13 to create a vacuum in the nasal cavity at this moment abut against the left side wall of the tripod 5 from the inside and prevent the displacement of the syringe cylinder 13. At the same time, air from the nasal cavity enters the cylinder of the syringe 13 through the connecting tube 7 and the channel 4 of olive 3. Atmospheric pressure in the nasal cavity decreases due to an increase in the total delimited volume of the nasal cavity, nasopharynx and syringe barrel to the piston 14. After creating a vacuum in the nasal cavity, the patient presses the other hand on the stop 16 of the rod 21 of the syringe supplying the drug solution, while the piston 20 delivers the drug the solution through the connecting tube 6 and olive 1 and the olive channel 2 into the nasal cavity from cylinder 18 and it enters the corresponding half of the nasal cavity and paranasal sinuses, in which negative pressure was created (in rvuyu turn in the sinus, which is in the optimum position for receipt of the solution). The emphasis 15 of the cylinder 18 abuts against the outer wall of the right side wall of the tripod 5, which prevents the displacement of the syringe.

Olives 1 and 3 are extracted from the vestibule of the nasal cavity.

2. Pneumohydraulic shock.

After saturation of the affected sinus with a solution from olive 1, channel 2, connecting pipe 6 and cylinder 18, the solution is removed and cylinder 18 is filled with air. Olive 1 is placed on the eve of the nasal cavity, on the side on which the affected sinus is located. The wing of the opposite half of the nose is pressed against the septum. After the reception of lifting the soft palate, the patient abruptly changes the position of the head to the drainage position for the affected sinus and immediately presses the rod 16 on the stop 16. At the same time, air is forced out of the cylinder 8 through the connecting tube 6 and channel 2 of olive 1 from cylinder 8. In the nasal cavity, pressure rises, which causes disturbance of the fluid in the affected sinus and mechanical effects on the biofilms covering its walls.

3. The movement of medicinal solutions in the sinus cavities due to inertia of the fluid in the cavity of the paranasal sinuses during head movements in is performed after saturation of the affected sinuses with a solution without using a device.

4 Sinus drainage.

The patient picks up a tripod 5 and inserts olive 3 in the vestibule of the nasal cavity from the affected side. The opposite wing of the nose is pressed with a finger to the septum. After occupying the drainage position, the piston 14 of the syringe is pulled by the stopper 11 of the rod 12 to the specified mark on the cylinder 13. At the same time, a vacuum is created in the nasal cavity and the solution is evacuated from the sinus.

Remains of the solution with biofilm detritus from the nasal cavity are removed by simple blowing or, if necessary, a nasal shower.

Example 1. Patient N., 46 years old, came with a relapse of chronic purulent rhinosinusitis. Complaints of headaches and nasal discharge of a mucopurulent nature. 2 months ago, the patient underwent an endoscopic revision of the maxillary sinuses. When washing both maxillary through natural anastomoses, which are quite expanded during the previous operation, a scanty mucopurulent discharge with pieces of films is obtained. A weekly course of treatment according to the proposed method was prescribed. After 7 days: no complaints, nasal breathing is good, with the control washing of the maxillary sinuses, the washings are clean.

Example 2. Patient D., 58 years old.

Suffers from chronic purulent polypous rhinosinusitis for 20 years. Appealed 4 months after the polysinusotomy. There is no relapse of polyps. Complaints of headaches and nasal discharge of a mucopurulent nature. When washing both maxillary through natural anastomoses, which are quite expanded during the previous operation, a turbid liquid with pieces of films is obtained. Assigned to a 10-day course of treatment according to the proposed method. After 10 days: no complaints, nasal breathing is good, with the control washing of the maxillary sinuses, the washings are clean.

Example 3. Patient R. Age 56 years. Suffers from chronic rhinosinusitis for 20 years. Appealed 1.5 months after the polysinusotomy. Complaints of mucopurulent discharge from the left half of the nose. When washing the left frontal and maxillary sinuses through natural anastomoses, which were quite expanded during the previous operation, a turbid liquid with pieces of films was obtained. Assigned to a 10-day course of treatment according to the proposed method. After 10 days: no complaints, nasal breathing is good, with control washing of the sinuses, the washings are clean.

Claims (3)

1. A method for the treatment of paranasal sinusitis, inflammatory diseases of the nasopharynx, including joint sealing of the nasal cavity, nasopharynx and paranasal sinuses, periodic changes in pressure in the nasal cavity with the creation of negative and positive pressure, the introduction of drugs into the nasal cavity after creating negative pressure in it, characterized in that saturation with a solution of a medicinal substance of the affected sinus is carried out after creating a negative pressure in it through the opposite half of the nose when the sinus position is opposite to the drainage, when the plane of its anastomosis is in an extremely upper position relative to the opposite side of the sinus wall or the junction of the front and back walls for the maxillary sinuses, and evacuation is in the drainage position when the plane of the sinus joint is in extreme lower position in relation to the opposite side of the sinus wall or the junction of the anterior and posterior walls of the maxillary sinuses; after filling the affected sinus with a solution of a medicinal substance, the biofilms located on its walls are mechanically affected by perturbation of the fluid with a pneumohydraulic shock, which is carried out by forcing air into the affected half of the nose before opening the auditory tubes, which is accompanied by a sensation of a “push” in the ears , with the closed vestibule of the opposite half of the nose, pressing the wing of the nose to the nasal septum and the technique of raising the soft palate in the sinus drainage position, as well as due to fluid movements in the sinuses arising from the use of fluid inertia in the paranasal sinus during mechanical movements of the head with a sharp stop not directed towards the anastomosis of the affected sinus; then, evacuation of the fluid from the sinuses using negative pressure created in the nasal cavity when the affected sinus is drained, along with pieces of biofilms and bacterial plankton. 2. A device for implementing the method according to claim 1, characterized in that it contains a tripod; movable pressure bar; a cylinder for injecting solutions or air into the nasal cavity, mounted in a tripod between the movable pressure bar and the stationary left side wall of the tripod; a balloon to create a vacuum in the nasal cavity, mounted on a tripod between the movable pressure bar and the stationary right side wall of the tripod; and olives with channels, connected by means of tubes to said cylinders; while the movable clamping bar is configured to move in two directions to the fixed right and left side walls of the tripod thanks to the upper and lower guides placed in the slots for the guides in the upper and lower covers of the tripod and to alternately compress the said cylinders. 3. A device for implementing the method according to claim 1, characterized in that it contains a tripod with holes in the side walls; a syringe to create a vacuum in the nasal cavity; a syringe for injecting solutions or air into the nasal cavity; and olives with channels attached by means of tubes to said syringes; the fixation of the syringe cylinders in the holes of the side walls of the tripod, preventing their displacement during operation, is carried out by cylinder stops so that the stops of the syringe cylinder to create a vacuum in the nose are located on the inner surface of the left side wall of the tripod, and the stops of the syringe cylinder for pumping solutions or air into the nasal cavity located on the outer surface of the right side wall of the tripod; moreover, the syringe cylinders are located in opposite directions to control them with both hands.

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