RU98883U1 - DEVICE FOR TRANSMEATAL AEROHYDRODYNAMIC DIAGNOSTICS AND THERAPY OF AVERAGE OTITIS (OTOBAROHYDROENDOSCOPE) - Google Patents

Abstract

 A device for transmeatal aerohydrodynamic diagnosis and treatment of otitis media (otobarohydroendoscope), including a device for measuring positive and negative pressure (tympanic manovacuum meter) connected to one of the channels of the three-channel tee, the second channel of which is connected to the cylinder to create pressure, and the third to the working channel a two-channel obturating cuff containing an air balloon connected to a non-return valve and worn on the otendoscope tube through its main channel, distinguishes the fact that the device further comprises a Siegel funnel without an optical lens through which the tube of the otoendoscope passes; a two-channel obturating cuff is located inside the optical nozzle of the Siegel funnel, and its air balloon in the inflated state the otendoscope tube is hermetically fixed in the optical nozzle of the Siegel funnel; the position of the two-channel obturating cuff and the Siegel funnel on the endoscope tube is such that the distal openings of the otendoscope tube and the ear of the Siegel funnel are aligned in the working static state of the device; at the distal end of the ear of the Siegel funnel is a single-channel obturating cuff with an air balloon connected to a non-return valve.

Description

The utility model relates to medical equipment and otorhinolaryngology.

A device for research and treatment of diseases of the middle ear (otobarohydroscope) according to the patent of the Russian Federation for utility model No. 59408 is known. The device contains a rubber canister for creating pressure (a rubber bulb), a device for measuring pressure (tympanic manovacuum meter - MW) and a Siegel funnel, consisting of the ear funnel itself (hereinafter - the ear part of the Siegel funnel) and an optical nozzle for it. The rubber balloon, MW and the Siegel funnel are connected through a tee into a single unit.

A single-channel obturating cuff is worn on the distal (inserted into the ear) end of the Siegel funnel. It contains an air cylinder connected through a non-return valve to a 2 ml disposable syringe to pump air into or remove air from the cylinder.

The device is used as follows. In the membranous-cartilaginous part of the patient’s ear canal, the ear part of the Siegel funnel is inserted with a single-channel obturating cuff previously put on it. A syringe with pre-drawn air is connected to the non-return valve. Air is injected into the cuff air balloon with a syringe until a tight seal is created between the cuff and the ear canal of the patient, as well as between the cuff and the funnel. Further, an optical nozzle is hermetically connected to the ear of the Siegl funnel, which is already connected to one of the tee channels through the adapter channel using a short rubber tube, and the rubber bulb and the MW are connected to the other two channels.

The air in the ear canal is pumped or evacuated with a rubber bulb. From it, air goes to the tee, then diverges through two tubes. On one of them, he goes to the MVT, which shows the air pressure in the system, and on the other through the optical nozzle, the ear of the Siegel funnel into the patient’s ear canal.

The doctor performs a visual examination through the optical nozzle of the Siegel funnel. Creating positive and negative pressure (above and below atmospheric) in the ear canal, cavities and channels of the middle ear, the doctor observes the changes that occur in the ear canal and the tympanic cavity of the patient, which allows for diagnosis and treatment.

The limitation of the device is a small increase in the optical nozzle (2.5-3 times), the inability to display the image on a computer monitor, to carry out photo documentation.

A device is known according to the patent of the Russian Federation for utility model No. 59407 for tympanendoscopy, diagnosis and treatment of middle ear diseases in a controlled bar mode (otobaroendoscope). It contains a tee connecting the rubber bulb to create pressure, MW and the working channel of the two-channel obturating cuff containing an air balloon and worn on the optical tube of the endoscope (otendoscope) through the main channel of the cuff. To provide an overview of the auditory meatus and tympanic cavity, a two-channel obturating cuff is placed at a distance of 1-2.5 cm from the end (inserted into the ear) end of the otendoscope optical tube. An air cylinder of a two-channel obturating cuff is connected through a non-return valve to a syringe for pumping air into the balloon or removing it from the balloon. The Otendoscope is connected to a computer or camera. The endoscope, along with a computer, provides magnification of the image tenfold.

The device is used as follows. An endoscope is inserted into the membranous - cartilaginous part of the patient’s ear canal with a two-channel obturating cuff previously put on it. The cuff working channel is already connected to the rest of the device - a rubber bulb and MW. The cuff air balloon is inflated until a tight seal is created between the cuff and the ear canal of the patient, as well as between the cuff and the endoscope.

The air in the ear canal is pumped or removed with a rubber bulb. From it, air goes to the tee, then diverges through two tubes. On one of them, he goes to the MVT, which shows the air pressure in the closed system, and on the other, through the working channel of the obstructing cuff, into the patient’s ear canal. The doctor carries out visual observation of the ongoing aerodynamic otoendoscopic changes using a computer monitor.

The device has some disadvantages. It can be used only in adults with a sufficiently large diameter of the ear canal into which an endoscope tube with a two-channel obturating cuff can be inserted (the total diameter of the two-channel obturating cuff in the inoperative state is 1.1 cm) and, having inflated its air balloon, tightly fix the endoscope tube in auditory canal of the patient. In children and adults with a small diameter of the ear canal, it is not possible to insert the endoscope tube with a two-channel obturating cuff on it into the ear canal. In these cases, the cuff air balloon is inflated and pressed externally to the patient’s ear canal. This creates a certain inconvenience in the work of the doctor. With one hand he holds the rubber bulb, creates variable pressure with it, and with the same hand he must hold the inflated air balloon of the two-channel cuff tightly pressed to the patient’s ear canal. The second hand of the doctor is busy holding the endoscope in the required position. In addition, the doctor should observe the ongoing changes inside the ear canal and tympanic cavity on a computer monitor. During the procedure, the tightness of a closed system is often broken. Performing a diagnostic and treatment procedure becomes impossible, because they are based on the creation of a certain pressure (above, below atmospheric), holding it for the necessary time.

Pressing the inflated balloon to the ear canal of the patient often leads to the fact that the distal end of the working channel of the two-channel obturating cuff abuts the patient’s auricle, without getting into the auditory canal. In such cases, it is impossible to create a variable pressure in the ear canal.

When manually holding the inflated balloon pressed to the ear canal of the patient, it is possible to injure the wall of the ear canal by the distal end of the endoscope tube. Uneven pressure on the air balloon leads to an involuntary displacement of the endoscope end face. The same danger exists when the obturating cuff is in the patient’s ear canal. When the cuff air balloon is inflated around the endoscope tube, its end shifts inside the ear canal and may injure its walls. The doctor should monitor the position in the ear of the end end of the endoscope tube on the computer monitor. With the quick or inept introduction of air into the air balloon, the doctor may not keep the endoscope end in a safe position, and then an abrasion occurs on the skin of the ear canal.

Injury to the ear canal can occur with a rapid change in the angle of view, as well as during manipulations related to the removal of pathological contents from the ear, when the tube of the endoscope is removed from the ear canal.

To remove the pathological contents extracted from the tympanic cavity, it is necessary to deflate the cuff air balloon each time, if it was inserted into the ear canal, and completely remove the device from the ear canal, which is also inconvenient (loss of time to find the working position of the cuff).

Disclosure of invention

The proposed device (otobarohydroendoscope) for transmeatal (through the auditory meatus) aerohydrodynamic diagnosis and therapy of otitis media is designed to perform otoendoscopy, aerodynamic, hydrodynamic and hydroaerodynamic otoendoscopy, aerodynamic, hydrodynamic and hydroaerodynamic drainage of cavities and canals of the middle ear, hydrodynamic injection, and membrane of a medicinal or contrast solution in the cavity and cana of the middle ear, performing after filling the cavities and channels with a medicinal solution their hydro- and hydroaerodynamic washing from pathological solid deposits and liquid contents, as well as photo-documentation of the resulting aero-, hydro- and hydroaerodynamic picture of the ear canal, tympanic membrane and tympanic cavity during diagnosis and treatment.

The proposed otobarohydroendoscope contains a device for measuring positive and negative pressure (tympanic manovacuum meter - MVT) connected to one of the channels of the three-channel tee, the second channel of which is connected to the cylinder to create pressure, and the third to the working channel of the two-channel obturating cuff containing an air cylinder connected with a non-return valve, and put on the optic tube of the otoendoscope (endoscope) through the main channel of the cuff. The tube of the endoscope passes through the Siegel funnel, from which the lens is removed from the optical camera (the Siegel funnel consists of an ear and an optical nozzle to it; inside the latter there is an optical camera). A two-channel obturating cuff, worn on the endoscope tube, is located inside the optical chamber of the Siegel funnel. The inflated balloon of the two-channel cuff hermetically fixes the endoscope tube in the optical nozzle of the Siegel funnel. The position of the two-channel cuff and the Siegel funnel on the endoscope tube is such that the holes of the distal (inserted into the ear) ends of the otendoscope tube and the Siegel funnel in the assembled (working) static state of the device are aligned. By alignment is meant the location of these holes in one plane perpendicular to the longitudinal axes of the Siegel funnel and the optical tube of the endoscope, or their relative position, in which their planes are no more than 3 mm apart from each other, and the distal end of the endoscope tube does not go out from the ear of the Siegel funnel. At the distal (inserted into the ear) end of the ear of the Siegel funnel is a single-channel obturating cuff with an air balloon connected to a non-return valve.

The otobarohydroendoscope contains the following elements (Figs. 1-4): tympanic manovacuum meter designed to measure positive and negative pressure values in the range from -80 to +80 mm Hg (1); 32 ml rubber balloon (pear) (2) to create pressure; two long rubber tubes (3); two plastic tubes (4); two short rubber tubes (5); plastic three-channel connecting tube-tee (6); an obturating single-channel latex cuff containing an air balloon and a non-return valve (7); two-channel obturating cuff made of latex (8), having a main and working channels, an air cylinder and a non-return valve in communication with it; Siegel funnel (9), from the optical nozzle of which an optical lens has been removed; otoendoscope (10) and non-return valve (11).

In the assembled state, the device is as follows (figure 1). MVT (1) through a long tube (3) is connected to one of the channels of the tee (6). A rubber bulb (2) is attached to another tee channel (6) through a plastic tube (4) and a short rubber tube (5). A long rubber tube (3) is connected to the third channel of the tee (6), which is connected through a plastic tube (4) to the working channel of the two-channel obturating cuff (8), the air cylinder of which is connected through a non-return valve with a syringe for pumping air into the air cylinder of the cuff. An endoscope optical tube (10) is inserted into the main channel of the two-channel cuff. An optical nozzle of the Siegel funnel (9) is put on the endoscope tube (10) with a two-channel obturating cuff on it, so that the air cylinder of the two-channel obturating cuff (8) is inside the optical nozzle of the Siegel funnel (9). The width of the two-channel optical cuff with an undisturbed air balloon is equal to the depth of the optical chamber of the Siegel funnel and is 1.5 cm, therefore, the proximal ends of the cuff and the optical chamber are in the same plane perpendicular to the longitudinal axis of the optical tube of the endoscope. A syringe with 4-5 ml of air drawn in to the non-return valve of the air cylinder of the two-channel obturating cuff is inserted and inserted into the air cylinder, as a result of which the endoscope tube is hermetically fixed inside the optical chamber of the Siegel funnel.

The length of the optical tube of the endoscope is 6 cm, and the length of the Siegel funnel in the assembled state is 5.5 cm. The optical nozzle of the Siegel funnel, together with the two-channel cuff located in it, is placed on the endoscope tube so that between the proximal ends of the optical chamber of the Siegel funnel and the endoscope tube there was a distance of 5-8 mm.

When using an endoscope with a longer optical tube, the position of the optical nozzle of the Siegel funnel with the two-channel cuff located in its chamber is determined so that the holes of the distal ends of the tube of the endoscope and the ear of the Siegel funnel in the assembled (working) static state are aligned.

A short rubber tube (5) is attached to the side channel adapter of the optical nozzle of the Siegel funnel, the free end of which is blocked by a non-return valve (11), because this channel of the Siegel funnel is not used in this device. A single-channel obturating cuff with an air balloon is attached to the distal end of the aural part of the Siegel funnel, to which a non-return valve (7) is attached. The ear part of the Siegel funnel with a single-channel obturating cuff on it is called by us the mobile part of the device, because it can be moved inside the ear canal to create different viewing angles without breaking the tightness between the ear canal and the funnel. The rest of the device is called its removable part.

By holding the rubber bulb half-compressed (so that both positive and negative pressure can be created in the assembled working condition of the device), the doctor combines the movable and removable parts of the otobarohydroendoscope into a single whole. The device is ready for use.

As part of the proposed device for diagnosis and treatment, you can use otoendoscopes with a diameter of 2.7 mm with an angle of view of 0 °, 30 ° and with a different angle of view. You can attach a video camera to the otoendoscope, for example, Endoscam-450. By connecting the camcorder through the system unit to the computer, the doctor receives an image on the monitor. The image can be archived in the form of photographs and films.

The inventive device is characterized by the following advantages in relation to analogues:

1) the distal end of the ear part of the Siegel funnel with a single-channel obturating cuff on it has a smaller diameter than the otendoscope tube with a two-channel obturating cuff on it, so it is easily inserted into the ear canal of the children's as well as adult ear with a small diameter of the ear canal. When using the proposed device in people with a small diameter of the ear canal, the doctor is spared the care of creating a stable tightness in the ear canal-device system;

2) the distal end of the ear of the Siegel funnel has rounded edges in contrast to the distal end of the endoscope optical tube, so the funnel cannot injure the skin surface of the ear canal. The possibility of safely changing the viewing angle is increasing;

3) when assembling the device into a single unit, the otendoscope tube does not come out of the ear of the Siegel funnel, which excludes injury to the distal end of the tube of the endoscope tube of the auditory canal skin when the movable and removable parts of the device are connected;

4) the ear part of the Siegel funnel attaches a central position to the endoscope tube in the patient’s ear canal. If necessary, the tube of the otoendoscope can be advanced into the bone section of the ear canal to the eardrum, or to the inner wall of the tympanic cavity. The central position of the tube of the endoscope in the ear canal excludes lateral contacts of the otoendoscope with the walls of the ear canal;

5) during the evacuation of pathological contents from the ear canal, it is not necessary to remove the moving part of the device from the ear canal. The removable part of the device is disconnected and the pathological contents are removed from the ear canal through the ear funnel by electro-aspiration or the ear pad;

6) the proposed device allows more efficient diagnosis and treatment than analogues (otobarohydroscope and otobaroendoscope). The scope of the otobarohydroendoscope is wider, because it allows you to perform not only a deep injection of medicinal and contrast solutions into the cavities and channels of the middle ear, but also after partially or completely filling them, to wash them from liquid or dense contents. Performing the washing of cavities and channels without the possibility of creating a stable tightness between the device and the ear canal is impossible.

The list of figures illustrative material:

Figure 1. Otobarohydroendoscope assembled.

Figure 2. Enlarged image of the connection of the Siegel funnel and otoendoscope through a two-channel obturating cuff.

In figures 1 and 2 between the proximal ends of the optical nozzle and the optical tube of the endoscope, a gap of 5-8 mm is not created. In figures 1 and 2 it can be seen that with this position the endoscope tube extends beyond the ear of the Siegel funnel.

Figure 3. The movable and removable parts of the otobarohydroendoscope are disconnected from each other.

Figure 4. Two-channel obturating cuff with an inflated air balloon on the otendoscope tube, air volume in the air cylinder is 4 ml.

Figure 5. Otendoscopy of the ear canal and tympanum before treatment.

6. Aerodynamic otoendoscopy, negative pressure phase. There is an exit of pathological contents from the posterior upper sections of the tympanum in the form of a spreading “cloud” and from the front sections (tympanic orifice of the auditory tube) in the form of a “cotton ball”.

7. Aerodynamic drainage, negative pressure phase. Pathological discharge began to flow into the ear canal.

Fig. 8. Aerodynamic drainage, negative pressure phase. Pathological discharge has reached the outer third of the bony section of the auditory meatus.

Fig.9. Hydrodynamic otoendoscopy, a medicinal solution in the ear canal and tympanic cavity until it is hydrodynamically introduced into the cavities and canals of the middle ear.

Figure 10. View of the auditory canal and tympanic cavity after the hydrodynamic administration of the drug solution, the hydrobiologization of the auditory tube and the washing of the cavities and channels of the middle ear from the pathological contents.

Device Usage Example

Patient O., 72 years old, from childhood, suffers from left-sided chronic purulent otitis media. In the previous 15 years, exacerbation of the disease rarely occurred, 1-2 times a year and always lasted 3-4 weeks. The last exacerbation began about 3 weeks ago. There were pains in the left temporal region, noise in the ear, hearing loss. Gait instability appeared a week after the start of fluid outflow from the left ear. Body temperature did not increase during exacerbation. It was treated as usual on its own: it made an ear toilet with a 3% hydrogen peroxide solution, and instilled cypromed ear drops.

At the doctor’s appointment after the toilet of the auditory canal (releasing it from the pathological contents), the patient was offered the diagnosis and treatment of otitis media using an otobarohydroendoscope.

A sterilized ear of the Siegel funnel was inserted into the skin-cartilage section of the patient’s left ear canal with a sterile disposable single-channel obturating cuff attached to its distal end. A non-return valve of the cuff was connected with a disposable 2 ml syringe with 0.8 ml of pre-drawn air. Through a non-return valve, air was introduced into the air balloon of the cuff, which led to the creation of a stable tightness between the ear canal of the patient and the ear of the Siegel funnel.

The removable part of the proposed device has already been assembled. The MVT was connected to one of the channels of the tee, a rubber bulb was attached to its other channel, and the third channel of the tee was connected to the working channel of the two-channel obturating cuff, the air cylinder of which was connected through a non-return valve with a syringe to pump air into the air cylinder of the cuff. An otendoscope tube was inserted into the main channel of the two-channel cuff, on which the optical nozzle of the Siegel funnel was attached (without a lens) so that the two-channel obturating cuff was inside the optical nozzle of the Siegel funnel. 4 ml of air was introduced into the air balloon of the two-channel obstructing cuff through a non-return valve using a syringe. The inflated air balloon sealed the endoscope tube inside the optical nozzle of the Siegel funnel. A gap of 7 mm was created between the proximal ends of the optical nozzle of the Siegel funnel and the endoscope tube (the length of the optical tube of the used otoendoscope was 6 cm, the length of the Siegel funnel in the assembled state was 5.5 cm). Holding the rubber bulb in a half-compressed state, the doctor combined the movable and removable parts of the otobarohydroendoscope into a single whole. The distal end of the optical tube of the endoscope did not come out from the ear of the Siegel funnel.

To enlarge the image, the doctor pushed the distal end of the endoscope tube from the ear of the Siegel funnel and brought it closer to the tympanum, for which he gently pressed the endoscope in the direction of the axis of the ear canal. The cushioning properties of two air cylinders of the cuff obstructing made it possible to perform such an approximation. Touching the walls of the auditory meatus, the tympanic cavity with the endoscope’s end while extending it from the ear of the Siegel funnel was excluded by the central position of the endoscope tube in the patient’s ear canal (due to the tube being in the Siegel funnel) and visual control on the computer monitor.

Changing the angle of inclination of the endoscope tube relative to the wall of the ear canal and tympanum allowed changing the viewing angle.

Changing the inspection angle, approaching the endoscope tube end face to the inner wall of the tympanic cavity expanded the inspection area of the tympanic cavity. Mucopurulent contents were found in the tympanic mouth of the patient’s auditory tube.

Figure 5 presents the otoendoscopic picture of the ear canal and the tympanic cavity of the patient before treatment.

By creating alternating negative and atmospheric pressure in the cavities and channels of the middle ear of the patient, pathological contents were extracted from them into the auditory canal (Fig. 6). The creation of alternating negative and positive air pressure in the cavities of the middle ear allowed to eliminate the block of their anastomoses, auditory tube, additionally extract about 0.3 ml of pathological contents from the deep sections of the middle ear (Figs. 7-8). The alternating positive and atmospheric pressure made it possible to determine the value of the positive pressure at which the air is discharged into the nasopharynx through the auditory tube using the MVT indices. establish the magnitude and degree of drainage function of the auditory tube, as well as remove pathological contents from it into the nasopharynx.

Then, the removable part of the device was carefully disconnected from the movable part of the device. Pathological contents from the ear canal were removed with a padded jacket through the ear of the Siegel funnel. After the toilet of the patient’s ear canal, the removable part of the device was reattached and the procedure for aerodynamic drainage of the middle ear cavities was continued. The pathological contents of them were removed into the ear canal and nasopharynx until the maximum possible removal.

At the end of the procedure, the removable part of the device was disconnected from the movable part of the device. By connecting a syringe to the non-return valve of the movable part, air was removed from the air balloon of the single-channel obturating cuff, after which the ear part of the Siegel funnel along with the single-channel obturating cuff were removed from the patient’s ear canal. By attaching the syringe to the non-return valve of the two-channel obturating cuff, air was also removed from its air cylinder. An endoscopic tube was removed from the optical chamber of the Siegel funnel along with a two-channel obturating cuff. Further, all elements of the device were disconnected and (with the exception of MVT and disposable elements) were sent for processing and sterilization.

The patient was diagnosed with exacerbation of left-sided chronic purulent otitis media. Only local daily treatment was prescribed using the method of transmeatal aerohydrodynamic diagnosis and treatment of otitis media using the inventive device.

Figure 9 shows the picture taken at the beginning of the hydrodynamic injection of the drug solution into the deep cavities and channels of the middle ear. Figure 10 shows a picture taken at the end of the hydrodynamic injection of the drug solution into the deep cavities and channels of the middle ear.

On the 5th day of treatment, the patient did not complain. At otoscopy, the mucosa of the tympanic cavity had a pale pink color, there were no pathological overlays. When examining the cavities and canals of the middle ear using an otobarohydroendoscope, pathological contents were not found in them. The drainage function of the auditory tube was good - 25 mmHg. Further treatment was canceled.

Over the entire treatment period, the patient underwent 4 procedures of aerodynamic drainage and aeration of the cavities and canals of the middle ear, followed by the hydrodynamic introduction of a medicinal solution into them and washing them from the pathological contents.

During subsequent diagnostic examinations using an otobarohydroendoscope (after a week, one, three, six months), exacerbation was not observed.

The use of the device allowed to reduce not only the duration of treatment, but also the drug costs of achieving remission.

At no session of research and treatment was the patient's ear canal injured.

Claims (1)

A device for transmeatal aerohydrodynamic diagnosis and treatment of otitis media (otobarohydroendoscope), including a device for measuring positive and negative pressure (tympanic manovacuum meter) connected to one of the channels of the three-channel tee, the second channel of which is connected to the cylinder to create pressure, and the third to the working channel a two-channel obturating cuff containing an air balloon connected to a non-return valve and worn on the otendoscope tube through its main channel, distinguishes the fact that the device further comprises a Siegel funnel without an optical lens through which the tube of the otoendoscope passes; a two-channel obturating cuff is located inside the optical nozzle of the Siegel funnel, and its air balloon in the inflated state the otendoscope tube is hermetically fixed in the optical nozzle of the Siegel funnel; the position of the two-channel obturating cuff and the Siegel funnel on the endoscope tube is such that the distal openings of the otendoscope tube and the ear of the Siegel funnel are aligned in the working static state of the device; at the distal end of the ear of the Siegel funnel is a single-channel obturating cuff with an air balloon connected to a non-return valve.