RU2543033C1 - Laryngeal mask - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: in laryngeal mask, an O-ring cuff is formed by a U-shaped rim and a part of a large-port gastrodrainage of a special shape, inserting a gastric probe into which forms two auxiliary gaping passes for promoting the free discharge of gastric material or gas found close to an oesophageal funnel to the mouth cavity. The device can additionally comprise reinforcing components are used to avoid respiratory canal occlusion by patient's teeth. The declared laryngeal mask, except for the reinforcing components, represents a monolith and is formed by 1 cycle of injection-moulding machine operation that causes its absolutely low cost price.

EFFECT: laryngeal mask provides high patient's safety ensured by the effective discharge of the gastric material from a glottal aperture and demonstrate the practical simplicity of installation and good hermetism; it can be effectively used in clinical practice even in the patients with a risk of regurgitation and emergency patients.

5 cl, 5 dwg

Description

The invention relates to the field of medical equipment, namely to laryngeal masks.

Over the years of use, the laryngeal mask has established itself as a safe duct, which rarely leads to complications. The primary laryngeal mask (LM) was used in elective surgery in patients without the risk of regurgitation.

But now LM has become so popular that its scope is constantly expanding. LM is included in standards for difficult intubation in many countries. Thus, LM has also been used in emergency patients with a risk of regurgitation. This fact leads to the need for a safer mask for regurgitation and aspiration. The massive use of the laryngeal mask also necessitates the use of an inflated cuff to exclude the patient's risks associated with improper inflation of the cuff or insufficient monitoring of the pressure inside the cuff during anesthesia.

To solve problems with regurgitation, a mask with an inflated cuff was created according to the patent RU 02366463. Since the publication of this patent, many patents of masks with an inflated cuff and a relatively large gastro-drainage have been issued, however, such masks have significant dimensions of the air-drainage part in comparison with the dimensions of the sealing cuff, which It will certainly make it difficult to install such a mask. The objective of this patent is to solve the problem of regurgitation using an easily and quickly installed mask with an inflated cuff, a large gastro-drainage and with the ability to not only divert the contents from the stomach through the probe, but also simultaneously drain the gastric contents or gases from the proximal part of the mask to the mouth.

To solve the problem of aspiration and regurgitation, it is necessary to solve the problem of adequate drainage of the stomach cavity with the ability to simultaneously remove the contents of the stomach, which can rise between the tube and the walls of the esophagus. To this end, the following devices have been developed, described in patents for inventions.

Patent WO 2012127436 describes a laryngeal mask with an inflatable cuff, which is capable of simultaneously removing the contents of the stomach along the probe and from the esophageal funnel along the second gastro-drainage opening, however, the exit points of the gastro-drainage are located not on the central line, but on the sides, which makes installation of the gastric tube extremely difficult.

US Pat. No. 20130125897 describes a complex laryngeal mask with a non-inflated cuff in design. At the same time, the height of the air-drainage part is clearly more than 50% of the maximum height of the sealing cuff. To facilitate installation, a special mechanism is provided that changes the configuration of the sealing cuff. In one of the mask options, a gastrodrainage small in diameter is provided. The connector is located along the respiratory canal.

Patent WO 2013182457 describes variants of a mask with a non-inflated cuff. The connector is located along the respiratory canal. At the same time, the height of the air duct is approximately 50% of the maximum height of the sealing cuff and the diameter of the gastro-drainage is about 17% of the maximum height of the sealing cuff. In addition, when the probe is inserted into the stomach, it will block the entire cross-sectional area of the gastro-drainage, while it becomes unlikely that the gastric contents or gases can be removed from the proximal part of the mask to the mouth.

A mask having a non-inflated cuff and a gastro-drainage channel adequate in diameter is the mask according to patent RU 02366463. It was chosen as a prototype.

Description of the prototype: the device contains a cuff in the form of an o-ring formed by a horseshoe-shaped rim, which can be opened either towards the respiratory canal, or in the opposite direction, and part of the gastro-drainage, while the plane of the o-ring is closed on one side by a shell. Device: when a special introducer is introduced into the gastrodrainage, the cuff changes its configuration, significantly flattening, which facilitates the introduction of the mask.

The disadvantages inherent in this mask are that changing the configuration of the mask by introducing and removing the introducer slows down the installation process, the airway and drainage part of the mask is large enough to make it difficult to install the mask, and, in case of spasm of the patient's masticatory muscles, it is possible to compress the respiratory canal .

These disadvantages are eliminated in the claimed invention.

The objective of the invention is the creation of a laryngeal mask, which allows you to adequately drain the stomach, ensuring unhindered passage of the gastric contents from the stomach and esophagus to the outside of the mouth, is easily and quickly installed without introducer, the airway-drainage part of the mask will be most compact, however, allowing an adequate probe into the stomach while at the same time leaving constantly gaping additional drainage channels for unhindered discharge of the gastric contents, raising Xia between the walls of the esophagus and the esophageal probe, and the possibility of cutting the prevented (kinked) teeth patient breathing mask channel.

This and other problems are solved in the inventive laryngeal mask having an improved geometric configuration.

As will become clear from the description of the invention, it can be implemented in different ways, and some details may vary in various respects, without going beyond the scope of the invention. Accordingly, the drawings and description should be considered as illustrative materials, not having a restrictive value, given the fact that the scope of claims is defined in the claims.

The problem is solved in that in the inventive device, the cuff in the form of a sealing ring is formed by a horseshoe-shaped rim and part of a flattened wide-channel gastro-drainage opening into the esophagus, while the horseshoe-shaped rim can be opened either outward or towards the respiratory tract. The horseshoe-shaped rim has walls adjacent to the gastro-drainage that are thinner than the rest, thus, when the sealing ring forces toward the gastro-drainage, the walls adjacent to the gastro-drainage easily bend with minimal deformation of the remaining mask elements, while the shape of the cuff is flattened, facilitating the insertion of the laryngeal mask into patient's body.

The drainage channel is open at one end into the esophageal funnel, and the other end is directed outward of the mouth.

The device further comprises a structural element that prevents biting (clamping) of the respiratory canal with the teeth of the patient in the form of a thickening of the wall of the respiratory canals. This structural element can be additionally reinforced with reinforcing elements in the form of tubes of various profiles or spirals. The respiratory channel passes through the airway-drainage part of the mask and connects the connector of the mask and the inside of the sealing cuff, conducting the respiratory mixture to the patient's larynx.

The airway-drainage part of the mask on the cut forms an oval, part of which, being a segment of the oval, is a gastrodrainage, and the other part contains two respiratory channels, also made in the form of segments of the oval, inscribed in the oval of the airway-drainage part of the mask and separated by partitions between themselves and between the gastro-drainage canal.

At the same time, the claimed laryngeal mask is quickly and easily installed without the use of an introducer.

As a result of using this LM, the following new technical result is achieved:

- gastric contents are freely removed to the outside of the mouth when a large diameter probe is installed in the stomach, not only from the stomach, but also from the esophagus funnel at the same time due to constantly gaping additional channels formed in the corners of the drainage channel when the gastric tube is installed;

- the mask is easily and quickly installed without introducer;

- the airway-drainage part of the mask is made most compact;

- prevented the possibility of biting (crushing) the patient's teeth of the respiratory channel of the mask.

A positive result is also the minimization of risks for the patient associated with personnel error, which are inevitable with mass use of the device. This is achieved due to the fact that the mask does not contain inflated parts, since if the personnel mistake, incorrect inflating can damage the patient. Additionally, the installation of the mask is facilitated due to the fact that the height of the air duct is less than 50% of the maximum height of the sealing cuff. In addition, it can be cast in 1 cycle of the injection molding machine and does not have glue joints (even the connector located at right angles, which allows you to connect the breathing circuit without an additional angle, is cast from the same material as the mask and is inextricably linked with it), which Undoubtedly reduces the cost of its production and is another constructive option for a disposable or reusable airway device with a laryngeal mask.

The inventive device has gastrodrainage in the form of a segment of a circle in cross section, with the introduction of a gastric tube through it, two additional constantly gaping channels are formed for free removal of the stomach contents from the funnel of the esophagus.

The air duct is divided into 2 channels, between which a partition is installed that prevents accidental bending or squeezing during twisting and bending of the airway-drainage part of the mask, which, together with the rounding (smoothing) of the angles of the cross section of the respiratory channel, guarantees free passage of the respiratory mixture to the patient's lungs when the angle changes tilting the neck and turning the patient’s head.

At the time of installation, the horseshoe-shaped rim is pressed against the gastro-drainage, optimizing the shape of the sealing cuff for easy insertion of the device into the patient. After passing through the tongue, the horseshoe-shaped rim falls into the natural expansion of the larynx and, under the influence of elastic forces, restores the shape, optimizing it for the best hermetic connection of the patient-laryngeal mask system.

The invention is accompanied by drawings, where

figure 1 shows a General view of the LM, figure 2 shows the constituent parts of the mask, figure 3 shows a section of the mask at the level of the structural element that prevents the clamping of the respiratory canal, without reinforcing inserts and with reinforcing inserts, figure 4 is a transverse section at the level of the airway and drainage part without an inserted probe and with a probe inserted, FIG. 5 is a transverse section at the level of the sealing cuff (mask variant when the horseshoe-shaped rim is open to the respiratory canal), FIG. 6 is a transverse section at the level of the sealing cuff Children (version of the mask when the horseshoe-shaped rim is open to the outside).

Laryngeal mask contains: connector 1; structural element that prevents compression of the respiratory canal 2; ductwork part 3; laryngeal part of mask 4; an elastic elastic horseshoe-shaped rim (shown in bold dotted line in FIG. 2) 5, which (with a part of the gastro-drainage) forms a sealing cuff in the form of an o-ring 6; gastro-drainage channel (in Fig. 2, the walls of the channel are marked in bold lines) 7, ending with a gastro-drainage hole 8; gastric tube (not an integral part of the laryngeal mask, but can be installed in the gastro-drainage canal) 9; respiratory canal 10; reinforcing insert (optional) 11; additional constantly gaping channels 12.

All parts of the LM (with the exception of reinforcing inserts in the structural element that prevents the clamping of the respiratory canal, if used) are cast simultaneously and are a monolith. This is an economically very important advantage of the invention.

The device is used as follows.

The horseshoe-shaped rim 5 is pressed against the gastro-drainage 7, while the transverse dimensions of the sealing cuff 4 are reduced.

The device is inserted through the patient's mouth until it stops into the upper esophageal sphincter (sphincter). While the drainage hole 8 is located at the level of the upper esophageal pulp and directed into the esophagus. The back of the laryngeal part of the mask formed by the gastro-drainage canal is adjacent to the posterior pharyngeal wall. A horseshoe-shaped rim 5 bends around the larynx on the sides and on the side of the root of the tongue.

When the mask is inserted into the patient’s body after narrowing the canal formed by the root of the tongue, the sealing cuff enters the zone of expansion of the channel and under the spring action of the polymer's elastic forces (which tend to acquire their original shape), the horseshoe-shaped rim 5 is straightened, filling the natural anatomical expansion of the larynx.

While the drainage hole 8 is located at the level of the upper esophageal pulp and directed into the esophagus. The drainage hole 8 (like the wide-channel gastrodrainage 7) is gaping and the gastric contents can freely flow through it in case of regurgitation. The back of the gastro-drainage canal is facing the back wall of the pharynx.

The connector 1 of the device is located at right angles to the respiratory canal and, if ventilation is planned, when the mask is connected to the respiratory circuit of the device, it externally covers the connected tee of the respiratory circuit without using an additional angular adapter. Through wide-channel gastrodrainage, an adequate probe 9 can be inserted into the stomach for active or passive removal of gastric contents, while additional constantly gaping channels 12 will be formed in the corners of the drainage channel of the mask to drain gas or liquid (which can rise to the level of the upper esophageal pulp between the probe and the wall of the esophagus due to the reverse peristalsis of the esophagus or due to obstruction of the drainage holes of the gastric tube with solid particles of the gastric contents) out of the mouth. The gastric contents from the esophagus freely penetrate into the gaping canals, since the cross-sectional area of the drainage hole 8 is larger than the cross-sectional area of the probe 9 inserted through the gastrodrainage 7 into the stomach. Thus, between the outer wall of the gastric tube 9 and the edge of the gastro-drainage opening 8 there is a gap through which the gastric contents from the esophagus penetrate into the gaping channels 12 at the corners of the gastro-drainage channel 7.

The inventive laryngeal mask relates to devices relatively simple and inexpensive to manufacture. The low manufacturing cost of this device allows you to use it as a one-time. The inventive laryngeal mask is safe for the patient and can be effectively used in clinical practice.

Claims (5)

1 A laryngeal mask containing air ducts, a wide-channel gastro-drainage, a sealing cuff formed by a horseshoe-shaped rim and part of the gastro-drainage, characterized in that the air-drainage part of the mask forms an oval in at least one section, part of which is an oval segment, which is a gastro-drainage, and the other part contains two respiratory channels, also made in the form of oval segments, inscribed in the oval of the air-duct-drainage part of the mask and separated by partitions between themselves and between the gas rodrenazhnym channel. 2. The laryngeal mask according to claim 1, characterized in that it further comprises a connector located at right angles to the respiratory canal, and covers the mating part of the respiratory circuit from the outside. 3. Laryngeal mask according to claim 1, characterized in that the hollow horseshoe-shaped rim can be opened towards the respiratory canal or in the opposite direction. 4. The laryngeal mask according to claim 1, characterized in that to exclude the teeth from compressing the respiratory canal, the latter may contain a reinforcing element, namely a tube, profile or spiral, which prevents the clamping of the respiratory canal. 5. The laryngeal mask according to claim 1, characterized in that the horseshoe-shaped rim has walls adjacent to the gastrodrainage, made with the possibility of folding, which simplifies the shape of the mask, while facilitating the entry of the laryngeal mask into the patient’s body.

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