WO2009035365A1

WO2009035365A1 - Laryngeal mask

Info

Publication number: WO2009035365A1
Application number: PCT/RU2007/000725
Authority: WO
Inventors: Mikhail Alexandrovich Kozhevnikov
Original assignee: Kozhevnikov Mikhail Alexandrov
Priority date: 2007-09-11
Filing date: 2007-12-24
Publication date: 2009-03-19
Also published as: RU2366463C2; RU2007133817A

Abstract

The invention relates to medical engineering, in particular to laryngeal masks. The inventive laryngeal mask comprises a cuff in the form of a seal ring which is formed by an U-shaped border and two large-channel gastrodrainages, the lumens of which are jointed in such a way that a common drainage orifice opened to the esophagus is formed, the plane of the seal ring being closed on one side thereof by a membrane. The device also comprises an introducer. Said laryngeal mask relates to relatively simple and low-cost in production devices. The low manufacturing cost of the device makes it possible to use it as a disposable device. The inventive laryngeal mask is harmless for a patient and can be efficiently used in clinical practice even for patients with regurgitation risk and for emergency patients. The mask can be mounted at a neutral position of the neck.

Description

Laryngeal mask

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 that rarely leads to complications. The primary laryngeal mask / JIM / was used in elective surgery in patients without the risk of regurgitation.

But now JTM has become so popular that its scope is constantly expanding. LM is included in standards for difficult intubation in many countries. Thus, JIM 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.

There are two principal ways to protect against aspiration. The first is to block the exit of gastric contents at the level of the esophagus or larynx so that it cannot exit and enter the trachea.

The second way - the opposite - to allow the gastric contents to freely exit, that is, to adequately drain the stomach.

The majority of developers follow the first path: they block the path of the contents of the stomach by inflating the cuff at the level of the esophagus or larynx. This raises a number of problems. Inflate the cuff over 60 cm of water. a column is impossible, since ischemia of the adjacent mucosa is possible. However, when the stomach is full to keep its pressure, such a cuff can not always.

To solve the problem of aspiration and regurgitation, it is necessary to solve the problem of adequate drainage of the stomach cavity. To this end, the following devices have been developed, described in patents for inventions.

SUBSTITUTE SHEET (RULE 26) US Pat. No. L25632271 describes an airway device with a laryngeal mask. In addition to the airway tube for ventilating the patient’s lungs, this device also includes a drainage tube for draining or removing the burped stomach contents. The distal end of the drainage tube is placed near the patient's usually closed esophagus. In addition to providing drainage, the drainage tube can be used as a guide for the insertion of a gastric tube.

US> GS6439232 describes a commercially available laryngeal mask with an inflated cuff and a small diameter gastro-drainage.

In patent WO Jfe2005 / 011784 - a mask with an inflated cuff and two gastro-drains of small diameter.

In patent WO Ж2004016308, a mask with an inflated cuff and gastro-drainage of a very small diameter.

In the patent X25878745, a mask with an inflated cuff and gastrodrainage of a larger diameter than that of the mask according to US patent> Гs6439232

In patent WO-NsO 1/24860, a mask with an inflated cuff and a large gastro-drainage sufficient to install an adequate probe into the stomach for drainage.

The diameters of the drainage channels of the masks according to US Pat. Nos. 6439232B1, WO.Ns.2005 / 011784, WO # 22004016308, are not adequate to ensure the outflow of gastric contents. Their channels are too small in diameter and can be blocked by solid particles of gastric contents. Through such a channel, it is impossible to establish a gastric tube of sufficient diameter to adequately drain the stomach cavity. The mask according to US patent JN25878745 has a channel of a larger diameter, but insufficient to install a gastric tube of significant diameter, which will adequately drain the stomach.

A mask having a gastro-drainage channel adequate in diameter is a mask according to WO .Na 01/24860. We chose her as a prototype.

SUBSTITUTE SHEET (RULE 26) Description of the prototype: the device consists of 2 air tubes, an inflated cuff and one wide-channel gastro-drainage, which runs along the midline of the laryngeal part of the device and opens into the esophagus.

The problem with this mask is that the gastro-drainage canal, passing along the midline, occupies most of the space intended to accommodate the anatomical formations of the larynx (mask nests). Due to the fact that the distance between the posterior pharyngeal wall and the larynx is limited, the gastro-drainage canal will inevitably put pressure on the larynx, which can lead to undesirable reflex responses. The second problem of the prototype mask: an adequate gastric tube conducted through the gastro-drainage opening covers the entire lumen of the gastro-drainage, and the gastric contents that rise to the level of the larynx in addition to the probe due to reverse peristalsis or during obstruction of the drainage holes of the gastric tube will not be removed from the larynx. This may result in aspiration of this contents into the trachea. This makes it difficult to use this device in patients with a risk of regurgitation and aspiration.

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, providing unhindered passage of gastric contents simultaneously from the stomach and esophagus to the outside of the mouth.

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

SUBSTITUTE SHEET (RULE 26) illustrative materials that are not restrictive in view of the fact that the scope of the 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 two wide-channel gastro-drains, the lumens of which are connected, forming a common gastro-drainage hole opening into the esophagus, while the plane of the o-ring is closed on one side by the sheath.

The device additionally contains an introducer, allowing you to change the shape of the sealing ring, in order to facilitate its introduction into the respiratory tract of the patient. And also contains a channel of a smaller diameter, the distal end directed to the glottis.

In the proximal part, two wide-channel gastro-drainage are interconnected, while the air tube is located on top, parallel to the junction. The horseshoe-shaped rim can be made as hollow or solid. The shell of the o-ring can be made as single-layer or multi-layer.

Moreover, the claimed laryngeal mask is quickly and easily installed even in the neutral position of the neck, that is, without bending the cervical spine, which is optimal in cases where the patient’s neck is damaged, there is a suspicion of a fracture of the neck or the neck is mobile.

As a result of using this LM, the following new technical result is achieved: unhindered removal of the gastric contents to the outside of the mouth with a large diameter probe installed in the stomach, not only from the stomach, but also from the esophagus at the same time. When removing the introduced introducer from wide-channel gastro-drains, the o-ring formed by a horseshoe-shaped rim and two wide-channel gastro-drains takes the form

SUBSTITUTE SHEET (RULE 26) the patient’s respiratory system is optimal for sealing the duct system, which makes it possible not to use the inflated cuff.

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 it should not contain inflated parts, since in case of personnel error, improper inflating can damage the patient. Additionally, if there is a need for endotracheal intubation, the introduction of drugs into the trachea or the vocal cords, the claimed device should simplify this procedure. In addition, it is relatively simple and inexpensive to manufacture and is another constructive option for a disposable or reusable airway device with a laryngeal mask.

The inventive device has two gastro-drainages of large internal diameter, up to 15 mm for an adult patient, one of which can be used to hold the probe into the stomach, with the aim of draining and washing the stomach, the second is used to freely drain the stomach contents from the esophagus. At the time of installation, the proximal part of the device, gastrodrainage and the sealing ring formed by them, under the influence of the introducer introduced into the wide-channel gastrodrainage, changes shape, optimizing it for easy insertion of the device into the patient. When using an introducer curved with a small radius, it is possible to introduce a device without tipping the head, that is, in the neutral position of the neck. Through an additional access channel to the vocal cords, the distal end of which is directed to the vocal cords, it is possible: to hold a thin catheter of any purpose for the vocal cords, including for the introduction of drugs into the trachea,

SUBSTITUTE SHEET (RULE 26) the introduction of a conductor for subsequent intubation of the trachea or irrigation of the vocal cords with drugs.

The invention is accompanied by drawings, where in FIG. 1 shows a general view of the JIM with an additional access channel to the glottis, in FIG. 2 is a side view of the laryngeal mask, in FIG. 3- introducer, in FIG. 4- laryngeal mask with introduced introducer, FIG. 5a, b — shows a section of the distal part of the sealing ring with and without introducer sheath introduced, and FIG. 6 shows a view of the mask from the back.

The laryngeal mask contains an air tube 1, two wide-channel gastro-drainage 2, 3, ending with a gastro-drainage hole 4, an elastic elastic horseshoe-shaped rim 5, which is the proximal part of the o-ring, the glottis access channel 6, closed with a plug 7. The JIM also contains a standard connector 8 (15 mm) (located on the proximal end of the air tube 1), introducer 9, the proximal part 10 of the device and the distal laryngeal part 11 of the device, sheath 12. Seal JIM noe ring formed horseshoe rim 5 and the distal portion, broadband gastrodrenazhey 2, 3. JIM made of elastic material such as silicone rubber or PVC. However, note that other materials may be used.

All parts of the JIM can be attached to it by heat sealing, gluing, or through another method of joining or bonding two elements. It is possible to manufacture the inventive device in one injection molding step (except for parts 8.9). This is an economically very important advantage of the invention.

The wide-channel gastro-drainages 2 and 3 in the proximal part are parallel and diverge at the level of the laryngeal part 11 of the device, while the airway tube 1 is located on top,

SUBSTITUTE SHEET (RULE 26) parallel to the junction. In the distal part, wide-channel gastro-drainages 2 and 3 are connected and form a single gastro-drainage hole 4, the cross-sectional area of which exceeds the cross-sectional area of one gastro-drainage. On the back side there is a shell 12 providing, together with the sealing ring (consisting of a horseshoe-shaped rim 5 on the proximal side and wide-channel gastrodrainages 2,3 on the distal side), the device is sealed by means of the breathing tube 1 with the patient's respiratory system. The shell 12 of the sealing ring can be made as single-layer or multi-layer, in the latter case, it is possible to change its shape by filling with air. Performing a horseshoe-shaped rim, both hollow and solid, allows you to change the elasticity of the o-ring, as well as determine the choice of manufacturing method for JIM.

The introducer 9 is two parallel plates with rounded distal ends and proximal ends connected by a handle. The plates are longitudinally curved in the form of a crescent.

The mask can be equipped with a channel 6 for access to the glottis, which is a hollow tube, the proximal end of which is closed by a plug 7 and is located in the proximal part 10 of the device. The distal end of this tube opens in the laryngeal part 11 of the device and is directed into the glottis. The device is used as follows.

The introducer 9 is introduced into the wide-channel gastro-drainage 2 and 3. In this case, the device takes the form of a crescent. The distal laryngeal part 11 of the device changes its shape: the transverse size is reduced, the sheath 12 forms a fold (Fig. 5. a). The device bends with a crescent moon and takes the form optimal for the easiest insertion.

SUBSTITUTE SHEET (RULE 26) A device with introducer 9 is introduced through the patient's mouth until it stops into the upper esophageal sphincter (sphincter). While the drainage hole 4 is located at the level of the upper esophageal pulp, and directed into the esophagus. The drainage hole 4 is flattened under the influence of the introducer 9. The back of the distal laryngeal part 11 of the device is adjacent to the back wall of the pharynx. The fold of the membrane 12 is directed to the larynx. The horseshoe-shaped rim 5 is located just above the larynx.

Then the introdisor 9 is removed from the device, while the sealing ring is straightened under the spring action of the horseshoe-shaped rim 5 and the elastic properties of the wide-channel gastrodrainages 2 and 3 (which tend to acquire their original shape), acquiring a shape optimal for the hermetic connection of the patient’s duct and respiratory system. While the drainage hole 4 is located at the level of the upper esophageal pulp and directed into the esophagus. The drainage hole 4 (as well as the wide-channel gastro-drainage 2,3) is gaping, and gastric contents can freely flow through it in case of regurgitation. The back of the membrane 12 and the back of wide-channel gastrodrainages 2,3 are facing the back wall of the pharynx.

The standard connector 8 can be connected to the ventilator, if you plan to conduct ventilator. Through one of the wide-channel gastrodrainages, an adequate tube can be inserted into the stomach for active or passive removal of gastric contents. The second wide-channel gastrodrainage serves to divert the contents of the stomach, which can rise to the level of the upper esophageal sphincter between the probe and the wall of the esophagus due to inverse peristalsis of the esophagus or due to obstruction of the drainage holes of the gastric tube with solid particles of gastric contents. Gastric contents from the esophagus freely penetrate into the second wide-channel

SUBSTITUTE SHEET (RULE 26) gastrodrainage, since the cross-sectional area of the drainage hole 4 is larger than the cross-sectional area of the wide-channel gastrodrainage 2.3, and hence the probe inserted through the gastrodrainage into the stomach. Thus, between the outer wall of the gastric tube and the edge of the gastro-drainage opening 4 there is a gap through which the gastric contents from the esophagus penetrate into the second wide-channel gastro-drainage, even with a probe inserted into the stomach.

Channel 6 of the access to the glottis can be used to administer drugs or hold a thin probe (for any purpose) or conductor for subsequent tracheal intubation behind the glottis.

The introducer allows you to change the shape of not only the proximal, but also the distal part of the JIM (O-ring). When introduced introducer, the device has an optimal shape to facilitate the introduction of the device into the respiratory tract of the patient. When removing the introduced introducer from the wide-channel gastrodrainage, the o-ring acquires the optimal shape for sealing the patient’s air duct and respiratory system, which makes it possible not to use the inflated cuff.

An advantage of the claimed device over the known ones is that it allows unhindered removal of the gastric contents outside the mouth (thereby preventing aspiration) when a large diameter probe (up to 15 mm for an adult patient) is installed in the stomach, not only from the stomach, but also from the esophagus at the same time due to the fact that it has two wide-channel gastro-drainage, each of which with a diameter not less than that of the prototype and the drainage hole cross section is larger than the gastro-drainage section. In addition, none of the rastrodrainage runs along the midline and does not take up space inside the o-ring of the mask designed to accommodate the larynx. Thus, the reflexogenic region remains free, preventing

SUBSTITUTE SHEET (RULE 26) possible reflexes from the larynx. The wide-channel gastrodrainages are placed in such a way that they themselves form the distal part of the sealing ring of the mask.

In this case, the device can be installed in a neutral position of the neck. The laryngeal additional channel with the distal end is directed to the glottis, and can be used both for irrigation of the vocal cords and trachea, as well as for catheters, including obstructive catheters.

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.

SUBSTITUTE SHEET (RULE 26)

Claims

Claim

P.l. A laryngeal mask containing an air tube, a cuff and a wide-channel gastro-drainage, which opens into the esophagus, characterized in that the cuff is made in the form of a sealing ring formed by a horseshoe-shaped rim and two wide-channel gastro-drainages, the gaps of which are connected, forming a common gastro-drainage hole that opens into the esophagus, while O-ring on one side covered by a sheath.

A.2. The laryngeal mask according to claim 1, characterized in that it further comprises an introducer, which allows changing the shape of the o-ring.

P.Z. The laryngeal mask according to claim 1, characterized in that it further comprises a channel of a smaller diameter, with a distal end directed to the glottis.

A.4. The laryngeal mask according to claim 1, characterized in that in the proximal part two wide-channel gastro-drainages are interconnected, while the airway tube is located parallel to the junction from above.

A.5. The laryngeal mask according to claim 1, characterized in that the horseshoe-shaped rim can be made as hollow or solid.

A.6. The laryngeal mask according to claim 1, characterized in that the shell of the o-ring can be made as single-layer or multi-layer.

SUBSTITUTE SHEET (RULE 26)