HK1023075B - Device for preventing snoring and apnoea during sleep - Google Patents

Description

The present invention relates to an intra-oral-pharyngeal device for the treatment of snoring.

In particular, the invention aims to suppress snoring and prevent sleep apnea, which occurs during sleep in some patients.

Figure 6 of the attached drawings provides an anatomical overview and a better understanding of the mechanisms of snoring.

Snoring is an inspiratory, or predominantly inspiratory, sound produced by vibration of the soft tissues of the pharynx.

The mechanism of snoring is not yet fully understood, but it is thought to be the result of a complex of several abnormalities: local anatomical factors, abnormally collapsible pharynx walls, muscle tone disorders, and the like.

Many abnormalities can reduce the light from the upper airway: nasal obstruction by deviation of the nasal partition 20, macroglossia or amygdala hypertrophy 23, retrograde or micro-gnatism.

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In severe snorers, in addition to noise, increased pharyngeal resistance limits the flow of breath at various levels, particularly in the region of the palate veil 15 and base of tongue 14 which are plated against the posterior pharynx wall 18.

In addition to causing discomfort to others, snoring causes poor sleep quality and reduces blood oxygenation to a greater or lesser extent, which can have adverse effects on the whole body. Severe snorers appear to have higher blood pressure and ischemic heart disease such as angina or myocardial infarction more often than mild snorers. They are also prone to cerebral ischemia.

Sleep apnea syndrome (SAS) is a more severe form of snoring, a severe snoring associated with actual apnea, which may be longer or shorter but may last up to two minutes and repeat throughout the night, with total obstruction of the airway through the pharynx.

These respiratory arrest causes successive awakenings (the back-up system working) so that the muscles of the pharynx contract and allow the breathing air to pass.

During the day, the main symptom is drowsiness, which can range in severity from a simple feeling of chronic fatigue to untimely falling asleep while on the job.

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It is found that all the methods and devices used in the earlier technique are either ineffective or effective but expensive and/or cumbersome and at least difficult to use by the patient himself outside the hospital environment.

US patent 3 057 347 refers to a respiratory rescue device, intended for the resuscitation of patients suffering from respiratory arrest such as that which occurs after electrocution or drowning and having the characteristics listed in the preamble to claim 1.

Specifically, the device consists of a cannula with a curved proximal and a straight distal part, intended to be inserted respectively to the base of the tongue and through the oral cavity, while protruding out of it where a rescuer can breathe air. The distal part is equipped with a support disc that surrounds it radially and presses on the patient's lips to ensure proper positioning of the whole. A filter placed in the distal part of the cannula prevents moisture breathed in with the rescuer's air from entering the patient's airway.The cannula is made of a semi-rigid, elastic material to accommodate the particular anatomical conformation of each patient. The application of this device is exclusively reserved for resuscitation of patients and is intended in particular to create an unobstructed channel between the mouth of the rescuer and the airways located downstream of the base of the tongue such as the larynx and the trachea.

The device of the earlier technique has the disadvantage that if it were used to treat snoring or sleep apnea, the tube may collapse during use, because unlike a patient in intensive care, a patient with snoring retains during sleep a certain muscle tone which tends to crush the tube by clenching the lips and teeth.

The purpose of the present invention is to propose a simple and effective device for the treatment of snoring and sleep apnea, which avoids all the disadvantages of devices and methods, surgical or otherwise, used up to now, the device being particularly convenient to use and which can be easily set up by a patient suffering from snoring and/or sleep apnea.

The invention therefore concerns a device for the treatment of snoring and sleep apnea, which has the characteristics defined in the characteristic part of claim 1.

The advantageous features of the treatment device of the invention are defined in subclaims 2 to 12.

Other features and advantages of the invention will be shown in the following description given by way of example only and made by reference to the attached drawings on which: Figure 1 shows the device of the invention in profile;Figure 2 shows the device of the invention from the front from the proximal side;Figure 3 shows the device of the invention in profile and in cut;Figure 4 shows the device of the invention from the front and in cut;Figure 5 shows a transverse cut of the tube of the device of the invention.Figure 6 shows an anatomical cut of the oropharynx;Figure 7 shows the device in place in the oropharynx and at the level of the pre-oral region, andFigure 7A shows a partial view of the device at the level of the oral region to show a variant of the invention.

The first feature of the device, based on these drawings, is a flexible and non-rigid intra-bowel tube 1 which is designed to be well supported by the patient when placed before and during sleep.

The flexible, non-rigid material of the tube must be compatible with the contact of the oral mucosa, and the flexibility must be adapted so that the walls between which it is inserted do not collapse under the pressure of the tissues of the palate and tongue.

It is important that the tube is deformable to a certain extent, but that it takes on an arc shape when the deformation force is released.

In view of the above considerations, tube 1 should preferably be made of a material with a Shore hardness of 10 to 50, silicone or latex being suitable.

The wall 8 of tube 1 is of variable thickness depending on the material used, for example about 2 mm, but the thickness may vary according to the required hardness.

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Tube 1 can be made by depositing silicone onto a preformed mold, but other methods of manufacture are possible, particularly by injection.

The soft tube 1 thus allows the inhaled air 10 to flow freely from the outside to the larynx, passing the barrier of the B-zone (Figure 7) which is made up of the tongue 13, the palate veil 15 and the base of the tongue 14.

Recent studies and unsatisfactory results of palate veil surgery tend to show that the airflow barrier, responsible for the vibration of the soft tissues or the complete obstruction of the airway, is located (Figure 6) at the level of zone B where the palate veil 15, the lute 16, the base of the tongue 14, against the posterior pharyngeal wall 18, and the tonsils 23 which narrow the pharynx in width, meet and adhere.

The invention allows air to pass through, bypassing the anatomical barriers in Zone B that cling together during sleep, so that airflow 10 travels unimpeded and without noise to the larynx.

According to another feature of the invention, an extra-buccal base 5 is supported by teeth 12 and lips 11. In addition, the first centimeters distal to tube 1 are reinforced by a socket-shaped part or reinforcement 6 made of a material other than tube 1 to increase its stiffness for supporting the teeth 12. The teeth are supported by this reinforcement 6 which escapes to the distal end, and the extra-buccal base 5 will, in turn, be supported by the lips 11.

Another important feature of the invention is that a filter 2 of sufficient filter surface is placed at the distal end of tube 1 to filter and moisten the air inhaled by a filter 3 part into a suitable material. This filter is solid base 5 by any appropriate means. It is essential to replace the nasal function by clearing the air of suspended particles, moistening it, and heating it. Without such a filter, the air would quickly dry out the laryngeal and tracheal mucosa and the device would not be tolerated. Dust inhaled during sleep also has a factor of intracerebral density causing irritation and tooth decay.

This filter can be of various shapes and made of various materials. In the present embodiment, it has an air-permeable ring cage 2a in which the filter part 3 is placed which can be in a synthetic foam with loose meshes, such as a PVC foam (Poly-Chloride Vinyl), or also in sheets of agglomerated fibers Polyamides or Polyesters, but other materials are used, as long as they do not block the passage of air 10. This excludes an internal installation in the tube 1 (which is the case in the above US patent device).

A system of fixing the filter 2 to tube 1 so that the entire filter can be changed, the filter being fixed or removable, may also be provided.

In the embodiment shown, the main tube 1 has an oval shape in the cut (Figure 5) about 20 mm wide by 10 mm high in its outer dimensions. The inner tube 9 is about 16 mm wide and 6 mm high. These dimensions may vary depending on the size of the tube and the material used for it. The flattened or oval section allows to provide a light 9 and therefore a sufficient airflow, without any brake on the airflow 10, so that it is silent, and also so that the device is well supported during sleep.

Depending on the anatomy of each patient, the length of tube 1 can be adjusted for each patient by a simple section of the proximal end 4 of tube 1 so that the proximal orifice does not come to bump against the epiglottis 17, which would cause pain or a nauseous reflex or cough.

Wall 8 of tube 1, base 5 and reinforcement 6 of tube 1 may be reinforced with another material, metal or synthetic, to increase their rigidity, such as wires, plates or other materials.

A fastening system is desirable to hold the device in the oropharynx during sleep. The simplest system may consist of one or more elastic bands 24 passing behind the ears, head or neck.

Figure 7A shows a variant of the device of the invention, in which a cap 25 is fitted on the reinforcement 6 against the base 5. This cap, made of a flexible material, e.g. the same as that of the tube, has in the free state a roughly conical shape with its convexity turned towards the distal end of the tube 1. This cap 25 is supported against the outside of the lips by deforming when the device is fitted, thus creating a seal preventing saliva flow outwards at the interface between the base 5 and the exit of the oral cavity.

Claims (12)

1. Device for treating ronchopathy and sleep apnoea adapted to be placed in the oro-pharynx and in the pre-buccal region, characterized in that it comprises in combination:

   an anatomical shape curved tube (1) so adapted that, when it is in situ in the oro-pharynx of a patient, it extends with a proximal end from at least the base (14) of the tongue until projecting with its distal end out of the buccal cavity,

   an extra-buccal base (5) rigid with said tube (6) and adapted, when the device is in use, to bear against a patient's teeth and the lips (11), and

   a filter (2) also rigid with said tube (1) and located at the distal end thereof in order to filter the air flowing through said tube (1) towards the patient's oro-pharynx, and reinforcing means (6) associated with said tube so as to prevent, in use, crushing thereof in a predetermined zone of its length,

      characterised in that    said reinforcing means (6) are provided on said tube at the side of an extra-buccal base (5) oriented towards the proximal end of the tube so as to reinforce said tube in the region of the teeth and the lips.
2. Device according to Claim 1, characterised in that the extra-buccal base (5) is rigid with said reinforcing means (6).
3. Device according to Claim 2, characterised in that the base (5) and/or said reinforcing means (6) are made of a material having a hardness greater than that of the material of the tube (1).
4. Device according to any one of Claim 1-3, characterised in that the filter (2) is fixed or removable.
5. Device according to any one of Claims 1-4, characterised in that the section of the tube (1) is flattened.
6. Device according to anyone of claims 1-5, characterised in that the length of the tube (1) can be adapted to suit each patient by simply cutting off its proximal end (4).
7. Device according to Claim 6 characterised in that the proximal end of the tube (1) has notches, projections or special marks (7) to specify and facilitate cutting.
8. Device according to any one of Claims 1-7, characterised in that the tube (1) is made of a flexible, non-rigid material that is non-irritant for the skin and the mucous membranes and non-toxic to the organism, its Shore hardness being in the range 10 to 50.
9. Device according to Claim 8, characterised in that the material of said tube (1) is silicone or latex.
10. Device according to any one of Claims 1-9, characterised in that the wall (8) of the tube (1) is reinforced with another material to modify its rigidity.
11. Device according to any one of Claims 1-10, characterised in that it includes a fixing system comprising elastic bands (24) attached to said base (5) and adapted to be passed behind the ears, the head or the neck in order to hold the device in the oro-pharynx during sleep.
12. Device according to any one of the preceding Claims, characterised in that a cap (25) is positioned on said tube (1) around the reinforcement to form a seal.