WO1996038207A1 - Apparatus for respiratory exercises - Google Patents

Abstract

The apparatus increases the basal tone of the oro-pharyngal and hypopharyngal musculature, and it is configured like a mouthpiece or respirator applied to a tube at the end of which is arranged a plurality of restrictive and variable passage orifices and a one way valve whose position can be reverted so as to control respectively the inspiration or the expiration, the device being applied during vigilance, in periods of two months and applications of about ten minutes, at least three times per day, with the result that the patient has to generate a higher inspiratory pressure in order to obtain the same air flow.

Description

APPARATUS FOR RESPIRATORY EXERCISES

DESCRIPTION

OBJECT OF THE INVENTION

Respiratory muscle training system in patients with snoring and OSAS, as well as the device for its implementation that increases the basal tone of the oropharyngeal and hypopharyngeal muscles and reduces the incidence of nocturnal events (snoring-hypopnea apnea) that is configured simple, not invasive, consisting of a mouthpiece, with an end rim and a hollow for conventional dentures or a mask, applied to a tube with adjustable orifices and a one-way double-positioning valve, applying this device during wakefulness, in a continuous treatment period of two months and in applications of 10 minutes three times a day.

It consists of making the patient breathe in through a resistant device that makes the subject have to apply higher inspiratory pressure to obtain the same air flow, ensuring that expiration is passive, while the airway musculature during inspiration The upper section is put on tension to withstand the negative pressure, without causing the road to collapse.

BACKGROUND OF THE INVENTION

Snoring is the sound produced by the vibration of the structures formed by the palate soft tissue, the pharyngeal wall, the tongue, the epiglottis and the uvula, the fundamental cause of its appearance being the decrease or abolition of the tone of the pharyngeal muscles that is accompanied by the partial or total collapse of the oropharynx or hypopharynx.

It is twice frequent in men than in women and there are causative or predisposing factors such as: obesity, smoking, anatomical or inflammatory alterations of the upper airway, alcohol, and sedative drugs, the incidence being in the general population is 40 to 60 percent.

Snoring alters the quality of normal sleep because it produces multiple awakenings and can be evolutionary in nature; It should be considered serious when associated with sleep apneas (decreased or absent breathing for periods of more than 10-15 seconds: OSAS), having been shown that subjects with nocturnal apneas (2 to 3% of the general population) have more incidence of cardiovascular and neurological diseases than the general population, being even a cause of the so-called sudden nocturnal death in adults.

Using appropriate techniques such as cineradiography and fiberoptic bronchoscopy, it has been observed that in snoring subjects without OSAS there is a decrease in the sagittal diameter of the oropharynx, followed by high-frequency oscillations of the soft palate, pharyngeal wall, tongue and epiglottis. before hearing snoring. In patients with OSAS, immediately after the onset of inspiration, the oropharynx and hypopharynx collapse. Subsequently, the partial opening of the airway occurs and the individual begins to snore. Snoring at this time is associated with rapid partial occlusions and openings of the pharynx.

The relationship between esophageal pressure and airway flow (flow-pressure curve) shows that there are two types of patterns. In the first pattern, snoring is preceded by severe airflow limitation. Esophageal pressure increases progressively, while flow reaches a plateau at low pressure levels and then increases substantially with the onset of snoring. This pattern is observed in patients with OSA, in whom closure of the oropharynx occurs as soon as inspiration begins.

In the second pattern, the resistance in the upper airway increases progressively and is followed by a limitation to air flow, with subsequent appearance of snoring, this pattern being typical of people who suffer from intense snoring. Snoring subjects without OSAS have recently been found to snore at higher frequencies than snorers with OSAS.

The syndrome of increased resistance of the upper airway is associated with snoring and is characterized by multiple transient arousals of short duration (2-14 sec) that fragment sleep and are not associated with apneas.

Other patients affected by other pathologies present snoring associated with apneas, as is the case in patients with chronic obstructive pulmonary disease (COPD). In this case the syndrome is called intermediate syndrome. On the other hand, 60 percent of patients with OSAS are obese, which indicates the importance of weight in this pathology.

Snoring patients with OSAS, in addition to their snoring attracting the attention of their partner, present daytime hypersomnolence, decreased ability to concentrate, headaches, personality changes, etc., as well as a large increase in the incidence of traffic accidents in these patients can be the cause of marital separation and have other important social implications.

The treatment of snoring with or without OSA is currently directed in three complementary directions: 1- Avoid predisposing factors, such as obesity, smoking, and alcohol and drug use. 2- Prevent collapse of the upper airway by applying continuous or cycled positive pressure. 3- Reduce the portion of the oropharynx that vibrates through reconstructive surgery, unfortunately none of them are definitive.

Different surgical techniques are used for the third option: uvulopalatopharyngoplasty (UPPP), tracheostomy, reconstruction techniques. Although UPP surgery is proven to be effective, it is not all operated patients respond to it and in some of them snoring or apneas reappear months after the intervention.

The application of continuous or cycled positive pressure in the upper airway CPAP, BIPAP, is currently the treatment of choice in patients with severe OSA, having also been applied to habitual snorers.

Its mechanism of action is not well known, although it is due to a mechanical effect of a pneumatic splint that prevents the collapse of the pharynx during inspiration, while producing an increase in its diameter. It is said that CPAP in turn reflexively activates the muscles of the upper airway, however this probable increase in muscle tone only lasts while the treatment is being given, since if it is withdrawn, snoring and snoring will reappear. Apneas the night after its completion, which means that the subject who is treated with CPAP must know that he will have to maintain this treatment indefinitely with the cost and the feeling of incapacity that this represents.

Finally, other invented devices (drops, probes, alarms, etc.) have not shown efficacy.

On the other hand, the training of the respiratory muscles by means of inspiratory loads has been applied with some success mainly in patients with obstructive diseases, diseases of the box thoracic and neuromuscular diseases. It is based on the fact that just as we can train the skeletal muscles progressively through isometric, isotonic exercises or training methods directed at effort, the respiratory muscles are part of the skeletal muscle economy and therefore it is capable of improving their resistance capacity to effort. The results have been generally positive, depending on the measured parameter, maximum pressure, basal muscle tone, maximum achievable ventilation, spirometric parameters, etc. This principle has not been applied until now to patients suffering from snoring with or without obstructive apneas.

DESCRIPTION OF THE INVENTION

The foundation of training the respiratory muscles through inspiratory loads is in itself basic: If the oropharyngeal musculature fails to maintain its basal tone during sleep, everything that tries to increase it by direct or reflex route will reduce the incidence of snoring and / or or apneas.

The invention of this now advocated system of respiratory muscle training in patients with snoring and OSAS, starts from the principle of increasing the basal tone of the orpharyngeal and hypopharyngeal muscles, in such a way that the wall of the airway is more resistant to variations in transmural pressure decreasing airway compliance.

The system reduces the incidence of nocturnal events (snoring-apneas hypopneas) after a continuous treatment period of two months. The system is simple, non-invasive and is applied during wakefulness.

This system makes the patient breathe in for a certain time (10 minutes) through a nozzle applied to a tube at the end of which he inserts another, both having groups of opposing recesses with variable opening by turning one piece with respect to the other. This device acts as a resistance and therefore makes the subject have, in general, to make higher inspiratory pressure to obtain or to expel the same air flow while a unidirectional valve located in the second tubular body, in either an internal or an internal position. external to the first body, it allows that when the aspiration is controlled the expiration is free and vice versa. The system can be fitted with an oral nasal mask, in cases where the use of the mouthpiece is not possible.

At the moment of inspiration, the respiratory muscles and therefore all the muscles of the upper airway are put under tension to withstand the negative pressure that is being generated without causing the collapse of the airway.

This effect acts progressively by increasing the tone of said muscles during sleep, which is when it physiologically decreases or disappears. Consequently, the compliance of the pathway is maintained or not diminished as much and the oropharynx does not collapse.

It is important that as all training muscle has a periodicity and assiduity that, to be effective, it is recommended that it be done three times a day, ten minutes each time and for at least two consecutive months.

The treatment must be controlled at all times by a doctor, taking into account that it should not be applied to those patients in whom the generation of high negative pressures may constitute a problem, as occurs in subjects affected by cardiovascular, respiratory or neurological diseases .

Training of the upper airway muscles can be beneficial in patients with snoring and / or OSA not only due to the fact that by itself it reduces the severity of the disease but also because it can be applied together with other treatments already used such as CPAP or BIPAP.

DESCRIPTION OF THE DRAWINGS

To complement the description that is being made and in order to help a better understanding of the characteristics of the invention, the present specification is attached, as an integral part thereof, to a set of drawings where with an illustrative and non-limiting nature the following has been represented:

Figure 1 is a schematic elevation of the main body of the invention showing different attachable nozzles, with detail of holes to house the - 9 - denture and, also, lip edge.

Figure 2 is a section of the system object of this invention with a built-in mask, all exploded.

Figure 3 is an ideal detailed representation of the operation, showing a free suction arrangement with maximum air passage and another arrangement, controlled expiration with minimum air passage.

Figure 4 is an ideal detailed representation of the operation, showing a forced suction arrangement with minimum air passage and another arrangement, free expiration with maximum air passage.

PREFERRED EMBODIMENT OF THE INVENTION

The respiratory muscle training system in patients with snoring and OSA, object of this invention, which can be applied together with other treatments already used such as CPAP or BIPAP, is a simple, non-invasive system that is applied during wakefulness. , increases the basal tone of the orpharyngeal and hypopharyngeal muscles, with a view to reducing the incidence of nocturnal events (snoring-hypopnea apnea) after a continuous treatment period of two months, in applications of 10 minutes three times a day, making the patient inspires through a resistant device that makes the subject have to make greater inspiratory pressure to obtain the same air flow, with mouthpiece (1) or mask (1 ') and variable air restriction holes, by opposing arrangement of the respective notches (3) and (3') of the support tube (2) of the mouthpiece (1) or the mask (1 '), on the one hand and the tube or regulating body (4) that is inserted into it through either of its ends and that has a one-way valve (7) that, depending on the position, allows or not the passage of air to the user during aspiration or expiration.

Thus, exercises of ten minutes duration can be performed, with the valve arranged internally, of free suction and expiration controlled by the valve, these exercises being carried out in any section of air passage, from the position of maximum passage to that of passage almost practically closed.

Likewise, exercises of the same duration can be carried out, with the valve arranged externally, suction controlled by the valve and free expiration, also in any section of air passage, from the position of maximum passage to that of passage almost practically closed.

It is not considered necessary to make this description more extensive for any person skilled in the art to understand the scope of the invention and the advantages derived from it.

The materials, shape, size and arrangement of the elements will be susceptible to variation as long as they do not alter the essentiality of the invention. The terms in which this specification has been described should always be taken in a broad and non-limiting sense.

Claims

I ^to muscle training .- respiratory system in patients with snoring and OSA, which increases the basal tone of the musculature orfaríngea and hypopharyngeal, in order to diminish the incidence of nocturnal events (apneas and hypopneas ronquido-) and can be applied together with other treatments already used such as CPAP or BIPAP, of those used in patients with obstructive diseases, rib cage and neuromuscular diseases, essentially characterized by being simple, non-invasive and applied during wakefulness, in a period of continuous treatment of two months and in applications of around 10 minutes, at least three times a day, consisting of having the patient breathe in through a resistant device that makes the subject have to make higher inspiratory pressure to obtain the same air flow, ensuring that expiration is passive, while on inspiration the upper airway musculature becomes in tension to withstand the negative pressure, without causing the collapse of the track. 2 .- System respiratory muscle training in patients with snoring and OSA, according to the first claim, characterized by performing exercises with the inner valve disposed in free inlet and controlled by expiration valve or the valve are performed inverted, arranged externally, with aspiration controlled by the valve and free expiration, performing both exercises in any section of air passage, from the position of maximum passage to that of almost practically closed passage. 3 .- respiratory muscle training device in patients with snoring and OSA, according to previous claims characterized by having a nozzle (1), with end flange lip, with hollow denture or single mouthpiece in conventional executions , applied to a tube (2) at the end of which variable air restriction holes are arranged, by opposing arrangement of the respective notches (3) and (3 ') of the support tube (2) of the nozzle (1), by a side and of the tube or regulating body (4) that is inserted into it through either of its ends and that has a one-way valve (7) that, depending on the position, allows or not the passage of air to the user during aspiration or during expiration. 4 Device .- respiratory muscle training in patients with snoring and OSA, characterized by having alternately to either nozzle (1), a mask (1 ') nasal buco, which can be coupled to the tube (2) in substitution of that one.