WO2022209847A1 - Oral insert, and kit for detecting presence of sleep apnea syndrome - Google Patents

Abstract

[Problem] To provide an oral insert used in order to accurately detect the presence of sleep apnea syndrome using a negative expiratory pressure (NEP) method. [Solution] An oral insert to be inserted into the oral cavity of a user, the oral insert being characterized by having: a cylindrical base part, the base part having an air port that penetrates therethrough; and an extension part extending in the longitudinal direction from an end of the base part, the extension part having a slit in a section thereof.

Description

Oral insert and kit for detecting the presence or absence of sleep apnea syndrome

The present invention relates to an oral cavity insertion device that is inserted into the user's oral cavity, and a kit for detecting the presence or absence of sleep apnea syndrome that includes the oral cavity insertion device.

Obstructive sleep apnea syndrome occurs due to narrowing of the upper airway during sleep, and in addition to fat deposits around the neck and throat, enlarged tonsils, and muscle relaxation, the base of the tongue and soft palate fall into the pharynx, resulting in obstruction of the airway. It is a disease in which apnea and hypopnea are repeated during sleep.

The basic pathophysiology of obstructive sleep apnea syndrome is narrowing/obstruction of the upper airway (especially the pharynx) that appears during sleep, and is defined as apnea when this continues for 10 seconds or more.

Humans usually sleep in the supine position. At this time, the uvula and base of the tongue sink under the influence of gravity, narrowing the upper airway. In the sleeping state, the muscles that make up the upper airway (for example, the muscles that expand the upper airway, such as the genioglossus muscle) become inactive and relax, further narrowing the upper airway. In general, in healthy individuals with no morphological or functional abnormalities in the upper airway, narrowing of the upper airway to this extent does not significantly affect respiration.
On the other hand, in patients with obstructive sleep apnea syndrome, morphological or functional abnormalities in the upper airway easily cause narrowing or obstruction of the upper airway during sleep, resulting in apnea.

Treatment and diagnosis of obstructive sleep apnea syndrome are performed, for example, as follows.
In particular, as reported in Non-Patent Document 1, in an epidemiological survey of 910 people, patients with obstructive sleep apnea syndrome were 3.3% for men and 0.5% for women. The total number of patients estimated from the results is approximately 2 million. On the other hand, Non-Patent Document 1 also reports that 85% or more of patients with obstructive sleep apnea syndrome to be treated are undiagnosed.
Therefore, enlightenment and popularization of the diagnosis of obstructive sleep apnea syndrome are required.

　Obstructive sleep apnea syndrome is usually treated with nasal continuous positive airway pressure (CPAP therapy). Specifically, at night, by supplying pressurized air from a pressurized air generator (CPAP device) used for CPAP therapy to the airways through an air tube and a nasal mask, the airways are opened, thereby reducing sleep prevent the occurrence of apnea.

Patent Literature 1 discloses an oral insertion device for use in the above CPAP therapy, the oral insertion device having a vestibular shield, gas passage means, and additional shield means for the mouth. US Pat. No. 6,200,000 also discloses an oral insert for use in CPAP therapy, the oral insert having a vestibular shield, a central portion, an outer portion, and gas passage means. Also, US Pat. No. 6,300,000 similarly discloses an oral insert for use in CPAP therapy, which oral insert includes a vestibular positioning portion and an airway conduit.

Diagnosis of obstructive sleep apnea syndrome is usually made by simple sleep breathing monitor and polysomnography performed during nighttime sleep. Specifically, when breathing stops for 10 seconds or more, it is called apnea, and when the ventilation volume drops to 50% or less of the normal state for 10 seconds or more, it is called hypopnea. It is diagnosed by the apnea-hypopnea index expressed in number of hits.

On the other hand, in recent years, a method for detecting the presence or absence of obstructive sleep apnea syndrome from the expiratory flow rate when negative pressure is sucked simultaneously with exhalation during wakefulness during the daytime described in Non-Patent Document 2 (NEP method: Negative Expiratory Pressure method ) has been proposed. Specifically, the NEP method is generally performed by using equipment equipped with a NEP unit that generates a negative pressure in a respiratory function testing device used to measure a person's respiratory function. In addition, when actually performing the NEP method, a dedicated oral cavity insertion device as described in Non-Patent Documents 3 and 4 (respectively, a mouthpiece for an electronic spirometer [autospiro] and a silicone mouthpiece HF-M-2 ) must be used.

Japanese Patent Application Laid-Open No. 2001-79091 JP-A-2000-51357 Japanese Patent Publication No. 2017-506929

However, in the NEP method using the oral cavity insertion device described in Non-Patent Documents 3 and 4, due to the structure of the oral cavity insertion device, when negative pressure is applied (hereinafter also referred to as suction) , airway narrowing due to the tongue and soft palate falling into the pharynx does not occur, and airway narrowing due to deformation of the tongue and soft palate occurs. As a result, there is a problem of causing false positives in detecting the presence or absence of obstructive sleep apnea syndrome.

The purpose of the present invention is to provide an oral cavity insertion tool used for accurately detecting the presence or absence of obstructive sleep apnea syndrome in the NEP method.

An oral cavity insertion device according to one aspect of the present invention is an oral cavity insertion device that is inserted into a user's oral cavity,
a cylindrical base portion having an air port penetrating through the base portion;
and an extension portion extending in the longitudinal direction from the end of the base portion, the extension portion having a slit in a part of the extension portion.

The oral cavity insertion device may further have a notch at the tip of the extending portion.

As a result, when the user wears the oral cavity insert, it is possible to prevent the vomiting reflex due to contact with the base of the tongue.

In the oral cavity insertion tool, the shape of the notch may be a quadrant.

Thereby, the strength of the extended portion and/or the notched end portion can be increased.

The oral cavity insert may further have a shield portion having a predetermined height such that it overlaps the user's teeth and/or gums when positioned between the user's lips and teeth.

As a result, air leakage can be prevented when the user wears the oral cavity insert.

In the oral cavity insertion device, the slit may exist on the lower surface of the extending portion.

This makes it possible to more efficiently prevent the vomiting reflex due to contact with the tongue (for example, the front tongue) when the user wears the oral cavity insert.

In the oral cavity insertion device, the shape of the slit may be a quadrangle.

This makes it possible to more efficiently prevent the vomiting reflex due to contact with the tongue (for example, the front tongue) when the user wears the oral cavity insert.

In the oral cavity insertion device, the extending portion is divided into a first extending portion and a second extending portion by the slit, and has a connecting portion that connects the first extending portion and the second extending portion. good too.

Thereby, the shape of the extension portion can be properly maintained when the extension portion receives force from the user's soft palate and tongue.

In the oral cavity insertion device, the side surface of the connecting portion may be rounded.

This can prevent injury to the user when the user wears the oral cavity insert.

In the oral cavity insertion tool, the air opening may be circular.

As a result, the air port can be easily connected to a respiratory function measuring device such as an expiratory flow rate measuring device or a spirometer.

In the oral cavity insertion device, the extending portion may extend from the lower side of the base portion.

As a result, when the user wears the oral cavity insert, it does not come into contact with the soft palate and uvula on the maxillary side of the user, so the vomiting reflex due to contact with the soft palate and uvula can be suppressed more efficiently.

In the above-described oral cavity-insertion tool, the base portion and the extending portion may be made of the same material.

In the oral cavity insert, the material may be a thermosetting elastomer.

The oral cavity insert may be used to detect the presence or absence of sleep apnea syndrome.

The oral cavity insert may be used to detect the presence or absence of obstructive sleep apnea syndrome.

The oral cavity insert may be used to detect the presence or absence of sleep apnea syndrome by the negative expiratory pressure method.

A kit for detecting the presence or absence of sleep apnea syndrome according to one aspect of the present invention includes the oral cavity insertion device according to one aspect of the present invention and an expiratory flow rate measuring device.

The above kit may further include a negative pressure load device.

The above kit may be used to detect the presence or absence of obstructive sleep apnea syndrome.

The above kit may be used to detect the presence or absence of sleep apnea syndrome by the Negative Expiratory Pressure method.

According to the oral cavity insert of the present invention, the presence or absence of obstructive sleep apnea syndrome can be accurately detected in the NEP method.

1 is a perspective view of an oral cavity insert of the present invention; FIG. 1 is a side view of an oral cavity insert of the present invention; FIG. 1 is a front view of an oral cavity insert of the present invention; FIG. FIG. 4 is a diagram showing a state in which the oral cavity insert of the present invention is attached to the user's mouth. It is a figure for demonstrating the principle of NEP method. It is a result figure of the NEP method using the oral-cavity insertion tool of this invention. It is a result figure of the NEP method using the oral-cavity insertion tool of this invention. It is a result figure of the NEP method using the oral-cavity insertion tool of the nonpatent literature 3. FIG. It is a result figure of the NEP method using the oral-cavity insertion tool of the nonpatent literature 3. FIG. FIG. 4 is a perspective view of an oral-insertion tool according to another embodiment of the present invention; FIG. 4 is a side view of an oral-insertion tool according to another embodiment of the present invention; FIG. 4 is a perspective view of an oral-insertion tool according to another embodiment of the present invention; FIG. 4 is a perspective view of an oral-insertion tool according to another embodiment of the present invention; FIG. 4 is a side view of an oral-insertion tool according to another embodiment of the present invention; FIG. 4 is a plan view of an oral-insertion tool according to another embodiment of the present invention;

[Structure of the Oral Insertion Tool of the Present Invention]
An oral cavity insert 1 according to a first embodiment of the present invention will be described with reference to FIGS. 1 to 3. FIG.
As shown in FIG. 1 , the oral cavity insert 1 includes a base portion 2 and an extension portion 3 .

Here, for the sake of convenience, the left side of the paper in FIGS. sometimes.

《Base part》
As shown in FIG. 2 , the cylindrical base portion 2 extends (communicates) from the outside of the user's oral cavity to the inside of the oral cavity, and when the user wears the oral cavity insertion device 1 , the outer side located outside the oral cavity. It has a portion 5, an inner portion 6 which is located in the oral cavity. In addition, as shown in FIG. 1, the base portion 2 is provided so as to penetrate the base portion 2 in the longitudinal direction, and when the user wears the oral cavity insertion device 1, it becomes an air passage path for air. It has a mouth 4 .

The shape of the base portion 2 is appropriately determined according to the shapes of the outer portion 5 and the inner portion 6, which will be described later.

The length in the major axis direction of the base part 2 (that is, the length in the direction from the outside of the oral cavity to the inside of the oral cavity) and the length in the minor axis direction (that is, the length in the direction that connects the maxillary side and the mandibular side) are , depending on the lengths of the outer portion 5 and the inner portion 6, which will be described later.

Materials forming the base portion 2 (including an outer portion 5 and an inner portion 6 to be described later) include, for example, paper, elastomer, plastic, etc. Elastomer is preferable. Examples of the elastomer include thermosetting elastomers such as urethane rubber, silicone rubber, and fluororubber, polystyrene elastomers, olefin/alkene elastomers, polyvinyl chloride elastomers, polyurethane elastomers, polyester elastomers, and polyamide elastomers. Thermosetting elastomers are preferred from the viewpoint of biocompatibility, biosafety, moldability, etc. Among them, silicone rubber is more preferred.
The hardness of the base portion 2 may be any as long as the shape of the base portion 2 can be appropriately maintained when the oral cavity insertion device 1 is worn. When applied to the detection of the presence or absence of apnea syndrome (in particular, the detection of the presence or absence of sleep apnea syndrome when using the NEP method), the base portion 2 preferably has a certain hardness. Moreover, as one form, for example, the hardness of the base portion 2 may be set higher than the hardness of the extension portion 3 described later. This is because the base portion 2 has a certain hardness, so that the base portion 2 does not easily deform even if the user's teeth come into contact with the base portion 2 when the user wears the oral cavity insert 1. This is because the user's expiratory flow rate is stabilized, and as a result, the presence or absence of sleep apnea syndrome can be detected with higher accuracy. Further, as such hardness, for example, when silicone rubber is used as the material constituting the base portion 2, the durometer type A hardness specified in JIS K6253 is in the range of 50 ° to 90 °. preferably in the range of 70° to 90°.
As a method for adjusting the hardness of the base portion 2 so as to obtain a desired hardness, a method commonly used in this field may be used, for example, a method of increasing the thickness of the base portion 2 itself. mentioned.

When the oral cavity insertion tool 1 is attached to the user, the base part 2 is present in the user's oral cavity, so the base part 2 may be coated with a biocompatible substance. The substance means, for example, a material that is difficult to deteriorate when placed in the oral cavity of a living body and that does not induce a significant immune response or harmful toxic reaction. Polyacetal, polycarbonate, polyphenylene ether, modified polyphenylene ether, polyester, polyphenylene oxide, polybutylene terephthalate, polyethylene terephthalate, polysulfone, syndiotactic polystyrene, polyethersulfone, polyphenylene sulfide, polyarylate, polyetherimide, polyetheretherketone , polyamideimide, polyimide, fluororesin, ethylene-vinyl alcohol copolymer, polymethylpentene, diallyl phthalate resin, polyoxymethylene, polytetrafluoroethylene, and the like. As a method for coating the above substance, a method commonly used in this field may be used, and examples thereof include a spin coating method, an inkjet method, a dipping method, a vacuum polymerization method, and the like.

<outer part>
As shown in FIG. 2 , the outer portion 5 extends outside the lips of the base portion 2 when the user wears the oral cavity insert 1 .

The length in the major axis direction (that is, the length in the direction from the outside of the oral cavity to the inside of the oral cavity) and the length in the minor axis direction (that is, the length in the direction that connects the maxillary side and the mandibular side) of the outer portion 5 are , and has a sufficient length that it is not covered by the lips so that it can be connected to a respiratory function measuring device such as an expiratory flow measuring device or a spirometer.

As shown in FIG. 1, the outer portion 5 may have any shape as long as it does not create a gap with the user's lips when the oral cavity insert 1 is worn. , Patent Literature 2, Non-Patent Literature 3, Non-Patent Literature 4, and the like, which have a circular cross section, as in oral cavity inserts.

<inner part>
As shown in FIG. 2 , the inner portion 6 extends inside the lips of the base portion 2 when the user wears the oral cavity insert 1 .

The length of the inner portion 6 in the major axis direction (that is, the length in the direction from the outside of the oral cavity to the inside of the oral cavity) and the length in the minor axis direction (that is, the length in the direction that connects the maxillary side and the mandibular side) are It has a length that does not contact the soft palate or uvula on the upper jaw side of the user and does not press down on the base of the tongue when the oral cavity insertion tool 1 is worn.

The shape of the inner portion 6 may be any shape as long as it extends (communicates) from the outside of the oral cavity to the inner side of the oral cavity, as shown in FIG. .

<Air port>
As shown in FIG. 1, the air port portion 4 is provided so as to penetrate the base portion 2 in the longitudinal direction (that is, the direction from the outer portion 5 to the inner portion 6 constituting the base portion 2), It provides a path for air to pass through when the user is exhaling or inhaling.

The shape of the air port 4 may be appropriately determined based on the shape of the connecting portion between the respiratory function measuring device such as an expiratory flow rate measuring device or a spirometer and the oral cavity insertion device 1 and the shape of an air tube or the like for connecting the two. For example, it is preferable to have a circular cross-section as in the oral cavity inserts described in Patent Literature 1, Patent Literature 2, Non-Patent Literature 3, Non-Patent Literature 4, and the like.

《Extension》
As shown in FIGS. 1 and 2, the extending portion 3 extends from the end of the inner portion 6 of the base portion 2 in the longitudinal direction (that is, the direction from the outer portion 5 to the inner portion 6 constituting the base portion 2). and has a slit (opening) 7 in a part thereof.

The extending portion 3 extends from the end of the inner portion 6 forming the base portion 2 . Specifically, as shown in FIGS. 1 and 2, it extends from the peripheral surface on the lower side (mandibular side) of the end of the inner portion 6 . As a result, when the oral cavity insertion device 1 is worn, the extended portion 3 does not come into contact with the soft palate or uvula on the maxillary side of the user, so that the occurrence of vomiting reflex due to such contact can be suppressed. In addition, obstruction of the airway due to deformation of the soft palate and tongue can be prevented by inhibiting deformation of the soft palate when negative pressure is introduced.
1 and 2, the extending portion 3 may be formed on the upper side of the end of the inner portion 6 (on the upper jaw side) in addition to the peripheral surface on the lower side (mandibular side) of the end of the inner portion 6, for example. ) may also be extended from the peripheral surface.

The length of the extending portion 3 in the horizontal direction (that is, the length in the direction from the outside of the oral cavity to the inside of the oral cavity) is such that the extending portion 3 does not touch the user's soft palate. Also, the length of the extending portion 3 in the vertical direction (that is, the length in the direction connecting the maxillary side and the mandibular side) is such that the extending portion 3 does not come into contact with the user's soft palate. An example of such a length is such that the distance from the user's soft palate to the tip of the extending portion 3 is within 5 mm to 10 mm.

Examples of the material forming the stretched portion 3 include paper, elastomer, plastic, etc. Elastomer is preferable. Examples of the elastomer include thermosetting elastomers such as urethane rubber, silicone rubber, and fluororubber, polystyrene elastomers, olefin/alkene elastomers, polyvinyl chloride elastomers, polyurethane elastomers, polyester elastomers, and polyamide elastomers. From the viewpoint of biocompatibility, biosafety, moldability, etc., thermosetting elastomers are preferred, and among these, silicone rubber is more preferred.
In addition, as described above, the hardness of the extension part 3 is such that when negative pressure is introduced into the user's oral cavity, an appropriate shape can be maintained to prevent the airway from being blocked due to deformation of the soft palate and tongue. Any material may be used, but it preferably has a certain degree of hardness in order to prevent injury due to contact between the extending portion 3 and the user's oral cavity when the oral cavity insertion tool 1 is worn. Moreover, as one form, for example, the hardness of the extending portion 3 may be lower than the hardness of the base portion 2 described above. Further, as such hardness, for example, when silicone rubber is used as the material constituting the stretched portion 3, the durometer type A hardness specified in JIS K6253 is in the range of 50 ° to 90 °. preferably in the range of 50° to 70°.
As a method for adjusting the hardness of the stretched portion 3 so as to obtain a desired hardness, a method commonly used in this field may be used, for example, a method of increasing the thickness of the stretched portion 3 itself. mentioned.

When the oral cavity insertion device 1 is attached to the user, the extending portion 3 is present in the user's oral cavity, so the extending portion 3 may be coated with a biocompatible substance. The substance and its coating method are the same as those described for the base portion 2 above.

In addition, the extended portion 3 may have a rounded side surface at the tip in order to prevent injury to the user when the user wears the oral cavity insertion device 1 .

<Slit>
The extension part 3 has a slit (opening) 7 in a part thereof, as shown in FIG.

The slit 7 may be present at a position that can reduce the area of contact between the extended portion 3 and the user's tongue (for example, the front tongue) when the oral cavity insertion tool 1 is attached (if provided) good). As a result, when the oral cavity-insertion tool 1 is worn, the contact area between the extended portion 3 and the user's tongue (for example, the front tongue) can be reduced. It can suppress the occurrence of vomiting reflex.

As described above, the slit 7 only needs to exist (or be provided) at a position that can reduce the contact area between the extended portion 3 and the user's tongue (for example, the front tongue). It is preferably present (applied) on the lower surface of the extending portion 3 . As a result, as shown in FIG. 1, the extension portion 3 is divided into the first extension portion 3a and the second extension portion 3b by the slit 7, and when the oral cavity insert 1 is attached, the extension portion 3 and the user can be easily separated. This is because the area in contact with the tongue (for example, the front tongue) can be reduced to the maximum, so that the occurrence of the vomiting reflex due to contact with the tongue (for example, the front tongue) can be suppressed more efficiently.
In this case, as shown in FIG. 3, the slit 7 is defined by a boundary line 8 connecting the center of the base portion 2 and the lower end of the first extending portion 3a, the center of the base portion 2 and the second extending portion 3b. The slit angle 10 formed by the boundary line 9 connecting the lower end is usually 30 degrees to 70 degrees, preferably 50 degrees to 65 degrees, more preferably 55 degrees to 60 degrees. It will happen.

As described above, the slit 7 may have any shape as long as it can reduce the contact area between the extending portion 3 and the user's tongue (for example, the front tongue). For example, as shown in FIG. be done. However, other shapes (for example, polygons such as triangles and pentagons, circles, combs, etc.) may be used instead of the shapes shown in FIG.

As shown in FIGS. 1 and 2, the slits 7 are present (provided) in the entire lateral direction of the extending portion 3 (that is, the length in the direction from the outside of the oral cavity to the inside of the oral cavity). This aspect is preferable from the viewpoint of reducing the area in contact with the user's tongue (for example, the front tongue), but the slit 7 may be present in a part of the extension part 3 (even if it is good). In addition, the slit 7 may be present in the lateral direction of the extending portion 3 (i.e., the length in the direction from the outside of the oral cavity to the inside of the oral cavity) to the inner portion 6 that constitutes the base portion 2 ( may have been applied).

[Method for using the oral cavity insert of the present invention]
A method for using the oral cavity insert of the present invention will be described below with reference to FIG.
The oral cavity insert of the present invention is used by inserting it into the user's mouth, as shown in FIG. Therefore, the oral cavity-insertion tool of the present invention may be in the form of a mouthpiece or the like, for example.

The oral cavity insertion device of the present invention can be used for various purposes, and is usually used for detecting the presence or absence of sleep apnea syndrome, treating sleep apnea syndrome, securing airways in emergency situations, and the like. Preferably, it is used for detecting the presence or absence of sleep apnea syndrome, or for treating sleep apnea syndrome, and more preferably for detecting the presence or absence of sleep apnea syndrome.

Specifically, the treatment of sleep apnea syndrome is preferably treatment of obstructive sleep apnea syndrome, and examples thereof include CPAP therapy. A specific method can be implemented by referring to the methods described in Patent Documents 1 and 2, for example.

Specifically, it is preferable to detect the presence or absence of obstructive sleep apnea syndrome, and the preferred method is the NEP method. A specific method can be implemented, for example, by referring to the method described in Non-Patent Document 2. One example is NEP, which generates negative pressure in a respiratory function measuring device such as an expiratory flow rate measuring device or a spirometer. A device equipped with a unit is prepared, the oral cavity insert is inserted into the user's oral cavity, and if necessary, the device and the oral cavity insertion device are connected via an air tube. Next, negative pressure is applied from the device to the oral cavity of the user, and the presence or absence of obstructive sleep apnea syndrome is detected based on changes in the expiratory flow rate at that time.

Here, as an example of how to use the oral cavity insertion device of the present invention, detection of the presence or absence of obstructive sleep apnea syndrome by the NEP method will be described below.

Specifically, as shown in FIG. 4, first, the user's tongue 11 is positioned below the extending portion 3, and the oral cavity insert 1 is placed in the user's oral cavity so that the extending portion 3 and the upper portion of the user's tongue 11 are in contact with each other. insert inside. The oral cavity insertion device 1 is fixed by the force of sandwiching the base portion 2 between the upper and lower teeth 13 of the user and the extension portion 3 being supported by the upper portion of the user's tongue. This allows the user to ventilate through the air opening 4 by mouth breathing.

Next, as described above, a device (not shown) equipped with a NEP unit that generates negative pressure in a respiratory function measuring device such as an expiratory flow rate measuring device or a spirometer is connected to the air opening 4 of the oral cavity insert 1 . At this time, if necessary, both may be connected via an air tube (not shown) or the like. After that, negative pressure is applied from the device to the user's oral cavity, and the presence or absence of obstructive sleep apnea syndrome is detected based on changes in the expiratory flow rate at that time.

Here, the oral cavity insertion device 1 inserted into the oral cavity of the user prevents the occurrence of vomiting reflex due to contact with the front tongue by the extending portion 3 and the slit 7 thereof, and deforms the tongue 11 toward the soft palate 12. can be suppressed. In addition, deformation of the soft palate 12 in the direction of the tongue 11 when the negative pressure is applied can be suppressed, whereby the airway is blocked by the deformation of the soft palate 12 and the tongue 11 when the negative pressure is applied. can be prevented.

Hereinafter, the embodiments of the present invention will be described in more detail with reference to Examples, but the scope of the present invention is not limited by these.

[Example 1: Verification of the effect of the oral cavity insert of the present invention]
The presence or absence of false positives in the NEP method using the oral cavity insert of the present invention was verified.

Here, before explaining the experimental method, results, etc., the principle of the NEP method will be explained in detail using FIG. As described in the Background Art section and the Usage Method section above, the NEP method is a technique used to detect the presence or absence of obstructive sleep apnea syndrome.

Specifically, when the subject wakes up during the day, negative pressure is applied at the same timing as the subject starts exhalation, and changes in the exhalation flow rate after that are observed.
More specifically, when suffering from obstructive sleep apnea syndrome, as shown in A of FIG. There is a large reduction in expiratory flow due to stenosis or airway obstruction. On the other hand, in healthy subjects not suffering from obstructive sleep apnea syndrome, as shown in FIG. Because airway narrowing and airway obstruction do not occur, there is no significant decrease in expiratory flow. Then, it is determined whether or not the subject is suffering from obstructive sleep apnea syndrome based on the difference in temporal changes in the expiratory flow rate.

<Experimental method>
With reference to the NEP method described in Non-Patent Document 2, the effect of the oral cavity insert of the present invention was verified.
Specifically, with reference to the experimental conditions described in Non-Patent Document 2 (negative pressure load (hereinafter sometimes referred to as negative pressure suction) conditions, equipment configuration, etc.), two subjects A and B ( The NEP method using the oral cavity insertion device of the present invention was performed on 2 healthy subjects who have not suffered from obstructive sleep apnea syndrome in the past to the present, and the presence or absence of false positives was verified.
The same experiment was conducted three times for Subject A, and the results are shown in FIG. Further, the same experiment was conducted three times for each subject B, and the results are shown in FIG.

As explained in the above NEP method, both subjects A and B are healthy subjects, so the change in expiratory flow rate when the NEP method is performed is as shown in FIG. 5B. is ideal (ie, once expiratory flow reaches a peak, there is no significant subsequent decrease in expiratory flow).

<Verification result>
As a result of the above experiment, as shown in FIGS. 6 and 7, an ideal result (ie, once the expiratory flow reaches a peak, the expiratory flow does not decrease significantly thereafter) was obtained.
That is, in subject A, after the negative pressure was applied, the expiratory flow rate reached a peak, and a significant decrease in the expiratory flow rate was not observed thereafter. Therefore, it was possible to determine that Subject A was a healthy subject who did not suffer from obstructive sleep apnea syndrome. Further, according to Subject A, when using the oral cavity insertion device of the present invention, he did not feel any discomfort and no vomiting reflex was confirmed.
In subject B, the expiratory flow rate once reached a peak after negative pressure was applied, and no significant decrease in the expiratory flow rate was observed thereafter. Therefore, it was possible to determine that Subject B was a healthy subject who did not suffer from obstructive sleep apnea syndrome. Further, according to Subject B, when using the oral cavity insertion device of the present invention, he did not feel any discomfort and no vomiting reflex was confirmed.
Therefore, in Example 1, occurrence of false positive was not confirmed in detecting the presence or absence of obstructive sleep apnea syndrome.

[Comparative Example 1: Verification of effect of oral cavity insert of Non-Patent Document 3]
The presence or absence of false positives in the NEP method using the oral cavity insertion device of Non-Patent Document 3 was verified.

<Experimental method>
With reference to the NEP method described in Non-Patent Document 2, the effect of an oral cavity insert having a shape similar to that of Non-Patent Document 3 was verified.
Specifically, under the same experimental conditions as in Example 1, the same subjects A and B as in Example 1 (2 healthy subjects who have not suffered from obstructive sleep apnea syndrome in the past or present) ), the NEP method was performed using an oral cavity insertion tool having a shape similar to that of Non-Patent Documents 3 and 4, and the presence or absence of false positives was verified.
The same experiment was conducted three times for Subject A, and the results are shown in FIG. Similar experiments were conducted three times for each subject B, and the results are shown in FIG.

As explained in the above NEP method, both subjects A and B are healthy subjects, so the change in expiratory flow rate when the NEP method is performed is as shown in FIG. 5B. is ideal (ie, once expiratory flow reaches a peak, there is no significant subsequent decrease in expiratory flow).

<Verification result>
As a result of the above experiment, as shown in FIGS. 8 and 9, the ideal result as in Example 1 (that is, once the expiratory flow rate reaches a peak, the expiratory flow rate does not significantly decrease thereafter) was not obtained. I didn't.
That is, in subject A, after the negative pressure was applied, the expiratory flow rate once reached a peak, after which a significant decrease in the expiratory flow rate was observed. Therefore, it could not be determined that Subject A was a healthy subject who did not suffer from obstructive sleep apnea syndrome.
In subject B, the expiratory flow rate once reached a peak after the negative pressure was applied, and the expiratory flow rate decreased sharply thereafter. Therefore, it was not possible to determine that Subject B was a healthy subject who did not suffer from obstructive sleep apnea syndrome.
This is because, due to the structure of the oral cavity insertion device of Comparative Example 1 (that is, the oral cavity insertion device of Non-Patent Document 3), when negative pressure is applied, the airway narrows due to the tongue and soft palate falling into the pharynx. It is thought that the narrowing of the airway has occurred due to the deformation of the tongue and soft palate.
Therefore, in Comparative Example 1, occurrence of false positives was confirmed in detecting the presence or absence of obstructive sleep apnea syndrome.

From the above Example 1 and Comparative Example 1, by using the oral cavity insert of the present invention, the occurrence of false positives in the NEP method can be reduced, so the presence or absence of obstructive sleep apnea syndrome can be detected with high accuracy. I found out.

Further, in Example 1, subjects A and B did not feel any discomfort when using the oral cavity insert of the present invention, and no vomiting reflex was observed. As is clear from this, according to the oral cavity insertion device of the present invention, since the vomiting reflex does not occur, it was also found that the presence or absence of obstructive sleep apnea syndrome can be detected without causing discomfort.
Further referring to this point, the detection accuracy of the presence or absence of obstructive sleep apnea syndrome is evaluated for the oral cavity insertion tool used for detecting the presence or absence of conventional obstructive sleep apnea syndrome such as Non-Patent Documents 3 and 4. If you try to improve it so that the tongue and soft palate do not deform when negative pressure is applied (for example, by stretching the base part in the present invention), it will cause a vomiting reflex. The inventors have found. That is, the present inventors have found for the first time that there is a trade-off relationship between accurately detecting the presence or absence of obstructive sleep apnea syndrome and causing the vomiting reflex. Therefore, it can be said that the oral cavity insertion device of the present invention that satisfies both of these (that is, solves this trade-off relationship) will greatly contribute to the detection of the presence or absence of obstructive sleep apnea syndrome.

[Variation]
Although the embodiment of the present invention has been described above, the present invention is not limited to this and can be modified as appropriate without departing from the technical idea of the invention.

<<First modification>>
The extension 3 has been described based on the shape shown in FIGS. 1 to 3, but as shown in FIGS. may be provided.

As shown in FIGS. 10 and 11, the notch 14 is present (applied) below the tip of the extension 3 (mandibular side), and the notch 15 is located at the tip of the extension 3. It is present on the upper side (upper jaw side) of the As a result, contact with the base of the user's tongue (specifically, swelling of the base of the tongue) can be avoided when the oral cavity insertion tool 1 is worn, and vomiting reflex caused by the contact can be prevented. In addition, obstruction of the airway due to deformation of the soft palate and tongue can be prevented by inhibiting deformation of the soft palate when negative pressure is introduced.

As described above, the notch 14 only needs to exist to the extent that it can avoid contact with the base of the user's tongue (it only needs to be provided). 10 and 11, and other shapes (polygons such as triangles and squares, ovals, etc.). preferable.

The length of the notch end 15 in the horizontal direction (that is, the length in the direction from the outside of the oral cavity to the inside of the oral cavity) is such that the extension 3 does not touch the user's soft palate. Also, the length of the extending portion 3 in the vertical direction (that is, the length in the direction connecting the maxillary side and the mandibular side) is such that the extending portion 3 does not come into contact with the user's soft palate. As an example, the longitudinal length of the notch end 15 (that is, the length in the direction connecting the maxillary side and the mandibular side) corresponds to the longitudinal length of the extension portion 3 (that is, the maxillary side and the mandibular side). 1/3 to 1/2 of the length in the direction connecting the side).

In addition, it is preferable that the notch end 15 has rounded side surfaces at the tip in order to prevent injury to the user when the user wears the oral cavity insertion device 1 .

<<Second Modification>>
Although the base portion 2 has been described based on the shapes shown in FIGS. 1 to 3, the base portion 2 may be provided with a shield portion 16 as shown in FIGS.

The shield part 16 may be formed on the base part 2, and it is preferable to determine the position of the shield part 16 based on the oral cavity condition of the user.

The shield part 16 has a predetermined height such that it overlaps the teeth and/or gums when positioned between the user's lips and teeth when the user wears the oral cavity-insertion device 1. , teeth and gums.

In addition, as shown in FIG. 13, the shield part 16 may have shield part notches 18 in its upper part (upper jaw side) and lower part (lower jaw side). In FIG. 13, as an example, the shield part notch 18 exists in the upper part (maxillary side) and the lower part (lower jaw side) of the shield part 16, but it exists only in one of them. good too. This avoids contact between the shield 16 and the upper lip frenulum that exists between the user's gums and teeth.

Examples of materials that constitute the shield part 16 include paper, elastomers, plastics, etc., and elastomers are preferable. Examples of the elastomer include thermosetting elastomers such as urethane rubber, silicone rubber, and fluororubber, polystyrene elastomers, olefin/alkene elastomers, polyvinyl chloride elastomers, polyurethane elastomers, polyester elastomers, and polyamide elastomers. Thermosetting elastomers are preferred from the viewpoint of biocompatibility, biosafety, moldability, etc. Among them, silicone rubber is more preferred. Moreover, the shield part 14 may have any hardness as long as it is soft enough to fit the user's mouth.

By providing the shield part 16 as described above, air leakage can be prevented when the user wears the oral cavity insertion device 1 .

<<Third modification>>
Although the extending portion 3 has been described based on the shapes shown in FIGS. 1 to 3, the extending portion 3 may have a connecting portion 17 as shown in FIG.

As shown in FIG. 12, the connecting part 17 is positioned so as to connect the first extending part 3a and the second extending part 3b divided by the slit 7. As shown in FIG. Further, the other physical shape (length, thickness, etc.) of the connecting portion 17 may be appropriately determined according to the shape of the extended portion 3 and the notched end portion 15 . Although the notch 14 is present in FIG. 12, the connecting portion 17 may be provided even if the notch 14 is not present. In that case, as shown in FIG. A connecting portion 17 may be provided so as to connect the tips of the 3.

Examples of the material forming the connecting portion 17 include paper, elastomer, plastic, etc., and elastomer is preferable. Examples of the elastomer include thermosetting elastomers such as urethane rubber, silicone rubber, and fluororubber, polystyrene elastomers, olefin/alkene elastomers, polyvinyl chloride elastomers, polyurethane elastomers, polyester elastomers, and polyamide elastomers. Thermosetting elastomers are preferred from the viewpoint of biocompatibility, biosafety, moldability, etc. Among them, silicone rubber is more preferred. Moreover, the hardness of the connecting portion 17 may be any as long as the shape of the extending portion 3 can be appropriately maintained.

When the user wears the oral cavity-insertion tool 1, the connecting part 17 is present in the oral cavity, so the connecting part 17 may be coated with a biocompatible substance. The substance and its coating method are the same as those described for the base portion 2 above.

In addition, the connection part 17 may have a rounded side surface at the tip in order to prevent injury to the user when the user wears the oral cavity insertion device 1 .

By providing the connecting portion 17 as described above, the shape of the extending portion 3 can be properly maintained even when the extending portion 3 receives force from the user's soft palate or tongue.

<<Fourth Modification>>
In the above <<base portion>>, as the shape of the base portion 2, as shown in FIGS. 1 and 2, a circular shape has been described, but the shape is not limited to this. For example, it may be polygonal, star-shaped, leaf-like, or the like. In particular, in the case of a polygon, it can be a triangle, quadrangle, pentagon, hexagon, heptagon, octagon, etc., and in the case of a quadrangle, it can be, for example, a rectangle or a square.

<<Fifth Modification>>
The inner part 6 has been described based on the shape shown in FIGS. 1 and 2, but as shown in FIG. It is good also as the structure cut diagonally so that it may not contact. With such a shape, the inner portion 6 has an inner notched end portion 19 as shown in FIG.

<<Sixth Modification>>
Although the base portion 2 has been described based on the shape shown in FIGS. 1 and 2, the inner portion 6 forming the base portion 2 may be provided with a depression (concave) 20 as shown in FIGS. In FIGS. 14 and 15, as an example, the recess (concave) 20 is provided in the inner portion 6 that constitutes the base portion 2, but it may be provided in the outer portion 5 that constitutes the base portion 2. to the inner portion 6. In addition, in FIGS. 14 and 15, the depression (concave) 20 is shown as an example, but the present invention is not limited to this, and may be, for example, a projection (convex). This allows the user to stably mount the oral cavity insertion tool 1 . Moreover, when the user wears the oral cavity insertion tool 1, it can be used as an aid for determining the length of insertion of the oral cavity insertion tool 1 into the oral cavity.

[Kit for detecting the presence or absence of sleep apnea syndrome of the present invention]
A kit for detecting the presence or absence of sleep apnea syndrome of the present invention (hereinafter sometimes abbreviated as the kit of the present invention) comprises an oral cavity insert according to an embodiment of the present invention and an expiratory flow rate measuring device. includes. The kit of the present invention may contain a negative pressure load device (negative pressure suction device) in addition to the above. Furthermore, the kit of the present invention includes a method for using the oral cavity insertion device of the present invention, the principle of a method for detecting the presence or absence of sleep apnea syndrome such as the NEP method, the operation procedure, the determination procedure, etc. substantially by text or diagrams. may include instruction manuals, attachments, pamphlets, leaflets, etc.
Needless to say, the oral cavity-insertion device in the kit of the present invention includes not only the oral cavity-insertion device according to the first embodiment of the present invention, but also the oral cavity-insertion device according to another embodiment of the present invention. stomach.

The breath measurement device may be any device that can measure the user's breath, mouth pressure, etc. Specifically, for example, a respiratory function measurement device such as a spirometer. Further, the negative pressure application device may be any device as long as it can apply negative pressure to the oral cavity of the user. is mentioned.

The kit of the present invention is used for detecting the presence or absence of sleep apnea syndrome, preferably for detecting the presence or absence of obstructive sleep apnea syndrome. As a method for detecting the presence or absence of obstructive sleep apnea syndrome, the above-described NEP method is preferable.

According to the kit of the present invention, the presence or absence of sleep apnea syndrome can be detected with high accuracy and simplicity.

The oral cavity insert of the present invention is useful for detecting the presence or absence of obstructive sleep apnea syndrome, including the NEP method.

1: Oral insert 2: Base part 3: Extension part 3a: First extension part 3b: Second extension part 4: Air port part 5: Outer part 6: Inner part 7: Slit 8: Boundary line 9: Boundary line 10 : Slit angle 11: Tongue 12: Soft palate 13: Teeth 14: Notch 15: Notched edge 16: Shield part 17: Connection part 18: Shield notch 19: Medial notched edge 20: Indentation

Claims (19)

1. An oral cavity insert that is inserted into a user's oral cavity,
   a cylindrical base portion having an air port penetrating through the base portion;
   an extending portion extending in the longitudinal direction from the end of the base portion, the extending portion having a slit in a part of the extending portion;
   An oral cavity insert comprising:
2. 2. The oral cavity insert according to claim 1, further comprising a notch at the distal end of said extending portion.
3. 3. The oral insert according to claim 2, wherein the shape of the notch is a quadrant.
4. 4. Any one of claims 1-3, further comprising a shield portion having a predetermined height such that it overlaps the user's teeth and/or gums when positioned between the user's lips and teeth. oral insert.
5. The oral cavity insert according to any one of claims 1 to 4, wherein the slit is present on the lower surface of the extending portion.
6. The oral cavity-insertion device according to any one of claims 1 to 5, wherein the slit has a rectangular shape.
7. Further, the extending portion is divided into a first extending portion and a second extending portion by the slit, and has a connecting portion connecting the first extending portion and the second extending portion. 1. Oral-insertion tool according to item 1.
8. 8. The oral cavity insert according to claim 7, wherein the connecting portion has rounded sides.
9. The oral cavity insert according to any one of Claims 1 to 8, wherein the air port is circular.
10. The oral cavity insert according to any one of claims 1 to 9, wherein the extending portion extends from the lower side of the base portion.
11. The oral cavity-insertion device according to any one of claims 1 to 10, wherein the base portion and the extension portion are made of the same material.
12. 12. An oral insert according to claim 11, wherein said material is a thermoset elastomer.
13. The oral cavity insert according to any one of claims 1 to 12, which is used for detecting the presence or absence of sleep apnea syndrome.
14. 14. The oral cavity insert according to claim 13, wherein the detection of presence or absence of sleep apnea syndrome is detection of presence or absence of obstructive sleep apnea syndrome.
15. 15. The oral cavity insertion device according to claim 14, wherein the presence or absence of obstructive sleep apnea syndrome is detected using a negative expiratory pressure method.
16. A kit for detecting the presence or absence of sleep apnea syndrome, comprising the oral cavity insert according to any one of claims 1 to 15 and an expiratory flow rate measuring device.
17. 17. The kit of Claim 16, further comprising a negative pressure load device.
18. 17. The kit according to claim 16, wherein detecting the presence or absence of sleep apnea syndrome is detecting the presence or absence of obstructive sleep apnea syndrome.
19. 19. The kit according to claim 18, wherein the presence or absence of obstructive sleep apnea syndrome is detected using a negative expiratory pressure method.
    

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