A device and method for the development of pharyngeal muscles

Abstract

An exercise device (1) is provided in the present disclosure. The device (1) comprises a body (10) having a contact surface (11), size and shape adapted to provide mechanical contact with one or more of the soft palate, the lingula, the palatal tonsil, the lingual tonsil and the pharynx when inserted into a user' s mouth along a main axis (A). The present disclosure further provides a method for developing pharyngeal muscles by use of such a device (1).

Description

[0001] A DEVICE AND METHOD FOR THE DEVELOPMENT OF PHARYNGEAL MUSCLES

[0002] Technical field

[0003] The present disclosure relates to an exercise device for the development of pharyngeal muscles and a method for this purpose .

[0004] State of the art

[0005] Sleep apnea is caused by a narrowed area in the trachea and thus inadequate airflow, resulting in the relaxation of the muscles surrounding the tongue base and the trachea during sleep in the supine position . Proposed solutions based on the use of device or surgery are aimed at reducing the narrowing that occurs after relaxation, rather than preventing the relaxation of the relevant muscles .

[0006] Various approaches to cope with sleep apnea are described in a review article by Gottlieb and Punj abi ( Gottlieb , D . J . and Punj abi , N . M . , 2020 . Diagnosis and management of obstructive sleep apnea : a review . Jama , 323 ( 14 ) , pp . 1389-1400 ) . These include the use of devices , surgical methods and exercisebased approaches . Each of the current approaches presents various limitations and challenges .

[0007] Solutions for the use of device fall into two main classes including CPAP and intraoral apparatus . CPAP devices can be uncomfortable and noisy, leading to poor compliance . Intraoral apparatus is not effective for everyone and can cause j aw discomfort in long-term use . An example of a device for activating nasal muscle groups is described in WO 2020 / 245482 Al document . Solutions for the use of the device can lead to a ris k of pneumonia when applied for long time ; this is particularly valid in the cases when the device is used to compress air into the user ' s lungs . Surgical solutions are generally interventional and carry associated risks .

[0008] US 2006 / 0124137 Al document can be shown as an example of exercise-based approaches . US 2015 / 0182373 Al document describes a device for oral exercises , NL 2004434 C2 document describes an oropharyngeal exercise device . US 2005 / 0263152 Al document describes an isometric exercise approach . Exercisebased solutions do not utilize the body ' s natural reflexes ; moreover , they are difficult to implement and require various types of exercises for short durations . Common exercise-based solutions are therefore insufficient to form sufficient muscle tone over time to eliminate sleep apnea .

[0009] Brief Description of the Invention

[0010] The main obj ect of the present disclosure is to remove the def iciencies in the state-of-the-art . Another obj ect of the present disclosure is to provide a device and method for increasing pharyngeal muscle tone . These obj ects are achieved by virtue of the set of elements disclosed in the appended independent claims .

[0011] The throat exerci se apparatus provided by the present disclosure presents a potentially novel and non-invasive approach to managing snor ing and sleep apnea . The development of fered by the present disclosure provides a more comfortable and accessible solution for people suffering from sleep apnea and / or snoring, without the need to use any apparatus during sleep , overcoming the limitations of known solutions .

[0012] The known exercise-based systems aim to improve the tone of various muscles in the throat area . The development provided by the present disclosure gives a different approach in terms of the natural gagging reflex to activate the relevant muscles . The present development additionally allows focusing on only one type of exercise over a relatively long time , thereby helping to obtain and maintain a high muscle tone over t im.e .

[0013] The development of the present disclosure differs from the prior art in terms of increasing pharyngeal muscle tone and increasing airway passage volume . In the present disclosure , a simple device that can be used at any time of the day is provided . The increased airf low volume improve s the sleep quality as the device helps prevent airway obstruction during s leep . Apart from snoring and sleep apnea, the device is also suitable to be used by vo cal artists who want to increase their voice level and improve their vocal utilization . The dimensions of the device can -ho K_. adapted according to parameters such as the gender of the user and the size of the oral cavity .

[0014] When the device is in use , it implement s a passive form of exerci se that. can help improve pharyngeal muscle tone by triggering the gagging ref lex . The fact that the exercise provided by the device is a passive exercise allows the exercise to be sustained for a relatively long' time , e . g . ten minutes , thereby allowing' for a more lasting' improvement in muscle tone compared to active exercises that can be performed for a relatively short duration such as tongue exercises . The improvements provided by the device and related method can be tracked by monitoring the sleep of the user, for example in a sleep laboratory and / or with one or more portable and / or wearable tracking devices .

[0015] The present invention is exemplified for the purpose of better understanding in the figures , brief descriptions of which are annexed below, said examples are only illustrative of the configurations of the present invention, and do not limit other configurations and general functions that provide the solution of the technical problem.. Figure 1 is a schematic perspective view of an example device configuration within the scope of the present disclosure.

[0016] Figure 2 is a schematic perspective view of another exemplary device configuration within the scope of the present disclosure; wherein the body of the device is provided with one or more air passage ducts .

[0017] Figure 3 is a schematic perspective view of another exemplary device configuration within the scope of the present disclosure; wherein the device is equipped with an exemplary pump .

[0018] Figure 4 is a schematic perspective view of another exemplary device configuration within the scope of the present disclosure; wherein the device is equipped with one or more electrodes and a control unit.

[0019] Detailed description

[0020] Referring to the figures briefly described above, an exercise device (1) is presented in the present disclosure. A schematic perspective view of an exemplary device configuration within the scope of the present disclosure is provided by Figure 1. The device (1) comprises a body (10) having a size and shape suitable for insertion into the mouth of a user in accordance with a main axis (A) - The placement of the body (10) in the mouth of a user may be regarded as the device (1) being in use in the context of the present disclosure.

[0021] When placed in the user's mouth, the body (10) comprises a contact surface (11) adapted to make mechanical contact with one or more of the soft palate , small tongue (i.e., uvula) , palatal tonsil (i.e., palatine tonsil) , lingual tonsil, and pharynx .

[0022] Therefore, when the device (1) is in use, the contact surface (11) mechanically contacts one or more of the aforesaid anatomical elements and the pharyngeal reflex is inevitably triggered. As the pharyngeal reflex is triggered, the pharyngeal muscles are activated and developed; i.e. the tonus of the pharyngeal muscles is increased by regular use of the device (1) . In this way, the device (1) provides a solution that can be used while awake and facilitates breathing by widening the airflow pathway. In addition to alleviating and even eliminating sleep apnea and snoring problems, the solution provided by the present disclosure is also suitable for improving the performance of vocal artists and athletes, as it allows the airflow pathway to be kept wide and controlled .

[0023] The body (10) may have an egg-shaped geometry in general appearance. A construction material of the body (10) and / or the contact surface (11) may comprise or consist of silicone suitable for medical use (e.g., a silicone copolymer according to the present disclosure) . For example, the contact surface (11) may comprise or consists of silicone suitable for medical use .

[0024] The fact that the construction material of the body (10) comprises silicone enables a flexible (i.e. non-rigid) body (10) . Such a device (1) can be considered suitable for use by users with different oral anatomies. In this way, devices (1) that are geometrically uniform in size and shape can be used by different users; production and logistics can be simplified and related costs can be kept low. It is possible to produce the silicone-containing body (10) with various Young's modulus values; the stiffness of the construction material can be measured using a Shore durometer as a relative measure of flexibility.

[0025] It is preferred that the contact surface (11) has as low a roughness as possible to avoid irritation of the mucosa and surrounding tissues during long term and / or frequent use.

[0026] In one configuration of the device (1) , the body (10) is provided with an extension (12) which extends outwardly from the mouth when in use. For example, the extension (12) may be adapted to extend from a distal end of the body (10) in an axial direction relative to the contact surface (11) .

[0027] An exemplary configuration of the device (1) may be provided with one or more alignment elements (13) projecting in one or more radial directions based on the main axis (A) on the extension (12) , In accordance with the description, the alignment element (13) may be generally of a T-shape. When in use, the alignment element (13) can be a measure to prevent the body (10) from becoming lodged in the user’s throat by resting against the user's teeth (e.g. incisors) , either externally or internally. The extension (12) may be regarded as accommodating the alignment element (13) . The schematic illustrations in Figure 1 and Figure 2 present examples of configurations of the device (1) equipped with an alignment element (13) .

[0028] In an exemplary configuration of the device (1) , the alignment element (13) is adapted to be slidable and fixable along the main axis (A) (i.e. axially) on the extension (12) . In such a configuration, the preparation of the device (1) for use may comprise the following steps: inserting the body (10) into the mouth such that the extension (12) extends outward from the mouth; sliding the alignment element (13) on the extension (12) along the main axis (A) towards the body (10) and resting it against the outer / front side of the user's teeth; thereby preventing swallowing by limiting the movement of the body (10) along the main axis (A) from the mouth to the inside during use.

[0029] The configurations shown in Figure 1 and Figure 2 provide an exemplary device (1) provided with an alignment element (13) comprising an exemplary button (131) configured to, when activated (e.g., pressed) , allow the alignment element (12) to slide on the extension (12) along the major axis (A) and, when deactivated (e.g., released) , allow" the alignment element (12) to be axially fixed on the extension (12) . Thanks to the slidable alignment element (13) , the device (1) can be regarded as having an adaptable dimension in the direction of the main axis (A) according to various oral depths. In other words, the device (1) according to this configuration is suitable for oral structures with different anatomical p r o p o r t i o n s .

[0030] An exemplary configuration of the device (1) is provided with one or more gripping elements (14 ) on the extension (12) . For example, the gripping element (14) may be in the form of a ring. The gripping element (14) facilitates the removal of the body (10) after use by pulling it outwardly from the mouth in the direction of the main axis (A) . A device (1) of the present disclosure, which is equipped with an exemplary gripping element (14) is illustrated in Figure 1.

[0031] Figure 3 is a schematic perspective view of another exemplary configuration of the device (1) of the present disclosure; wherein the device is equipped with an exemplary pump (15) . Referring to Figure 3, in an exemplary configuration of the device (1) , the body (10) may have a flexible structure, and the body (10) may have a hollow" geometry. In such a configuration, it can be said that the body (10) may be adapted to be inflatable. A pump (15) adapted to inflate the body (10) by sending air into and deflating the body (10) by drawing air out of the body may be located on the extension (12) . For use of such a configuration, the body (10) may be inserted into the mouth in an empty state and inflated for use; after use, air may be purged from the body (10) , after which the body (10) may be conveniently removed from the mouth. The device (1) according to such a configuration may also be accepted to be compatible with oral structures having different anatomical, proportions.

[0032] Referring again to Figure 1 and Figure 2, one configuration of the device (1) may comprise a convex portion to provide an increased mechanical contact with the palate of the user and a concave portion to provide an increased contact with the tongue of the user when in use, and thus may be adapted to provide a mechanical contact with a higher efficiency. For example, a first side (16) of the body (10) in a radial direction relative to the major axis (A) may be convex and a second side (17) opposite the first side (16) may be concave. Figure 2 is a schematic perspective view of another exemplary device configuration within the scope of the present disclosure; wherein the body of the device is provided with one or more air passage ducts. Referring to Figure 2, in one configuration of the device (1) , the body (10) may comprise one or more air passage ducts (18) adapted to allow air passage in the direction of the main axis (A) - Such a configuration of the device (1) allows mouth breathing when in use .

[0033] Figure 4 is a schematic perspective view of another exemplary device configuration according to the present disclosure, which is provided with one or more electrodes and a control unit. Referring to Figure 4, in one configuration of the device (1) , the contact surface (11) may be provided with one or more electrodes (19) . The said one or more electrodes (19) may be adapted to receive current from one or more batteries. The pharyngeal reflex can be triggered by electric current even in cases where the contact of the contact surface (11) with the relevant anatomical elements does not provide an adequate pharyngeal reflex due to such a configuration.

[0034] Referring again to Figure 4, the device (1) of the present disclosure may be further equipped with a control unit (21) adapted to control one or more of pulse intensity, current intensity, frequency and duration of the current supplied to the electrodes (19) . The frequency of the pharyngeal reflex and the intensity of contraction of the pharyngeal muscles can be controlled due to such a configuration. The present disclosure further provides an exercise method using the device (1) . In the context of the present disclosure, the method provided for developing the pharyngeal muscles comprises inserting a device (1) according to one or more of the configurations described above to the mouth of the user. In other words, the method comprises inserting a device (1) comprising a body (10) having a contact surface (11) , size and shape adapted to provide mechanical contact with one or more of the soft palate, small tongue, palatal tonsil, lingual tonsil and pharynx when placed in a user’s mouth in the direction of a main axis (A) . In such a way, the method allows the pharyngeal muscles to be activated and developed by triggering the gagging reflex.

[0035] A version of the method, which can be regarded as compatible with the use of electrode (19) , may include transmitting electrical impulses through the contact surface (11) to one or more of the soft palate, small tongue, palatal tonsil, lingual tonsil and pharynx. This version of the method allows activating the pharyngeal muscles by electrical stimulation in addition to the natural reflex, besides the exercise efficiency can be adjusted by regulating the intensity, frequency and duration of the impulse.

[0036] A version of the method that may be regarded as compatible with the use of an inflatable body (10) may comprise inflating the body (10) with air after inserting the body into the mouth as preparation for use, and evacuation of air in the body (10) after use.

[0037] Exemplary configuration 1:

[0038] An exemplary configuration of the throat exercise device (1) of the present disclosure for improving pharyngeal muscle tone and reducing the possibility of airway obstruction during sleep comprises a body (10) , which may be made of medical grade silicone and may have a generally egg-shaped geometry. The body (10) may have a smooth contact surface (11) to prevent irritation through abrasion.

[0039] The device (1) may comprise an extension (12) connected at one end to the body (10) , extending in the direction of a main axis (A) and having a generally cylindrical geometry.

[0040] The device (1) may comprise one or more alignment elements (13) projecting in one or more radial directions relative to the main axis (A) on the extension (12) to prevent accidental ingestion of the body (10) . The alignment member (13) may be permanently fixed in an axial alignment located on the extension (12) . Or the device (1) may comprise an alignment element (13) , which may be T-shaped, adapted to be fixed to the teeth, palate or lips for adjusting the length of a portion of the extension (12) that remains in the mouth. The alignment element (13) may be adapted to be fixed on the extension (12) at different distances by sliding it along the main axis (A) , so that the distance between the extension (12) and the body (10) can be adjusted according to the needs of the user. In other words, in such a configuration, the T- shaped alignment element (13) can be adjusted to adapt to different mouth sizes and tooth placements, enabling different users with various mouth depths, mouth structures and tooth placements to each use a single device (1) model, thereby manufacturing and logistics costs are reduced.

[0041] Ei x e mp 1 a r y configuration 2 :

[0042] The body (10) may have a sealed and flexible structure adapted to be inflated by pumping air into it and deflated when the air is drained from it. Therefore, it can be ensured that the volume occupied by the body (10) and its geometrical shape during use are variable / adaptable .

[0043] Exemplary configuration 3:

[0044] The extension (12) may comprise one or more flow pathways (20) to allow air communication with the body (10) along the major axis (A) . The body (10) may comprise one or more air passage ducts (18) adapted to provide fluid communication between said flow pathway (20) and a user's respiratory tract when in use. The flow pathway (20) can also be regarded as a breathing channel .

[0045] Exemplary configuration 4 :

[0046] The device (1) may comprise one or more electrodes (19) which may be arranged on a first side (16) of the body (10) or contact surface (11) corresponding to the palate when in use (e.g. , which may have a convex geometry) , and may be adapted to provide electrical stimulations / pulses / impulses through the electrodes (19) with a current low enough not to cause damage to the user but high enough to trigger the pharyngeal reflex (i.e. , to contract the pharyngeal muscles) . Referring again to Figure 4, said current may be supplied by means of one or more batteries which may be contained in a control unit (21) located on the device (1) , for example at a remote end of the extension (12) compared to the body (10) .

[0047] E x e mp 1 a r y configuration 5 :

[0048] The device (1) may be provided with a timer and / or a biofeedback mechanism, which may be adapted to provide said electrical impulses during a predefined exercise period (e.g. 10 minutes) and preferably to guide the user in this process. E x e mp 1 ary use:

[0049] An exemplary configuration of the presented method for improving pharyngeal muscle tone, i.e. an exemplary use of the device (1) , may comprise the following elements: inserting the body (10) of the device (1) into the mouth; holding the body (10) in the mouth for a predefined exercise duration (e.g. 10 min) ; keeping the contact surface (1) of the device (11) in mechanical contact with one or more of the soft palate, lingula, palatal tonsil, lingual tonsil and pharynx during this process; thus triggering the gagging reflex in / during the exercise period . The use of the device (1) may be repeated, for example, two or three times in a day.

[0050] Taking into account that snoring is not a disease, that monitoring improvements in snoring frequency is not considered a diagnosis, and that improving sleep quality is not a treatment, except for the treatment of apnea, the present disclosure is also directed to monitoring improvements in sleep quality and / or snoring frequency over time through the use of the device (1) .

[0051] Improvements in sleep quality and / or snoring frequency can be tracked by monitoring sleep wherever the user is (e.g. at home) , for example in a sleep laboratory or by one or more portable or wearable tracking devices . In this way, the effects of exercise on the user (i.e. improvement in muscle tone) can be indirectly monitored over a period during which the device (1) is used. The tracking device may be, for example, a wearable tracking device such as a smart bracelet, smart watch, or the like, which can monitor sleep (e.g. sleep stages, depth, and reliability) . The tracking device may also be a portable tracking device that includes a microphone that listens to ambient noise and is adapted to acoustic tracking (e.g. , record snoring overtime during sleep) . The tracking device may also be a combination of a wearable tracking device and a portable tracking device that processes the data received from the device (for example, a smart bracelet or watch and a portable tracking device that runs a mobile application connected to it, records and preferably interprets said records ) .

[0052] Reference Numbers and Descriptions:

[0053] I Device

[0054] 10 Body

[0055] II Contact surface

[0056] 12 Extension

Claims

CLAIMS1. An exercise device (1) comprising a body (10) having a contact surface (11) , size and shape adapted to make mechanical contact with one or more of the soft palate, lingula, palatal tonsil, lingual tonsil and pharynx when inserted into a user's mouth in the direction of a main axis (A) .

2. The device according to claim 1, wherein the body (10) is provided with an extension (12) that extends outward from the mouth when in use.

3. The device according to claim 2, wherein the extension (12) comprises one or more alignment elements (13) projecting in one or more radial directions relative to the main axis (A) .

4. The device according to claim 3, wherein the alignment element (13) is adapted to be axially slidable and fixable on the extension (12) .

5. The device according to any one of claims 2 to 4 comprising one or more gripping elements (14) on the extension (12) .

6. The device according to any one of claims 2 to 5 , wherein the body (10) is inflatable, comprising a pump (15) adapted to inflate the body (10) by sending air to it on the extension (12) and to deflate it by drawing air from the body.

7. The device according to any one of claims 1 to 6, wherein the extension (12) comprises one or more flow pathways (20) to allow air communication with the body (10) along the main axis (A) .

8. The device according to any one of claims 1 to 7 , wherein the body (10) comprises one or more air passage ducts (18) adapted to allow air passage in the direction of the main axis (A) .

9. The device according to any one of claims 1 to 8 , wherein a first side (16) of the body (10) in the radial directionrelative to the main axis (A) is convex and a second side (17) in the opposite direction is concave.

10. The device according to any one of claims 1 to 9, wherein the contact surface (11) comprises one or more electrodes (19) , wherein the electrodes (19) are adapted to receive current from one or more batteries.

11. The device according to claim 10, being provided with a control unit (21) for controlling one or more of pulse intensity, current intensity, frequency and duration of the current supplied to the electrodes (19) .

12. The device according to any one of claims 1 to 11, wherein the contact surface (11) comprises a material suitable for long term and frequent contact with the mucosa.

13. The device according to claim 12, wherein said material contains silicone copolymer.

14. A method for improving pharyngeal muscle, comprising inserting a device into the user's mouth, wherein the device (1) comprises a body (10) having a contact surface (11) , size and shape adapted to provide mechanical contact with one or more of the soft palate, the lingula, the palatal tonsil, the lingual tonsil and the pharynx when placed in a user's mouth in the direction of a main axis (A) .

15. The method according to claim 14 comprising the delivery of electrical impulses through the contact surface (11) to one or more of the soft palate, lingula, palatal tonsil, lingual tonsil and pharynx.

16. The method according to any one of claims 14 or 15 comprising inflation of the body (10) with air after inserting it into the mouth as preparation for use, and air evacuation of the body (10) after use.

17. The method according to any one of claims 14 to 16 comprising tracking improvements in sleep quality and snoring frequency by monitoring the user's sleep.18 . The method according to claim 17 comprising monitoring of sleep in a sleep laboratory .19 . The method according to claim 17 comprising monitoring sleep by means of one or more portable or wearable tracking devices .

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