WO2017135907A1

WO2017135907A1 - Devices and methods for alleviating of obstructive sleep apnea and snoring

Info

Publication number: WO2017135907A1
Application number: PCT/TR2016/050026
Authority: WO
Inventors: Emin Toprak
Original assignee: Emin Toprak
Priority date: 2016-02-04
Filing date: 2016-02-04
Publication date: 2017-08-10

Abstract

The present invention relates to snoring and obstructive sleep apnea prevention devices and methods. A device according to the invention comprises a suction cup (33) adapted to adhere a tongue (25) by vacuum suction, and an anchor (13) integral or coupled to the suction cup (33). The anchor (13) is adapted to fit in, around or outside a mouth (12) portion. During use of the device (11) the anchor (13) is fitted in, around or outside the mouth (12) portion and the suction cup (33) is adhered to the tongue (25). By this way at least part of the tongue (25) is resisted from moving posteriorly to obstruct an airway of a person.

Description

DEVICES AND METHODS FOR ALLEVIATING OF OBSTRUCTIVE SLEEP

APNEA AND SNORING

Technical Field of the Present Invention

The present invention relates to devices and methods for the prevention of obstructive sleep apnea and snoring as a condition in general, which comprises simple snoring as well as unhealthy or harmful snoring.

Background of the Present Invention

Snoring is the vibration of airway tissues and the resulting sound that can be heard as a consequence of obstructed air flow during sleeping. Simple snoring occurs in the case of a partial obstruction of the airway due to the collapse of soft tissues belonging to the throat. In simple snoring, the person is able to maintain adequate breathing since the obstruction is incomplete. The simple snoring is not a health problem but an irritating social problem.

On the other hand, if adequate breathing is not maintained, harmful effects arises, and this clinical situation is called obstructive sleep apnea (OSA). Snoring associated with OSA is called harmful, unhealthy or serious snoring. Airway passage between the pharynx and the tongue is typically maintained in an unobstructed manner when the tongue is retained in its natural position. However, during sleep, since the tongue becomes lax, it may move posteriorly thereby collapsing the posterior wall of the pharynx which, in turn results in snoring and/or OSA. The collapse during snoring and/or OSA usually occurs between the soft palate and/or the back of the tongue and the pharynx; therefore, the treatment of OSA and snoring is usually addressed by preventing this collapse at these throat parts. There is a plurality of different solutions used to reduce the above described snoring and OSA problem. One of them is continuous positive airway pressure (CPAP), which is a method working by opening the obstructed airway with pressurized air. Another solution is mandibular advancement device (MAD), performing by moving the lower jaw anteriorly relative to the upper jaw so that the tongue, which is attached to the lower jaw, moves away from the pharynx.

In consideration of tongue retaining devices, another solution proposes a cavity into which the tip of the tongue is placed such that tongue is prevented from moving posteriorly to the pharynx. Devices of this type retain the tip of the tongue by utilizing a suction device. Still other devices are designed to keep the soft palate anteriorly away from the pharynx. There are also some surgical procedures for prevention of OSA and/or snoring comprising the stiffening of tissues of the airway to reduce the likelihood of the collapse. Other surgical procedures aim to remove or anteriorly position some airway tissues likely to collapse. All of the devices or procedures in the prior art have some drawbacks including treatment failure, side effects, life threatening surgical complications, noncompliance, uncomfortableness, etc. Therefore there is a need to provide devices or methods eliminating some or all of the drawbacks of the prior art. The present invention therefore proposes devices and methods for alleviating snoring as well as the obstructive sleep apnea by way of providing a comfortably usable device during sleep.

A prior art publication in the technical field of the present invention may be referred to as US8074656 B2 among others, the document disclosing an oral device for improving airway patency comprising a tongue constraint and a negative pressure source, where the tongue constraint engages the patient's tongue to maintain a clear region below the palate in an oral cavity. By applying a negative pressure in the clear region, an airway behind the soft palate or tongue of the patient can be maintained. The tongue constraint is usually connected to an anchor. The anchor may be held between the patient's teeth or may engage the inferior surface of the palate. Another oral device for improving airway patency comprises a lateral tongue structure and a negative pressure source.

Objects of the Present Invention

The present invention provides devices and methods for inhibition of simple snoring and obstructive sleep apnea.

Primary object of the present invention is hence to provide snoring and OSA preventing devices and methods which can be applied comfortably during sleep.

Summary of the Present Invention

The present invention is directed to devices and methods for alleviating snoring and obstructive sleep apnea. In one aspect of the invention, devices for alleviating snoring and obstructive sleep apnea may comprise a suction cup and an anchor coupled or integral to the suction cup, where the tongue of a person can be adhered, hold or engaged by the suction cup through negative pressure (vacuum suction), the devices may optionally further comprise a tongue actuator that is able force and move, with a contacting means, a part of a tongue surface within periphery of an aperture of the suction cup.

In a further aspect of the invention, methods for prevention of snoring and obstructive sleep apnea comprise a) adhering a suction cup to a tongue surface, b) fitting or placing an anchor coupled or integral to the suction cup, in, around or outside a mouth portion of a person, the methods may optionally further comprise forcing and moving, with a contacting means, the tongue surface within periphery of an aperture of the suction cup.

The described methods and devices of embodiments of the invention may be used for obstructive sleep apnea (OSA), and for snoring as a general condition comprising: simple and harmful snoring.

Brief Description of the Technical Drawings Accompanying drawings are given solely for the purpose of exemplifying a snoring prevention device whose advantages over prior art were outlined above and will be explained in brief hereinafter.

The drawings are not meant to delimit the scope of protection as identified in the claims nor should they be referred to alone in an effort to interpret the scope identified in said claims without recourse to the technical disclosure in the description of the present invention.

Fig. 1 demonstrates a general sectional view of a mouth and oral cavity of a person.

Fig. 2 demonstrates a schematic block diagram of an exemplary device weared by a person according to one of the preferred embodiments of the present invention.

Fig. 3A to 3C demonstrate general schematic views of an exemplary device as placed on a tongue surface according to one of the preferred embodiments of the present invention.

Fig. 4A to 4C demonstrate general schematic views of an exemplary device and vacuum source according to one of the preferred embodiments of the present invention. Fig. 5 demonstrates a general schematic view of an exemplary device and vacuum source according to one of the preferred embodiments of the present invention.

Fig. 6 demonstrates a general schematic view of plurality of suction cups and vacuum conduit according to one of the preferred embodiments of the present invention.

Fig. 7 A to 7B and 7C to 7D demonstrate general schematic views of a suction cup having a tongue actuator according to one of the preferred embodiments of the present invention.

Fig. 8A to 8D demonstrate general schematic view of a suction cup having a tongue actuator according to one of the preferred embodiments of the present invention. Fig. 9A to 9B demonstrate general schematic views of a suction cup having a tongue actuator according to some further embodiments of the present invention.

Fig. 10A to 10B and 10c to 10D demonstrate general schematic views of a suction cup having a tongue actuator according to one of the still further preferred embodiments of the present invention.

Fig. 11A to 11B and 11C to 11D demonstrate general schematic views of a suction cup having a tongue actuator according to one of the still further preferred embodiments embodiments of the present invention.

The following numerals are assigned to different parts demonstrated in the drawings and referred to in the present detailed description of the invention:

11) Snoring and OSA prevention device

12) Mouth

13) Anchor 15) Connector arm

17) Vacuum source

18) Actuator

19) Contacting means

21) Control unit

23) Oral cavity

24) Pharynx

25) Tongue

26) Hard palate

27) Front teeth

28) Tongue surface

29) Soft palate

30) Back of tongue

31) Roof

32) Side wall

33) Suction cup

34) Aperture

35) Interior space

36) Suction cup connector

37) Vacuum conduit

38) Gate

39) Tip portion

40) Leaf portion

41) Connection rod

42) Lips

43) Flange portion

44) Valve

46) Slot

47) Clamp

48) Spring

51) Membrane 52) Locking means

53) Roof spring

54) Notch

55) Protrusion

56) Protrusion spring

57) Piston

58) Upper division

59) Lower division

60) Fluid gate

61) Pressure sensor

62) Pressure source

63) Platform

64) Planar surface

65) Lead screw

66) Button

67) Platform spring

94) Cylinder

Detailed Description of the Present Invention

Now referring to the technical drawings, Fig. 1 shows sagittal view of a mouth (12) of a person and position of a tongue (25) with respect to oral cavity (23) and pharynx (24). The tongue (25) is a mobile muscular organ that may change its shape and position, for example, during swallowing, speaking, etc. When the mouth (12) is closed and the tongue (25) is in resting position, the tongue (25) occupies essentially the entire oral cavity (23), touching the hard palate (26), soft palate (29) and the back of the front teeth (27). The tongue (25) has a generally flat superior surface, i.e. tongue surface (28). During unobstructed breathing, the tongue (25) has muscular tonus that limits its posterior movement. When that tonus is not enough, the tongue (25) may move posteriorly to the pharynx (24) and obstruct the air flow through the same, causing OSA and/or snoring. In reference to Fig. 1, dashed line 30 shows position of back of the tongue (25) when the latter moved posteriorly. As used herein, "posterior" refers to the direction toward the back of the oral cavity (23), opposite the anterior direction, "anterior" refers to the direction toward the front of the oral cavity (23) or lips (42), "superior" refers to the direction toward the top of the oral cavity (23) (or top of the head), "inferior" refers to the direction opposite the superior direction. Now some exemplary devices and methods and functionality thereof according to the present invention will be described with respect to the technical drawings. In this specification the term "device" refers to a snoring and OSA prevention device and the term "method" refers to a snoring and OSA prevention method.

Fig. 2 demonstrates an exemplary snoring and OSA prevention device (11) weared by a user. The snoring and OSA prevention device (11) comprises a suction cup (33), an anchor (13) and a connector arm (15) coupling suction cup (33) to anchor (13). Although in some embodiments (not shown) there may be no connector arm (15), it allows anchor (13) and suction cup (33) to be positioned separately or remotely to each other. Suction cup (33) as used herein comprises any vacuum or suction port, tube and cup, as long as they are able to adhere the tongue surface (28) by application of negative pressure thereto through an aperture. Although suction cup (33) may be adhered to any part of the tongue by vacuum suction, suction cup (33) is shown adhered to a superior tongue surface (28) of the tongue (25) posterior to the tip portion (39) of the tongue (25) and thereby leaving the tip portion (39) free. By this way, the tip portion (39) of the tongue (25) is not prevented from moving and provides more comfort to the user during use of the snoring and OSA prevention device (11). Additionally the superior surface of the tongue (25) adhered by suction cup (33) can be moved, while the tip portion (39) of the tongue (25) not passing the front teeth (27), to a more anterior position than the position of that part in the resting tongue (25). In other words, the tongue (25) can stay within the mouth (12) while back part of the tongue (25) can be moved anteriorly. In preferable embodiments, suction cup (33) may be placed anterior to and not touching to the soft palate (29) such that suction cup (33) does not elicit gag reflex. Anchor (13) may be adapted to be fitted in, around or external to the mouth. In this embodiment, anchor (13) is shown as having two generally parallel flat leaf portions (40) connected generally at the center by a connection rod (41) such that when anchor (13) is fitted, one leaf oirtion (40) fits between the front teeth (27) and the lips (42), and the other leaf portion (40) fits externally on the lips (42). Leaf portions (40) may have a flat shape and soft texture to be comfortably and stably fitted between the front teeth (27) and the lips (42). Alternatively, the anchor (13) may have only one leaf portion (40) adapted to fit between the front teeth (27) and the lips (42), or to fit externally on the lips (42). Further, anchor (13) may be adapted to fit to the front teeth (27), between upper and lower lips (42), to hard palate (26), to cheeks, to chin, etc. Alternatively, anchor (13) may have two or more fitting regions and each one of the regions is adapted to fit to different structures, e.g., lips (42), front teeth (27), hard palate (26), cheeks and chin. Of importance is not specific shape and size of anchor (13) or the structure it is adapted to fit, but that anchor (13) can be relied on for support or stability for the snoring and OSA prevention device (11) such that it is able to resist or prevents at least a part of the tongue surface (28) adhered by suction cup (33) from moving posteriorly. In embodiments (not shown) in which anchor (13) is placed in a posterior part of the oral cavity (23), e.g., on teeth other than the anterior ones, connector arm (15) may extend generally laterally between suction cup (33) and anchor (13). After device (11) is weared by a user, tongue surface (28) may be resisted moving posteriorly by suction cup (33).

Width of a normal adult tongue (25) at the widest part of the tongue (25) is about 35 to 55 mm and length of the tongue (25) from the tip portion (39) to the rearmost point is about 70 mm to 90 mm. Preferably, suction cup (33) is small enough such that the user comfortably wears the snoring and OSA prevention device (11). The aperture of the suction cup (33) may be sized to be closed or sealed by the superior surface of the tongue (25) alone and the size of suction cup (33) may preferably be too small for insertion of the anterior one third, and more preferably anterior one fourth, of an adult tongue (25). In some preferable embodiments, the aperture of suction cup (33) in its widest part may be less than 40 mm, more preferably less than 30, even more preferably less than 20 mm, and thus the aperture can be closed or sealed by superior surface of the tongue (25) alone and can leave the tip portion (39) of the tongue (25) free. In some preferable embodiment, the aperture of suction cup (33) in its widest part may be more than 5 mm, preferably more than 7 mm and more preferably more than 10 mm. The height of suction cup (33) may be preferably less than 20 mm, more preferably less than 15 mm and even more preferably less than about 10 mm. In a particularly comfortable exemplary suction cup (33), the aperture (34) of suction cup (33) in its widest part is less than about 20 mm, and the height of suction cup (33) is less than about 8 mm. Prior art suction cups for adhering tip portion (39) of the tongue (25) for snoring treatment are generally sized to accommodate at least anterior one third of the tongue (25) for stably adhering the tongue (25); that means, height of more than 20 mm. Also the aperture of these prior art suction cups at its widest part are generally at least 35 mm to 45 mm so as to be able to accommodate the anterior portion of the tongue (25). On the other hand, in embodiments of the present invention, smaller suction cups (33) may be preferable. However, other sizes of suction cup (33) and/or the aperture is contemplated as well. For adhering suction cup (33) to the tongue (25), different levels of vacuum pressure may be used. For small suction cups (33), needed pressure may be at least 160 cm H₂0, more preferably at least 200 cm H₂0, even more preferably at least 300 cm H₂0 and most preferably at least 450 cm H₂0 below the local atmospheric pressure. For relatively large suction cups (33) needed pressure may be in the range from 10 cm H₂0 to 150 cm H₂0 below the local atmospheric pressure.

Fig. 3A and 3B show an exemplary suction cup (33) according to one embodiment of the invention. In this embodiment, suction cup (33) has a roof (31) and a side wall (32) lower end portion of which defines an aperture (34) through which interior space (35) of suction cup (33) communicates with the exterior of suction cup (33). Suction cup (33) is shown to be placed on a generally flat tongue surface (28) in Fig. 3B. When aperture (34) is sealed or closed by the tongue surface (28) and vacuum is developed in the interior space (35) by application of vacuum via a gate (38). The tongue surface (28) responds vacuum suction by slightly moving into the suction cup (33) generally by deflection and tensioning. When vacuum develops within suction cup (33) the tongue surface (28) within the periphery of the aperture (34) under the suction effect may take a generally convex shape as shown in Fig. 3C. Generally, the more vacuum suction power is applied to the tongue surface (28), the more the tongue surface (28) moves into the suction cup (33). A vacuum conduit (37) may be fluidly connecting the interior space (35) of suction cup (33) to a vacuum source (17). At the junction of vacuum conduit (37) and suction cup (33), gate (38) is disposed. Gate (38) is shown disposed on lateral wall and is adapted to provide vacuum to the interior space (35) of suction cup (33) from vacuum conduit (37). Alternatively, gate (38) may be on the roof along the roof (31). In embodiments in which vacuum source (17) is within suction cup (33), there may be no need to gate (38) and vacuum conduit (37). Optionally, lower end of the side wall (32) bends inwardly or outwardly forming a generally horizontal flange portion (43) for enlarging surface area in contact with the tongue surface (28), when the suction cup (33) is adhered to the tongue surface (28). Although some flexibility may be possible, suction cup (33) has preferably sufficient structural strength not to collapse completely onto the tongue surface (28) before vacuum level sufficient to adhere the suction cup (33) to the tongue surface (28) is developed. When vacuum develops within suction cup (33), flange portion (43) and the tongue surface (28) is forced to each other due to higher atmospheric pressure outside and lower vacuum pressure within suction cup (33), resulting in adherence of suction cup (33) to the tongue surface (28). In this technical disclosure, the expression "negative pressure" and the term "vacuum" each refers to a pressure level that is less positive than the reference pressure level, and the reference pressure refers to ambient air pressure unless otherwise specified.

Now referring to Fig. 4, exemplary vacuum transmission routes from a vacuum source (17) to a suction cup (33) is now described. In some embodiments, vacuum source (17) may be external to the snoring and OSA prevention device (11). Vacuum may be transmitted from external vacuum source (17) directly to suction cup (33) by vacuum conduit (37). Vacuum conduit (37) may be disconnectibly connected to the gate (38) of suction cup (33) such that after vacuum application, vacuum conduit

(37) may be disconnected from gate (38), and in these embodiments a controllable valve (44) may be disposed in gate (38) or within suction cup (33) for preventing air inflow to suction cup (33) through gate (38) when vacuum conduit (37) is disconnected from gate (38). Controllable valve (44) may be closed by the user or otherwise. Controllable valve (44) may preferably have a one-way mechanism. In another embodiment shown in Fig. 4B, vacuum conduit (37) may pass on or within anchor (13) and extend between anchor (13) and suction cup (33) coupling anchor (13) to suction cup (33); by this way, vacuum conduit (37) may form connector arm (15). In a variation (not shown), vacuum conduit (37) may extend separately but along with connector arm (15) from anchor (13) to suction cup (33). In another embodiment shown in Fig. 4C, connector arm (15) may have a tubular structure for transmission of vacuum from vacuum conduit (37) to suction cup (33). Tubular connector arm (15) may be disconnectibly connectible to vacuum conduit (37) for transmitting vacuum from vacuum conduit (37) to gate (38) of suction cup (33). Controllable valve (44) may be positioned in anchor (13), tubular connector arm (15), gate (38) or suction cup (33). Preferably, controllable valve (44) may be disposed on a distal end of tubular connector arm (15) as shown in Fig. 4C. Controllable valve (44) may be provided within at least one of anchor (13), gate

(38) , tubular connector arm (15) or suction cup (33) for preventing inflow of air to suction cup (33) via gate (38) after disconnection of the vacuum conduit (37) from device (11). By this way adherence of suction cup (33) to tongue surface (28) continues after disconnection of vacuum conduit (37). In further embodiments, vacuum may be produced within suction cup (33); hence removing the need for vacuum conduit (37).

There are various ways to produce vacuum within the snoring and OSA prevention device (11). For example, in an embodiment (not shown), electrically driven small vacuum pump and a small battery may be provided within the device. Alternatively, the device may have a resilient cavity that is in fluid communication with suction cup (33) and a one-way valve fluidly connecting the interior of the cavity to the exterior, the cavity is pressed and air in the cavity gets out therefrom via the one-way exit valve, thus when the cavity is allowed to relax, vacuum is formed within the cavity. Alternatively, suction cup (33) may be resilient and placed on the tongue surface (28) closing its aperture (34) and suction cup (33) is then pressed to empty air within suction cup (33) through a one-way exit valve; thus when suction cup (33) is allowed to relax, vacuum is formed within suction cup (33). The present invention is devised under the recognition that although suction cups (33) without an exit gate are possible, adherence results are inferior possibly due to soft texture of the tongue since the usual suction cups are known to adhere satisfactorily only to surfaces that are both stiff and smooth. Therefore using exit gate is preferable.

In a further alternative (not shown), a mini vacuum pump may be disposed within suction cup (33) in fluid communication with an exit gate disposed on suction cup (33) such that air or fluid within suction cup (33) may be pumped out via the exit gate to develop vacuum within suction cup (33).

Now referring to Fig. 5, an exemplary device (11) having an anchor (13), a suction cup (33) and a connector arm (15) is shown. Anchor (13) may be fitted to the lips (42) and suction cup (33) may be adhered to superior tongue surface (28) of a tongue (25) posterior to the tip portion (39) of the tongue (25). Anchor (13) is similar to the anchor (13) of Fig. 4 except that it has only one leaf portion (40) adapted to fit externally on the lips (42) or between the lips (42) and teeth (27).

Aperture (34) of suction cup (33) is shown closed or sealed by the superior tongue surface (28) alone. Anchor (13) may be fitted to the lips (42) before or after suction cup (33) is adhered to the superior tongue surface (28) by vacuum suction. Suction cup (33) of the device may be adhered to the superior tongue surface (28) when the tongue (25) is in its extended position and then optionally the tongue (25) may be pulled or retracted by the user to a non-extended position; during the retraction, suction cup (33) may force and move the adhered superior tongue surface (28) anteriorly if the connector arm (15) is short enough. In a variation, suction cup (33) may be adhered to the superior tongue surface (28) when the tongue (25) is in non- extended position and then anchor (13) may be fit to the lips (42), and during this fitting, suction cup (33) and the adhered superior tongue surface (28) may be pulled and moved anteriorly since connector arm (15) may be short enough. Snoring and OSA prevention device (11) may be configured such that anchor (13) is able to remain fitted to the lips (42) (or to another region in, around or outside a mouth portion) while the aperture (34) remains closed by the superior tongue surface (28) alone. The superior tongue surface (28) sealing the aperture (34) preferably does not comprise the tip portion (39) of the tongue (25), thereby the superior tongue surface (28) can be moved, by suction cup (33), to a position more anterior than the position of the superior tongue surface (28) in resting tongue (25), while the tip portion (39) of the tongue (25) is allowed to remain posterior to the anterior teeth (27); that is, the tongue (25) may remain in non-extended position. Tubular connector arm (15) may be formed by and continuum of vacuum conduit (37). Vacuum conduit (37) or tubular connector arm (15) may be slidable within a slot

(46) in anchor (13). The sliding movement may be controlled by an optional clamp

(47) that is able to lock tubular connector arm (15) within anchor (13). Clamp (47) may be turned on and off manually or by an actuator as needed. A further optional feature of the device may be an elastic structure, shown in the form of a spring (48), disposed between anchor (13) and vacuum conduit (37) in the manner that the sliding of tubular connector arm (15) or vacuum conduit (37) causes spring (48) to be compressed, stretched or relaxed. Alternatively or additionally, tubular connector arm (15) may be elastic and/or stretchable. Thereby, position of suction cup (33) relative to anchor (13) may change continuously during use of the device (11) according to the forces acting on spring (48) and/or tubular connector arm (15); and thus allows the tongue's (25) movement and provides comfort. Any elastic structure other than spring (48) may also be used. The stretching or compression of spring (48) and/or tubular connector arm (15) may allow suction cup (33) to move away from anchor (13) an extra length of at least 10 mm, preferably at least 20 mm, more preferably at least 30 mm and most preferably 40 mm compared to the relaxed state of spring (48) or tubular connector arm (15). Preferably tubular connector arm (15) may be able to elastically stretch in longitudinal direction preferably at least 10 %, more preferably at least 20 %, even more preferably at least 50 % and most preferably at least 100 % of the normal length of tubular connector arm (15). The elastic stretching may provide tubular connector arm (15) an extra length of at least 10 mm, preferably at least 15 mm, more preferably at least 25 mm and even more preferably at least 40 mm. In a further variation, connector arm (15) may not be tubular but may be in the form of an inelastic fiber or thread separate from vacuum conduit (37) as in the embodiment of Fig. 4A. In a further embodiment, connector arm (15) may be in the form of an elastic fiber that allows suction cup (33) to move in all directions up to the elastic limit of the fiber. In this embodiment, suction cup (33) may be placed for use in such a way that the distance between fitted anchor (13) and suction cup (33) is longer than the length of the relaxed elastic fiber; hence the elastic fiber tries to shorten, pulling suction cup (33) anteriorly, until its relaxed length is achieved. Therefore, the anterior force applied to suction cup (33) and thus to the adhered tongue surface (28) may be adjusted. For example, the anterior force may be applied a) continuously irrespective of the position of the tongue (25) or the adhered superior tongue surface (28), b) applied only when the adhered superior tongue surface (28) moves posteriorly from its resting position or c) applied only when the tongue is in non-extended position. Therefore, even when the tongue (25) is in non- extended position, the device can alleviate or prevent snoring and OSA. The elastic limit of the elastic fiber may be adjusted such that the tongue (25) may be allowed to move posteriorly during swallowing. After swallowing the tongue (25) is returned to its previous position by the stretched elastic fiber. This embodiment provides excellent comfort. In still further embodiments, the tongue (25) may not be forced anteriorly when the tongue (25) is resting, or when the tongue (25) is in a position not posterior than the resting position of the tongue (25), but may be forced anteriorly when the tongue (25) begins to move posteriorly. This provides comfortable use since the device does not apply force to the tongue (25) when the tongue is not likely to obstruct the airway; in other words, the device does not restrict the tongue (25) movement if the tongue (25) does not move to a more posterior position than the resting position of the tongue (25). To this end, it is to be noted that these arrangements provide comfortability to the user during both placement and use of the device. Although anchor (13) fitting to the lips (42) is described above, other anchor (13) designs may be used as well. For example, anchor (13) may be configured to be placed on the teeth (e.g., on the molar teeth) such that connector arm (15) may extend between anchor (13) and the tongue (25) generally laterally.

The oral cavity (23) have a limited volume; that volume is mostly filled by the soft and mobile tongue (25). According to the present invention, it is found that when the tongue (25) is forced or moved inferiorly away from the palate (26, 29), some part of the tongue (25) moves posteriorly and this posterior movement of the tongue (25) can cause obstruction of the airway. Therefore it is advantageous not to restrict at least some part of the tongue (25), particularly posterior part thereof, from moving superiorly to the palate (26, 29). In an exemplary embodiment, suction cup (33) may be small enough and/or positioned superiorly when the snoring and OSA prevention device (11) is placed for use such that the tongue (25) is able to touch the palate (26, 29). In a further variation, suction cup (33) is configured to be capable of moving superiorly relative to anchor (13). Device may preferably be configured such that during the use thereof, at least some part of the tongue (25) is not restricted from moving to and even touching the palate (26, 29). In another preferable embodiment, during use, device (11) allows the tongue (25) at least in the region of the soft palate (29) such that the tongue (25) is capable of blocking vacuum propagation or passage to the region of the soft palate (29) from a neighboring oral region that is between the tongue (25) and the hard palate (26) even without forcing the tongue (25) superiorly by the user of device. Since the tongue (25) is not restricted inferiorly away from the palate (26, 29), the tongue (25) is able to move superiorly blocking vacuum propagation from an oral region between the tongue (25) and the palate (26, 29) even when the user is not forcing the tongue (25) to move superiorly. In these embodiments, the tongue (25) is not forced inferiorly by the snoring and OSA prevention device (11) to keep a vacuum passage unobstructed between the soft palate (29) and a neighboring oral region that is between the tongue (25) and the hard palate (26). In a particularly practical embodiment, device may comprise: a suction cup (33) having an aperture (34), the suction cup (33) may be adapted to adhere a superior surface of a tongue (25) by vacuum suction of the suction cup (33) and the aperture (34) may be able to be closed by the superior surface of the tongue (25) alone; an anchor (13) coupled or integral to the suction cup (33), the anchor (13) may be adapted to be fitted in, around or outside a human mouth portion; a gate (38), other than the aperture (34), is disposed on the suction cup (33), the gate (38) is able to fluidly connect the interior space (35) of the suction cup (33) to an exterior space such that vacuum can be developed within the suction cup (33) by emptying at least some of prefilled fluid within the suction cup (33) through the gate (38); and a controllable valve (44) disposed within the device (11) for preventing air inflow to the suction cup (33) via the gate (38) and thus maintaining vacuum within the suction cup (33) after disconnection of a vacuum source (17) from the device; the device may be configured such that it is disconnectibly connectible to the vacuum source (17) and the anchor (13) is able to remain fitted in, around or outside the mouth portion while the aperture (34) remains closed by the superior surface of the tongue (25) alone.

Optionally, the snoring and OSA prevention device (11) may have more than one suction cup (33). Referring now to Fig. 6, a plurality of suction cups (33) are shown. Vacuum may be applied to the tongue (25) via these suction cups (33) independently. This may be provided by connecting each of the suction cups (33) to different controllable vacuum sources (17). Alternatively, controllable flow control means such as valves (44) may be provided within suction cups (33) or between the vacuum sources (17) and the suction cups (33) in a way that controls the applied vacuum to suction cups (33) so that vacuum may be turned on and off, increased or decreased as best suits the particular needs. For example, one or more of suction cups (33) may be turned off completely or partially while the other one or more is applying vacuum. By this way, same part of the tongue (25) may be prevented from long lasting exposure to vacuum. Valves (44) may be any type and in anywhere from vacuum source (17) to suction cup (33) so as to control vacuum level within suction cups (33). One or more connectors (36) may connect suction cups (33) to each other and to vacuum conduit (37). Vacuum conduit (37) may extend within connectors (36). Preferably connector (36) may be formed by vacuum conduit (37). Suction cups (33) may be movable relative to each other. The relative movability may be provided, e.g., by elasticity of at least one of suction cups (33), connectors (36), or by movably coupling suction cups (33) to connectors (36). Valves (44) may be in the form of an electrically driven valve, such as a solenoid valve. A control unit (21) electrically connectible with solenoid valves (44) may control vacuum application according to a predefined or arbitrary pattern. The pattern may be changeable to provide optimum comfort to each user. An exemplary pattern may include 3 minute vacuum application followed by 2 minutes decreased vacuum or rest (i.e. not applying vacuum) in turn. When air leaks in one or more of the suction cups (33) decreasing the degree of vacuum and adherence to the tongue (25), the other suction cups (33) may not be affected and continue adhere the tongue (25). It is also to be noted that when the tongue (25) moves, plurality of suction cups (33) that are movable relative to each other adapts or conforms easily to the tongue's (25) movement.

Now referring to Fig. 7, a suction cup (33) having a roof (31) in the shape of a partial hemisphere is shown. Suction cup (33) is shown placed on a tongue surface (28), and the aperture (34) of suction cup (33) is closed by the tongue surface (28). The tongue surface (28) within the periphery of the aperture (34) may move from a first position to a second position by vacuum effect of a first level of vacuum pressure of suction cup (33). The more vacuum suction is applied to the tongue surface (28), the more the tongue surface (28) moves into suction cup (33) and the more vacuum damage occurs. For relieving or preventing vacuum damage, the present invention provides a series of embodiments as will be delineated hereinafter. According to the solution, at least a part of the tongue surface (28) moved into suction cup (33) by vacuum suction is forced and moved by a contacting means (19). In preferable embodiments, suction cup (33) may have a tongue actuator (18) that is able to move the at least a part of the tongue surface (28) in the second position to a third position as a result of force application of the actuator (18) via the contacting means (19) to the at least part of the tongue surface (28). The third position is closer to the first position than the second position is to the first position and the third position is closer to the aperture (34) than the second position is to the aperture (34). During movement of the at least part of the tongue surface (28) from the second position to the third position, pressure of suction cup (33) may change. When the at least part of the tongue surface (28) is in the third position pressure of suction cup (33) may be the first level of vacuum pressure or a second level of vacuum pressure. Absolute pressure of the second level of vacuum pressure may be more than that of the first level of vacuum pressure. Without force application of tongue actuator (18), position of the at least part of the tongue surface (28) at any vacuum pressure would be more remote to the aperture (34) of suction cup (33) and to the first position compared to the situation in which tongue actuator (18) applies force to the at least part of the tongue surface (28). In this manner, tongue actuator (18) may work against vacuum effect.

In preferable embodiments, tongue actuator (18) may be able to move the at least part of the tongue surface (28) from the second position to a fifth position, vacuum pressure of the suction cup (33) being the second level when said part is moved to the fifth position by tongue actuator, suction cup (33) being adapted to move the at least part of the tongue surface (28) from the second position to the fourth position at the second level of vacuum pressure, the fifth position being closer to the aperture (34) than the fourth position is to the aperture (34), absolute pressure of the second level of vacuum pressure is more than absolute pressure of the first level of vacuum pressure.

The tongue actuator (18) may generate force on its own or transmit it from another power source, e.g., a person. The user of the device (11) may provide necessary initial force and movement. The contacting means (19) may be integral to the actuator (18), or may be coupled but not integral to the actuator (18). Surface area of the contacting means (19) may change according to various embodiments. In some embodiments, the tongue actuator (18) may be configured to force, with the contacting means (19), at least one fifth, more preferably at least one third and even more preferably at least half of the total surface area of the tongue surface (28) within the suction cup (33). Roof (31) of suction cup (33) may be configured such that it is able to undergo snap transformation. When pressure difference between the interior and exterior of the suction cup (33) reaches to a certain point, roof (31) may undergo snap transformation on its own, and moves tongue surface (28) inferiorly, for example, to the third position. The roof (31) in this embodiment therefore acts as a contacting means (19) and an actuator (18). After that, the tongue surface (28) and roof (31) may maintain their positions, i.e., roof (31) remains in contact with the tongue surface (28) at the third position. Alternatively, after a desired level of vacuum development within suction cup (33), the user may press roof (31) downward to initiate the snap transformation of roof (31). Increasing absolute pressure of suction cup (33) can move the tongue surface (28) inferiorly within suction cup (33) but roof (31) may be able to move, as a result of snap action force, the tongue surface (28) inferiorly without needing to increase absolute pressure of suction cup (33). By this way, vacuum damage may be relieved without needing to decrease suction force and hence adhesion power of suction cup (33). To relieve or prevent vacuum injury, the tongue surface (28) does not have to return exactly to the same position in which the tongue surface (28) was previous to vacuum application (i.e., the first position in this example). In this embodiment, the transformed roof (31) and the tongue surface (28) that is in contact with the transformed roof (31) also provide an additional friction surface. To relieve vacuum damage, roof (31) does not need to force and move all but only part of the tongue surface (28) within the suction cup (33) that moved due to vacuum effect of suction cup (33). In one exemplary device (11) or suction cup (33), the tongue actuator (18) may be configured to force, with the contacting means (19), surface area of at least one third of 1 cm², preferably at least of 1 cm², and more preferably at least 3 cm² and most preferably at least 8 cm². In some preferable embodiments, roof (31) is adapted to force and move the part of the tongue surface (28) that moved longest distance due to vacuum suction of suction cup (33), since, according to the present invention, it is found that the more distance the tongue (25) tissue moves due to vacuum suction, the more vacuum injury results. Generally, this part may be the highest part of the tongue surface (28) within suction cup (33) when the aperture (34) faces downward. As shown in this example, the tongue surface (28) in the central axis (X, Fig. 7A) of suction cup (33) (apex of the convexity of the tongue surface (28) in this embodiment) is the tongue surface (28) that moved longest distance due to vacuum suction; however, in other suction cup configurations, it may not be in the center axis (X) of suction cup (33) and even in some other suction cup (33) designs, the tongue surface (28) may not form a convex shape by vacuum suction. The above described preferable properties of the tongue actuator (18) in the form of a roof (31) of this embodiment may also practicable and preferable in all other actuator embodiments described in this application. In a variation, regions of suction cup (33) other than roof (31) may additionally or alternatively be able to undergo snap transformation. In a further variation, roof (31) of suction cup (33) may comprise shape memory material for functioning as an actuator (18) and may not need to undergo snap action. The shape memory material changes its shape to a preset shape when stimulated or actuated by a particular stimulus. The preset shape of the material is so adjusted that the shape memory material forces and moves the tongue surface during changing from a current shape to a preset shape, in a similar way that is described above with respect to the snap action of the roof (31). For example, roof (31) of suction cup (33) may comprise nitinol, a shape memory material. After heating the nitinol, roof (31) turns to its preset shape. It is to be noted that particular shape or place of the shape memory material with respect to the suction cup (33) is not important as long as the shape transformation forces and moves the tongue surface (28) as described above. Electricity may be used to heat the nitinol or warmth of the oral cavity (23) may be exploited for heating. In a further variation, shape memory material may be present in a structure other than suction cup (33) itself; the structure is positioned within suction cup (33) such that transformation of the structure to preset shape forces and moves the tongue surface (28) as described above. In preferable embodiments, suction cup (33) may additionally include a membrane (51) attached to both tongue actuator (18, 31) and lower end portions of sidewall (32) portions of suction cup (33) that defines the aperture (34) of the suction cup (33). Membrane (51) constitutes the contacting means (19) for transmitting force from the tongue actuator (18, 31) to the tongue surface (28). Membrane (51, 19) may preferably be elastic. Membrane (51, 19) may also be used with other types of suction cup (33) and tongue actuator (18) designs. Membrane (51, 19) provides more uniform force application to the tongue surface (28). According to a further variation, a liquid may be provided between membrane (51, 19) and suction cup (33). In this way, membrane (51, 19) will force the tongue surface (28) even more uniformly. Now referring to Fig. 8, a suction cup (33) is shown placed on a tongue surface (28). Suction cup (33) of this embodiment is similar to suction cup (33) of Fig. 7. The roof (31) may be snugly fitted to the interior surface of the side walls (32) and may still be able to slide inferiorly if forced by enough power to overcome friction between roof (31) and interior surface of side walls (32). Roof (31) may resist, due to the friction, sliding inferiorly until a certain desired vacuum level develops within suction cup (33) and after this level, roof (31) moves inferiorly to force and move the tongue surface (28) and remains inferiorly due to the friction or a locking means

(52) . In a variation, the roof (31) may not be snugly fitted to the interior surface but there may be an elastic structure in the form of a roof spring (53) coupling roof (31) to side walls (31). In this manner, the roof (31) can be elastically guided in the direction to the tongue surface (28). Elastic structure may be adapted to prevent roof (31) from moving inferiorly before desired vacuum level is reached within suction cup (33). As shown in Fig. 8B, the tongue surface (28) is applied vacuum suction by suction cup (33), thereby moving the tongue surface (28) into suction cup (33) but the roof (31) is prevented from moving inferiorly due to said roof spring

(53) . After that, roof (31) may be forced downward by a person, or by an electronic control means to slide roof (31) downward. Alternatively, the roof (31) may overcome the friction and moves downward on its own. As roof (31) moves downward, the tongue surface (28) is forced and moved downward as shown in Fig. 8C. Roof (31) constitutes a contacting means (19) and a tongue actuator (18). Roof (31) may stay in downward position owing to the friction or an optional locking means (52), even if the person stops pressing the roof (31). An exemplary locking means (52) is shown in Fig. 8D; roof (31) may have a recess or notch (54) to fit to a projection or protrusion (55) on side walls (32). When the roof (31) moves inferiorly, notch (54) comes near to and fits to protrusion (55) preventing further movement of roof (31), similar to a latch or detent mechanism. Protrusion (55) may optionally be elastic and/or coupled to a protrusion spring (56) for pushing or sliding protrusion (55) into notch (54). Apart from this, there are innumerable locking mechanisms and lock types in the mechanical art and any of them may be used. Referring now to Fig. 9, another exemplary suction cup (33) having a tongue actuator (18) in the form of a piston (57) is shown. Piston (57) is disposed slidingly within a cylinder (94) and fluidly divides cylinder (94) into upper division (58) and a lower division (59). In this embodiment, the piston (57) and the part of cylinder (94) below said piston (57) defines the suction cup (33) and the lower division (59) forms the interior space (35) of suction cup (33). The structure may be placed on the tongue surface (28) and vacuum may be developed within suction cup (33) (i.e., in lower division (59)) moving the tongue surface (28) into suction cup (33) similar to that shown in previous embodiments. Then a fluid may be allowed to enter into the upper division (58) via a fluid gate (60) on the roof of cylinder (94). Piston (57) then moves inferiorly to force and move the tongue surface (28). In a variation instead of piston (57), a membrane (51) may be disposed peripherally fixedly attached to the inner surface of cylinder (94). When a fluid enters via the fluid gate (60) into the upper division (58), membrane (51) swells or distend inferiorly pressing and moving the tongue surface (28) inferiorly. Piston (57) or membrane (51) constitutes a tongue actuator (18) and lower surfaces thereof constitute a contacting means (19). The entrance of the fluid may be passive or active, i.e., the fluid may enter the upper division (58) passively in response to vacuum development in lower division (59), or the fluid may be actively pumped into upper division (58), e.g., manually or by an electrical pump (not shown). In either cases, it may be adjusted that in a given time, a defined volume of fluid may enter the upper division (58).

Referring now to Fig. 10, suction cup (33) of this embodiment is similar to suction cup (33) of Fig. 9 except that there is no upper division (58) in this embodiment and membrane (51) may be smaller compared to the membrane (57) of Fig. 9. A part of roof (31) of suction cup (33) may be formed by a relatively small elastic membrane (51). Membrane (51) constitutes a contacting means (19) and a tongue actuator (18). The lower side of the membrane (51) may be in contact with the interior space (35) of suction cup (33) and the upper side of membrane (51) may be in contact with the ambient air. The aperture (34) of suction cup (33) is placed on and closed by a tongue surface (28) as shown in Fig. 10A. When vacuum is developed within suction cup (33), the tongue surface (28) is moved into suction cup (33). Also membrane (51) begins to inflate like a balloon within suction cup (33), as shown in Fig. 10B, and comes in contact with the tongue surface (28) forcing and moving the tongue surface (28), similar to tongue actuators (18) of previous embodiments. Additionally or alternatively, membrane (51) may also be disposed in other parts of suction cup (33), e.g., on the side walls (32) of suction cup (33).

In a further variation, the upper side of the membrane (51) may be fluidly connected or connectible to a pressure source (62) other than the ambient air, including a gas or liquid pump, pressurized air tank, etc. It may be adjusted that how fast said membrane (51) comes in contact with and moves the tongue surface (28); for instance, by changing the size of the membrane (51), configuration of suction cup (33), pressure of pressure source (62). The user may cover membrane (51), with her/his finger or a lid (not shown) disposed near membrane (51), to prevent the inflation or swelling of membrane (51) until desired level of vacuum develops within suction cup (33). In a further variation, the upper side of the membrane (51) may be connected or connectible to pressure source (62) through a controllable valve (44). Controllable valve (44) may be controlled manually or by an actuator. In a further aspect, controllable valve (44) may have pressure sensitive opening feature in the manner that it opens on its own when the pressure difference between the two sides of controllable valve (44) increases to a set point. In addition, controllable valve (44) may close on its own before pressure levels at the two sides of controllable valve (44) completely equalize, i.e., when the pressure difference is decreased to a set point. Controllable valve (44) may be a solenoid valve, air- operated valve or the like. Controllable valve (44) may be opened automatically according to the preset rules or algorithms, or manually by the user. A pressure sensor (61) may be provided to measure vacuum level of the interior space (35) and it may be set that controllable valve (44) opens when the measured vacuum levels drops to a certain level. In another example, controllable valve (44) may be opened after a preset time duration has elapsed subsequent to the initiation of the vacuum application. These functions may be automatically accomplished by the control unit (21) operably connected to at least one of controllable valve (44), pressure source (62) and pressure sensor (61). Controllable valve (44) may also be used to fluidly connect the external (upper) side of membrane (51) with the ambient air pressure as shown in Fig.lOD. In Fig. 11A, another exemplary suction cup (33) having an actuator (18) in the form of a magnetic actuator (18) disposed on roof (31) portion of suction cup (33) is shown. Suction cup (33) is shown to be placed on the tongue surface (28) such that the aperture (34) of suction cup (33) is closed or sealed by the superior surface of the tongue (25) alone. Preferably, in some embodiments, the rim of the suction cup (33) forming the aperture (34) may be slightly curved as extending laterally from the center to better conform to and to be sealed by the superior surface of the tongue (25). Magnetic actuator (18) is shown coupled to a platform (63) having a generally planar surface (64) to force and moves the tongue surface (28) with planar surface (64) of platform (63). Planar surface (64) constitutes contacting means (19) in this embodiment. After actuation of magnetic actuator (18), platform (63) moves inferiorly and planar surface (64) comes in contact with the tongue surface (28) and applies planarly distributed force to the tongue surface (28) moving it inferiorly. Planar surface (64) may be in contact with the superior surface of the tongue (25) to which it applies force before actuation of magnetic actuator (18). Magnetic actuator (18) may be actuated by control unit (21) or by a person. Magnetic actuator (18) may be configured to apply adjustable level of force to the tongue surface (28) as desired prior or during use of said suction cup (33). For example, an electric current supplied to magnetic actuator (18) may be increased, decreased or stopped as desired. The adjustability of magnetic actuator (18) and hence the force applied to the tongue surface (28) have many advantages. For example, it may be adjusted according to comfort of a user. Also, it may be prevented that the superior surface of the tongue (25) is exposed to the force for extended times. In further embodiments, two or more magnetic actuators (18) may be provided to apply force to different regions of the tongue surface (28) and at least one of them may be adjustable to apply varying level of force. Magnetic actuator (18) may be adjusted such that a region of the tongue (25) may not be applied force or may be applied varying level of force at a predefined or arbitrary time intervals. For example, no force or a decreased level of force may be applied for 5 minutes during every 10 minutes. Time intervals may be adjusted for every user or use as desired. In embodiments having two or more magnetic actuators (18), the force power may be controlled independently. For these functions, control unit (21) operably coupled to magnetic actuators (18) may be provided.

In a variation, platform (63) may move horizontally within suction cup (33) to force and move the tongue surface (28) inferiorly as shown in Fig 11B where dashed line shows position of the tongue surface (28) before platform (63) is moved horizontally within suction cup (33) by magnetic actuator (18). Although magnetic actuator (18) is shown in Fig. 10, any types of actuators may be used as well. For example, a tongue actuator (18) in the form of a leadscrew (65) is shown coupled to the platform (63) in Fig. 11C. When leadscrew (65) is actuated, platform (63) may force and move tongue surface (28). In a further variation shown in Fig. 11D, instead of leadscrew (65), platform (63) is coupled to actuator (18) in the form of a button (66) on suction cup (33). When a desired vacuum level is developed within suction cup (33), a person presses button (66) to force and move the superior surface of the tongue (25) inferiorly by platform (63). Platform (63) may remain inferiorly, even when the person stops pressing, e.g., by friction between the interior of suction cup (33) and platform (63) or by an optional locking means (52) for keeping platform (63) inferiorly. Optionally, an elastic structure, e.g., a platform spring (67), is disposed between button (66) and suction cup (33) in a way that the platform spring (67) forces platform (63) superiorly. Locking means (52) may have mechanism similar to that shown in Fig. 8D or any other lock or latch mechanism in the art.

Although a limited number of actuator (18) designs are described above, any type of actuator suited for the purpose may be used; including but not limited to, snap action, thermal bimorph, magnetic, hydraulic, piezoelectric, electrostatic, electromagnetic, pneumatic, electric, thermal, magnetostrictive, mechanical and shape memory alloy or polymer actuator. Mechanical actuators (18) include gear, rail, pulley, chain, a rack and pinion, leadscrew, etc. In addition to these actuators (18), other actuator (18) types may be utilized as well. Reading the detailed description, the skilled man in the art can easily apply other types of actuators (18) or designs for the purposes of the present invention. Although some regions of the tongue (25) is more preferable to be adhered by suction cups (33), other regions thereof may also be adhered in various embodiments of the present invention. When a tongue surface (28) is applied vacuum by a conventional suction cup, the tongue surface (28) is pulled and moved more or less into the interior of the conventional suction cup, the tongue surface (28) may reach the upper part of the conventional suction cup and stop abutting the upper part. A suction cup (33) with an actuator (18) of the present invention, however, has features defined by claim 1 of the present invention. The device may be made of any suitable material. Contemplated materials include, but not limited to metals, plastics, ceramics, composites and so forth. Other suitable materials will be apparent to those skilled in the art.

In a nutshell, the invention proposes a snoring and OSA prevention device (11) comprising:

a suction cup (33) having an aperture (34), the suction cup (33) being adapted to adhere to a surface of a tongue (25) by vacuum suction and,

an anchor (13) coupled or integral to the suction cup (33) and being adapted to be fitted in, around or outside a human mouth (12) portion characterized in that the suction cup (33) further comprises a tongue actuator (18) and a contacting means (19) coupled or integral to the tongue actuator (18) for transmitting force from the tongue actuator (18) to the surface of the tongue (25),

the suction cup (33) being adapted to move, when the aperture (34) is closed by a superior surface of the tongue (25) alone, a part of the superior surface of the tongue (25) within the periphery of the aperture (34), from a first position to a second position other than the first position within the suction cup (33) by a first level of vacuum pressure of the suction cup (33),

the tongue actuator (18) being adapted to move said part in the second position to a third position by force application of the actuator (18) via the contacting means (19) to said part in the second position,

the third position being closer to the first position than the second position is to the first position,

the third position being closer to the aperture (34) than the second position is to the aperture (34) and,

the device (11) being configured such that the anchor (13) is able to remain fitted in, around or outside the mouth (12) portion while the aperture (34) remains closed by the superior surface of the tongue (25) alone.

In a further embodiment of the present invention, the suction cup (33) and the anchor (13) are coupled to each other by a connector arm (15). In a further embodiment of the present invention, said part in the second position comprises a part of the superior surface of the tongue (25) that moved the longest distance by the first level of vacuum pressure of the suction cup (33). In a further embodiment of the present invention, said part in the second position comprises the highest part of the superior surface of the tongue (25) when vacuum pressure of the suction cup (33) is at the first level and the aperture (34) faces downward. In a further embodiment of the present invention, the device (11) is able to move, by the suction cup (33), the superior surface of the tongue (25) to a position that is anterior to position of the superior surface the tongue (25) when the tongue (25) is resting, while the tongue (25) is in non-extended position. In a further embodiment of the present invention, the suction cup (33) is adapted to move said part of the superior surface of the tongue (28) from the second position to a fourth position by a second level of vacuum pressure of the suction cup (33), the tongue actuator (18) being adapted to move said part in the second position to a fifth position by forcing, via the contacting means (19), said part in the second position, vacuum pressure of the suction cup (33) being the second level when said part is moved to the fifth position by tongue actuator, the fifth position being closer to the aperture (34) than the fourth position is to the aperture (34), absolute pressure of the second level of vacuum pressure is more than absolute pressure of the first level of vacuum pressure.

In a further embodiment of the present invention, a gate (38) disposed on the suction cup (33) is proposed, the gate (38) fluidly connecting the interior space (35) of the suction cup (33) such that vacuum can be developed in the interior space (35) by emptying at least some of fluid in the interior space (35) through the gate (38).

In a further embodiment of the present invention, a part of the suction cup (33) constitutes the tongue actuator (18), said part having shape changing ability associated with the actuation of the actuator (18).

In a further embodiment of the present invention, the tongue actuator (18) comprises a contacting means (19) movable in response to pressure difference across a first and a second sides thereof.

In a further embodiment of the present invention, the tongue actuator (18) is a snap-action actuator.

In a further embodiment of the present invention, the suction cup (33) has a height of less than 15 mm.

In a further embodiment of the present invention, the longest diameter of the aperture (34) is less than 30 mm.

In a further embodiment of the present invention, a controllable valve (44) configured to control application of fluid pressure from a pressure source (62) to the first side of the contacting means (19) is proposed.

In a further embodiment of the present invention, the pressure source (62) is the ambient air.

In a further embodiment of the present invention, the controllable valve (44) is pressure sensitive.

In a further embodiment of the present invention, the controllable valve (44) is configured to fluidly connect the pressure source (62) to the first side when pressure difference between the pressure source (62) and the first side is bigger than a predefined value. In a further embodiment of the present invention, the contacting means (19) and the tongue actuator (18) is a membrane (51) or a piston (57).

In a further embodiment of the present invention, the tongue actuator (18) has a leadscrew (65).

In a further embodiment of the present invention, the tongue actuator (18) is of a type selected from the group consisting of snap action, thermal bimorph, magnetic, hydraulic, piezoelectric, electrostatic, electromagnetic, pneumatic, electric, thermal, magnetostrictive, shape memory alloy or polymer, gear, rail, pulley, chain, a rack and pinion and lead screw actuator.

In a further embodiment of the present invention, the tongue actuator (18) is a fluidic type actuator.

In a further embodiment of the present invention, the tongue actuator (18) is a pneumatic type actuator.

In a further embodiment of the present invention, a non-therapeutic method of preventing simple snoring is proposed, which comprises the steps of placing a suction cup (33) on a superior surface of a tongue (25), closing an aperture (34) of the suction cup (33) by the superior surface of the tongue (25) alone, adhering the suction cup (33) to the superior surface of tongue (25) by vacuum suction through the aperture (34) of the suction cup (33), moving a part of the superior surface of the tongue (25) within periphery of the aperture (34) from a first position to a second position by application of a first level of vacuum pressure, fitting an anchor (13) coupled or integral to the suction cup (33) in, around or outside a human mouth (12) portion, moving, by force application via a contacting means (19) to, said part of the superior surface of tongue (25) in the second position to a third position, the third position being closer to the first position than the second position is to the first position, the third position being closer to the aperture (34) than the second position is to the aperture (34) and maintaining the anchor (13) fitted in, around or outside the mouth (12) portion while maintaining the aperture (34) closed by the superior surface of the tongue (25) alone. In a further embodiment of the present invention, the aperture (34) is sealed by the superior surface of the tongue (25) other than the tip portion (39) thereof.

In a further embodiment of the present invention, resting position of the superior surface of tongue (25) adhered by the suction cup (33) is a rest position, the method further comprising: forcing the superior surface of the tongue (25) adhered by the suction cup (33) anteriorly by the suction cup (33) when the superior surface of the tongue (25) adhered by the suction cup (33) is posterior to a front position while allowing the tongue (25) to be in non-extended position, the front position being anterior to the rest position.

In a further embodiment of the present invention, the method further comprising: allowing the tongue (25) such that the tongue (25) is capable of blocking vacuum propagation to a region of a soft palate (29) from a neighboring oral region between the tongue (25) and a hard palate (26) without forcing the tongue (25) superiorly.

In a further embodiment of the present invention, the method further comprising: moving the superior surface of the tongue (25) adhered by the suction cup (33) to the front position. In a further embodiment of the present invention, the method further comprising: developing vacuum in an interior space (35) of the suction cup (33) by emptying fluid in the interior space (35) via a gate (38) disposed on the suction cup (33).

In a further embodiment of the present invention, the moving step is accomplished by a tongue actuator (18) coupled or integral to the contacting means (19) . In a further embodiment of the present invention, type of the tongue actuator (18) is a pneumatic or hydraulic.

In a further embodiment of the present invention, wherein type of the tongue actuator (18) is a snap-action.

In a further embodiment of the present invention, the contacting means (19) and the tongue actuator (18) is a membrane (51) and the moving step is accomplished by swelling the membrane (51) by increasing pressure difference across the opposite sides thereof.

In a further embodiment of the present invention, the method further comprising: providing a piston (57) as a the contacting means (19) and a tongue actuator (18), and moving the piston (57) inferiorly by increasing fluid pressure difference between inferior and superior surfaces thereof.

Claims

1) A snoring and OSA prevention device (11) comprising:

2) A snoring and OSA prevention device (11) as set forth in Claim 1, wherein the suction cup (33) and the anchor (13) are coupled to each other by a connector arm (15). 3) A snoring and OSA prevention device (11) as set forth in Claim 2, wherein said part in the second position comprises a part of the superior surface of the tongue (25) that moved the longest distance by the first level of vacuum pressure of the suction cup (33).

4) A snoring and OSA prevention device (11) as set forth in Claim 2, wherein said part in the second position comprises the highest part of the superior surface of the tongue (25) when vacuum pressure of the suction cup (33) is at the first level and the aperture (34) faces downward.

5) A snoring and OSA prevention device (11) as set forth in Claim 2, wherein the device (11) is able to move, by the suction cup (33), the superior surface of the tongue (25) to a position that is anterior to position of the superior surface the tongue (25) when the tongue (25) is resting, while the tongue (25) is in non- extended position.

6) A snoring and OSA prevention device (11) as set forth in Claim 2, wherein the suction cup (33) is adapted to move said part of the superior surface of the tongue (28) from the second position to a fourth position by a second level of vacuum pressure of the suction cup (33), the tongue actuator (18) being adapted to move said part in the second position to a fifth position by forcing, via the contacting means (19), said part in the second position, vacuum pressure of the suction cup (33) being the second level when said part is moved to the fifth position by tongue actuator, the fifth position being closer to the aperture (34) than the fourth position is to the aperture (34), absolute pressure of the second level of vacuum pressure is more than absolute pressure of the first level of vacuum pressure.

7) A snoring and OSA prevention device (11) as set forth in Claim 2, further comprising a gate (38) disposed on the suction cup (33), the gate (38) fluidly connecting the interior space (35) of the suction cup (33) such that vacuum can be developed in the interior space (35) by emptying at least some of fluid in the interior space (35) through the gate (38).

8) A snoring and OSA prevention device (11) as set forth in Claim 2, wherein a part of the suction cup (33) constitutes the tongue actuator (18), said part having shape changing ability associated with the actuation of the actuator (18).

9) A snoring and OSA prevention device (11) as set forth in Claim 2, wherein the tongue actuator (18) comprises a contacting means (19) movable in response to pressure difference across a first and a second sides thereof.

10) A snoring and OSA prevention device (11) as set forth in any one of the preceding Claims, wherein the tongue actuator (18) is a snap-action actuator.

11) A snoring and OSA prevention device (11) as set forth in any one of Claim 1 to 9, wherein the suction cup (33) has a height of less than 15 mm.

12) A snoring and OSA prevention device (11) as set forth in Claim 11, wherein the longest diameter of the aperture (34) is less than 30 mm. 13) A snoring and OSA prevention device (11) as set forth in Claim 9, further comprising a controllable valve (44) configured to control application of fluid pressure from a pressure source (62) to the first side of the contacting means (19).

14) A snoring and OSA prevention device (11) as set forth in Claim 13, wherein the pressure source (62) is the ambient air.

15) A snoring and OSA prevention device (11) as set forth in Claim 9, 13 or 14, wherein the controllable valve (44) is pressure sensitive. 16) A snoring and OSA prevention device (11) as set forth in Claim 15, wherein the controllable valve (44) is configured to fluidly connect the pressure source (62) to the first side when pressure difference between the pressure source (62) and the first side is bigger than a predefined value.

17) A snoring and OSA prevention device (11) as set forth in any one of Claim 8, 9, 12, 13, 14 or 16, wherein the contacting means (19) and the tongue actuator (18) is a membrane (51) or a piston (57).

18) A snoring and OSA prevention device (11) as set forth in any one of Claim 1 to 7, wherein the tongue actuator (18) has a leadscrew (65).

19) A snoring and OSA prevention device (11) as set forth in any one of Claim 1 to 7, wherein the tongue actuator (18) is of a type selected from the group consisting of snap action, thermal bimorph, magnetic, hydraulic, piezoelectric, electrostatic, electromagnetic, pneumatic, electric, thermal, magnetostrictive, shape memory alloy or polymer, gear, rail, pulley, chain, a rack and pinion and lead screw actuator.

20) A snoring and OSA prevention device (11) as set forth in any one of Claim 1 to 7, wherein the tongue actuator (18) is a fluidic type actuator.

21) A snoring and OSA prevention device (11) as set forth in any one of Claim 1 to 7, wherein the tongue actuator (18) is a pneumatic type actuator.

22) A non-therapeutic method of preventing simple snoring, which comprises: placing a suction cup (33) on a superior surface of a tongue (25);

closing an aperture (34) of the suction cup (33) by the superior surface of the tongue (25) alone

adhering the suction cup (33) to the superior surface of tongue (25) by vacuum suction through the aperture (34) of the suction cup (33);

moving a part of the superior surface of the tongue (25) within periphery of the aperture (34) from a first position to a second position by application of a first level of vacuum pressure;

fitting an anchor (13) coupled or integral to the suction cup (33) in, around or outside a human mouth (12) portion;

moving, by force application via a contacting means (19) to, said part of the superior surface of tongue (25) in the second position to a third position, the third position being closer to the first position than the second position is to the first position, the third position being closer to the aperture (34) than the second position is to the aperture (34) and;

maintaining the anchor (13) fitted in, around or outside the mouth (12) portion while maintaining the aperture (34) closed by the superior surface of the tongue (25) alone.

23) A non-therapeutic method of prevention of simple snoring according to Claim

22, wherein the aperture (34) is sealed by the superior surface of the tongue (25) other than the tip portion (39) thereof.

24) A non-therapeutic method of prevention of simple snoring according to Claim

23, wherein resting position of the superior surface of tongue (25) adhered by the suction cup (33) is a rest position, the method further comprising: forcing the superior surface of the tongue (25) adhered by the suction cup (33) anteriorly by the suction cup (33) when the superior surface of the tongue (25) adhered by the suction cup (33) is posterior to a front position while allowing the tongue (25) to be in non-extended position, the front position being anterior to the rest position. 25) A non-therapeutic method of prevention of simple snoring according to Claim

24, further comprising: allowing the tongue (25) such that the tongue (25) is capable of blocking vacuum propagation to a region of a soft palate (29) from a neighboring oral region between the tongue (25) and a hard palate (26) without forcing the tongue (25) superiorly.

26) A non-therapeutic method of prevention of simple snoring according to Claim 24, further comprising: moving the superior surface of the tongue (25) adhered by the suction cup (33) to the front position.

27) A non-therapeutic method of prevention of simple snoring according to any one of Claim 22 to 26, further comprising: developing vacuum in an interior space

(35) of the suction cup (33) by emptying fluid in the interior space (35) via a gate (38) disposed on the suction cup (33).

28) A non-therapeutic method of prevention of simple snoring according to Claim 22, wherein the moving step is accomplished by a tongue actuator (18) coupled or integral to the contacting means (19).

29) A non-therapeutic method of prevention of simple snoring according to Claim 28, wherein type of the tongue actuator (18) is a pneumatic or hydraulic.

30) A non-therapeutic method of prevention of simple snoring according to Claim 28, wherein type of the tongue actuator (18) is a snap-action.

31) A non-therapeutic method of prevention of simple snoring according to Claim 28, wherein the contacting means (19) and the tongue actuator (18) is a membrane

(51) and the moving step is accomplished by swelling the membrane (51) by increasing pressure difference across the opposite sides thereof.

32) A non-therapeutic method of prevention of simple snoring according to Claim 28, further comprising: providing a piston (57) as a the contacting means (19) and a tongue actuator (18), and moving the piston (57) inferiorly by increasing fluid pressure difference between inferior and superior surfaces thereof.