WO2022251907A1

WO2022251907A1 - Sleeping aid

Info

Publication number: WO2022251907A1
Application number: PCT/AU2022/050529
Authority: WO
Inventors: Laurence Nash Kalnin
Original assignee: Laurence Nash Kalnin
Priority date: 2021-06-04
Filing date: 2022-05-31
Publication date: 2022-12-08

Abstract

Sleeping aid 1 has body 2 extending between an oral end 3 and a distal end 4. The oral end 3 includes proximal face 5 and distal end 4 having distal face 6. Aperture 15 is disposed in body 2 and extends from proximal face 5 through distal face 6 whereby flange 16 is mounted about oral end 3 of body 2 and extends outwardly therefrom. A pair of spaced apart bite blocks 23,24 each have a web 25 extending from flange 16 and configured to be disposed between opposing teeth 11, 13. A support tab 29 is mounted to each bite block web 25 distal the flange 16 wherein each support tab 29 has a greater thickness on a lower portion 31 than an upper portion 30 to offset lower opposing teeth 11 toward the oral face 5 a predetermined distance relative to the upper opposing teeth 13.

Description

SLEEPING AID

Field

[0001] The present invention relates to sleeping disorders and, in particular, to a sleeping aid to assist in the management or treatment of such disorders.

[0002] The invention has been developed primarily for use as a sleeping aid in the management or treatment of snoring by a person and will be described hereinafter with reference to this application. However, it will be appreciated the invention is not limited to this particular field of use and is applicable for use with other sleeping disorders.

Background

[0003] Snoring during sleep is a well-known phenomenon that affects many people. Whilst snoring can be perfectly normal it can be the cause of many deleterious effects. The most prominent of those is obstructive sleep apnoea where pauses occur during breathing resulting in a lack of oxygen to the brain. It is believed more than 30% of people who snore have obstructive sleep apnoea to some degree.

[0004] Less threatening but still significant symptoms can be associated with snoring. One of these is a person sleeping with their mouth open as it is well-known that optimal breathing occurs through the nose. However, as the nasal airway is relatively small and can be blocked at times with mucous, oral breathing during sleep is common. During sleep, the throat and tongue muscles become particularly relaxed (most notably during the REM deep sleep cycle) and in order to keep the airway open the throat muscles must be properly supportive with the tongue also supporting the airway. If the tongue falls backward into the airway this blocks the path of normal breathing and may also cause the deprivation of oxygen.

[0005] In addition, snoring and sleeping with an open mouth can expose a person to significant dental problems such as xerostomia commonly known as dry mouth. This is strongly associated with dental decay and gum disease, and can be exacerbated by some medications. [0006] In cases where snoring does not affect the health of the person it can be undesirable as a distraction or annoyance to other people nearby. This includes affecting the person/s proximal to the snorer. As such, many over-the-counter or fitted mouthpiece arrangements have been developed to treat or manage snoring in a person.

[0007] In attempting to address the problem, an early attempt at a solution involved the use of a chinstrap arrangement to essentially bias a jaw into a closed position. A chinstrap was configured to extend from each side of the chin of a person upwardly between the ears and the eyes and over the top of the head. At least a portion of the chinstrap arrangement is elastic providing predetermined bias allowing a user to open their mouth but for the jaw to be pulled shut against any desire of the mouth to open. Unfortunately, such arrangements have a significant disadvantage in that they can promote bruxism or teeth grinding as it is commonly known and it is also possible that if a sleeping person were to vomit the chinstrap arrangement may cause that to be retained. Furthermore, there is the obvious common disadvantage that wearing a chinstrap with such an arrangement is not comfortable and does not promote sleep in the person.

[0008] A more modern attempt at a solution to the problem is provided in US 2010/0268107. This discloses a flange to be disposed intermediate the gums and lips/cheek of the person where an air passage is disposed in a central portion of the flange and extends through a protuberance provided on an outer or gum facing face of the flange. Such an arrangement is known to have limited success in treating or preventing snoring in a person but is understood to be a vast improvement over earlier chinstrap-type designs.

[0009] Currently, of the many devices available attempting to treat the problem is the 02VentTM produced by Oventus Medical (https://o2vent.com/osa-and-o2vent-2/).

Here, a pair of opposing mouthpieces are provided for the user to wear. Each mouthpiece for the upper and lower teeth is moulded to fit each individual user. The upper and lower mouthpieces are adapted to provide a seal preventing the flow of air between the upper and lower mouthpieces. With the mouthpieces providing a seal, the , ^r, ^'udes an aperture extending through the forward section thereof terminating at a protuberance disposed between the lips of the person using the device.

[0010] An other attempted solution is disclosed in US2020/0215384 where a one-piece mouth guard includes upper and lower bearing surfaces to receive most or all of a user’s teeth. This mouthpiece includes a central opening with a tube to extend beyond a user’s lips. In this embodiment, an internally projecting tongue training device is also provided.

[0011] Whilst particularly this latter prior known device is understood to have an effect in treating or managing snoring and other sleep apnoea effects in a person these devices are known to be particularly uncomfortable to wear by virtue of their bulky nature. Furthermore, these devices are not recommended for people who wear dentures, are missing many teeth or have multiple tooth decay issues. Furthermore, these devices should be fitted by a dentist to ensure movement of either upper or lower mouthpieces maintains a seal between the two.

[0012] Furthermore, there are numerous intra-oral devices that utilise heat and bite technology. Such devices are not recommended for persons with denture, caps, implants or loose/decayed or unstable teeth.

[0013] The object of the invention is a desire to provide a sleeping aid which overcomes one or more of the disadvantages of the prior art, or to provide a useful alternative.

Summary of Invention

[0014] According to a first aspect of the invention there is provided a sleeping aid comprising: a body extending a predetermined depth between an oral end and a distal end, the oral end having a proximal face and the distal end having a distal face, the body having a width intermediate left and right hand sides wherein the body extends a predetermined height; an aperture disposed in the body extending from the proximal face through the distal face; a flange mounted about the oral end and extending outwardly a predetermined distance therefrom; a pair of spaced apart bite blocks each having a ie flange away from the oral end of the body and configured to be disposed between opposing teeth; and a support tab mounted to each bite block web distal the flange and extending substantially perpendicularly to the web wherein each support tab has a greater thickness on a lower portion than an upper portion to offset lower opposing teeth toward the oral face of the body a predetermined distance relative to the upper opposing teeth.

[0015] According to a second aspect of the invention there is provided a sleeping aid comprising: a body extending a predetermined depth between an oral end and a distal end, the oral end having a proximal face and the distal end having a distal face, the body having a width intermediate left and right hand sides wherein the body extends a predetermined height; an aperture disposed in the body extending from the proximal face through the distal face; a flange mounted about the oral end and extending outwardly a predetermined distance therefrom; a pair of spaced apart bite blocks each having a web extending from the flange away from the oral face of the body and configured to be disposed between opposing teeth; a support tab mounted to each bite block web distal the flange and extending substantially perpendicularly to the web; and a membrane disposed substantially across the body aperture, the membrane adapted to prevent or minimise moisture travelling through the body aperture from the oral end to the distal end.

[0016] According to a third aspect of the invention there is provided a sleeping aid comprising: a body extending a predetermined depth between an oral end and a distal end, the oral end having a proximal face and the distal end having a distal face, the body having a width intermediate left and right hand sides wherein the body extends a predetermined height; an aperture disposed in the body extending from the proximal face through the distal face; and a supplementary airline connector disposed in or on the body and configured to receive a supplemental airline such that air flowing through the supplemental airline connector flows through to the body aperture.

[0017] According to fourth aspect of the invention there is provided a sleeping aid comprising: a body extending a predetermined depth between an oral end and a distal end, the oral end having a proximal face and the distal end having a distal face, the body having a width intermediate left and right hand sides wherein the body extends a a_n aperture disposed in the body extending from the proximal face through the distal face; a nasal cannula rotatably mounted to the body and extending away from it; and a nasal airline connector releasably attachable with the nasal cannula mount to provide air through to the cannula.

[0018] According to another aspect of the invention there is provided a sleeping aid comprising: a body extending between an oral end and a distal end, the oral end having a proximal face and the distal end having a distal face; an aperture extending through the body from the proximal face through the distal face; a flange mounted about the oral; a pair of spaced apart bite blocks each having a web extending from the flange away from the oral end of the body; and a support tab mounted to each bite block web distal the flange and extending substantially perpendicularly to the web wherein each support tab has a greater thickness on a lower portion than an upper portion to offset lower opposing teeth toward the oral end of the body a predetermined distance relative to the upper opposing teeth.

[0019] It can therefore be seen that there is advantageously provided a sleeping aid which can assist in the treatment or management of snoring apnoea related problems. The device allows for mandibular advancement whilst retaining a seal about the mouth without the use of large resiliently biased mouthpieces. Furthermore, the sleeping aid can also be used for people requiring oxygen supplementation such as when having severe sleeping/respiratory problems.

Brief Description of Drawings

[0020] Preferred embodiments of the drawings will now be described, by way of example only, with reference to the accompanying drawings in which:

[0021] Fig. 1 is an elevated front perspective view of a sleeping aid according to a preferred embodiment of the invention;

[0022] Fig. 2 is an elevated rear perspective view of the sleeping aid of Fig.1 ;

[0023] Fig. 3 is a perspective view of a patient wearing a modified sleeping aid of Fig.1 ; [0024] Fig. 4 is a cutaway right-hand side view through the patient of the sleeping aid of Fig.1 ;

[0025] Fig. 5 is the view of Fig.4 indicating airflow through the sleep aid of Fig.1 ; and

[0026] Fig. 6 is a cutaway right-hand side view of the patient with a sleeping aid according to another preferred embodiment of the invention.

Description of Embodiments

[0027] Referring to the drawings generally, like reference numerals have been used to denote like components unless expressly noted otherwise. It will also noted that throughout this specification, air and concentrated oxygen are used interchangeably.

[0028] Turning firstly to Figs 1 & 2, there is shown two perspective views of a sleeping aid 1 according to the preferred embodiment of the invention. The sleeping aid includes a body 2 in the form of a rectangular prism, however, this could be oval or any other desired shape. The body 2 has a depth defined from an oral end 3 adapted to be engaged about the lips 20 of a person 21 using the sleeping aid 1 (this is best shown in Figs 4 & 5) to a distal end 4 adapted to extend beyond the lips 20 of the person 21.

[0029] The oral end 3 terminates at a proximal face 5 and the distal end 4 terminates at a distal face 6. The body 2 has a predetermined width extending intermediate left 7 & right 8 sides. As can be seen in the drawings the body 2 of the preferred embodiment has a height or thickness substantially corresponding to a distance intermediate the gums and teeth of the person from below the gum line 10 of the bottom teeth 11 to above the gum line 12 of the top teeth 13.

[0030] An aperture or duct 15 is disposed through the body 2 from the oral end 3 proximal face 5 to the distal face 6 of distal end 4. This provides an unobstructed airway through the body 2 from within an oral cavity. Mounted about the oral end 3 of the body 2 is a flange 16. As can be seen in the drawings, flange 16 is curved to conform to the general shape of the front of the mouth intermediate the lips and the teeth of a person 21. [0031] The flange 16 extends between a left hand side 17 and a right hand side 18 where sides 17 & 18 extend a predetermined distance from the respective left 7 & right 8 hand sides so as in use to extend between the lips/checks of the person and the gum from the central incisors each side to approximately the canines or beyond if desired. The flange 16 is shaped to be disposed intermediate the teeth and gums of a person and is preferably of a minimal thickness 19.

[0032] The sleeping aid 1 further includes a pair of spaced apart bite blocks 23 & 24 disposed on an inside face 22 of the flange 16. Each bite block 23 & 24 includes a web member 25 extending a predetermined distance away from the flange 16 inside face 22. Each web member 25 has a length or distance from the flange 16 that is sized to accommodate the distal ends 27 of lower teeth 11 on opposing sides thereof. In this way, the flange 16 is disposed intermediate the lips and cheeks and the gums and teeth of a person 21 whereby the bite block web is 25 are located intermediate opposing teeth 11 & 13.

[0033] In the preferred embodiment, each web member 25 includes a substantially perpendicular support tab 29 that extend substantially perpendicular to each web member 25 and is disposed at a distal end thereof. Each support tab 29 includes an upper end 30 and a lower end 31 each perpendicular to the web member 25. Each support tab 29 is adapted in use to be disposed contiguous with a rear face 27 of teeth disposed about web member 25.

[0034] In the preferred embodiment of the invention, each support tab 29 has a thickness extending away from the proximal end of the web 25. The thickness of the upper portion 30 of the support tabs 29 is thinner by a predetermined amount than the thickness of the lower portion 31 of the support tabs 29. In the preferred embodiment, the differential thickness of the upper and lower portions 30 & 31 of the support tabs 29 most advantageously provides a mandibular advancement by a predetermined amount. That is, the lower teeth 11 of the lower jaw are moved slightly forward relative to the upper teeth 13 so that the lower teeth 11 are moved from their relaxed position. The difference in thickness between the upper and lower portions 30 & 31 of the support tabs can be between 1 mm to greater than 5 mm or otherwise dimensioned to provide ^{rio iraH} , ^r ^vancement to minimise, diminish or eliminate snoring. [0035] Is noted that in the preferred embodiment of Figs 1 & 2 the sleeping aid 1 is moulded from a medical grade silicone rubber or similar material whereby the body 2, flange 16 and bite blocks 23 & 24 are moulded as an integral unit. The flange 16 is semi-rigid and able to conform to the cavity provided intermediate the teeth 11 & 13 and the lips 20 of the person. It will also be appreciated that the aperture 15 can have a constant cross-sectional shape intermediate oral distal ends 3 & 4 of the body 2 as shown in the drawings but this need not be the case. Similarly, the cross-sectional shape of the aperture 15 can be circular, oval, rectangular, polygonal or any symmetrical or asymmetrical shape as desired.

[0036] The sleeping aid 1 in the preferred embodiment further includes a membrane 35 disposed across aperture 15 at or adjacent the distal end 4 of the body 2. Although not clearly illustrated, the membrane 35 is attached to a membrane frame 36 that is configured to be removably mounted across aperture 15. The membrane 35 is formed from a preferred material that allows air to flow this through from the oral end 3 of the aperture 15 to the distal end 4 whereby moisture in exhaled breath is at least partly prevented from crossing the membrane 35 and escaping the oral cavity. It will be appreciated that the membrane 35 can be formed from any preferred material or materials including polytetrafluoroethylene, polyvinylidene fluoride or cotton amongst many others. Further, it will be appreciated that the membrane 35 may be formed from a laminate of same or different materials.

[0037] In the preferred embodiment, the sleeping aid 1 is configured to receive a pair of supplementary air lines 40 & 41. The body 2 includes a supplementary airline connector 42 mounted thereto where connector 42 is configured to releasably engage with air line 40 that is connected to a supplementary air oxygen supply (not illustrated) and to extend into the body 2 to provide oxygen directly into aperture 15. Fig. 5 best illustrates flow of air through supplementary airline 40 through the body 2 and into the aperture 15 cavity.

[0038] Also in the preferred embodiment, supplementary nasal air or oxygen supply is also provided. Flere, a nasal conduit 45 is rotatably mounted to the outside of body 2 by a cannula mount 46 disposed on left and right hand sides 7 & 8 of the body 2. A U- ~7 ^emends from each mount 46 where a pair of nasal tubes or cannula 48 extend from a lower end of the U conduit 47. A right-hand side nasal mount 46 also includes a nasal air line connector 43 which is releasably connectable to the nasal air line 41. Fig. 5 illustrates the flow of air through the nasal cannula when in use. It will be appreciated the embodiment of Fig. 3 differs from Figs 1 & 2 by having air line connector 43 and nasal conduit mount 46 integral.

[0039] When a person 21 users sleeping aid 1 , the flange 16 is disposed intermediate the teeth 11 & 13 and the lips 20 where opposing teeth are disposed either side of the web member 25 of each bite block 23 & 24. The support tabs 29 of each bite block 23 & 24 with different thickness upper 30 and lower 31 portions configures the jaw of the person 21 to retain the sleeping aid 1 whereby body 2 substantially protrudes from the lips 20. It has been found that sleeping aid 1 in use advantageously persists in the treatment or management of snoring related problems. Rather than having separate upper and lower mouthpieces connected together by a highly resilient elastic band or the like, as bite blocks 23 & 24 provide mandibular advancement without the known discomfort and whilst retaining a seal about the mouth. It will be further appreciated that people with missing teeth or having significant tooth decay, particularly the rear teeth, the sleeping aid 1 is able to be retained within the mouse the person 21 without undue stress on decayed teeth or relying on the presence of rear teeth to retain it.

[0040] More advantageously, the moisture impermeable or substantially impermeable membrane 35 is found to significantly reduce symptoms of dry mouth resulting from breathing through the oral cavity which provides a significant benefit to oral health. Being mounted in frame 36 in the preferred embodiment, membrane 35 can be replaced or sanitized.

[0041] It will be appreciated that supplementary air or oxygen can be provided through the body 2 of the sleeping aid 1 to augment air breathable by the person (in contrast to embodiment of Fig. 6 which has no air line input. The air is advantageously fed directly into the aperture 15 of the body 2 so that when a person 21 commences breathing through their mouth, additional air or oxygen is available as required. Furthermore, the nasal cannula airline is mounted to the outside of the body 2 the sleeping aid 1 which itself acts as an anchor to retain the nasal cannula rather than as is conventionally known by looping airlines over a patient’s ears. This has been found to be significant improvement in people who snore and still require supplementary air or oxygen.

[0042] If desired, the sleeping aid 1 can further include a strap or similar means to retain it in the oral cavity replacing the air lines 40 & 41 shown in the drawings to act to retain the aid 1 when disposed over the ears. Preferably, an elastic strap is attached to either side of the body 2 which then can be located behind the head of the person or the neck, or under the chin. Similarly, a plurality of elastic straps may be provided, one on each side 7 & 8 of the body 2 but where each strap includes a loop for engagement about respective ears.

[0043] Turning to Fig. 6, there is shown a cutaway side view of a sleeping aid 1 according to another preferred embodiment of the invention. This embodiment is similar to that described above, however, no airline connector 40 or nasal cannula 45 are included so that the sleeping aid 1 is used by person 21 whereby their bottom teeth 11 are caused to move forward towards the lips relative to the upper teeth 13. This is dependent on the relative thicknesses of the support tab 29 upper portion 30 and the support tab 29 lower portion 31. The use of support tabs 29 on webs 25 with thinner upper portions 30 than lower portions 31 advantageously assists in at least minimising snoring. Furthermore, it will be appreciated that the bite blocks 23, 24 preferably do not extend to the molars on either side of the person which minimises or eliminates bruxing and in some preferred embodiments such as Fig. 1 the bite blocks 23,24 are configured to be disposed about extend to the central incisors

[0044] The foregoing describes only one embodiment of the present invention and modifications, obvious to those skilled in the art, can be made thereto without departing from the scope of the present invention.

[0045] The term “comprising” (and its grammatical variations) as used herein is used in the inclusive sense of “including” or “having” and not in the exclusive sense of “consisting only of.

Claims

1. A sleeping aid comprising: a body extending a predetermined depth between an oral end and a distal end, the oral end having a proximal face and the distal end having a distal face, the body having a width intermediate left and right hand sides wherein the body extends a predetermined height; an aperture disposed in the body extending from the proximal face through the distal face; a flange mounted about the oral end and extending outwardly a predetermined distance therefrom; a pair of spaced apart bite blocks each having a web extending from the flange away from the oral end of the body and configured to be disposed between opposing teeth; and a support tab mounted to each bite block web distal the flange and extending substantially perpendicularly to the web wherein each support tab has a greater thickness on a lower portion than an upper portion to offset lower opposing teeth toward the oral face of the body a predetermined distance relative to the upper opposing teeth.

2. A sleeping aid according to claim 1 wherein the flange is semirigid and able to conform to an oral cavity intermediate the teeth and lips of the user.

3. A sleeping aid according to claim 1 or 2 wherein the flange extends outwardly a predetermined distance from the oral face of the body.

4. A sleeping aid according to any one of claims 1 to 3 wherein the body, flange, bite blocks and support tabs are integrally formed from a silicone rubber material.

5. A sleeping aid according to any one of claims 1 to 4 wherein the lower portion of each support tab is between 1 mm to 5 mm thicker than each upper portion.

6. A sleeping aid according to any one of claims 1 to 5 wherein the body aperture is oval or rectangular in cross-section whereby the long axis of the oval or long side of the rectangle extends intermediate the body left and right hand sides.

7. A sleeping aid according to any one of claims 1 to 6 including a supplementary airline connector disposed in or on the body and configured to receive a supplemental airline such that air flowing through the supplemental airline connector flows through to the body aperture.

8. A sleeping aid according to any one of claims 1 to 7 including a nasal cannula rotatably mounted to the body and extending away therefrom.

9. A sleeping aid comprising: a body extending a predetermined depth between an oral end and a distal end, the oral end having a proximal face and the distal end having a distal face, the body having a width intermediate left and right hand sides wherein the body extends a predetermined height; an aperture disposed in the body extending from the proximal face through the distal face; a flange mounted about the oral end and extending outwardly a predetermined distance therefrom; a pair of spaced apart bite blocks each having a web extending from the flange away from the oral face of the body and configured to be disposed between opposing teeth; a support tab mounted to each bite block web distal the flange and extending substantially perpendicularly to the web; and a membrane disposed substantially across the body aperture, the membrane adapted to prevent or minimise moisture travelling through the body aperture from the oral end to the distal end.

10. A sleeping aid according to claim 9 wherein the membrane is disposed at or adjacent the distal end.

11. A sleeping aid according to claim 9 or 10 wherein the membrane is configured to be releasably mounted across the body aperture.

12. A sleeping aid according to any one of claims 9 to 11 wherein the membrane is a laminate material, or includes polytetrafluoroethylene, polyvinylidene fluoride or cotton.

13. A sleeping aid according to claim 12 wherein the membrane is mounted to a frame adapted to be received in the body aperture at the distal end thereof.

14. A sleeping aid comprising: a body extending a predetermined depth between an oral end and a distal end, the oral end having a proximal face and the distal end having a distal face, the body having a width intermediate left and right hand sides wherein the body extends a predetermined height; an aperture disposed in the body extending from the proximal face through the distal face; and a supplementary airline connector disposed in or on the body and configured to receive a supplemental airline such that air flowing through the supplemental airline connector flows through to the body aperture.

15. A sleeping aid according to claim 14 including: a flange mounted about the oral end and extending outwardly a predetermined distance therefrom; a pair of spaced apart bite blocks each having a web extending from the flange away from the oral face of the body and configured to be disposed between opposing teeth; and a support tab mounted to each bite block web distal the flange and extending substantially perpendicularly to the web.

16. A sleeping aid comprising: a body extending a predetermined depth between an oral end and a distal end, the oral end having a proximal face and the distal end having a distal face, the body having a width intermediate left and right hand sides wherein the body extends a predetermined height; an aperture disposed in the body extending from the proximal face through the distal face; a nasal cannula rotatably mounted to the body and extending away from it; and a nasal airline connector releasably attachable with the nasal cannula mount to provide air through to the cannula.

17. A sleeping aid according to claim 16 including: a flange mounted about the oral end and extending outwardly a predetermined distance therefrom; a pair of spaced apart bite blocks each having a web extending from the flange away from the oral face of the body and configured to be disposed between opposing teeth; and a support tab mounted to each bite block web distal the flange and extending substantially perpendicularly to the web.

18. A sleeping aid according to paragraph 16 or 17 wherein the nasal cannula is mounted to a left and right hand side of the body forming a U-shape.

19. A sleeping aid comprising: a body extending between an oral end and a distal end, the oral end having a proximal face and the distal end having a distal face; an aperture extending through the body from the proximal face through the distal face; a flange mounted about the oral; a pair of spaced apart bite blocks each having a web extending from the flange away from the oral end of the body; and a support tab mounted to each bite block web distal the flange and extending substantially perpendicularly to the web wherein each support tab has a greater thickness on a lower portion than an upper portion to offset lower opposing teeth toward the oral end of the body a predetermined distance relative to the upper opposing teeth.