GB2537399A

GB2537399A - Device for retaining in a user's mouth

Info

Publication number: GB2537399A
Application number: GB1506435.5A
Authority: GB
Inventors: C Basson Johannes
Original assignee: Individual
Current assignee: Individual
Priority date: 2015-04-16
Filing date: 2015-04-16
Publication date: 2016-10-19
Also published as: WO2016166556A1; GB201506435D0

Abstract

An anti-snoring mandibular advancement device 20 may comprise a first member 22 arranged to engage the user's teeth and/or gums and at least one second member 40a,b extending from the first member 22 and arranged to engage a portion of a users mouth inside of the mandible, preferably posterior to the lower teeth. The device 20 may further comprise a third member 30 extending from the first member and arranged to engage a portion of the users maxillary alveolar process; the second 40a,b and third 30 members exerting a tension on the users mouth so as to cause the users lower mandible to be advanced. The device may alternatively comprise both an upper (12, Figure 1) and a lower (16, Figure 1) portion, each arranged to engage the teeth and/or gums of a user. A claim is also provided directed to a method of forming an anti-snoring device.

Description

DEVICE FOR RETAINING IN A USER'S MOUTH

Field of the Invention

The present invention relates to a device for retaining in a user's mouth, and in particular relates to an anti-snoring device.

Background to the Invention

Snoring is an age-old, incredibly common phenomenon. Studies have shown that approximately 24% of men and 13.8% of women snore habitually, this rising to approximately 60% of men and approximately 40% of women when over the age of 60.

Aside from the strain it can place on relationships, snoring is also associated with various health problems. Interrupted, low-quality sleep caused by snoring leads to drowsiness and fatigue the following day, with resultant loss of concentration and productivity in the workplace. Sleep apnoea is a relatively more serious problem whereby the snorer stops breathing for longer than ten seconds at a time. Sleep apnoea is linked with serious health conditions including stroke, ischaemic heart disease, irregular heartbeat, acid reflux, headaches, mental health issues such depression, and more.

Snoring is caused when, during sleep, the muscles in the mouth, tongue and throat, relax. If they relax too much, the jaw and tongue collapse and block the airway, thus restricting the flow of oxygen to the lungs, heart and brain. When breathing, the muscles and uvula vibrate and knock against the back of the throat, causing the well-known snoring sound.

People have tried to find a cure for snoring for a long time, and many different devices and methods have been tried, some with more success than others, but snoring nonetheless remains a big problem.

One attempt at addressing snoring is the use of devices developed for preventing the jaw and tongue from collapsing and blocking the airway. These so-called mandibular advancement devices come in various shapes and sizes, but all of them essentially resemble mouth guards that are used in contact sports to prevent fractures to the facial bones. The difference is that mandibular advancement devices generally cover both the upper (maxillae) and lower (mandible) jaws. They are held in position by precise indentations matching the teeth of the wearer.

The medical profession regards the use of mandibular advancement devices as the best known method to lessen or prevent snoring. However, there are several problems associated with these devices, namely: * they are frequently expelled during sleep; and * they cause gum and/or dental pain due to the sustained traction exerted on the teeth.

These problems are more acute in the elderly, due to the fact that their teeth and gums are (usually) not in the best of health. Having missing teeth, as many older people do, can compound the problem, making it difficult or impossible to use a mandibular advancement device.

There therefore remains a need in the art to provide an improved device for retaining in one's mouth, and in particular a device that addresses at least some of the above-identified disadvantages of current mandibular advancement devices.

Summary of the Invention

In a first aspect of the invention, there is provided a device arranged for retention in a user's mouth. The device comprises a first member arranged to engage one or more of the user's teeth and/or gums. The device also comprises at least one second member extending from the first member and arranged to engage a portion of the user's mouth on the inside of the user's mandible.

The first member may generally have an arcuate shape so as to conform to the shape of the user's dentures and/or gums. The first member may engage the user's teeth and/or gums through relatively firm or soft contact, and may be arranged to contact only specific portions of the teeth/gums.

The second member may engage or contact any portion of the user's mouth, and on the inside of the user's mandible, that provides an ideal location for allowing retention of the device within the user's mouth. That is, the portion of the user's mouth in engagement with the second member is preferably shaped such that the second member may relatively easily hook or otherwise engage the portion of the user's mouth so as to provide a locking function to aid retention of the device within the user's mouth. To aid in implementing this locking function, the second member may comprise a reinforced portion for providing the second member with sufficient strength to hook around the inside of the mandible and urge the mandible anteriorly. Suitable materials for forming the reinforced portion may be selected accordingly by the skilled person. For example, the reinforced portion may be made from a metal (coated in a non-toxic plastic such as silicone) or composite material.

The first and second members are preferably formed of a material that is at least slightly resiliently deformable, so as not to apply too much pressure on the user's teeth and/or gums. In addition the material should be non-toxic to the user such that the device may be retained in the user's mouth for long periods of time, without fear of harming the user. Silicone is one such example.

By providing a device with a first member that engages one or more of the user's teeth and/or gums, and a second member that engages a portion of the user's mouth on the inside of the user's mandible, between them the first and second members may provide a locking force such that the device is more easily retained within the user's mouth. The risk of expulsion of the device during sleep is therefore lessened.

The portion of the user's mouth engaging with the second member may comprise a portion of the user's mouth approximately posterior and/or approximately inferior to the user's lower teeth. As described in more detail below, there is an area of the user's mouth on the inside of the mandible, slightly to the rear and below the line of the lower teeth, that comprises a protrusion or ridge-like area to which the second member may be more easily engaged and 'locked', thus improving the retainability of the device within the user's mouth. The second member may be arranged to hook around the portion of the user's mouth approximately posterior and/or approximately inferior to the user's lower teeth, so as to assist in retaining the device in the user's mouth.

The device may comprise a left second member and a right second member. Each of the left and right second members may extend from the first member and may be arranged to engage respective left and right portions of the user's mouth on the inside of the user's mandible. By providing two such second members, an improved clamping or locking force may be provided between the device and the user's mouth.

The first member may be arranged to protect the user's teeth and/or gums. For example, the first member may comprise a mouth guard or mandibular advancement device. The first member may take the form of traditional mouth guards that generally protect only a user's upper teeth. However, the first member may comprise a more complete mouth guard which engages both a users upper and lower dentures.

The at least one second member may extend from a lower portion of the first member. The lower portion may comprise a portion of the device arranged to engage or protect one or more of the user's lower teeth and/or lower gums. The first member may also comprise an upper portion arranged to protect or engage one or more of the user's upper teeth and/or upper gums. The at least one second member and the first member may be integrally formed with one another. The at least one second member may extend from a posterior end of the first member, and may be bent laterally and inferiorly to engage the portion of the user's mouth on the inside of the user's mandible.

The first member may comprise at least one grooved portion for receiving one or more of the user's teeth. In particular, the first member may comprise an upper grooved portion for receiving one or more of the user's upper teeth. The first member may also comprise a lower grooved portion for receiving one or more of the user's lower teeth.

The device may comprise a third member extending from the first member and arranged to engage at least a portion of the user's maxillary alveolar process. The third member may be arranged to engage or mould to substantially all of the maxillary alveolar process. The third member may be arranged to engage a recess located between the user's maxillary alveolar process and anterior nasal spine. This recess is a naturally occurring anatomical feature of the human skull. The third member may be integrally formed with the first member.

In order to improve the clamping, locking or general retention function of the device, in addition to the one or more second members a third member may be provided to provide a locking feature that locks onto a second portion of the user's mouth. In an embodiment, the first member resembles a traditional mouth guard or mandibular advancement device. The first member is modified to extend upwards -how much exactly depends on the specific wearer's anatomy. This extension protrudes above the level of the upper teeth where it is moulded around the alveolar -4 -process of the maxillae. Above the level of the upper teeth the alveolar process does not rise vertically, but rather at an angle backwards -thus creating a 'ridge' around which the extension can be moulded.

The third member may comprise a notched portion for accommodating the user's superior labial frenulum. The notched portion is generally centrally located with respect to the ends of the third member.

The at least one second member and the first member may exert a tension directed substantially along a line passing from the portion of the user's mouth engaged with the at least one second member and a point of contact between the first member and the user's mouth, so as to cause the user's lower mandible to be advanced.

The at least one second member and the third member may exert a tension directed substantially along a line passing from the portion of the user's mouth engaged with the at least one second member and the recess engaged with the third member, so as to cause the user's lower mandible to be advanced.

Thus, in the embodiment described in more detail below, the traction between the moulded part of the device that hooks around the alveolar process of the maxillae and the 'hooks' that are moulded around the inner surface on each side of the mandible help keep the device in place, to prevent expulsion during sleep.

In addition, because the device is generally moulded around the maxillary alveolar process above the upper teeth, and around the inside of the mandible on both sides behind and slightly below the level of the lower teeth, a significant amount of traction is taken up by these components, thereby relieving some of the strain on the teeth and gums. This may enable users with missing teeth, unhealthy teeth or diseased gums, to use the device.

The device may comprise a medicament arranged to be released from the device. The medicament may take many different forms such as anti-epileptic medication. The device encompassed by the invention is therefore more than a mere mandibular advancement device, and may serve a drug-delivery purpose as will be described in more detail later.

The device may comprise one or more sensors arranged to sense one or more biometrics of the user. The sensors may be arranged to communicate data relating to the user's biometrics, for example in real time. In some embodiments, the sensors could trigger the release of medicaments from the device. -5 -

As already mentioned the device may also provide an anti-snoring function. In particular, by providing a mandibular advancement function, the user's airway may be kept open and snoring may be prevented or at least lessened. In addition, the locking features described above (with the second and third members engaging respective portions of the user's mandible and maxillae) significantly decrease the likelihood of the device being expelled during sleep.

In a second aspect of the invention, there is provided a method of forming a device for retaining in a user's mouth. The method comprises providing a device having a first member comprising a grooved portion for receiving the user's teeth; and one or more second members extending from the first member and arranged to engage a portion of the user's mouth on the inside of the user's mandible when the user's teeth are received in the grooved portion. The method also comprises moulding the device to the user's teeth.

The step of moulding may comprise heating the device, and may also comprise locating the user's teeth within the grooved portion and biting down on the first member. Heating generally comprises placing the device in boiling water until sufficiently deformable.

The device may further comprise a third member extending from the first member. The step of moulding may further comprise moulding the third member to at least a portion of the user's maxillary alveolar process. The third member may be arranged to engage or mould to substantially all of the maxillary alveolar process. The third member may be arranged to engage a recess located between the user's maxillary alveolar process and anterior nasal spine.

In a third aspect of the invention there is provided a kit of parts comprising a device arranged for retention in a user's mouth. The device includes a first member for receiving a user's teeth, and one or more second members extending from the first member and arranged to engage a portion of the mouth and on the inside of the user's mandible when the user's teeth are received in the first member. The kit further includes instructions for moulding the device to the user's teeth.

Any feature of the above-described first aspect of the invention may be combined with the second and third aspects of the invention.

Brief Description of the Drawings

Embodiments of the invention will now be described in detail, in connection with the accompanying drawings of which: Figure 1 shows an example of a prior art mandibular advancement device; Figure 2 shows a front view an anti-snoring device in accordance with an embodiment of the invention; Figure 3 shows a rear view the anti-snoring device of Figure 2; Figure 4 shows the upper locking member of the anti-snoring device of Figures 2 and 3, in accordance with an embodiment of the invention; Figure 5 shows the lower locking members of the anti-snoring device of Figures 2 and 3, in accordance with an embodiment of the invention; Figure 6 is a lateral view of part of a human skull, comprising the maxilla and surrounding skull bones; Figure 7 is perspective view of a human mandible; Figure 8 is a lateral view of a human skull and mandible; Figure 9 is a front view of a human skull with an anti-snoring device according to an embodiment of the invention retained in the skull's mouth; Figure 10 is a rear view of the human skull of Figure 9; and Figures 11A and 11B are rear views showing in more detail the lower mandible and anti-snoring device of Figures 9 and 10.

Detailed Description of Specific Embodiments

The present invention seeks to provide a device for retaining in a user's mouth, and in particular seeks to provide an improved anti-snoring device. Whilst various embodiments of the invention are described below, the invention is not limited to these embodiments, and variations of these embodiments may well fall within the scope of the invention which is to be limited only by the appended claims.

Figure 1 illustrates a traditional mandibular advancement device 10 as known in the prior art. Mandibular advancement device 10 is shaped to conform to the size and shape of the user's upper and lower dentures. Mandibular advancement device 10 comprises an upper groove 12 comprising a front upper wall 14a and a rear upper wall 14b. Similarly, although shown in less detail, mandibular advancement device 10 comprises a lower groove 16 comprising a front lower wall 18a and a rear lower -7 -wall 18b. Upper and lower grooves 12 and 16 are generally arc-shaped so as to follow the curvature of the user's upper and lower dentures.

As the relative positions and sizes of dentures vary from one person to the next, mandibular advancement device 10 is usually initially provided in the form of a boil-and-bite mouth guard, generally made of silicone or a similar plastic. A user first heats mandibular advancement device 10 by placing it in boiling water, so as to render it deformable. Once sufficiently heated, the user bites down in upper and lower grooves 12 and 16, thereby forming indentations in upper and lower grooves 12 and 16. Mandibular advancement device 10 rapidly cools and hardens, and in doing so mandibular advancement device 10 is moulded to the size and shape of the user's teeth, providing a relatively firm fit.

As explained above, whilst mandibular advancement devices of the type shown in Figure 1 are useful in assisting the prevention of snoring, by causing the mandible to be advanced such that the user's airway is not blocked during sleep, they are nonetheless frequently expelled during sleep, usual from involuntarily mouth movement. In addition, such mandibular advancement devices can place undue stress on the user's teeth and gums.

Turning to Figures 2 and 3, there are shown respective front and rear views of an anti-snoring device 20 in accordance with an embodiment of the invention. Anti-snoring device 20 comprises a mandibular advancement device 22 (hereon referred to as a mouth guard) comprising an upper locking member 30 and a pair of lower locking members 40a and 40b. Mouth guard 22 is similar to mandibular advancement device 10 and like features are numbered using like references.

Upper locking member 30 is shown in more detail in Figure 4. Upper locking member 30 comprises a curved portion 32 which rises from the ends of upper locking member 30 to be generally wider near the centre of curved portion 32. Curved portion 32 includes a notched portion or similar indentation 34, formed substantially at the centre of curved portion 32. Returning to Figures 2 and 3, upper locking member 30 is seen to be integrally formed with front upper wall 24a, such that curved portion 32 extends upwards away from mouth guard 22.

Turning to Figure 5, there is shown a pair of lower locking members 40a and 40b Lower locking members 40a and 40b each comprise respective elongations 42a and 42b, and respective hooked members 44a and 44b. Hooked members 44a and 44b extend away from respective elongations 42a and 42b in a direction slightly downward relative to a direction of extension of elongations 42a and 42b.

Now returning to Figures 2 and 3, lower locking members 40a and 40b are shown integrally formed with and extending away from rear lower wall 28b of mouth guard 22. Lower locking member 40a extends away from a left-hand portion 27 of lower rear wall 28b, slightly downwards relative to the base of groove 26. Hooked member 44a is seen extending away from left-hand portion 27 of lower rear wall 28b. Similarly, lower locking member 40b extends away from a right-hand portion 29 of lower rear wall 28b, slightly downwards relative to the base of groove 26. Hooked member 44b is seen extending away from right-hand portion 29 of lower rear wall 28b.

The correct positioning of anti-snoring device 20 in relation to a user's mouth will now be described in connection with Figures 6-8.

Figure 6 shows a lateral view of a portion of a human skull. The ridge of bone enclosing the upper teeth is known as the alveolar process of the maxillae, and is referenced as 61. Alveolar process 61 is seen extending just above the upper middle two incisors (one of which is indicated as 62) and towards the anterior nasal spine 63. Between anterior nasal spine 63 and alveolar process 61 is a recessed portion or depression 64.

Now turning to Figure 7, there is shown a perspective view of a human's mandible, or lower jaw 70. A mass of bone (referred to hereon as mandible protrusion 71) is located roughly posterior and slightly downwards from the last lower molars 72.

In order to correctly position anti-snoring device 20 within a user's mouth, mouth guard 22 together with integrally formed upper and locking members 30, 40a and 40b is first heated for example by placing anti-snoring device 20 in boiling water. In much the same way as described above in connection with mandibular advancement device 10 of Figure 1, once sufficiently heated the user bites down within the grooves to form indentations for their teeth.

Upper locking member 30, rendered deformable through the heating process, is then moulded along the user's alveolar process. Thus, curved portion 32 will mould to the user's maxilla alveolar process 61. In particular, curved portion 32 is moulded to recessed portion 64, such that curved portion 32 substantially conforms to the shape of recessed portion 64. Notched portion 34 receives or accommodates -9 -the user's superior labial frenulum. The moulding of upper locking member 30 to recessed portion 64 therefore provides a first 'lock' of anti-snoring device 20 with the user's mouth.

A second 'lock' is formed with lower locking members 40a and 40b. With mouth guard 22 positioned within the user's mouth, each lower locking member 40a, 40b extends away from lower rear wall 28b and hooks onto a respective mandible protrusion 71 using a respective hooked member 44a and 44b. Thus, lower locking members 40a and 40b, one on each side of the tongue, hook around the inside of the user's mandible 70.

Because the mandible's joint is situated relatively above the level of hooked members 44a and 44b, a tension or traction is generated between each of the points of engagement of hooked members 44a and 44b with mandible protrusions 71, and the area of engagement of curved portion 32 with recessed portion 64. The line of tension A-B is illustrated in Figure 8. Thus, the mandible or lower jaw 70 is pulled to the front and upwards, to assist in the prevention of snoring. Furthermore, anti-snoring device 20 is effectively retained within the user's mouth due to the locking action of upper and lower locking members 30, 40a and 40b.

It should be noted that the moulding of anti-snoring device 20 to a user's mouth need only be carried out once. Once anti-snoring device 20 has cooled and hardened following the heating process, it is effectively fitted to the user's teeth and recessed portion 64, and does not need to be reheated. Most mandibular advancement devices can be re-heated and moulded a number of times until the best fit is achieved. It is, however, possible to get a good fit with only one attempt.

It is envisaged that anti-snoring device 20 with lower locking members of different lengths may be provided, for example depending on the distance separating the user's rearmost lower molars 72 and their mandible protrusions 71.

It is also envisaged that the lower locking members may hook onto or attach to other portions on the inside of the user's mandible, provided a sufficient locking force may be generated in conjunction with upper locking member 30.

Figures 9-11B show in more detail anti-snoring device 20 retained in a user's mouth (represented in this case by a human skull). Figure 9 shows upper locking member 30 and in particular curved portion 32 moulded to recessed portion 64, whilst Figures 10, 11A and 11B show lower locking members 40a and 40b hooking onto respective mandible protrusions 71.

Whilst the invention has been described in connection with preferred embodiments, it is to be understood that the invention is not limited to these embodiments, and that alterations, modifications, and variations of these embodiments may be carried out by the skilled person without departing from the scope of the invention. For example, whilst the invention has been described primarily in the context of an anti-snoring device, its use and applicability extend more generally to a medical device that may be effectively retained or locked within a user's mouth.

For example, there is a general need in the medical community at large to carry out monitoring of biometrics without resorting to invasive techniques. The present invention provides a simple device that may be easily retained within a user's mouth for long periods of time, for example whilst the user is sleeping. Because of the locking members of the device, the device is not easily expelled. The device therefore provides an ideal plafform from which biometrics may be monitored and/or drugs delivered. This is especially true when one considers the highly vascular nature of the human or animal mouth.

For instance, sensors may be located on the device and may be configured to take readings or measurements of biometrics of the user whilst they sleep. For example, 02 and CO2 readings may be taken, as well as blood glucose levels and pulse rate, amongst others. In addition, the device may be arranged as a drug delivery device. For example, drugs or other medicaments (such as glucose and anti-epileptic medication, etc.) may be controllably released from the device whilst the device is retained in the user's mouth.

Thus, whilst primarily designed as an anti-snoring device, the device is more generally a simple medical device that may be used as a platform for the safe and non-invasive delivery of drugs to a patient, and/or as a sensor platform for taking readings of a patient over extended periods of time, without fear of the device being expelled from the mouth.

Claims

CLAIMS1. A device arranged for retention in a user's mouth, comprising: a first member arranged to engage one or more of the user's teeth and/or gums; and at least one second member extending from the first member and arranged to engage a portion of the user's mouth on the inside of the user's mandible.
2. The device of claim 1, wherein the portion comprises a portion of the user's mouth approximately posterior to the user's lower teeth.
3. The device of any preceding claim, wherein the portion comprises a portion of the user's mouth approximately inferior to the user's lower teeth.
4. The device of any preceding claim, wherein the device comprises a left second member and a right second member, each of the left and right second members extending from the first member and arranged to engage respective left and right portions of the user's mouth on the inside of the user's mandible.
5. The device of any preceding claim, wherein the first member is arranged to protect the user's teeth and/or gums
6. The device of any preceding claim, wherein the first member comprises a mouth guard.
7. The device of any preceding claim, wherein the at least one second member extends from a lower portion of the first member.
8. The device of any preceding claim, wherein the first member comprises: an upper portion arranged to engage one or more of the user's upper teeth and/or upper gums; and a lower portion arranged to engage one or more of the user's lower teeth and/or lower gums.-12 -
9. The device of any preceding claim, wherein the first member comprises at least one grooved portion for receiving one or more of the user's teeth.
10. The device of claim 9, wherein the first member comprises: an upper grooved portion for receiving one or more of the user's upper teeth; and a lower grooved portion for receiving one or more of the user's lower teeth.
11. The device of any preceding claim, further comprising a third member extending from the first member and arranged to engage at least a portion of the user's maxillary alveolar process.
12. The device of claim 11, wherein the third member is arranged to engage a recess located between the user's maxillary alveolar process and anterior nasal spine.
13. The device of claim 11 or 12, wherein the third member comprises a notched portion for accommodating the user's superior labial frenulum.
14. The device of any of claims 11-13, wherein the at least one second member and the third member exert a tension directed substantially along a line passing from the portion of the user's mouth engaged with the at least one second member and the recess engaged with the third member, so as to cause the user's lower mandible to be advanced
15. The device of any preceding claim, wherein the at least one second member and the first member exert a tension directed substantially along a line passing from the portion of the user's mouth engaged with the at least one second member and a point of contact between the first member and the user's mouth, so as to cause the user's lower mandible to be advanced.
16. The device of any preceding claim, wherein the device comprises a medicament arranged to be released from the device.
17. The device of any preceding claim, wherein the device comprises one or more sensors arranged to sense one or more biometrics of the user.
18. The device of any preceding claim, wherein the device is an anti-snoring device.
19. The device of any preceding claim, wherein the second member is arranged to hook around the portion of the mouth on the inside of the user's mandible, so as to assist in retaining the device in the user's mouth.
20. A method of forming a device for retaining in a user's mouth, comprising: providing a device having: a first member comprising a grooved portion for receiving the user's teeth; and one or more second members extending from the first member and arranged to engage a portion of the mouth on the inside of the user's mandible when the user's teeth are received in the grooved portion; and moulding the device to the user's teeth.
21. The device of claim 20, wherein the step of moulding comprises: heating the device; locating the user's teeth within the grooved portion and biting down on the first member.
22. The device of claim 20 or 21, wherein the device further comprises a third member extending from the first member, and wherein the step of moulding further comprises: moulding the third member to the user's maxillary alveolar process and such that the third member engages at least a portion of the user's maxillary alveolar process.
23. A kit of parts comprising: a device arranged for retention in a user's mouth, comprising: a first member for receiving a user's teeth; and -14 -one or more second members extending from the first member and arranged to engage a portion of the mouth on the inside of the user's mandible when the user's teeth are received in the first member; and instructions for moulding the device to the user's teeth.
24. A device arranged for retention in a user's mouth, substantially as described hereinbefore and with reference to Figures 2-5.
25. A method of forming a device for retaining in a user's mouth, substantially as described hereinbefore and with reference to Figures 2-5 and 9-11B.