Patent Description:
OSA is a chronic condition which affects many sufferers around the world. One treatment which has been applied is the continuous positive air pressure (CPAP) system, in which a mask and associated pump is used to apply positive air pressure to the airway in order to prevent its collapse. Whilst CPAP is effective in many cases, it suffers from an issue of poor on-going compliance from patients.

Another approach has been to use oral appliances of various kinds. Mandibular advancement splint (MAS) devices hold the lower jaw forward, so as to better open the airway, and keep the base of the tongue forward from the airway opening. Holding the lower jawbone forward helps open up the pharyngeal space above the airway, however, in most cases it is the base of the tongue falling back that blocks the pharyngeal airway. Holding the lower jaw forward exerts some forward influence on the resting position of the tongue. However the tongue is only loosely connected to the lower jaw bone, so holding the lower jaw forward does not necessarily hold the tongue far enough forward to prevent airway obstruction.

MAS devices are very well tolerated, however, they have proved most effective in cases of snoring and mild OSA, particularly when patients have relatively low BMI. In more severe OSA and higher BMI patients, MAS devices have proved less effective.

Other devices have been proposed which operate by directly gripping the tongue. For example, <CIT>discloses a tongue gripping and restraining device having a surface with relatively sharp protrusions which mechanically squeezes the tongue from both sides. Other tongue control devices are disclosed, for example, in <CIT>, and <CIT>.

<CIT> by the present applicant (the prior application) discloses several types of oral appliances which directly address the issue of tongue positioning. In <CIT> a dental orthotic is disclosed that comprises a mandibular orthotic conforming to a user's mandibular dentition and including oral contours adapted for adjusting the user's tongue/tooth/mouth interaction, and may include extensions for positioning the user's tongue. The contours are designed and applied to specific locations on the orthotic and extensions of the orthotic to promote a desired tongue response for specific physiological symptoms. The contours change the shape of the mandibular orthotic as well as the dental shapes within the mouth, resulting in repositioning and/or reshaping of the tongue and tissue of the throat, thereby improving the oral functions as well as relieving neuromuscular responses and autonomic nervous system dysfunctions. The dental orthotic may include a maxillary orthotic that is fixed with respect to the mandibular orthotic. In <CIT> a dentition mouthpiece is disclosed which maintains a patients airway by stably holding the tongue of the patient. This document shows the preamble of independent claim <NUM>. In <CIT> a nonrigid, epigenetic-pneumopedic appliance is disclosed comprising a wiretype framework supporting bow, bands, brackets or a clasp. The appliance includes active elements adapted to provide brief doses of cyclic forces to induce sutural osteogenesis. The active elements are vibrational, ultrasonic or oscillatory components.

It is an object of the present invention to provide oral appliances including tongue positioning structures which are useful in treating snoring, OSA and related disorders.

In a first broad form, the present invention provides a passive tongue location device which includes cavities located on the internal surface adjacent the tongue, the cavities operatively providing a retentive effect on the tongue when it is in its relaxed state.

According to one aspect, the present invention provides an oral device adapted to operatively enhance the operation of a sleeping user's airway, including a carrier adapted to be positioned over at least some of the lower teeth of the user and having an interior projection over at least part of the gums of a user, the projection defining a pair of opposed cavities, the cavities being shaped and operatively adapted so that the tongue of the sleeping user will passively engage the cavities, in accordance with appended claim <NUM>.

According to another aspect, the present invention provides a method of forming an oral device adapted to operatively enhance the operation of a sleeping user's airway, the method including the steps of forming a device adapted to be positioned over at least some of the lower teeth of the user, and forming an interior projection over at least part of the gums of a user, the projection defining a pair of opposed cavities, the cavities being shaped and operatively adapted so that the tongue of the sleeping user will passively engage the cavities, in accordance with appended claim <NUM>.

Implementations of the present invention provide advantages in effective positioning of the tongue, so as to maintain an effective airway, while minimising the discomfort and risk of injury for the user.

Illustrative implementations of the present invention will be described with reference to the accompanying drawings, in which:.

The present invention will be described with reference to several specific implementations. However, it is important to understand that the present invention may be implemented as an addition to many existing types of oral devices, and that the implementations are not limited in any way to the specific examples disclosed. It is specifically contemplated that in some of the applications the present invention will be combined with structures such as MAS devices, other types of splints and oral devices, and such variations are to be understood as falling within the scope of the disclosure.

It has been recognized by the present inventor that it is critical for the success of any practical device to not only assist in preventing the tongue from moving to an obstructive position during sleep, but also to ensure that the device is both safe and comfortable for the user. No device, however effective, will achieve long term user compliance unless it is well tolerated and provides only a minimum of discomfort for the user. The device must be tolerated for relatively long periods of time, and minimise any disruption to sleep.

In order to better understand the operation of implementations of the present invention, it is important to consider the behaviour of the tongue. The tongue is a difficult organ to retain in a desired position in the mouth because it is very sensitive, slippery and, most importantly, variable in size, shape and mechanical properties. The underside of the tongue is a very delicate mucous membrane, while the upper surface is a much tougher yet still sensitive surface.

The tongue is a muscular organ, with its own complex set of reflexes and autonomous behaviours. It performs many complex tasks without conscious control. Failure to recognise and take account of the complex characteristics of the tongue when designing and implementing oral devices is likely to lead to unsatisfactory outcomes.

One aspect of tongue behaviour which has been newly identified by the inventor is tongue flow adaptability, or TFA. During sleep, the tongue generally becomes softer and smaller, reduces in tone, and in general enters a relaxed state. When the tongue is placed over another surface in this relaxed state, the surface of the tongue flows in a fluid-like way so as to intimately conform its surface to the other, external surface it is in contact with. It will flow over, around and grip or adhere to the surface. It is this TFA feature which provides the surfaces and shapes according to implementations of the present invention with the ability to become enveloped by tongue tissues and thus to tend to hold the corresponding tongue surface, so as to maintain the relaxed tongue in the desired position.

The degree of grip or attachment provided according to implementations of the present invention, which will be further explained below, will not resist a conscious withdrawal of the tongue, and serves only to maintain adequate engagement between the device and the tongue in the event of changes in the size and consistency of the tongue.

Implementations of the present invention do not in any way seek to actively restrain the tongue. Rather, the relaxed tongue naturally and spontaneously interacts with the surfaces provided, and is sufficiently held in place during sleep by the TFA effect. Implementations of the present invention accordingly encourage the tongue, by exploiting its natural behaviour, to remain in a forward position in the mouth and adjacent the lower palate, so as to reduce the likelihood of obstructions of the airway by the tongue. The tongue can at any time be consciously withdrawn.

An important factor for any device seeking to correctly position the tongue is the necessity to allow the tongue to be instantly withdrawn from the device without trauma. The tongue is very powerful and flexible, and attempts to hold it with sufficient force to resist all attempts at withdrawal are virtually impossible, because even if the action results in trauma, one can pull ones tongue out of virtually any entrapment. Sudden events such as sneezing, coughing or yawning require instant reflex tongue withdrawal. Any method of restraining or holding the tongue which does not allow for instant involuntary reflex withdrawal will inevitably result in trauma to the tongue upon sudden withdrawal. Devices using surfaces with angular or protruding gripping elements are likely to traumatize the tongue if it is suddenly withdrawn.

Another aspect of tongue behaviour is the tongue-tongue reflex. When a pressure or touch is applied to the tip and surrounding areas of the tongue, the tongue orients itself towards that stimulus. The stronger the stimulus, the greater the probability that the tongue will move towards the stimulus. Further details regarding tongue reflexes can be obtained from the literature, for example from <NPL>, the disclosure of which is hereby incorporated by reference.

The present invention is primarily contemplated to be used in association with a custom formed splint device, of the type that dentists routinely take impressions for in relation to other devices. The device may be formed from any suitable material, for example a dental acrylic, for example PMMA. However, the present invention may be implemented using any suitable material, or any suitable fitting process.

It will be appreciated that this implementation lends itself well to CAD manufacture, for example using conventional 3D printing such as is used by Resmed Limited with their Narval device. Alternatively, conventional dental appliance manufacturing techniques and material may be used. It will be appreciated that implementations of the present invention, in which a tongue support structure is integrated into a lower splint, may be developed with most existing oral sleep devices.

As a general point, it has been found important by the inventor in any practical device to ensure that the surfaces to be engaged by the tongue are sufficiently smooth, and avoid sharp edges, sharp curves and projections. The tongue is a highly adaptive organ and is constantly seeking onformation about the objects and surfaces within the mouth. If sharp or abrupt projections are perceived, the tongue will worry at them, thereby reducing the comfort of the device. The tongue may even be injured in this case. This is turn will likely lead to lower levels of user compliance with the use fo the device. This is an issue not only at the general design level, but at the level of each specific device as constructed for a user. If issues such as this are encountered, the device needs to be modified to make it suitable for the comfort of the user. This may require re-shaping, abrasive removal or smoothing or material, or building up of surfaces.

<FIG> illustrates device <NUM> according to one aspect of the present invention. The device is based around a generally conventional splint adapted to cover the lower teeth, which are received within passage <NUM>. Tongue support <NUM> projects from the front of the splint into the opening within the arc of the teeth, onto the lower palate. It includes a groove or recess <NUM> into which the lingual frenum of the tongue can be received, so as to maximise the ability of the tongue to project forward in the mouth.

Cavities <NUM> and <NUM> are formed within the interior walls of the device <NUM>. These cavities provide a space within which the tongue will flow in its rested or relaxed state. Grooves <NUM>, <NUM> are provided to encourage the tongue to sit forward in the mouth, using the tongue tongue reflex. Device <NUM> also includes lugs <NUM>, <NUM> associated with operation of the device as part of an MAS device. The MAS aspects, and upper splint and associated elastics, may be entirely conventional, for example as in the devices available commercially from Somnomed Limited and other manufacturers. Accordingly, no detailed discussion of such devices will be included.

It will be appreciated that the present implementation may be a stand alone device, and not part of an MAS construction. Lugs <NUM>, <NUM> are provided in this implementation as a convenience, as in the event that an MAS device is determined to be clinically appropriate, a whole new lower splint is not required.

In this implementation, the interior walls <NUM>, <NUM> preferably project inwardly and away from the main section of the splint, at angle of preferably <NUM> to <NUM> degrees. Cavities <NUM>, <NUM> are provided within the walls <NUM>, <NUM>. Cavities <NUM>, <NUM> in a preferred form should enclose a space which is as large as possible, within the constraints of comfort, function and structure.

<FIG> illustrates an alternative implementation of the present invention. Device <NUM> includes openings <NUM>, <NUM> extending completely through the interior side wall of the device. These operatively produce an opening into which the tongue may flow in a relaxed state, similar in principle to the device of <FIG>. Other features of <FIG> are similar to <FIG>.

Alternative devices similar to <FIG> or <FIG> may include a projection onto the floor of the mouth, with a cavity formed therein. Thus, the cavity need not be formed in the side walls generally parallel to the gums, but may be formed in a more vertical way, so that the cavity is generally or roughly parallel to the floor of the mouth.

<FIG> illustrates a small portion of the device of <FIG>, with a notional teeth and gums to better illustrate the principle of the implementation. It will be appreciated that the device and oral anatomy shown are intended schematically, and not to be anatomically or precisely accurate.

It can be seen that teeth, generally <NUM>, are within the device <NUM>, as is part of the associated gum <NUM>. The opening <NUM> extends fully through the device onto the gum <NUM>. As can be seen in <FIG>, which is a section along line A-A, the cavity <NUM> extends from at or slightly above the gum line, to near the base of the gums, and along a substantial part of the length of the teeth, corresponding to the tongue position desired.

<FIG> is a view, partly in section, from the rear of the mouth, particularly to illustrate the position of the tongue in the operative condition, when the tongue is relaxed and the user is asleep. The device <NUM> can be seen, together with teeth <NUM>, 51A and tongue <NUM>. The sides of the tongue relax and conform of their own accord into the cavities <NUM>, <NUM>, with sections of tongue <NUM>, <NUM> projecting into the cavities on each side.

This implementation provides a passively actuated, natural tongue resting position, in which the TFA effect retains the tongue in the desired, forward position between the teeth, without any need for an active restraint. The tongue may be consciously withdrawn, or moved as part of a reflex action such as a sneeze or yawning, without any risk of damage to the tongue.

Trials have indicated that this is effective for many patients to retain the tongue in a more suitable position during sleep, and improve or eliminate their sleep apnoea.

<FIG> illustrates an alternative implementation, in which a wire extension <NUM> is attached to the side of the splint <NUM>. This is retained by recesses <NUM>, <NUM> and the tension in the extension <NUM>. This forms a similar cavity to those in other implementations, bounded by the device <NUM>, extension <NUM> and the teeth and gums <NUM>, <NUM>. The wire extension <NUM> serves in effect to frame the recess. <FIG> illustrates the wire extension in more detail. The wire may be, for example, stainless steel wire such as is commonly used in dental applications, or any suitable biocompatible material.

<FIG> illustrates yet a further implementation, in which a plastic extension <NUM> is attached to the side of the splint <NUM>. This is retained by recesses <NUM>, <NUM> and the outward tension in the extension <NUM>. This forms a similar cavity to those in other implementations, bounded by the device <NUM>, extension <NUM> and the teeth and gums <NUM>, <NUM>. <FIG> illustrates the plastic extension in more detail. The plastic section may be formed from any biocompatible material with appropriate structural properties, for example a suitable dental polymer. This component could be custom formed, or mass produced in one or more sizes for fitting to the custom splint.

It will be appreciated that a variety of attachment mechanisms could be used for the extension component, depending upon the mechanical arrangement selected and the properties of the material chosen.

<FIG> illustrates another alternative implementation according to the present invention. In this implementation, the device <NUM> includes metal sections <NUM>, <NUM> extending from the inside face 71of the device. In this implementation, the metal sections <NUM>, <NUM> are moulded within the structure, as can be seen by dotted recesses <NUM>, <NUM>. The cross sectional shape of metal sections <NUM>, <NUM> is preferably rounded, and most preferably tear drop shaped, with a somewhat thicker section at the bottom than the top. In this implementation, the cavities are formed by the openings within metal sections <NUM>, <NUM>.

It will be appreciated that in order to obtain optimal benefit, the device needs to be correctly sized for the mouth of the user. Further, the correct spacings between the components need to be present. Space <NUM> and space <NUM> need to be equal or close to equal, and the gap <NUM> must be neither too wide nor too narrow. This will be reflected in the reports of comfort by the user. Modification is required if the user reports discomfort, by adjusting the positions and curvature of the metal sections <NUM>, <NUM>.

<FIG> is a sectional view illustrating an device similar to the device of <FIG> in a user's mouth. In this implementation, there is no upper splint or MAS device. Upper teeth <NUM> are not involved. Lower teeth <NUM> have a device <NUM> fitted. It can be seen that tongue <NUM> has a portion <NUM> projecting within the curve created by metal section <NUM>.

In some patients, particularly those with very large tongues (macroglossia), trials have indicated that an additional component is of assistance. For some such patients, moving the tongue merely up to the inside of the lips does not provide sufficient forward movement of the tongue to adequate open the airway. However if the tongue simply protrudes from the mouth, this creates an issue of the tongue drying out and becoming a source of discomfort.

In this instance, a small, thin flexible protector may be provided which fits inside the lips and into which the tongue is inserted. The tongue is thereby protected from drying out, and the cap is retained by a abutting the lips, with a closed part protruding further. This is particularly applicable with a simple lower splint, and no MAS device.

In the implementation of <FIG>, a tongue protector <NUM> is also provided. This allows for the user's tongue <NUM> to project out of the mouth, past teeth <NUM> and lips <NUM>, <NUM>. The protector has bubble section <NUM> projecting out of the mouth, and a flange <NUM> extending around the periphery of the protector <NUM>, which serves to locate and retain the protector inside the mouth of the user.

<FIG> illustrate the protector in more detail. It will be appreciated that protector <NUM> may be formed in a variety of shapes, and that this is merely a suitable example. The protector may be formed from any suitable material, for example a polymer or silicone material. It must be somewhat flexible, but retain sufficient rigidity, especially around the flange, in order to be effectively retained in use, particularly noting that the user is intended to be asleep during use.

It is emphasises that the tongue protector does not exert any hold on the tongue. It is not intended to retain the tongue, by suction or narrowing, as the retention is accomplished by the cavities in the lower splint.

From the examples, it will be apparent that the present invention may be implemented in various ways. Whilst recognising that there are of course other possible implementations, below we will discuss several specific implementations.

In one version, the present invention can be added to an MAS device, without providing a tongue tip space in the MAS device. This will leave the tongue positioned at rest behind the teeth. In this implementation, the MAS device operates in a conventional way, but its operation is enhanced by the cavities reducing the likelihood of the tongue sagging backwards, particularly in supine sleep. This is beneficial, for example, for supine OSA in many cases where there in not a particularly large tongue, or obesity issues.

In a second application, the present invention may be added to an MAS device, with a tongue tip space, so that the tongue projects at rest past the teeth but inside the lips.

In a third application, the present invention may be applied to an MAS device, with the addition of the tongue protector. In this case, the tongue will project past the lips into the protector.

In a fourth application, the present invention may be applied to a lower splint only, with the addition of a tongue protector. This is particularly useful for cases in which mandibular advancement is contra-indicated, such for patients with jas joint issues. It is also useful where persistent snoring cannot be resolved by other means. So long at the nasal airway is patent, this is effective as the tongue protector prevents breathing through the mouth, and snoring noises are not generally present with nasal breathing. This has application, for example, where there is more tongue crowding or obstruction issues, Down Syndrome, or macroglossia.

Although the present invention is preferably implemented with a custom moulded splint, it could be implemented using a pre- formed device which is heat mouldable for example as is common for mouth guards or similar devices. For example, a variety of preformed shapes could be used. Other moulding or manufacturing processes could be used. While it is preferred, it is not essential that the device cover all the teeth, what is required is that an adequate structure is provided to provide the cavity and other structures which are provided to engage the tongue.

The cavity may be provided by any suitable structure, formed from any suitable material. For example, this may be a biocompatiable metal (e.g. titanium or stainless steel), biocompatiable plastic (e.g. polycarbonate) or any other suitable material. The term cavity is to be understood in the broadest sense, and may include a opening partly or fully through the device, or a space defined by a peripheral frame or structure. The shape may be any suitable shape which achieves the desired function, of allowing the resting tongue to flow in and around the cavity and retain the tongue by virtue of the TFA effect. Preferably, the shape is selected to maximise tongue retention. The same criteria apply to the positioning of the cavity. In some implementations, it is foreseen there may be multiple cavities.

However, it is equally important that the retention be such that the tongue may be rapidly withdrawn if required. The structures defining the cavities preferably have cross sectional shapes which minimise tongue irritation, yet assist with tongue retention. In particular, the splints would be formed so that at the rear there is a minimal labial flange thickness.

It will be appreciated that there are many other ways in which a cavity or recess can be provided along the gum wall, or adjacent thereto, or along the floor of the mouth, for the tongue to rest within. For example, the shape of the cavity may be more complex, or could be discontinuous. The edges of the cavity could in relatively tapered, or less so, or vary in this along the edge. The key requirement is that operatively the relaxed tongue rests adjacent to and moves to an extent into the cavity. Any suitable shape of cavity or similar structure which provides an opening and which is operative to retain the relaxed tongue may be used to implement the present invention.

The precise shape and dimensions of the cavity or recess are subject to both the specific anatomy of the proposed user, and the constraints of the selected design. Preferably, the recess is several millimetres deep. The extensions are preferably angled inwardly, at an angle of between about <NUM> degrees and about <NUM> degrees. The tongue supporting extensions (or other structures), in a preferred form, should extend from approximately the position of the canine teeth, to the posterior molar region, generally the second molar.

In one form, the wire or plastic extensions described above could be pro-formed to specific sizes, or a variety of sizes could be available and fitted for comfort by the practitioner. In another form, the extensions (particularly in wire) could be custom modified and fitted to each user. Similar principles apply to the formed cavity or opening alternatives. It will be appreciated that there are many ways in which devices can be manufactured.

In preferred forms, as shown in <FIG>, pre-formed connection points are provided for the extension, to provide a more consistent device and simplify fitting and manufacture.

The walls <NUM>, <NUM> in which the cavities <NUM>, <NUM> are provided preferably project inwardly and away from the splint, at angle of preferably <NUM> to <NUM> degrees. The cavity, or other structure are will be described below, should enclose a space which is as large as possible, within the constraints of comfort, function and structure. It will be understood that there may need to be an adjustment to the size and shape of the cavities in order to meet the required level of comfort for the user, on a trial and error basis.

The process of fitting a device to a user according to the preferred implementation is as follows. A dentist takes a bottom mouth impression, and then a bite record which registers the correct vertical opening of the jaw. The dental laboratory then constructs a standard bottom splint, according to the bite record and impression provided by the dentist. In the case that an extension type system is used, the laboratory includes the attachment recesses for such extensions. In some implementations, the wire may be inserted into the splint.

In implementations with a recess or opening, then this is created from the custom moulded device by the technician, either in a standard position or one specified by the dentist.

At the time of fitting, the dentist will insert the extension devices, and ensure that they are the correct size to optimise the retention effect.

In the event that an MAS device is to be provided, incorporating the features of the present invention in the lower splint, then reference should be had to the details in the prior application, incorporated above by reference. Specifically, it is important to provide a tongue tip space, as described in that disclosure, between the upper and lower splints, so that the tongue is able to move as far forward as possible in the mouth. If there is no room for the tongue to move as far forward as possible, for example between or immediately behind the lips, then the optimum effect cannot be obtained from the present invention.

Claim 1:
An oral device to operatively enhance the operation of the airway of a sleeping user, the device comprising a carrier (<NUM>) adapted to be positioned over at least some of the lower teeth of the user, wherein the carrier (<NUM>) has an interior projection over at least part of the gums of a user, characterised in that the projection defining a pair of opposed cavities (<NUM>, <NUM>), the cavities (<NUM>, <NUM>) being shaped and adapted to allow for a user's tongue to flow in and around the cavity, wherein the cavity is defined by one or more of a recess (<NUM>, <NUM>) in the projection, an opening (<NUM>, <NUM>) in the projection, and the projection forming a frame.