Patent Description:
The invention relates to a coupling device for use with a dental appliance for mandibular repositioning, a mandibular repositioning appliance comprising said coupling device, and a kit or system for making or providing a readily adjustable mandibular appliance.

It will be convenient to hereinafter describe the invention in relation to a mandibular repositioning device or mandibular advance splint that is useful for the treatment of snoring and/or obstructive sleep apnoea, however it should be appreciated that the present invention is not limited to that application only.

Sleep apnoea (or more correctly obstructive sleep apnoea) is a condition that affects about <NUM>% of adults. Sleep apnoea can occur when the airway in the throat that leads from the nose and mouth to the lungs collapses when asleep and muscles are relaxed. If the collapse is severe enough it causes an apnoea (absence of breath). If it is a partial collapse it usually causes snoring. A person with severe sleep apnoea may have hundreds of these events each night which results in lack of oxygen to the body's vital organs and disrupted sleep. Long term consequences are high blood pressure and an increased risk of heart attack or stroke and, of course, sleepiness.

There are many treatments that have been tried for sleep apnoea but the treatment that is most effective, controlling the symptoms in almost everyone who uses it effectively, is Continuous Positive Airway Pressure (CPAP). Unfortunately a number of people with sleep apnoea do not tolerate CPAP and turn to other treatments such as surgery to the airway or an oral appliance.

Oral appliances are also called mandibular advancement splints (MAS) or mandibular advancement devices (MAD) and there are many types, not all of which are equally effective. The usual oral appliance consists of a "mouth guard" fitted to both the top teeth and the bottom teeth and then joined together in such a way that the bottom teeth are positioned slightly forward of the top teeth. Pushing the bottom jaw forward in most people opens up the airway and supports it so that it is less likely to collapse, in this way helping to reduce either the number or severity of the apnoea events. For most people, advancing the jaw by about <NUM> to <NUM> is enough to make a difference but the optimum amount of advancement varies from person to person and for each individual may require adjustment to reach a setting that is both effective and tolerably comfortable.

A number of different forms of mandibular advancement devices are available or have been proposed, however known devices have not been without limitation. For example, <CIT> discloses a dental device which fastens together the upper and lower dental splints at the front. When fastened the device is adjusted so that the lower splint is fixed in relation to the upper splint in order to appropriately reposition the mandible. However, when fastened the user is not permitted any substantial movement of the jaw, which can be disconcerting, uncomfortable and inconvenient for the user.

Another example of a mandibular advancement device can be seen in <CIT>. In this form of device the upper and lower plates are provided with opposed flange protrusions with angled engagement surfaces. When the user's jaw is closed, the flange engagement surfaces bear against one another with the effect of advancing the lower (mandible) plate relative to the upper. However, once the mouth begins to open the effective mandibular repositioning is lost, and furthermore the device is not readily adjustable and/or does not provide an adequate range of adjustment. This form of device also does not permit the user any substantial degree of lateral jaw movement.

A further example of a mandibular advancement device is Spanish patent published as <CIT>. This is similar to <CIT> in as far as it discloses a device which fastens upper and lower dental splints ventrally over the central incisors. The device includes anterior flanges mounted in pockets which sit above the front teeth on the dental splints. These flanges are associated with a central screw mechanism which is advanced centrally in the mouth along the dorsal ventral axis of the patient to obtain the required mandibular displacement. The flanges are to some extent able to move in the pockets allowing some flexibility however the device includes a number of small fiddly parts making manufacture and adjustment of the device complex and relatively difficult.

<CIT> discloses a device for articulating an orthodontic system intended for movement of a mandible in relation to a maxilla. The device including an upper splint and lower splint connected by a system of rods. This device comprises the features of the preamble of the independent claims.

<CIT> discloses a mandibular advancement device intended to cause a slight advancement of the lower jaw.

<CIT> discloses a two-part oral telescope connector and lower jaw protrusion splints having such telescopic connectors.

<CIT> discloses an orthodontic correction system which is intended to attach to a patient's permanent or near permanent dentition. The correction system includes one or more adjustable length assemblies. This system comprises the features of the preamble of the independent claims.

In view of the foregoing, it is desired to address or ameliorate one or more disadvantages or limitations associated with the prior art, or to at least provide a useful alternative.

It is to be appreciated that any discussion of documents, devices, acts or knowledge in this specification is included to explain the context of the present invention. Further, the discussion throughout this specification comes about due to the realisation of the inventor and/or the identification of certain related art problems by the inventor. Moreover, any discussion of material such as documents, devices, acts or knowledge in this specification is included to explain the context of the invention in terms of the inventor's knowledge and experience and, accordingly, any such discussion should not be taken as an admission that any of the material forms part of the prior art base or the common general knowledge in the relevant art in Australia, or elsewhere, on or before the priority date of the disclosure and claims herein.

The present application claims priority from <CIT> and <CIT>.

In one aspect of the present invention there is provided a coupling device for use with a dental appliance for mandibular repositioning as defined in claim <NUM>.

In one aspect the present invention there is provided a mandibular repositioning appliance as defined in claim <NUM>. The mandibular reposition application according to the present disclosure may include:.

In yet another aspect the present invention provides a kit or system for making a readily adjustable mandibular appliance as defined in claim <NUM>. The kit or system according to the present disclosure may include:.

The coupling device for use with a dental appliance for mandibular repositioning according to the present disclosure may include :.

The mandibular repositioning appliance according to the present disclosure may include:.

The first and second splints are preferably maxillary and mandibular splints, respectively, wherein the pivotal coupling of the link arm permits a range of side-to-side relative movement of the mandibular splint when in use. Furthermore, the slideable coupling permits a range of open-and-close relative movement of the mandibular splint when in use. Meanwhile, the relative position of the mandibular splint in the axial dimension is substantially maintained by the coupling.

The coupling device for use with a dental appliance for mandibular repositioning according to the present disclosure may include:.

The device for coupling first and second splints in a mandibular repositioning appliance, may include:.

The engagement between the projecting flange of the second connecting member and the coupling bar preferably allows movement of the projecting flange along the slot formation. Preferably the slot formation is curved at its ends to facilitate rotational movement.

The position adjustment member may be provided with a tool socket or head by use of which the position adjustment member may be rotated relative to the coupling link member to effect adjustment of the location of the coupling link member along the position adjustment member through action of the screw threaded engagement.

A mandibular repositioning appliance including a maxillary splint and a mandibular splint and a coupling device as defined above interconnecting the maxillary and mandibular splints. Preferably the mandibular repositioning device includes two coupling devices, one on each side thereof. The first connecting member of the coupling device is attached to a side of the maxillary splint with the position adjustment member extending along the side. The second connecting member is attached to the side of the mandibular splint with the flange formation protruding laterally.

The appliance according to embodiments of the invention may be used to alleviate snoring, sleep apnoea and other sleep disorders; to alleviate certain types of temporal mandibular dysfunction or in temporal mandibular joint pain treatment; for orthodontic treatment; in post pharyngeal operations and examinations; or to retain the mandible in a forward opening position for other therapeutic purposes.

The devices of the present invention may be used:.

Further disclosure, objects, advantages and aspects of preferred and other embodiments of the present application may be better understood by those skilled in the relevant art by reference to the following description of embodiments taken in conjunction with the accompanying drawings, which are given by way of illustration only, and thus are not limitative of the disclosure herein, and in which:.

A coupling mechanism constructed in accordance with an embodiment of the present invention is described hereinbelow, and illustrated in various views in <FIG>. The primary purpose of the coupling mechanism described is for use with a mandibular repositioning appliance (MRA), such as illustrated in various views in <FIG>.

The coupling mechanism <NUM> is shown in perspective view in <FIG>, from which the main mechanical features can be discerned. The coupling mechanism <NUM> includes a first attachment member <NUM> which is, in use, attached to one splint of an MRA, and a second attachment member <NUM>, in use attached to the other MRA splint. The first and second attachment members are coupled to one another through a position adjustment member <NUM> and a positioning link arm <NUM>.

The position adjustment member <NUM> is of elongate form and supported at each end by the first attachment member to be freely rotatable about its elongate axis. Between the ends supported by the first attachment member the position adjustment member is cylindrically shaped with an external screw thread formation (not detailed in the drawings for the sake of simplicity). The positioning link arm <NUM> has, at one end, a flange with a through-hole having an internal screw thread formation matching that of the position adjustment member. When assembled, as seen in <FIG>, the position adjustment member extends through the positioning link arm through-hole secured by the respective screw thread formations. The location of the positioning link arm along the length of the position adjustment member can be altered by relative rotation of the position adjustment member, which function is described in greater detail below. The positioning link arm <NUM> projects perpendicularly to the position adjustment member axis and has a slot opening of lateral extent to said axis. The second attachment member <NUM> has a portion that extends through the slot opening and allows the second attachment member movement within the slot opening towards and away from the first attachment member <NUM>.

<FIG> shows the coupling mechanism components in an exploded view which enables the mechanism assembly to be explained. As shown, the first attachment member <NUM> is constructed from two end parts <NUM> and an interconnecting shield part <NUM>. Each end part has a base <NUM> and an upstanding flange <NUM>. Alternatively shield <NUM> and end parts <NUM> may be used in this embodiment (shield <NUM> and end part <NUM> are described later). Each end part flange <NUM> is formed with a bearing hole <NUM>. When the first attachment member is in the assembled condition, the end parts <NUM> are positioned so that their bearing holes are coaxial to support the ends of the position adjustment member <NUM>. The shield part <NUM> bridges between and interconnects the end parts <NUM>, when assembled, leaving a gap between the end parts for access by the positioning link arm <NUM>.

The position adjustment member <NUM> is an elongate and substantially cylindrical shaft. Each end of the position adjustment member has a portion <NUM> formed with a slightly smaller diameter than the screw threaded intermediate length. The end portions <NUM> are designed to fit into the bearing holes <NUM> of the first attachment member end parts <NUM> to allow free rotation of the position adjustment member about its axis. One or each end of the position adjustment member <NUM> is formed with a socket recess <NUM> for engagement with a hex-key or the like. The socket recess <NUM> is accessible within the bearing hole <NUM> when the coupling mechanism is in its assembled condition.

The positioning link arm <NUM> has an end flange <NUM> through which the internally screw-threaded through-hole <NUM> extends. Link arm <NUM> may be of varying lengths as shown in <FIG>. An arm portion <NUM> projects radially with respect to the through-hole, and is formed with slot opening <NUM> of extent that is transverse to the through-hole axis. Slot opening <NUM> may have correspondingly different lengths and is curved at its ends to facilitate smooth rotational movement of spigot <NUM> described below.

The second attachment member is constructed in two parts: a spigot part <NUM> and a fastener part <NUM>. The spigot part <NUM> has a base <NUM> and an upstanding spigot <NUM>. The spigot may be of cylindrical form, for example, and has an internally screw-threaded hole <NUM> in its end distal to the base. The spigot <NUM> is of a size to allow it to extend through the slot opening <NUM> of the positioning link arm. The fastener part <NUM> is in the form of a bolt, for example, having a screw-threaded shaft <NUM> projecting from an enlarged head <NUM>. The head <NUM> has a socket recess <NUM>, coaxial with the shaft, for engagement by a hex-key or the like. The screw-threaded shaft of the fastener part is adapted to engage with the screw-threaded hole in the end of the spigot.

The coupling mechanism is assembled with the spigot <NUM> located in the slot opening <NUM> of the positioning link arm. The fastener part <NUM> is fastened to the end of the spigot so that the head <NUM> and base <NUM> are disposed at opposite sides of the arm portion <NUM>, thereby retaining the spigot within the slot opening. This construction permits the second attachment member <NUM> to move relative to the first attachment member <NUM> within the extent of the spigot in the slot opening. The width of the slot opening is marginally larger than the diameter of the spigot so that movement of the second attachment member is relatively restricted in the direction parallel to the axis of the position adjustment member <NUM>. The length of the spigot is somewhat greater than the thickness of the arm portion <NUM> so that there is a degree of freedom for movement of the second attachment member relative to the first attachment member in the circumferential sense of the position adjustment member.

The resulting coupling mechanism <NUM> is shown in various views in <FIG>, <FIG> show the mechanism with the shield part <NUM> removed from the first attachment member and the fastener part <NUM> removed from the second attachment member, so that some aspects of the arrangement of components can be better seen in these drawings. The freedom of movement allowed whilst retaining protrusive positioning in a controlled manner significantly reduces pressure on the anterior teeth from the splints thereby reducing tooth movement.

As outlined above, when the coupling mechanism is assembled (e.g. as seen in <FIG>) there are several modes of relative free movement between the first and second attachment members. One is defined by the spigot <NUM> in the slot opening <NUM> which permits relative movement of the first and second attachment members toward and away from one another transverse to the position adjustment member (e.g. as indicated by arrow <NUM> in <FIG>). This allows opening and closing movements of the mandible. Another is defined by rotation about the axis of the position adjustment member <NUM> which allows the positioning link arm and second attachment member to move circumferentially (e.g. as indicated by arrow <NUM> in <FIG>).

The main purpose of the coupling mechanism <NUM> is to provide coupling between upper (maxillary) and lower (mandibular) splints in an MRA. In general the idea is that, with the MRA fitted to the user, the splints promote relative forward advancement of the mandible which can assist in opening the user's airway. It is the coupling between the upper and lower splints that determines their relative positioning. Different users may require a different degree of mandibular advancement, so in order for the MRA to be applicable to a broad range of users the coupling mechanism is preferably adjustable to suit. <FIG> illustrate an adjustment feature of the coupling mechanism <NUM>.

When the coupling mechanism <NUM> is fitted to an MRA (described in greater detail hereinbelow), the first attachment member <NUM> is attached at a side of the upper splint, and the second attachment member <NUM> attached to the lower (mandibular) splint. When fitted, therefore, the position adjustment member <NUM> extends generally in the forward/backward direction relative to the user. Thus, adjustment of the location of the positioning link arm <NUM> along the length of the position adjustment member <NUM> can be used in practice to determine the amount of advancement of the mandibular splint relative to the maxillary splint. The adjustment can be accomplished by rotation of the position adjustment member relative to the positioning link arm through use of a hex-key in the end socket <NUM>. Turning the position adjustment member in this way moves the positioning link arm along the position adjustment member by action of the screw-threaded engagement, whereby the pitch of the screw thread determines the amount of linear movement per rotation. A marker <NUM> (<FIG>) on the positioning link arm may be provided for use with linear scale markings along the shield part <NUM> (not shown) to enable repeatable calibrated adjustment.

In <FIG> the coupling mechanism is shown at one end of its adjustment range, and in <FIG> the mechanism is shown at the other end of its range.

In <FIG> a mandibular repositioning appliance (MRA) <NUM> is shown incorporating the coupling mechanism <NUM> according to an embodiment of the present invention. The MRA <NUM> has an upper (maxillary) splint <NUM> and a lower (mandibular) splint <NUM>. The splints <NUM>, <NUM> are generally moulded to fit around the upper and lower teeth, respectively, of a user. The structure of each splint may, for example, comprise a hard polymer (e.g. polycarbonate) outer shell portion and a softer polymer (e.g. polyurethane) inner material that surrounds the user's teeth. In the drawings only the hard shell portion of the splints are shown for simplicity.

Each splint <NUM>, <NUM> is U-shaped with generally parallel legs or sides joined by a curved front. The MRA <NUM> includes two coupling mechanisms <NUM>, one for each side. This lateral placement of the couplings in the buccal vestibule provides uninterrupted airflow and allows greater potential oxygenation for a patient compared to devices which are located anteriorly. Further there is no restriction of the lingual/palatal anterior tongue space. The fact that there is no midline obstruction provides significant advantages.

In <FIG>, <FIG> the coupling mechanism <NUM> disposed to the right-hand side of the MRA <NUM> is best seen. The first attachment member <NUM> is attached to the right-hand side of the upper splint <NUM>, and the second attachment member <NUM> is attached to the right-hand side of the lower splint <NUM>. The attachment members <NUM>, <NUM> may be attached to the splints <NUM>, <NUM> by moulding, adhesive bonding or other means. For example the attachment may be made by moulding the hard polymer material of the splint shell around the base of the attachment member thereby forming a unified structure.

As shown, when the coupling mechanism <NUM> is attached in the MRA <NUM> the first attachment member <NUM> is mounted so that the position adjustment member <NUM> extends substantially parallel to the side of the upper splint <NUM> (i.e. substantially parallel to the mid-sagittal plane), and the second attachment member <NUM> is mounted so that the spigot <NUM> protrudes outwardly from the side of the lower splint <NUM>. Alternatively attachment member <NUM> described later may be employed. The positioning link arm <NUM> mounted on the position adjustment member <NUM> extends down to its engagement with the spigot <NUM> in the slot opening <NUM>. The forward/backward position of the lower splint is restricted by the engagement of the spigot in the slot opening, which can be adjusted as described above by adjusting the location of the positioning link arm along the position adjustment member. In <FIG>, for example, the lower splint is shown advanced forward of the upper splint by an amount 'A'.

To provide for greater comfort and convenience of the user, the MRA <NUM> utilising the coupling mechanism <NUM> is designed to allow for some freedom of movement of the mandibular splint whilst still maintaining the desired repositioning (advancement). For example, <FIG> and <FIG> illustrate how the lower splint <NUM> of the MRA <NUM> can be moved in a manner that permits the user to open their mouth whilst still maintaining the desired mandibular advancement. This is enabled by the spigot and slot opening engagement that allows movement of the lower splint toward and away from the upper splint, vertically, whilst restricting the forward/backward movement.

The MRA <NUM> also permits the user sideways movement of the lower jaw by virtue of the coupling mechanism design. <FIG>, for example, illustrates how coupling mechanism allows the lower splint to be displaced sideways relative to the upper splint. As well as greater comfort and convenience, allowing the user some lateral movement in this manner can also be beneficial to the tempo mandibular joint.

Optionally bite pad <NUM> may be used to provide greater comfort. Bite pad <NUM> is a lozenge shape member with tongue <NUM> on its underside. Bite pad <NUM> is secured in place by mating of tongue <NUM> with correspondingly shaped groove <NUM> in a top wall of lower splint <NUM> to form a dove tail joint. Bite pad <NUM> may be of varying height (for example from <NUM> to <NUM>) and different heights may be used on the left and right sides of MRA <NUM> as required. Posterior bite pads assist in relieving stress on the masticular and facial muscles while wearing the appliance.

While this invention has been described in connection with specific embodiments thereof, it will be understood that it is capable of further modification(s). This application is intended to cover any variations uses or adaptations of the invention following in general, the principles of the invention and including such departures from the present disclosure as come within known or customary practice within the art to which the invention pertains and as may be applied to the essential features hereinbefore set forth.

The coupling mechanism <NUM> may be constructed substantially from stainless steel, for example, as known for medical and dental devices. When assembled, the shield part <NUM> may be laser welded to the end parts <NUM>. In order to ensure that the positioning link arm <NUM> is maintained in its desired location on the position adjustment member <NUM> without shifting during use, it is preferred that the screw-threaded engagement between these two components have substantially greater friction than that between the ends of the position adjustment member in the bearing holes. In other words, the position adjustment member <NUM> should be able to rotate relative to the first attachment member <NUM> much more easily than relative to the positioning link arm <NUM>. For this reason, the positioning link arm <NUM> may be constructed from a different material, such as acetyl resin for example, that provides the increased friction with the screw thread of the adjustment member <NUM>.

By way of example only, some relevant dimensions of the coupling device <NUM> are indicated below:.

A coupling mechanism according to a second embodiment of the invention is shown in <FIG> and described below. The coupling mechanism <NUM> is shown in <FIG> assembled but not incorporated with splints into a mandibular repositioning appliance. The coupling mechanism of the second embodiment has several structural differences in comparison with the first embodiment, but functions in fundamentally the same way as described above when in situ.

The coupling mechanism <NUM> has three primary components: a first attachment member <NUM>, a second attachment member <NUM>, and an integrated shaft and adjustment link arm <NUM>. The first attachment member <NUM> is in use mounted to the upper splint of an MRA, and the second attachment member <NUM> mounted to the MRA lower splint. The arrow <NUM> shown in <FIG> corresponds to what would be the forward direction if the coupling mechanism were incorporated in an MRA. The coupling mechanism <NUM> shown in <FIG> is adapted for use on the left-hand side of an MRA.

The first attachment member <NUM> comprises a pair of end parts <NUM> that are similar in structure to the end parts <NUM> of the first embodiment. An end part <NUM> is shown in various views in <FIG>. Each end part <NUM> has a base <NUM> and an upstanding flange <NUM>. The base <NUM> is in use mounted to the side of the upper MRA splint. The flange <NUM> is formed with a bearing hole <NUM> and an axially aligned receiving slot <NUM>. The end parts are bridged by shield <NUM> and are fixed in relation to one another. When so mounted, the two end parts are arranged with their bearing holes coaxially aligned and spaced apart. The two end parts <NUM> for one coupling mechanism <NUM> are actually formed as mirror images of one another, such that receiving slots <NUM> are also aligned when mounted in use.

The second attachment member <NUM> is generally similar in form to the attachment member <NUM> of the first embodiment, but is of unitary construction. The second attachment member <NUM> has a base <NUM> that is in use mounted to the outside of the MRA lower splint. Extending outwardly from the base is a spigot <NUM> on the end of which is an enlarged head formation <NUM>. In this case the enlarged head <NUM> is formed integrally with the spigot, but is asymmetrically shaped.

The integrated adjustment link arm <NUM> provides the function of the position adjustment member shaft (<NUM>) and link arm (<NUM>) of the first embodiment, but is formed as a single structure. An adjustment link arm is shown in isolation in <FIG>. The adjustment link arm <NUM> has a cylindrical rod portion <NUM> with narrowed diameter sections <NUM> at each end adapted to fit into the bearing holes (<NUM>) of respective end parts of the first attachment member. Extending transversely from the rod <NUM> is an arm portion <NUM> with an elongate slot opening <NUM>. The slot opening <NUM> is shaped to enable the spigot <NUM> of the second attachment member to extend therethrough, and is also dimensioned so that the enlarged head <NUM> can fit through the slot in one orientation but not the other. This enables the second attachment member to be engaged with the arm portion by rotating one with respect to the other through ninety degrees and inserting the head <NUM> through the slot <NUM>.

One of the main differences between the coupling mechanism of the second embodiment and that of the first embodiment is the way in which the mechanism is adjusted to control the amount of mandibular advancement for a given user or from time to time. In the coupling mechanism <NUM> of the first embodiment the link arm <NUM> has a screw threaded engagement on the elongate position adjustment member shaft <NUM>, whereby the position of the arm <NUM> along the member <NUM> can be adjusted by use of the screw thread. In coupling mechanism <NUM> of the second embodiment, however, the adjustment link arm <NUM> is integrally formed whereby the arm portion <NUM> is fixed with respect to the shaft or rod portion <NUM>. Therefore, to provide for adjustment of mandibular advancement the coupling mechanism <NUM> employs a plurality of differently configured adjustment link arms <NUM> that can be readily interchanged. Seven adjustment link arm configurations are illustrated in <FIG>.

The purpose of the axially aligned slot in the first attachment member end parts <NUM> is to allow for the adjustment link arm <NUM> to be conveniently removed and replaced in the coupling mechanism <NUM>. The end part <NUM> may be constructed from a polymer material, for example, that may be resiliently deformed to enable the rod portion end section <NUM> to snap-fit through open ended receiving slot <NUM> into the bearing hole <NUM>, and to be similarly removed. Thus, to adjust the amount of mandibular advancement provided by the coupling mechanism one adjustment link arm can be removed from the mechanism and replaced by another of different configuration. As seen in <FIG>, the various adjustment link arm configurations differ from one another by the position of the arm portion along the length of the rod portion. For example, the configuration shown in <FIG> corresponds to the minimum advancement amount, whilst the configuration of <FIG> represents the maximum advancement amount. In addition arm portion <NUM> may be of varying lengths with corresponding elongate slot openings <NUM> to provide more, or less vertical opening of the mandible as required (see <FIG>.

In functional respects, when incorporated in an MRA and in situ, the coupling mechanism <NUM> performs in the same way as the mechanism <NUM>. The mechanism is able to maintain a desired degree of mandibular advancement whilst still allowing some freedom of movement for the user to open their mouth and move their jaw from side to side. The coupling mechanism <NUM> has the advantage of being somewhat simpler in construction, although the trade-off is that the advancement distance is quantized rather than continuously variable as provided by the mechanism <NUM>.

Since the coupling mechanism <NUM> does not involve a screw thread engagement it may be easier than the mechanism <NUM> to construct entirely from polymer materials. In fact the components of the coupling mechanism may be formed through any of a variety of processes known in the manufacturing arts. Injections moulding, for example, could be employed to form the components from suitable polymer materials, which process is particularly advantageous for the production of components in large numbers. Alternatively, components may be formed through the use of more recently developed manufacturing processes such as additive or subtractive manufacturing. Additive manufacturing, sometimes also referred to as 3D printing, is particularly useful for producing relatively small components on-demand without the need for specific and expensive production tooling. Regardless of the manufacturing technique, polymer materials used for the coupling mechanism components are preferably recognized for intra-oral biocompatibility and may include materials such as nylon (PA2200) or polycarbonate (PC-ISO). Those skilled in the art will recognize that various other and alternative materials may also be suitable.

The advantages of the present invention include provision of an easily modifiable device for fitting to a MRA. This means that the device may be provided as an off-the-shelf kit for patient use or be fitted by a clinician. The devices are easily modified for different patients as well are easily modifiable for the changing needs in a single patient. Further any changes required to the degree of mandibular protrusion and/or movement of the mandible can easily be made by the patient or clinician without the need to send the device to the laboratory for alteration.

In particular interchangeable arms <NUM> provide varying protrusive positions and the fact that different length of slot <NUM> can be provided means that varying vertical mandibular movement (opening and closing) can be obtained. Further the height of spigot <NUM> in second attachment member <NUM> provides for varying degrees of lateral (side to side) movement. The combination of features means that when fitted a patient can rotate the mandible without retrusion allowing the patient to gain relief from any discomfort while still obtaining therapeutic benefit from the protrusive position in which MRA <NUM> retains the mandible.

A description of an embodiment with several components or features does not imply that all or even any of such components/features are required. On the contrary, a variety of optional components are described to illustrate the wide variety of possible embodiments of the present invention(s). Unless otherwise specified explicitly, no component/feature is essential or required.

Claim 1:
A coupling device (<NUM>) for use with a dental appliance for mandibular repositioning, including:
a first mount adapted for lateral attachment to a first splint (<NUM>) with a generally forward facing axis with respect to the user of the dental appliance when in use;
a second mount adapted for lateral attachment to a second splint (<NUM>) of the dental appliance; and
a link arm (<NUM>) coupled to the first and second mount, the link arm (<NUM>) extending transverse to said forward facing axis along a transverse axis in a transverse dimension to engage with said second mount in a slideable coupling that allows in use a range of relative movement in said transverse dimension, wherein the coupling allows for sliding movement along the transverse axis accompanied by free pivotal movement about the forward facing axis, protrusive positioning of a mandible being provided in use by relative positioning of the link arm along said forward facing axis;
characterised in that
the first mount is a pivot mount and the second mount is a fixed mount,
the pivot mount allows for free pivotal movement about said forward facing axis,
the pivot mount comprises a first connecting member (<NUM>) with a forward facing axis and supports a position adjustment member (<NUM>);
the fixed mount comprises a second connecting member and includes a spigot (<NUM>);
the first and second connecting members are coupled to one another through the position adjustment member (<NUM>) and the link arm (<NUM>);
the link arm (<NUM>) projects perpendicularly to an axis of the position adjustment member (<NUM>) and comprises a slot opening (<NUM>) for coupling with the spigot (<NUM>), the slot opening (<NUM>) having a lateral extent to said position adjustment member (<NUM>) axis, the width of the slot opening (<NUM>) marginally larger than the diameter of the spigot (<NUM>) so that movement of the second connecting member (<NUM>) is relatively restricted in a direction parallel to the axis of the position adjustment member (<NUM>);
the slidable coupling provided by the spigot (<NUM>) located in the slot opening (<NUM>) enabling the second connecting member (<NUM>) to move relative to the first connecting member (<NUM>) within the lateral extent of the spigot (<NUM>) in the slot opening (<NUM>).