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Title:
A MANDIBULAR ADVANCEMENT DEVICE
Document Type and Number:
WIPO Patent Application WO/2019/008177
Kind Code:
A1
Abstract:
A mandibular advancement device (1) having a first member (2) and a second member (3) adapted to fit substantially over a portion of the teeth of the upper jaw and to fit substantially over a portion of the teeth of the lower jaw of the user respectively. The mandibular advancement device (1) further has an engagement arrangement (4) having a first member engagement component (5) and a second member engagement component (6) configured to be operatively engageable with one another to retain the first member (2) and second member (3) in a lower jaw resting position and in a lower jaw protruding position. The first member engagement component (5) and second member engagement component (6) are operable between the lower jaw resting position and in a lower jaw protruding position upon forward manipulation of the lower jaw by the user only.

Inventors:
PURVIS WILLIAM (GB)
PURVIS JUDY (GB)
Application Number:
PCT/EP2018/068450
Publication Date:
January 10, 2019
Filing Date:
July 06, 2018
Export Citation:
Click for automatic bibliography generation   Help
Assignee:
PURVIS WILLIAM (GB)
PURVIS JUDY (GB)
International Classes:
A61F5/56; A63B71/08
Domestic Patent References:
WO2014043008A12014-03-20
Foreign References:
US20080199824A12008-08-21
US20110017220A12011-01-27
US20150238284A12015-08-27
US20030015198A12003-01-23
Attorney, Agent or Firm:
HANNA, John (GB)
Download PDF:
Claims:
CLAIMS

(1 ) A mandibular advancement device comprising: a first member, the first member adapted to fit substantially over a portion of the teeth of the upper jaw of a user, and a second member, the second member adapted to fit substantially over a portion of the teeth of the lower jaw of the user, and an engagement arrangement, the engagement arrangement comprising first member engagement means and second member engagement means, wherein the first member engagement means and second member engagement means are configured to be operatively engageable with one another to retain the first member and second member in a lower jaw resting position and in a lower jaw protruding position and being operable between the lower jaw resting position and the lower jaw protruding position upon forward manipulation of the lower jaw by the user only so that the engagement arrangement retains the lower jaw of the user in a protruding position relative to the upper jaw of the user.

(2) A mandibular advancement device as claimed in claim 1 , wherein the lower jaw

resting position is forward relative to that of the lower jaw's natural biting position and the first member engagement means and second member engagement means are configured to be operatively engageable with one another to urge the lower jaw from the lower jaw's natural biting position to the lower jaw resting position.

(3) A mandibular advancement device as claimed in any one of the preceding claims, wherein the first member and second member are separate members.

(4) A mandibular advancement device as claimed in any one of the preceding claims, wherein the first member and second member are arcuate structures.

(5) A mandibular advancement device as claimed in any one of the preceding claims, wherein the engagement arrangement comprises a pair of first member engagement means and a pair of second member engagement means.

(6) A mandibular advancement device as claimed in claim 5 when dependent on claim 4, wherein the engagement arrangement comprises a pair of first member engagement means and a pair of second member engagement means, on opposing locations of the arcuate first member and arcuate second member respectively. (7) A mandibular advancement device as claimed in claim 5 or claim 6 when dependent on claim 5, wherein the engagement arrangement comprises a pair of first member engagement means radially equispaced from the centre of curvature of the arc of the first member and a pair of second member engagement means radially equispaced from the centre of curvature of the arc of the second member.

(8) A mandibular advancement device as claimed in any one of the preceding claims, wherein the first member engagement means and second member engagement means are adjacent one another when the jaw is in its resting position and when the jaw is in its protruding position.

(9) A mandibular advancement device as claimed in any one of the preceding claims, wherein the first member engagement means and second member engagement means are overlapping when the jaw is in its resting position and at least partially overlapping when the jaw is in its protruding position.

(10) A mandibular advancement device as claimed in any one of the preceding claims, wherein the first member engagement means and second member engagement means are mutually opposing when the jaw is in its resting position and when the jaw is in its protruding position.

(1 1 ) A mandibular advancement device as claimed in any one of the preceding claims, wherein the first member engagement means and second member engagement means are substantially parallel to one another in both the jaws resting position and protruding position.

(12) A mandibular advancement device as claimed in any one of the preceding claims, wherein the first engagement means of the engagement arrangement is locatable proximal to the first member and the second engagement means is locatable proximal to the second member.

(13) A mandibular advancement device as claimed in any one of the preceding claims, wherein the engagement means of the first member is locatable proximal to the posterior teeth of the upper jaw of the user. (14) A mandibular advancement device as claimed in any one of the preceding claims, wherein the engagement means of the first member is locatable in the premolar region of the upper jaw of the user.

(15) A mandibular advancement device as claimed in any one of the preceding claims, wherein the engagement means of the second member is locatable proximal to the posterior teeth of the lower jaw of the user.

(16) A mandibular advancement device as claimed in any one of the preceding claims, wherein the engagement means of the second member is locatable in the premolar region of the lower jaw of the user.

(17) A mandibular advancement device as claimed in any one of the preceding claims, wherein the engagement arrangement is located in an occlusal area where the teeth of the upper jaw would normally contact the teeth of the lower jaw.

(18) A mandibular advancement device as claimed in any one of the preceding claims, wherein relative movement between the second member and the second member engagement means is possible.

(19) A mandibular advancement device as claimed in any one of the preceding claims, wherein the first member engagement means and second member engagement means are embedded or partially embedded within their respective first and/or second member.

(20) A mandibular advancement device as claimed in any one of the preceding claims, wherein the first member engagement means and second member engagement means are housed within their respective first and/or second member.

(21 ) A mandibular advancement device as claimed in any one of the preceding claims, wherein the first member engagement means and second member engagement means are contained within a cavity within their respective first and/or second member.

(22) A mandibular advancement device as claimed in any one of the preceding claims, wherein the engagement arrangement is adapted to enable the first member engagement means and second member engagement means to releasably engage in use.

(23) A mandibular advancement device as claimed in any one of the preceding claims, wherein the engagement arrangement comprises a releasable retaining means adapted to enable the engagement arrangement to releasably engage in use.

(24) A mandibular advancement device as claimed in claim 23, wherein the releasable retaining means comprises releasable retaining components to enable the first member engagement means and second member engagement means to releasably engage in use.

(25) A mandibular advancement device as claimed in claim 24, wherein the releasable components are first releasable retaining component and second releasable retaining component wherein the first releasable retaining component is locatable proximal to the first member and the second releasable retaining component is correspondingly locatable proximal to the second member.

(26) A mandibular advancement device as claimed in claim 25, wherein relative

movement between the second member and the second releasable retaining component is possible.

(27) A mandibular advancement device as claimed in claim 25 or claim 26, wherein the second member is movable relative to the second releasable retaining component under the influence of the user moving their lower jaw forward to the protruding position.

(28) A mandibular advancement device as claimed in claim 27, wherein the second

member is slidably movable relative to the second releasable retaining component under the influence of the user moving their lower jaw forward to the protruding position.

(29) A mandibular advancement device as claimed in claim 27 or claim 28, wherein the second member is slidably movable relative to the second releasable retaining component in a direction to and from the protruding position under the influence of the user moving their lower jaw forward and backwards. (30) A mandibular advancement device as claimed in any one of claims 25 to 29, wherein the first releasable retaining component is fixed.

(31 ) A mandibular advancement device as claimed in any one of claims 25 to 30, wherein the second releasable retaining component remains in a state of rest throughout the movement of the second member from the jaw resting position to the lower jaw protruding position with respect to the first releasable retaining component when the first member and second member are in contact. (32) A mandibular advancement device as claimed in any one of claims 25 to 31 , wherein when in operational engagement with the first releasable retaining component and upon movement of the second member from the lower jaw resting position to the lower jaw protruding position under the influence of a user moving their lower jaw forward, the second releasable retaining component is spatially displaced to an opposing end of the second member engagement means from that to which the second releasable retaining component was located when at the lower jaw resting position.

(33) A mandibular advancement device as claimed in any one of claims 25 to 32, wherein when in operational engagement with first releasable retaining component and upon movement of the second member from the lower jaw resting position to the lower jaw protruding position under the influence of a user moving their lower jaw forward, the second releasable retaining component is spatially displaced from a position proximal to the outer arcuate perimeter of the second member to a position proximal to the inner arcuate perimeter of the second member.

(34) A mandibular advancement device as claimed in any one of claims 25 to 33, wherein when in operational engagement with first releasable retaining component and upon movement of the second member from the lower jaw resting position to the lower jaw protruding position under the influence of a user moving their lower jaw forward, the second releasable retaining component is laterally displaced from a position proximal to the outer arcuate perimeter of the second member to a position proximal to the inner arcuate perimeter of the second member.

(35) A mandibular advancement device as claimed in any one of claims 25 to 34, wherein when in operational engagement with first releasable retaining component and upon movement of the second member from the lower jaw resting position to the lower jaw protruding position under the influence of a user moving their lower jaw forward, the second releasable retaining component is longitudinally displaced from a position proximal to the anterior of the second member to a position proximal to the posterior of the second member.

(36) A mandibular advancement device as claimed in any one of claims 25 to 35, wherein when in operational engagement with first releasable retaining component and upon movement of the second member from the lower jaw resting position to the lower jaw protruding position under the influence of a user moving their lower jaw forward, the second releasable retaining component is simultaneously displaced laterally from a position proximal to the outer arcuate perimeter of the second member to a position proximal to the inner arcuate perimeter of the second member and displaced longitudinally from a position proximal to the anterior of the second member to a position proximal to the posterior of the second member.

(37) A mandibular advancement device as claimed in any one of claims 25 to 36, wherein when in operational engagement with first releasable retaining component and upon movement of the second member from the lower jaw resting position to the lower jaw protruding position under the influence of a user moving their lower jaw forward, the second releasable retaining component is radially displaced inwards relative to the centre of curvature of the second member.

(38) A mandibular advancement device as claimed in any one of claims 25 to 37, wherein the engagement arrangement is configured such that the second releasable retaining component is held stationery by the first releasable retaining component as the second member moves.

(39) A mandibular advancement device as claimed in any one of claims 25 to 38, wherein the second member engagement means is configured such that the second releasable retaining component is held stationery by the first releasable retaining component as the second member moves.

(40) A mandibular advancement device as claimed in any one of claims 25 to 39, wherein the second releasable retaining component comprises a leading end and a trailing end, the trailing end located proximal to the anterior of a user's mouth and the leading end located proximal to the posterior of the user's mouth. (41 ) A mandibular advancement device as claimed in any one of claims 23 to 40, wherein the releasable retaining means comprises magnets.

(42) A mandibular advancement device as claimed in claim 41 wherein, the magnetic force of the magnets is such that it is sufficient to restrain the movement of the lower jaw under gravity but can easily be overcome by the user who can cause the first member and second member to separate and/or slide relative to one another by a simple movement of their jaw.

(43) A mandibular advancement device as claimed in claim 41 or claim 42, wherein the releasable retaining means comprises a pair of magnets on either the first member or second member.

(44) A mandibular advancement device as claimed in any one of claims 41 to 43, wherein the releasable retaining means comprises a pair of magnets on either the first member or second member, the magnets engageable with a pair of ferromagnetic components on either the second member or first member respectively.

(45) A mandibular advancement device as claimed in any one of claims 41 to 43, wherein the releasable retaining means comprises a pair of magnets on each member.

(46) A mandibular advancement device as claimed in claim 45, wherein the magnets are arranged having respective polarities such that their mutual magnetic forces cause the first member engagement means and second member engagement means to remain in contact in use.

(47) A mandibular advancement device as claimed in claim 45 or claim 46, wherein the magnet located within the second member engagement means is fixed relative to the correspondingly located magnet located within the first member engagement means when the first and second member are in contact.

(48) A mandibular advancement device as claimed in any one of claims 45 to 47, wherein relative movement between the second member and the magnet located within the second member engagement means is possible.

(49) A mandibular advancement device as claimed in any one of claims 43 to 48, wherein the magnet located within the first member engagement means is fixed. (50) A mandibular advancement device as claimed in any one of claims 43 to 49, wherein the magnet located within the second member engagement means remains in a state of rest throughout the movement of the second member from the jaw resting position to the lower jaw protruding position with respect to the magnet located within the first member engagement means when the first and second member are in contact.

(51 ) A mandibular advancement device as claimed in any one claims 25 to 50, wherein the mandibular advancement device further comprises housings for housing respective first releasable retaining component and second releasable retaining component.

(52) A mandibular advancement device as claimed in claim 51 , wherein the housings comprise a base portion, a top portion and four side portions extending between the base portion and top portion.

(53) A mandibular advancement device as claimed in claim 51 or claim 52, wherein a portion of the first and second releasable retaining component housings are couplable to the respective first member and second member.

(54) A mandibular advancement device as claimed in any one of claims 51 to 53, wherein a portion of the first releasable retaining component housing and second releasable retaining component housing are integral to their respective first member and second member.

(55) A mandibular advancement device as claimed in any one of claims 51 to 54, wherein a portion of the first releasable retaining component housing and second releasable retaining component housing are embedded or partially embedded within their respective first member and second member.

(56) A mandibular advancement device as claimed in any one of claims 51 to 55, wherein a portion of the housings of both the first releasable retaining component and second releasable retaining component is detachable.

(57) A mandibular advancement device as claimed in claim 56, wherein the detachable portions of the housings abut one another once the engagement arrangement is engaged. (58) A mandibular advancement device as claimed in claim 56 or claim 57, wherein the detachable portion has snap fit, press fit or other mechanical engagement means with the housing.

(59) A mandibular advancement device as claimed in any one of claims 56 to 58, wherein the detachable portion further comprises a gasket, the gasket extending around all or part of the perimeter of the detachable portion.

(60) A mandibular advancement device as claimed in claim 59, wherein upon attaching the detachable portion to the housing, the detachable portion is pushed against the external perimeter of the housing resulting in the gasket being compressed such that the releasable component within the housing is secure.

(61 ) A mandibular advancement device as claimed in any one of the preceding claims, wherein the mandibular advancement device further comprises movement restriction means, the movement restriction means restricts movement of the lower jaw of the user.

(62) A mandibular advancement device as claimed in claim 61 , wherein the movement restriction means restricts the lower jaw of the user from moving from the protruding position relative to the upper jaw of the user in a direction towards the posterior of the user's mouth.

(63) A mandibular advancement device as claimed in claim 61 or claim 62, wherein the second member engagement means comprises the movement restriction means to restrict movement of the lower jaw of the user.

(64) A mandibular advancement device as claimed in any one of claims 25 to 40 or any one of claims 41 to 63 when dependent on any one of claims 25 to 40, wherein the movement restriction means restricts the relative slidable movement between the second member and the second releasable retaining component.

(65) A mandibular advancement device as claimed in claim 63 or claim 64, wherein the movement restriction means comprises longitudinally spaced apart abutment portions, a first abutment portion defining the resting position of the jaw for the mandibular advancement device proximal to the anterior part of the second member and a second abutment portion defining the protruding position, the second abutment portion spaced longitudinally towards the posterior of the second member.

(66) A mandibular advancement device as claimed in any one of claims 25 to 40 or any one of claims 41 to 65 when dependent on any one of claims 25 to 40, wherein the engagement arrangement further comprises locating means for securing the second releasable retaining component in the protruding position.

(67) A mandibular advancement device as claimed in claim 66, wherein the locating

means is located within the second member engagement means.

(68) A mandibular advancement device as claimed in claim 66 or claim 67, wherein the locating means comprises male and female components.

(69) A mandibular advancement device as claimed in claim 68 when dependent on claim 66, wherein the locating means has a male or female component located on the second abutment portion of the movement restriction means.

(70) A mandibular advancement device as claimed in claim 69, wherein the female

member of the locating means is a groove or recess within the second releasable retaining component.

(71 ) A mandibular advancement device as claimed in any one of claims 25 to 40 or any one of claims 41 to 70 when dependent on any one of claims 25 to 40, wherein the engagement arrangement comprises guide means to guide the spatial displacement of the second releasable retaining component from a position proximal to the outer arcuate perimeter of the second member to a position proximal to the inner arcuate perimeter of the second member when in operational engagement with first releasable retaining component and upon movement of the second member from the lower jaw resting position to the lower jaw protruding position under the influence of a user moving their lower jaw forward.

(72) A mandibular advancement device as claimed in any one of claims 25 to 40 or any one of claims 41 to 71 when dependent on any one of claims 25 to 40, wherein the engagement arrangement comprises guide means to guide a simultaneous longitudinal displacement of the second releasable retaining component from a position proximal to the anterior of the second member to a position proximal to the posterior of the second member and a lateral displacement from a position proximal to the outer arcuate perimeter of the second member to a position proximal the inner arcuate perimeter of the second member when in operational engagement with first releasable retaining component and upon movement of the second member from the lower jaw resting position to the lower jaw protruding position under the influence of a user moving their lower jaw forward.

(73) A mandibular advancement device as claimed in any one of claims 65 to 72 when dependent on any one of claims 25 to 40, wherein the engagement arrangement comprises guide means to guide the second releasable retaining component to the second abutment portion of the movement restriction means for securement of the second member in the protruding position.

(74) A mandibular advancement device as claimed in any one of claims 25 to 40 or any one of claims 41 to 73 when dependent on any one of claims 25 to 40, wherein the engagement arrangement comprises revert means to urge the second releasable retaining component from its displaced position to the position to which the second releasable retaining component was located when at the lower jaw resting position, when the first releasable retaining component and the second releasable retaining component are disengaged.

(75) A mandibular advancement device as claimed in claim 74, wherein the revert means is located proximal to an anterior portion of the second member engagement means. (76) A mandibular advancement device as claimed in claim 74 or claim 75, wherein

magnetic attraction between the second releasable retaining component and the revert means urges the second releasable retaining component from its displaced position to the position to which the second releasable retaining component was located when at the lower jaw resting position, when the first releasable retaining component and the second releasable retaining component are disengaged.

(77) A mandibular advancement device as claimed in any one of the preceding claims, wherein the engagement arrangement further comprises braking means operable between the first member and second member for engaging the first member and second member for fixing the first member and second member in a lower jaw resting position and in a lower jaw protruding position. (78) A mandibular advancement device as claimed in claim 77, wherein the braking means comprises a male component engageable with a female component.

(79) A mandibular advancement device as claimed in claim 78, wherein the braking

means female component extends from a position proximal to the outer arcuate perimeter of the first member or second member to a position proximal the inner arcuate perimeter of the first member or second member.

(80) A mandibular advancement device as claimed in any one of the preceding claims, wherein the mandibular advancement device is a mouthguard for sports.

(81 ) A mandibular advancement device comprising: a first member for covering at least part of the teeth of the upper jaw, a second member for covering at least part of the teeth of the lower jaw and means for fixing the first and second member in at least a lower jaw resting position and a lower jaw protruding position, the fixing means operable between the lower jaw resting position and in a lower jaw protruding position upon forward manipulation of the lower jaw by the user only.

(82) A method of manufacturing a mandibular advancement device having a first member for covering at least part of the teeth of the upper jaw, a second member for covering at least part of the teeth of the lower jaw and means for fixing the first and second member in at least a lower jaw resting position and a lower jaw protruding position, the fixing means operable between the lower jaw resting position and in a lower jaw protruding position upon forward manipulation of the lower jaw by the user only, the method comprising the steps of: forming a first member and a second member, forming housings for the respective first releasable retaining component and second releasable retaining component within the first member and second member, inserting a first releasable retaining component within its housing and inserting a second releasable retaining component within its housing.

(83) A method of manufacturing a mandibular advancement device having a first member for covering at least part of the teeth of the upper jaw, a second member for covering at least part of the teeth of the lower jaw and means for fixing the first and second member in at least a lower jaw resting position and a lower jaw protruding position, the fixing means operable between the lower jaw resting position and in a lower jaw protruding position upon forward manipulation of the lower jaw by the user only, the method comprising the steps of: accessing a 3D printer, acquiring a 3D model, and generating a print file in the design printing mode in accordance with the 3D model.

Description:
A MANDIBULAR ADVANCEMENT DEVICE

The present invention relates to a mandibular advancement device which is insertable in, and removeable from, the mouth by the user. In particular, to a mandibular advancement device for the treatment and prevention of snoring, sleep apnoea and similar disorders. The present invention further relates to a mandibular advancement device for use by athletes participating in sport. In particular to a mandibular advance device in the form of a mouthguard to improve airflow to optimise the athletes breathing during sports. A muscular relaxation in the throat area can occur in humans during sleep. This reduction in muscle tone causes a narrowing of the individual's pharynx. In some individuals, this narrowing of the pharynx can cause snoring. Snoring is a common problem and is caused by turbulence inside the airway during inspiration. In certain cases, snoring is often a manifestation of sleep apnoea whereby due to the narrowing of the pharynx, respiration is temporarily suspended for a certain period of time. This suspension of respiration causes the individual to awaken from sleep and is often repeated which can affect the quality of sleep; thus, effecting a person's day to day life and performance.

There are numerous devices to prevent snoring and sleep apnoea many of which operate by holding an individual's jaw forward and slightly ajar during sleep. As a result of this positioning, the muscles are stretched and strengthened minimising the narrowing of the pharynx due to muscular relaxation. This in turn reduces turbulence within the airway. By keeping the jaw slightly ajar airflow is also improved through the lips and mouth. Nonetheless, conventional mandibular advancement devices have several drawbacks.

First, these conventional devices tend to be bulky and because they hold the jaw permanently and rigidly in place. As a result, users tend to be intolerant of them due to their uncomfortable restrictiveness.

Secondly, conventional devices tend to be required to be removed from the mouth, adjusted and then reinserted. This method of adjustment can be disruptive, cumbersome and time-consuming especially considering the very nature of the device worn while the user is sleeping.

Finally, other conventional devices such as those noted in WO2014/043008 utilise hardware components such as expansion screws mounted upon an occlusal surface in order to facilitate and control the positional adjustment of the lower jaw. This mechanical adjustment method again being cumbersome and time-consuming.

In sports a mouthguard (commonly also referred to as a gumshield or mouth protector) is a device worn in the mouth of the athlete which is intended to protect the teeth, gums and jaw of the user. These conventional devices are adapted to fit over the teeth and a substantial portion of the gums of the upper jaw. However, conventional devices tend to be bulky and the natural position which provides the most comfort to users tends to be the natural biting position of the jaw. This results in muscular relaxation of the throat area, causing a narrowing of the athlete's pharynx which can cause turbulent airflow inside the airway during inspiration. This turbulent airflow reduces the flow rate of air inside the airway, thus the breathing efficiency of the athlete is reduced.

It is an object of the present invention to obviate or mitigate one or more problems associated with the prior art and provide a more efficient mandibular advancement device with an increased ease of use.

It is a further object of the present invention to provide a mandibular advancement device for use in sports to improve air flow for an athlete.

Accordingly, the present invention provides a mandibular advancement device comprising:

a first member, the first member adapted to fit substantially over a portion of the teeth of the upper jaw of a user, and

a second member, the second member adapted to fit substantially over a portion of the teeth of the lower jaw of the user,

and an engagement arrangement, the engagement arrangement comprising first member engagement means and second member engagement means,

wherein the first member engagement means and second member engagement means are configured to be operatively engageable with one another to retain the first member and second member in a lower jaw resting position and in a lower jaw protruding position and being operable between the lower jaw resting position and the lower jaw protruding position upon forward manipulation of the lower jaw by the user only so that the engagement arrangement retains the lower jaw of the user in a protruding position relative to the upper jaw of the user. It will be appreciated that the protruding position of the lower jaw is one which is forward relative to the upper jaw and that of the lower jaw's resting position.

Ideally, the lower jaw resting position is forward relative to that of the lower jaw's natural biting position.

Preferably, the engagement arrangement retains the lower jaw of the user in a lower jaw resting position relative to the upper jaw. Ideally, the first member engagement means and second member engagement means are configured to be operatively engageable with one another to urge the lower jaw from the lower jaw's natural biting position to the lower jaw resting position.

Advantageously, a mandibular advancement device which comprises an engagement arrangement having engagement means configured to be operatively engageable with one another and upon forward manipulation of the lower jaw by the user urge and retain the lower jaw of the user into a protruding position provides the user with a simple and comfortable manual positional adjustment of the jaw positions beyond that of the prior art; one that can be achieved from the user's sleeping position with little to no disruption to the user. The forward manipulation being a simple and natural movement of the lower jaw and the urging of the lower jaw by the user provides a semi-autonomous adjustment mechanism moving the lower jaw from the rest position to the protruding position. This can be contrasted to the

cumbersome adjustment mechanisms of the prior art which require that the mandibular advancement device be removed from a user's mouth, adjusted and subsequently reinserted or requires a mechanical adjustment carried out with an external adjustment device entering the user's mouth.

Preferably, the first member and second member are separate members.

Ideally, the first member and second member are arcuate structures.

Advantageously, having the first member and second member being arcuate structures enables a comfortable and non-irritating fit of the mandibular advancement device as the structure mimics the shape of the user's jaw.

Preferably, the engagement arrangement comprises a pair of first member engagement means and a pair of second member engagement means, most preferably on opposing locations of the arcuate first member and arcuate second member respectively.

Ideally, the engagement arrangement comprises a pair of first member engagement means radially equispaced from the centre of curvature of the arc of the first member and a pair of second member engagement means radially equispaced from the centre of curvature of the arc of the second member.

Advantageously, having a pair of first member engagement means and a pair of second member engagement means on opposing locations of the arc enables the user's lower jaw to remain comfortably in a natural balance and equilibrium. The arrangement further maintains the lower jaw in alignment and in a stable position with a more secure engagement between the lower and upper jaw.

Preferably, the first member engagement means and second member engagement means are adjacent one another when the jaw is in its resting position and when the jaw is in its protruding position. Ideally, the first member engagement means and second member engagement means are overlapping when the jaw is in its resting position and at least partially

overlapping when the jaw is in its protruding position.

Preferably, the first member engagement means and second member engagement means are mutually opposing when the jaw is in its resting position and when the jaw is in its protruding position.

Ideally, the first member engagement means and second member engagement means are substantially parallel to one another in both the jaws resting position and protruding position.

Preferably, the first engagement means of the engagement arrangement is locatable proximal to the first member and the second engagement means is locatable proximal to the second member.

Ideally, the engagement means of the first member is locatable proximal to the posterior teeth of the upper jaw of the user.

Most Ideally, the engagement means of the first member is locatable in the premolar region of the upper jaw of the user.

Preferably, the engagement means of the second member is locatable proximal to the posterior teeth of the lower jaw of the user.

Most preferably, the engagement means of the second member is locatable in the premolar region of the lower jaw of the user.

Ideally, the engagement arrangement is located in an occlusal area where the teeth of the upper jaw would normally contact the teeth of the lower jaw.

Advantageously, having the engagement arrangement located within an occlusal area provides a comfortable location which will not irritate a user during use unlike conventional mandibular advancement devices which comprise bands or hooks etc. which run along the outside of teeth and could irritate the adjacent soft tissue of the user's cheek. Additionally, the engagement arrangement is located in the free space which is created when the lower jaw is moved forwards and downwards.

Further advantageously, the engagement arrangement located within an occlusal area enables the jaw to remain slightly and comfortably open. This reduces the likelihood of an airway obstruction.

Ideally, relative movement between the second member and the second member engagement means is possible.

Preferably, first member engagement means and second member engagement means are embedded or partially embedded within their respective first and/or second member. Ideally, first member engagement means and second member engagement means are housed within their respective first and/or second member.

Preferably, first member engagement means and second member engagement means are contained within a cavity within their respective first and/or second member.

Ideally, the engagement arrangement comprises a releasable retaining means adapted to enable the engagement arrangement to releasably engage in use.

Preferably, the engagement arrangement is adapted to enable the first member engagement means and second member engagement means to releasably engage in use.

Preferably, the releasable retaining means comprises releasable retaining

components to enable the first member engagement means and second member engagement means to releasably engage in use.

Ideally, the releasable components are first releasable retaining component and second releasable retaining component wherein the first releasable retaining component is locatable proximal to the first member and the second releasable retaining component is correspondingly locatable proximal to the second member.

Preferably, the releasable components are first releasable retaining component and second releasable retaining component wherein the first releasable retaining component is locatable in the first member and the second releasable retaining component is

correspondingly locatable in the second member.

Ideally, relative movement between the second member and the second releasable retaining component is possible.

Preferably, the second member is movable relative to the second releasable retaining component under the influence of the user moving their lower jaw forward to the protruding position.

Ideally, the second member is slidably movable relative to the second releasable retaining component under the influence of the user moving their lower jaw forward to the protruding position.

Preferably, the second member is slidably movable relative to the second releasable retaining component in a direction to and from the protruding position under the influence of the user moving their lower jaw forward and backwards.

Ideally, the first releasable retaining component is fixed.

Preferably, the second releasable retaining component remains in a state of rest throughout the movement of the second member from the jaw resting position to the lower jaw protruding position with respect to the first releasable retaining component when the first member and second member are in contact.

Ideally, when in operational engagement with the first releasable retaining component and upon movement of the second member from the lower jaw resting position to the lower jaw protruding position under the influence of a user moving their lower jaw forward, the second releasable retaining component is spatially displaced to an opposing end of the second member engagement means from that to which the second releasable retaining component was located when at the lower jaw resting position.

Preferably, when in operational engagement with first releasable retaining component and upon movement of the second member from the lower jaw resting position to the lower jaw protruding position under the influence of a user moving their lower jaw forward, the second releasable retaining component is spatially displaced from a position proximal to the outer arcuate perimeter of the second member to a position proximal to the inner arcuate perimeter of the second member.

Ideally, when in operational engagement with first releasable retaining component and upon movement of the second member from the lower jaw resting position to the lower jaw protruding position under the influence of a user moving their lower jaw forward, the second releasable retaining component is laterally displaced from a position proximal to the outer arcuate perimeter of the second member to a position proximal to the inner arcuate perimeter of the second member.

Preferably, when in operational engagement with first releasable retaining component and upon movement of the second member from the lower jaw resting position to the lower jaw protruding position under the influence of a user moving their lower jaw forward, the second releasable retaining component is longitudinally displaced from a position proximal to the anterior of the second member to a position proximal to the posterior of the second member.

Ideally, when in operational engagement with first releasable retaining component and upon movement of the second member from the lower jaw resting position to the lower jaw protruding position under the influence of a user moving their lower jaw forward, the second releasable retaining component is simultaneously displaced laterally from a position proximal to the outer arcuate perimeter of the second member to a position proximal to the inner arcuate perimeter of the second member and displaced longitudinally from a position proximal to the anterior of the second member to a position proximal to the posterior of the second member.

Preferably, when in operational engagement with first releasable retaining component and upon movement of the second member from the lower jaw resting position to the lower jaw protruding position under the influence of a user moving their lower jaw forward, the second releasable retaining component is radially displaced inwards relative to the centre of curvature of the second member. Preferably, the engagement arrangement is configured such that the second releasable retaining component is held stationery by the first releasable retaining component as the second member moves.

Ideally, the second member engagement means is configured such that the second releasable retaining component is held stationery by the first releasable retaining component as the second member moves.

Preferably, the second releasable retaining component comprises a leading end and a trailing end, the trailing end located proximal to the anterior of a user's mouth and the leading end located proximal to the posterior of the user's mouth.

Ideally, the releasable retaining means comprises magnets.

Preferably, the releasable retaining means comprises a pair of magnets on either the first member or second member.

Ideally, the releasable retaining means comprises a pair of magnets on either the first member or second member, the magnets engageable with a pair of ferromagnetic

components on either the second member or first member respectively.

It will be appreciated that in the case that the pair of magnets are on the first member the pair of ferromagnetic components will be on the second member and if the pair of magnets are on the second member the pair of ferromagnetic components will be on the first member

Preferably, the releasable retaining means comprises a pair of magnets on each member.

Ideally, the magnets are neodymium magnets.

Preferably, the magnets are arranged having respective polarities such that their mutual magnetic forces cause the first member engagement means and second member engagement means to remain in contact in use.

Ideally, the magnetic force of the magnets is such that it is sufficient to restrain the movement of the lower jaw under gravity (and thereby maintain the second member at an advanced position in use) but can easily be overcome by the user who can cause the first member and second member to separate and/or slide relative to one another by a simple movement of their jaw.

Advantageously, having the magnetic force of the magnets such that it is sufficient to restrain the movement of the lower jaw under gravity, but can be easily overcome by the user provides a freedom to the user whereby the user is free to open their mouth to speak, get a drink and/or otherwise move their jaw in any direction temporarily before re-closing their mouth again to operatively engage the engagement arrangement. Preferably, the magnet located within the second member engagement means is fixed relative to the correspondingly located magnet located within the first member engagement means when the first and second member are in contact.

Ideally, relative movement between the second member and the magnet located within the second member engagement means is possible.

Preferably, the magnet located within the first member engagement means is fixed.

Ideally, the magnet located within the second member engagement means remains in a state of rest throughout the movement of the second member from the jaw resting position to the lower jaw protruding position with respect to the magnet located within the first member engagement means when the first and second member are in contact.

Ideally, the mandibular advancement device further comprises housings for housing respective first releasable retaining component and second releasable retaining component.

Preferably, the housings comprise a base portion, a top portion and four side portions extending between the base portion and top portion.

Ideally, a portion of the first and second releasable retaining component housings are couplable to the respective first member and second member.

Preferably, a portion of the first releasable retaining component housing and second releasable retaining component housing are integral to their respective first member and second member.

Preferably, a portion of the first releasable retaining component housing and second releasable retaining component housing are embedded or partially embedded within their respective first member and second member.

Ideally, a portion of the housings of both the first releasable retaining component and second releasable retaining component is detachable.

Preferably, the top portion of the housings of both the first releasable retaining component and second releasable retaining component is detachable.

Ideally, a flexible, gasket or seal, preferably polymeric, may be affixed to one or more of the four side portions of the housing.

Ideally, a flexible, gasket or seal, preferably polymeric, may be affixed at or about all or part of the perimeter of the opening of the housings.

Preferably, a flexible, polymeric gasket or seal may be affixed to the detachable portion of the housing

Ideally, the detachable portions of the housings abut one another once the engagement arrangement is engaged.

Preferably, the detachable portion is a lid.

Ideally, the lid has snap fit, press fit or other mechanical engagement means with the housing. Ideally, the lid further comprises a gasket.

Preferably, the gasket is integrated into the lid.

Preferably, the gasket extends around all or part of the perimeter of the lid.

Ideally, upon attaching the lid to the housing, the lid is pushed against the external perimeter of the housing resulting in the gasket being compressed such that the releasable component within the housing is secure.

Advantageously, having a mandibular advancement device with housings for housing respective first releasable retaining component and second releasable retaining component wherein the lid of said housings is detachable and comprises a gasket provides a user with an improved magnetic attraction between the first releasable retaining means and the second releasable retaining means.

Preferably, the mandibular advancement device further comprises movement restriction means, the movement restriction means restricts movement of the lower jaw of the user.

Ideally, the second member engagement means comprises the movement restriction means to restrict movement of the lower jaw of the user.

Preferably, the movement restriction means restricts the lower jaw of the user from moving from the protruding position relative to the upper jaw of the user in a direction towards the posterior of the user's mouth.

Ideally, the movement restriction means restricts the relative slidable movement between the second member and the second releasable retaining component.

Preferably, the movement restriction means comprises abutment portions located within the housing of the second releasable retaining component to define limits for the relative slidable movement between the second member and the second releasable retaining means.

Ideally, the engagement arrangement further comprises locating means for securing the second releasable retaining component in the protruding position.

Preferably, the movement restriction means comprises longitudinally spaced apart abutment portions, a first abutment portion defining the resting position of the jaw for the mandibular advancement device proximal to the anterior part of the second member and a second abutment portion defining the protruding position, the second abutment portion spaced longitudinally towards the posterior of the second member.

Preferably, the locating means is located within the second member engagement means.

Ideally, the locating means comprises male and female components.

Preferably, the locating means has a male or female component located on the second abutment portion of the movement restriction means. Preferably, the locating means comprises a plurality of male components engageable with the female component.

Ideally, the female member of the locating means is a groove or recess within the second releasable retaining component.

Preferably, the female member of the locating means is a groove or recess located within the trailing end of the second releasable retaining component.

Preferably, the engagement arrangement comprises guide means to guide the spatial displacement of the second releasable retaining component from a position proximal to the outer arcuate perimeter of the second member to a position proximal to the inner arcuate perimeter of the second member when in operational engagement with first releasable retaining component and upon movement of the second member from the lower jaw resting position to the lower jaw protruding position under the influence of a user moving their lower jaw forward.

Ideally, the engagement arrangement comprises guide means to guide the lateral displacement of the second releasable retaining component from a position proximal to the outer arcuate perimeter of the second member to a position proximal to the inner arcuate perimeter of the second member when in operational engagement with first releasable retaining component and upon movement of the second member from the lower jaw resting position to the lower jaw protruding position under the influence of a user moving their lower jaw forward.

Preferably, the engagement arrangement comprises guide means to guide the longitudinal displacement of the second releasable retaining component from a position proximal to the anterior of the second member to a position proximal to the posterior of the second member when in operational engagement with first releasable retaining component and upon movement of the second member from the lower jaw resting position to the lower jaw protruding position under the influence of a user moving their lower jaw forward.

Ideally, the engagement arrangement comprises guide means to guide the simultaneous longitudinal displacement of the second releasable retaining component from a position proximal to the anterior of the second member to a position proximal to the posterior of the second member and the lateral displacement from a position proximal to the outer arcuate perimeter of the second member to a position proximal the inner arcuate perimeter of the second member when in operational engagement with first releasable retaining component and upon movement of the second member from the lower jaw resting position to the lower jaw protruding position under the influence of a user moving their lower jaw forward. Preferably, the engagement arrangement comprises guide means to guide the second releasable retaining component to the second abutment portion of the movement restriction means for securement of the second member in the protruding position.

Ideally, the second releasable retaining component has a first position within the second member corresponding to the resting position of the lower jaw and a second position corresponding to the lower jaw protruding position.

Preferably, the second releasable retaining component has a first position where the trailing end of the second releasable retaining component is engaged with the first abutment portion of the movement restriction means and a second position where the trailing end of the second releasable retaining component is engaged with the second abutment portion of the movement restriction means.

Ideally, in the second releasable retaining component first position the trailing end of the second releasable retaining component abuts the first abutment portion of the movement restriction means and a second position where the trailing end of the second releasable retaining component abuts the second abutment portion of the movement restriction means.

Preferably, the guide means is engageable with at least a portion of the leading end of the second releasable retaining component.

Ideally, the guide means is engageable with a portion of the leading end of the second releasable retaining component and a portion of the trailing end of the second releasable retaining component.

Ideally, the guide means is a bevelled region of the internal perimeter of the second member engagement means.

Preferably, the bevelled region of the second member engagement means is located proximal to a portion of the housing opposing the second abutment portion of the movement restriction means.

Ideally, the guide means is two opposing bevelled regions of the internal perimeter of the second member engagement means.

Preferably, the first bevelled region is located proximal to a portion of the housing opposing the second abutment portion of the movement restriction means and the second bevelled region extending from the first abutment portion of the movement restriction means to the second abutment portion of the movement restriction means.

Ideally, the first bevelled region is engageable with the leading end of the second releasable retaining component and the second bevelled region is engageable with the trailing end of the second releasable retaining component.

Advantageously, having a guide means having two bevelled portions; the first bevelled region located proximal to a portion of the housing opposing the second abutment portion of the movement restriction means and engageable with the leading end of the second releasable retaining component and the second bevelled region extending from the first abutment portion of the movement restriction means to the second abutment portion of the movement restriction means enables a smooth and stable movement from the second releasable retaining component's first position where the trailing end of the second releasable retaining component is engaged with the first abutment portion of the movement restriction means and it's second position where the trailing end of the second releasable retaining component is engaged with the second abutment portion of the movement restriction means.

Preferably, the first bevelled region and the second bevelled region extend

substantially parallel to one another.

It will be appreciated that multiple abutment portions of the movement restriction means may be present enabling an incremental securement in various protruding position.

Ideally, the engagement arrangement comprises revert means to urge the second releasable retaining component from its displaced position to the position to which the second releasable retaining component was located when at the lower jaw resting position, when the first releasable retaining component and the second releasable retaining component are disengaged.

Preferably, the revert means is located proximal to an anterior portion of the second member engagement means.

Ideally, the revert means is embedded or partially embedded within the second member.

Preferably, the revert means is embedded or partially embedded within the housing of the second releasable retaining component, most preferably embedded or partially embedded within the side portion of the housing.

Ideally, the second releasable retaining component is engageable with the revert means in both the lower jaw resting position when the second releasable retaining component is engaged with the first releasable retaining component and when the first releasable retaining component and the second releasable retaining component are disengaged.

Preferably, magnetic attraction between the second releasable retaining component and the revert means urges the second releasable retaining component from its displaced position to the position to which the second releasable retaining component was located when at the lower jaw resting position, when the first releasable retaining component and the second releasable retaining component are disengaged.

Ideally, the revert means is a magnet.

Preferably, the magnetic force of the magnet within the revert means is such that it is sufficient to restrain the movement of the second releasable retaining component when the first releasable retaining component is disengaged but can easily be overcome by the user who can cause the revert means and the second releasable retaining component to separate by a simple movement of their jaw.

Ideally, the magnetic connection between the magnet within the revert means and the second releasable retaining component is weaker than that of the magnetic connection force between the first releasable retaining component and the second releasable retaining component.

Preferably, the revert means is a ferromagnetic component.

Advantageously, a mandibular advancement device with a revert means provides a user with a simpler mechanism beyond that of the prior art to return the second releasable retaining component from its displaced position to the position to which the second releasable retaining component was located when at the lower jaw resting position, when the first releasable retaining component and the second releasable retaining component are disengaged. The revert means provides a semi-autonomous re-adjustment mechanism to return the second releasable retaining component to it first position. This can be contrasted to the cumbersome adjustment mechanisms of the prior art.

Further advantageously, the revert means prevents the second releasable retaining component to freely move within its respective housing, when the first releasable retaining component and the second releasable retaining component are disengaged.

Ideally, the engagement arrangement further comprises braking means.

Preferably, the braking means is operable between the first member and second member.

Preferably, the braking means engages the first member and second member for fixing the first member and second member in a lower jaw resting position and in a lower jaw protruding position.

By fixed it will be appreciated that it is meant that the first member and second member is releasably fixed temporarily at the lower jaw resting position and in a lower jaw protruding position. The fixing would be sufficient to prevent the weight of the user's jaw pulling the second member backwards if the user is lying on their back or side and/or overcoming the magnetic field between the magnets.

Advantageously, use of a braking means enables the mandibular advancement device to be releasably fixed temporarily at the lower jaw resting position and in a lower jaw protruding position preventing the weight of the user's jaw pulling the second member backwards and/or overcoming the magnetic field between the magnets. This braking further enables the use of reduced sized magnets and/or those of lesser magnetic strength.

Ideally, the braking means is couplable to the first member and second member.

Preferably, the braking means are integral to the first member and second member. Ideally, a portion of the braking means is embedded or partially embedded within their respective first member and second member.

Preferably, the braking means is locatable proximal to the housings for housing respective first releasable retaining component and second releasable retaining component.

Ideally, the braking means is couplable to a portion of the housings for housing respective first releasable retaining component and second releasable retaining component.

Preferably, a portion of the braking means is integral to a portion of the housings for housing respective first releasable retaining component and second releasable retaining component.

Ideally, a portion of the braking means is embedded or partially embedded with a portion of the housings for housing respective first releasable retaining component and second releasable retaining component.

Preferably, the braking means comprises a male component engageable with a female component.

Ideally, the braking means comprises a male component engageable with two female components, the female components spaced apart from one another located at positions corresponding to the lower jaw resting position and the lower jaw protruding position.

Ideally, the braking means male component protrudes from the second member or first member a short distance in a direction towards the first member or second member.

Preferably, the braking means female component is a groove or recess within the first member or second member.

Most preferably, the braking means male component protrudes from the second member a short distance in a direction towards the first member and the female component is a groove or recess within the first member.

Ideally, the braking means female component extends from a position proximal to the outer arcuate perimeter of the first member or second member to a position proximal the inner arcuate perimeter of the first member or second member.

Advantageously, having the braking means female component extending from a position proximal to the outer arcuate perimeter of the first member or second member to a position proximal the inner arcuate perimeter of the first member or second member enables the male component to be spatially displaceable from a position proximal to the outer arcuate perimeter of the first member or second member to a position proximal the inner arcuate perimeter of the first member or second member when in engagement with the respective female member. This provides increased comfort to the user while the mandibular advancement device is in use accommodating for natural lateral movements of the lower jaw which may occur during sleep while the first member and second member in a lower jaw resting position and in a lower jaw protruding position by enabling the male component to move within the groove or recess of the female component.

Preferably, the groove or recess of the braking means female component is configured to be an arcuate structure extending from a position proximal to the outer arcuate perimeter of the first member or second member to a position proximal the inner arcuate perimeter of the first member or second member.

Advantageously, having the female component being an arcuate structure enables a comfortable and non-irritating fit of the mandibular advancement device which

accommodates the natural lateral movements of the lower jaw which may occur during sleep.

Ideally, the mandibular advancement device is a mouthguard for sports for optimising the breathing of a user by improved airflow.

Preferably, the mandibular advancement device is a protective mouthguard for sports for optimising the breathing of a user by improved airflow while providing protection from physical impact.

Ideally, in use and upon an instance of sleep a user inserts the mandibular advancement device into their mouth such that the first member is fitted substantially over a portion of the teeth of the upper jaw and that the second member is fitted substantially over a portion of the teeth of the lower jaw. The user naturally bites down on the first and second members placing the jaw into the natural biting position. When in the biting position the engagement arrangement is operatively engaged and urges the lower jaw of the user forward to the resting position. Upon identification that snoring has occurred, a user of the mandibular advancement device manipulates the lower jaw forward into a protruding position. In response to this manual movement of the lower jaw by the user the second member slidably moves and the releasable retaining component of the second member engagement means is guided by the guide means to the second abutment portion of the movement restriction means for securement of the second member in the protruding position.

Accordingly, the present invention provides a mandibular advancement device comprising:

a first member for covering at least part of the teeth of the upper jaw,

a second member for covering at least part of the teeth of the lower jaw

and means for fixing the first and second member in at least a lower jaw resting position and a lower jaw protruding position, the fixing means operable between the lower jaw resting position and a lower jaw protruding position upon forward manipulation of the lower jaw by the user only. Accordingly, the present invention provides a method of manufacturing a mandibular advancement device of the type having a first member for covering at least part of the teeth of the upper jaw, a second member for covering at least part of the teeth of the lower jaw and means for fixing the first and second member in at least a lower jaw resting position and a lower jaw protruding position, the fixing means operable between the lower jaw resting position and the lower jaw protruding position upon forward manipulation of the lower jaw by the user only, the method comprising the steps of:

forming a first member and second member,

forming housings for the respective first releasable retaining component and second releasable retaining component within the first member and second member,

inserting a first releasable retaining component within its housing and inserting a second releasable retaining component within its housing.

Ideally, the method further comprising connecting lids to the housings for the respective first releasable retaining component and second releasable retaining component.

Preferably, the method comprising pressure forming the first member and second member.

Ideally, the method comprising embedding housings with the first member and second member.

Accordingly, the present invention provides a method of manufacturing a mandibular advancement device of the type having a first member for covering at least part of the teeth of the upper jaw, a second member for covering at least part of the teeth of the lower jaw and means for fixing the first and second member in at least a lower jaw resting position and a lower jaw protruding position, the fixing means operable between the lower jaw resting position and lower jaw protruding position upon forward manipulation of the lower jaw by the user only, the method comprising the steps of:

accessing a 3D printer,

acquiring a 3D model, and

generating a print file in the design printing mode in accordance with the 3D model.

Preferably, the method of manufacturing a mandibular advancement device further comprising the step of acquiring a mould of both the user's teeth of the upper jaw and of the lower jaw.

Advantageously, this mould will form the basis of the first and second member of the mandibular advancement device. Further advantageously, the mould of the user's teeth of the upper and lower jaw can be created within a general dentist/orthodontist surgery without the requirement for specialist training beyond that of conventional dental practise.

Ideally, the method of manufacturing a mandibular advancement device further comprising the step of scanning the mould of the user's teeth of the upper jaw to acquire a 3D model of the teeth of the upper jaw of a user.

Preferably, the method of manufacturing a mandibular advancement device further comprising the step of scanning the mould of the user's teeth of the lower jaw to acquire a 3D model of the teeth of the lower jaw of a user.

Ideally, the method of manufacturing a mandibular advancement device further comprising the step of generating a 3D model of the mandibular advancement device first member in accordance with the lines, shapes, contours and/or configuration of the user's teeth of the upper jaw.

Preferably, the method of manufacturing a mandibular advancement device further comprising the step of generating a 3D model of the mandibular advancement device second member in accordance with the lines, shape, contours and/or configuration of the user's teeth of the lower jaw.

Advantageously, generating a 3D model of the mandibular advancement device's first member and second member in accordance with the lines, shape, contour and configuration of the user's teeth in their upper and lower jaw respectively enables the generation of a mandibular advancement device bespoke to the user which will be a secure and comfortable fit.

Further advantageously 3D printing of the mandibular advancement device would enable a fast turnaround schedule from generation of the mould from a general

orthodontist/dentist surgery to the end user beyond that of conventional devices.

Ideally, the method further comprising generating a 3D model of at least part of the engagement arrangement.

Preferably, the method further comprising generating a 3D model of at least part of the engagement means.

Ideally, the method further comprising generating a 3D model of at least a portion of the housings.

Preferably, the method further comprising generating a 3D model of a lid for the housings. Accordingly, the present invention provides a sports mouthguard for optimising the breathing of a user by improved air flow, preferably, while providing protection from physical impact comprising: a first member, the first member adapted to fit substantially over a portion of the teeth of the upper jaw of a user, and

a second member, the second member adapted to fit substantially over a portion of the teeth of the lower jaw of a user,

and an engagement arrangement, the engagement arrangement comprising first member engagement means and second member engagement means,

wherein the first member engagement means and second member engagement means are configured to be operatively engageable with one another to retain the first member and second member in a lower jaw resting position and in a lower jaw protruding position and being operable between the lower jaw resting position and the lower jaw protruding position upon forward manipulation of the lower jaw by the user only so that the engagement arrangement retains the lower jaw of the user in a protruding position relative to the upper jaw of the user.

Advantageously, as a result of the advanced positioning of the mandible unlike conventional mouthguards, the muscles are stretched and strengthened minimising the narrowing of the pharynx due to muscular relaxation. This stretching and strengthening of the muscles reduces turbulence within the airway. By keeping the jaw slightly ajar airflow is also improved through the lips and mouth beyond that of the conventional mouthguard. This increased and improved airflow can increase athletic performance by optimising breathing beyond that of the conventional mouthguard utilised by athletes participating in sport.

The skilled man will appreciate that all preferred or optional features of the invention described with reference to only some aspects or embodiments of the invention may be applied to all aspects of the invention.

It will be appreciated that optional features applicable to one aspect of the invention can be used in any combination, and in any number. Moreover, they can also be used with any of the other aspects of the invention in any combination and in any number. This includes, but is not limited to, the dependent claims from any claim being used as dependent claims for any other claim in the claims of this application.

The invention will now be described with reference to the accompanying drawing which shows by way of example embodiments of an apparatus in accordance with the invention.

Figure 1 is a schematic diagram showing the second member of the mandibular advancement device in the jaw's resting position. Figure 2 is a is a schematic diagram showing the first member and second member of the mandibular advancement device in the lower jaw protruding position.

Figure 3 is a top view of the second engagement means with the second releasable retaining component of the mandibular advancement device in the jaw's resting position.

Figure 4 is a is a top view of the second engagement means with the second releasable retaining component of the mandibular advancement device in the jaw's protruding position.

Figure 5 is a is a top view of an alternative embodiment of the second engagement means of the mandibular advancement device.

Figure 6 is a top view of the second releasable retaining component of the alternative embodiment illustrated within Figure 5.

Figure 7 is a is a top view of a further alternative embodiment of the second engagement means of the mandibular advancement device with the second releasable retaining component of the mandibular advancement device in the jaw's resting position (or biting position).

Figure 8 is a top view of the second releasable retaining component of the further alternative embodiment illustrated within Figure 7 with the second releasable retaining component of the mandibular advancement device in the jaw's protruding position.

Figure 9 is a perspective view of a housing for housing either the first or second releasable retaining component of the mandibular advancement device.

Figure 10 is a cross-sectional view of a further embodiment of a mandibular advancement device having a braking means of the engagement arrangement located upon the first member and second member.

Figure 1 1 is a top view of an alternative housing for housing either the first or second releasable retaining component of the mandibular advancement device having the male component of the braking means of the engagement arrangement.

Figure 12 is a top view of top view of the alternative housing for housing either the first or second releasable retaining component of the mandibular advancement device having the female component of the braking means of the engagement arrangement.

In the drawings, there is shown a mandibular advancement device indicated generally by the reference numeral 1 . The mandibular advancement device 1 having a mandibular advancement device having a first member 2 and a second member 3. The first member 2 adapted to fit substantially over a portion of the teeth of the upper jaw of a user (not shown) and the second member 3 adapted to fit substantially over a portion of the teeth of the lower jaw of the user (not shown). The mandibular advancement device 1 further has an engagement arrangement 4. The engagement arrangement 4 having first member engagement component 5 and second member engagement component 6 wherein the first member engagement component 5 and second member engagement component 6 are configured to be operatively engageable with one another to retain the first member 2 and second member 3 in a lower jaw resting position (see figure 1 ) and in a lower jaw protruding position (see figure 2). The first member engagement component 5 and second member engagement component 6 are operable between the lower jaw resting position (figure 1 ) and in a lower jaw protruding position (figure 2) upon forward manipulation of the lower jaw (not shown) by the user only so that the engagement arrangement 4 retains the lower jaw (not shown) of the user in a protruding position relative to the upper jaw (not shown) of the user. As illustrated in figure 2 in relation to the first member 2 and second member 3 it will be appreciated by the skilled person that the protruding position of the lower jaw (not shown) is one which is forward relative to the upper jaw and that of the lower jaw's resting position. The lower jaw resting position is forward relative to that of the lower jaw's natural biting position and the engagement arrangement 4 retains the lower jaw of the user in the lower jaw resting position relative to the upper jaw (not shown). The first member engagement component 5 and second member engagement component 6 are configured to be operatively engageable with one another to urge the lower jaw (not shown) from the lower jaw's natural biting position to the lower jaw resting position.

A mandibular advancement device 1 which has an engagement arrangement 4 having engagement components (5 and 6) configured to be operatively engageable with one another and upon forward manipulation of the lower jaw (not shown) by the user retains the lower jaw (not shown) of the user into a protruding position provides the user with a simple and comfortable manual positional adjustment of the jaw positions beyond that of the prior art; one that can be achieved from the user's sleeping position with little to no disruption to the user. The forward manipulation being a simple and natural movement of the lower jaw (not shown) and the urging of the lower jaw by the user provides a semi-autonomous adjustment mechanism moving the lower jaw from the rest position to the protruding position. This can be contrasted to the cumbersome adjustment mechanisms of the prior art which require that the mandibular advancement device be removed from a user's mouth, adjusted and subsequently reinserted or requires a mechanical adjustment with an external adjustment device entering the user's mouth.

The first member 2 and second member 3 are arcuate members (see figures 1 and 2). Having the first member 2 and second member 3 being arcuate structures enables a comfortable and non-irritating fit of the mandibular advancement device 1 as the structure mimics the shape of the user's jaw. The engagement arrangement 4 comprises a pair of first member engagement components 5 and a pair of second member engagement components 6 located at opposing locations of the arcuate of the first member 2 and second member 3 respectively. More specifically, the pair of first member engagement components 5 the pair of second member engagement components 6 are radially equispaced from the centre of curvature of the arcuate of their respective member (see figure 2). This has the advantage of enabling the user's lower jaw (not shown) to remain comfortably in a natural balance and equilibrium. The arrangement of pairs of engagement components (5 and 6) further maintain the lower jaw (not shown) in alignment and in a stable position with a more secure engagement between the lower jaw (not shown) and upper jaw (not shown).

The first member engagement component 5 and second member engagement component 6 are mutually opposing and are substantially parallel to one another in both the jaws resting position and protruding position. The engagement arrangement 4 is located in an occlusal area (not shown) where the teeth of the upper jaw (not shown) would normally contact the teeth of the lower jaw (not shown). Having the engagement arrangement 4 located within the occlusal area provides a comfortable location which will not irritate a user during use unlike conventional mandibular advancement devices which comprise bands or hooks etc. which run along the outside of teeth and could irritate the adjacent soft tissue of the user's cheek. Additionally, the engagement arrangement 4 is located in the free space which is created when the lower jaw is moved forwards and downwards. Further, the engagement arrangement 4 located within an occlusal area enables the jaw (not shown) to remain slightly and comfortably open. This reduces the likelihood of an airway obstruction. The engagement component 5 of the first member 2 is located proximal to the pre-molar region of the upper jaw of the user (not shown) and the engagement component 6 of the second member 3 is located proximal to the pre-molar region of the user's lower jaw (not shown).

The first member engagement component 5 and second member engagement component 6 are housed within their respective first member 2 and second member 3.

Relative movement between the second member 3 and the second member engagement component 6 is possible.

The engagement arrangement 4 is a releasable retaining arrangement 4 adapted to enable the engagement arrangement 4 to releasably engage in use. The engagement arrangement 4 is adapted to enable the first member engagement component 5 and the second member engagement component 6 to releasably engage in use by releasable retaining components 7. The releasable retaining components 7 are first releasable retaining components 34 and second releasable retaining components 9 wherein the first releasable retaining components 34 are located proximal to the first member 2 and the second releasable retaining components 9 are correspondingly located proximal to the second member 3. Relative movement between the second member 3 and the second releasable retaining component 9 is possible. The second member 3 is slidably movable relative to the second releasable retaining components 9 under the influence of the user moving their lower jaw (not shown) forward to the protruding position. The first releasable retaining components 34 are fixed. The second releasable retaining component 9 remains in a state of rest throughout the movement of the second member 3 from the jaw resting position to the lower jaw protruding position (see figures 2 and 3) with respect to the first releasable retaining component 34 when the first member 2 and second member 3 are in contact. The second releasable retaining component 9 is held stationery by the first releasable retaining component 34 as the second member 3 moves. The second releasable retaining component 9 has a leading end 10 and a trailing end 1 1 . The trailing end 1 1 is located proximal to the anterior of a user's mouth and the leading end 10 is located proximal to the posterior of the user's mouth

The releasable retaining components 7 are magnets. The releasable retaining arrangement 4 has a pair of magnets 7 on each member (2 and 3). The magnets 7 are neodymium magnets and are arranged having respective polarities such that their mutual magnetic forces cause the first member engagement component 5 and second member engagement component 6 to remain in contact in use. However, it will also be appreciated that the releasable retaining arrangement 4 may also have a pair of magnets 7 on either the first member 2 or second member 3 and this pair of magnets 7 are engageable with a pair of ferromagnetic components on the other member.

The magnetic force of the magnets 7 is such that it is sufficient to restrain the movement of the lower jaw (not shown) under gravity (and thereby maintain the second member 3 at an advanced position in use) but can easily be overcome by the user who can cause the first member 2 and second member 3 to separate and/or slide relative to one another by a simple movement of their jaw. Having the magnetic force of the magnets 7 such that it is sufficient to restrain the movement of the lower jaw (not shown) under gravity but can be easily overcome by the user provides a freedom to the user whereby the user is free to open their mouth to speak, get a drink and/or otherwise move their jaw in any direction temporarily before re-closing their mouth again to operatively engage the engagement arrangement 4.

When in operational engagement with the magnet within the first member

engagement component 5 and upon movement of the second member 3 from the lower jaw resting position (see figure 1 ) to the lower jaw protruding position (see figure 2) under the influence of a user moving their lower jaw (not shown) forward, the magnet 7,9 within the second engagement component 6 is simultaneously displaced laterally from a position proximal to the outer arcuate perimeter 12 of the second member 3 to a position proximal to the inner arcuate perimeter 13 of the second member 3 and displaced longitudinally from a position proximal to the anterior of the second member 3 to a position proximal to the posterior of the second member 3.

The mandibular advancement device 1 further has housings (14 and 15) for housing respective first releasable retaining component (not shown) and second releasable retaining component 9. The housings 14/15 have a base portion 16, a top portion 17 and four side portions 18 extending between the base portion 16 and top portion 17. A portion of the first releasable retaining component housing 14 and second releasable retaining component housing 15 are integral and embedded or partially embedded within their respective first member 2 and second member 3 and a portion of the housings (14 and 15) is detachable. The detachable portions of the housings (14 and 15) abut one another once the engagement arrangement 4 is engaged. The detachable portion is a lid (not shown) having snap fit, press fit or other mechanical engagement means with the housing (14 and 15). It will be

appreciated that the detachable portion as shown in figure 9 the housing top portion 17 can act as a lid for the housings 14/15. The lid 17 has a gasket (not shown) extending around all or part of the perimeter of the lid 17. Upon attaching the lid 17 to the housing (14 or 15), the lid 17 is pushed against the external perimeter of the housing (14 or 15) resulting in the gasket (not shown) being compressed such that the releasable retaining component ((not shown) or 9) within the housing (14 or 15) is secure. This further improves the magnetic attraction of the magnets 7 of the mandibular advancement device 1 .

The mandibular advancement device 1 within the second member engagement component 6 further comprises movement restriction arrangement 19. The movement restriction arrangement 19 restrict movement of the lower jaw of the user (not shown). The movement restriction arrangement 19 restricts the lower jaw (not shown) of the user from moving from the protruding position relative to the upper jaw (not shown) of the user in a direction towards the posterior of the user's mouth. The movement restriction arrangement 19 also restricts the relative slidable movement between the second member 3 and the second releasable retaining component 9. The movement restriction arrangement 19 has abutment portions 20 located within the housing 15 of the second releasable retaining component 9 to define limits for the relative slidable movement between the second member 3 and the second releasable retaining component 9. The abutment portions 20 are longitudinally spaced apart; a first abutment portion 21 defining the resting position of the jaw for the mandibular advancement device 1 proximal to the anterior part of the second member 3 and a second abutment portion 22 defining the protruding position. The second abutment portion 22 is spaced longitudinally towards the posterior of the second member 3.

The engagement arrangement 4 further comprises locating elements 23 for securing the second releasable retaining component 9 in the protruding position. The locating elements 23 are located within the second member engagement component 6 and comprise male 24 and female 25 components. It is preferred, as shown in the drawings, that the male component 24 of the locating element 23 is located on the second abutment portion 22 of the movement restriction arrangement 19 and the female component 25 of the locating element 23 is a groove or recess within the trailing end 1 1 of the second releasable retaining component 9. However, it will be appreciated that the female component 25 of the locating element 23 may be located on the second abutment portion 22 of the movement restriction arrangement 19 and the male component 24 of the locating element 23 may be located on the trailing end 1 1 second releasable retaining component 9.

The engagement arrangement 4 further has guide assembly 26 engageable with a portion of the leading end 10 of the second releasable retaining component 9 and a portion of the trailing end 1 1 of the second releasable retaining component 9 to guide the simultaneous longitudinal displacement of the second releasable retaining component 9 from a position proximal to the anterior of the second member 3 to a posterior of the second member 3 and the lateral displacement from a position proximal to the outer arcuate perimeter 12 of the second member to a position proximal the inner arcuate perimeter 13 of the second member 3 when in operational engagement with first releasable retaining component 34 and upon movement of the second member 3 from the lower jaw resting position to the lower jaw protruding position under the influence of a user moving their lower jaw (not shown) forward. The guide assembly 26 guides the second releasable retaining component 9 to the second abutment portion 22 of the movement restriction arrangement 19 for securement of the second member 3 in the protruding position.

The second releasable retaining component 9 has a first position within the second member 3 corresponding to the resting position of the lower jaw and a second position corresponding to the lower jaw protruding position. More specifically, the second releasable retaining component 9 has a first position with the trailing end 1 1 of the second releasable retaining component 9 is engaged with the first abutment portion 21 of the movement restriction arrangement 19 and a second position where the trailing end 1 1 of the second releasable retaining component 9 is engaged with the second abutment portion 22 of the movement restriction arrangement.

The guide assembly 26 is two bevelled regions of the internal perimeter 27 of the second member engagement component 6 extending substantially parallel to one another. The first bevelled region 28 is located proximal to a portion of the housing 15 opposing the second abutment portion 22 of the movement restriction arrangement 19 and the second bevelled region 29 extending from the first abutment portion 21 of the movement restriction arrangement to the second abutment portion 22 of the movement restriction arrangement. The first bevelled region 28 is engageable with the leading end 10 of the second releasable retaining component 9 and the second bevelled region 29 is engageable with the trailing end 1 1 of the second releasable retaining component 9.

Having a guide assembly 26 having two bevelled regions (28 and 29); the first bevelled region 28 located proximal to a portion of the housing opposing the second abutment portion 22 of the movement restriction arrangement 19 and engageable with the leading end 10 of the second releasable retaining component 9 and the second bevelled region 29 extending the first abutment portion 21 of the movement restriction means to the second abutment portion 21 of the movement restriction arrangement 19 enables a smooth and stable movement from the second releasable retaining component's 9 first position with the trailing end 1 1 of the second releasable retaining component 9 engaged with the first abutment portion 21 of the movement restriction arrangement 19 and it's second position where the trailing end 1 1 of the second releasable retaining component 9 is engaged with the second abutment portion 22 of the movement restriction arrangement 19.

The engagement arrangement 4 further has revert components 30 to urge the second releasable retaining component 9 from its displaced position to the position to which the second releasable retaining component 9 was located when at the lower jaw resting position, when the first releasable retaining component 34 and the second releasable retaining component 9 are disengaged. The revert component 30 is located proximal to an anterior portion of the second engagement component 6. The revert component 30 is embedded within a side portion of the housing 15 of the second member 3. The revert component 30 further prevents the second releasable retaining component 9 to freely move within its housing 15, when the engagement arrangement 4 is disengaged.

The engagement arrangement 4 further has braking components 31 operable between the first member 2 and the second member 3. The braking components 31 engage the first member 2 and the second member 3 for fixing the first member 2 and second member 3 in the lower jaw resting position and lower jaw protruding position. By fixed it will be appreciated that it is meant that the first member 2 and second member 3 are releasably fixed temporarily at the lower jaw resting position and in a lower jaw protruding position. The braking components 31 are a male component 32 engageable with a female component 33. As shown in figures 10 and 12 the braking components 31 are a male component 32 engageable with two female components 33, the female components spaced apart from one another located at positions corresponding to the lower jaw resting position and the lower jaw protruding position. When the engagement arrangement 4 is engaged the male braking component 32 protrudes from it's respective member towards the member containing the female braking member 33. As shown in figure 10 it is preferred that the male braking component 32 protrudes from the second member 3 a short distance in a direction towards the first member 2 and the female component 33 is a groove or recess within the first member 2. As shown in figure 12, the braking means female component 33 extends from a position proximal to the outer arcuate perimeter 35 of the first member 2 (or second member 3, outer arcuate perimeter 12) to a position proximal the inner arcuate perimeter 36 of the first member 2 (or second member 3, inner arcuate perimeter 13).

In use and upon an instance of sleep a user inserts the mandibular advancement device 1 into their mouth such that the first member 2 is fitted substantially over a portion of the teeth of the upper jaw (not shown) and that the second member 3 is fitted substantially over a portion of the teeth of the lower jaw (not shown). The user naturally bites down on the first and second members (2 and 3) placing the jaw into the biting position, when in the biting position the engagement arrangement 4 is operatively engaged and urges the lower jaw (not shown) to the resting position. Upon identification that snoring has occurred, a user of the mandibular advancement device 1 manipulates the lower jaw (not shown) forward into a protruding position. In response to this manual movement of the lower jaw (not shown) by the user the second member 3 slidably moves and the releasable retaining component 9 of the second member engagement component 6 is guided by the guide assembly 26 to the second abutment portion 22 of the movement restriction arrangement 19 for securement of the second member 3 in the protruding position. To disengage the engagement arrangement 4 the user naturally reopens their mouth.

While the above in-use refers to instances of sleep it will be appreciated that the mandibular advancement device 1 is also a mouthguard for sports for optimising the breathing of a user by improved airflow wherein a user inserts the mandibular advancement device 1 into their mouth such that the first member 2 is fitted substantially over a portion of the teeth of the upper jaw (not shown) and that the second member 3 is fitted substantially over a portion of the teeth of the lower jaw (not shown). The user naturally bites down on the first and second members (2 and 3) placing the jaw into the biting position, when in the biting position the engagement arrangement 4 is operatively engaged and urges the lower jaw (not shown) to the resting position. To achieve improved airflow, a user of the mandibular advancement device 1 manipulates the lower jaw (not shown) forward into a protruding position. In response to this manual movement of the lower jaw (not shown) by the user the second member 3 slidably moves and the releasable retaining component 9 of the second member engagement component 6 is guided by the guide assembly 26 to the second abutment portion 22 of the movement restriction arrangement 19 for securement of the second member 3 in the protruding position. To disengage the engagement arrangement 4 the user naturally reopens their mouth.

In relation to the detailed description of the different embodiments of the invention, it will be understood that one or more technical features of one embodiment can be used in combination with one or more technical features of any other embodiment where the transferred use of the one or more technical features would be immediately apparent to a person of ordinary skill in the art to carry out a similar function in a similar way on the other embodiment.

In the preceding discussion of the invention, unless stated to the contrary, the disclosure of alternative values for the upper or lower limit of the permitted range of a parameter, coupled with an indication that one of the said values is more highly preferred than the other, is to be construed as an implied statement that each intermediate value of said parameter, lying between the more preferred and the less preferred of said alternatives, is itself preferred to said less preferred value and also to each value lying between said less preferred value and said intermediate value.

The features disclosed in the foregoing description or the following drawings, expressed in their specific forms or in terms of a means for performing a disclosed function, or a method or a process of attaining the disclosed result, as appropriate, may separately, or in any combination of such features be utilised for realising the invention in diverse forms thereof.