Title of Invention	METHOD AND DEVICE FOR MANDIBULAR ADVANCEMENT
Abstract	An orthotic device (100) for retaining a patient's mandible in an advanced or protrusive position comprises an intraoral anterior mandibular abutment surface (125) for resisting mandibular retraction by abutting the gingiva covering the mandible and an extramaxillary anterior maxillary abutment surface (115) against which the intraoral anterior mandibular abutment surface (125) is braced. In order to resist rotation of the dental orthotic produced by the interaction of the intraoral anterior mandibular abutment surface and the extramaxillary anterior maxillary abutment surface, the orthotic device is provided with an intraoral posterior maxillary abutment surface (140). The relative positions of the maxillary and/or mandibular abutment surfaces may be adjusted to suit the requirements of the user.

Title of Invention

METHOD AND DEVICE FOR MANDIBULAR ADVANCEMENT

Abstract

An orthotic device (100) for retaining a patient's mandible in an advanced or protrusive position comprises an intraoral anterior mandibular abutment surface (125) for resisting mandibular retraction by abutting the gingiva covering the mandible and an extramaxillary anterior maxillary abutment surface (115) against which the intraoral anterior mandibular abutment surface (125) is braced. In order to resist rotation of the dental orthotic produced by the interaction of the intraoral anterior mandibular abutment surface and the extramaxillary anterior maxillary abutment surface, the orthotic device is provided with an intraoral posterior maxillary abutment surface (140). The relative positions of the maxillary and/or mandibular abutment surfaces may be adjusted to suit the requirements of the user.

Full Text	WO 2006/072147 PCT/AU2006/000023 1 METHOD AND DEVICE FOR MANDIBULAR ADVANCEMENT CROSS-REFERENCE TO RELATED APPLICATIONS The present application claims priority from Australian Provisional Patent Application No. 2005900090 filed on 10 January 2005, the content of which is incorporated herein by reference. FIELD OF THE INVENTION The present invention relates to a dental orthotic and methods of using a dental orfhotic. In particular the present invention relates to a method and device for retaining the mandible in protrusive position. BACKGROUND TO THE INVENTION During normal breathing, air passes, through the nose and past the flexible structures in the back of the throat such as the soft palate, uvula and tongue. When an individual is awake, muscles hold the airway open, but during sleep, these muscles relax and can potentially cause problems. Sleep disordered breathing such as snoring, upper airway resistance syndrome (UARS) and obstructive sleep apnoea (OSA) are thought to occur when there is at least partial occlusion of the airway, with the tongue often being associated with the occlusion. During OSA, the tongue is sucked against the back of the throat, completely blocking the air flow. When oxygen levels in the brain become low enough, the sleeper partially awakens and the muscles contract opening the airway again. This cyclic occlusion of the airway can have serious repercussions, including contributing to cardiovascular diseases potentially leading to cardiac arrest and death. There are a number of treatment options available including surgery, nasal continuous positive airway pressure (CPAP) and the use of orfhotic devices. Orthotic devices are becoming an increasingly favoured option as they are generally small and easy to wear and relatively inexpensive. Another benefit of orthotic devices is that the treatment is reversible and non-invasive. Mandibular advancement device (MAD) is one type of orthotic device which is used to hold the mandible in a protrusive position, which has proved effective in the treatment of sleep disordered breathing. Retaining the mandible in a protruded position has been found to help control the symptoms of sleep disordered breathing by clearing the airways and reducing the likelihood of the tongue impacting on breathing. WO 2006/072147 PCT/AU2006/000023 2 Boil and bite MADs are prefabricated and are lined with a soft, thermoplastic material that is moulded to the patient's teeth in the patient's home. The MAD engages the mandible mainly at the incisors and therefore applies the force of advancement across only a couple of teeth. While these MADs are relatively cheap and easy to use, they have the disadvantage in that they can potentially apply excessive force to the lower anterior teeth in some patients and this can cause discomfort, movement of the teeth and problems with the fit of the device over time. Another potential problem is that they are not adjustable once moulded to the patient, limiting their applicability to a wider range of patients. Furthermore, some patients may not have healthy gums and teeth in both the upper and lower jaws upon which to brace the MAD in the mouth. Another example is a laboratory fabricated MAD which requires the attendance of a dentist to take mouth impressions which are used to make models of the teeth and gums. These moulds are then used to make dental overlays to overlay all of the lower and upper teeth, and protrude the mandible and help to clear the airways. A laboratory fabricated MAD can also cause excessive force on the teeth, leading to pain and tooth movement. Moreover, laboratory fabricated MADs can be problematic to customize to the patient's dental requirements as they require both healthy gums and teeth. Any discussion of documents, acts, materials, devices, articles or the like which has been included in the present specification is solely for the purpose of providing a context for the present invention. It is not to be taken as an admission that any or all of these matters form part of the prior art base or were common general knowledge in the field relevant to the present invention as it existed before the priority date of each claim of this application. Throughout this specification the word "comprise", or variations such as "comprises" or "comprising", will be understood to imply the inclusion of a stated element, integer or step, or group of elements, integers or steps, but not the exclusion of any other element, integer or step, or group of elements, integers or steps. SUMMARY OF THE INVENTION According to a first aspect, the present invention provides a dental orthotic device for retaining a patient's mandible in a protrusive position, the dental orthotic device comprising: an intraoral anterior mandibular abutment surface for resisting mandibular retraction by abutting the patient's gingiva covering the mandible; an extramaxillary anterior maxillary abutment surface against which the intraoral anterior mandibular abutment surface is braced; WO 2006/072147 PCT/AU2006/000023 3 an intraoral posterior maxillary abutment surface to resist rotation of the dental orthotic produced by interaction of the intraoral anterior mandibular abutment surface and the extramaxillary anterior maxillary abutment surface. In another aspect, the present invention provides a method of retaining a patient's mandible in a protrusive position, the method comprising: resisting retraction of the mandible by abutting on the gingiva covering the mandible an intraoral anterior mandibular abutment surface; bracing the intraoral anterior mandibular abutment surface against an extramaxillary anterior maxillary abutment surface; and bracing against rotation produced by the interaction of the intraoral anterior mandibular abutment surface and the extramaxillary anterior maxillary abutment surface, with an intraoral posterior maxillary abutment surface. In yet a further aspect, the present invention provides a kit of parts comprising an intraoral anterior mandibular abutment surface, and/or an extramaxillary anterior abutment surface and/or an intraoral posterior maxillary abutment surface. In one embodiment of the invention, the anterior maxillary abutment surface is concave and preferably the anterior maxillary abutment surface is of a shape to comfortably fit upon and conform to the shape of the tissue covering the maxillary bone. In another embodiment of the invention, the anterior maxillary abutment surface is extraoral and pushes on the soft tissue covering the subnasal maxillary bone. In another embodiment of the invention, the anterior maxillary abutment surface is adjustably mounted on the orthotic device so (hat the extent of protrusion of the mandible can be controlled. In yet another embodiment of the invention, the orthotic device comprises a tongue abutment surface which contacts the tongue when the mandible is in a protruded position. The tongue abutment surface may be adapted to retain the tongue in an anterior position, and/or a depressed position, to discourage the tongue from blocking the airway. In an alternative embodiment of the invention, the orthotic device may be shaped to give the tongue sufficient room for the comfort of the patient In a further embodiment of the invention, the intraoral anterior mandibular abutment surface is convex and in one embodiment, the abutment surface is formed of an elastomeric thermoplastic material which is of a shape to fit comfortably upon the gingiva covering the mandible. Preferably the intraoral anterior mandibular abutment surface is made from a silicone rubber. In another embodiment of the invention, the orthotic device comprises at least one guide surface to resist lateral movement of the orthotic device in the patient's WO 2006/072147 PCT/AU2006/000023 4 mouth. Preferably the orthotic device has at least two guide surfaces for positioning the orthotic device. In yet a further embodiment, the orthotic device further comprises a soft palate abutment surface, adapted to support the patient's soft palate, preferably the soft palate abutment surface is of a shape to conform to the surface of the soft palate. In some preferred embodiments, the orthotic device is provided with air holes to facilitate airflow through the device. In one embodiment, the orthotic device further comprises a tooth stabilizing plate adapted to be fitted to the lower dentition and/or upper dentition. BRIEF DESCRIPTION OF THE DRAWINGS Examples of the invention will now be described with reference to the accompanying drawings in which: Figure 1 is a perspective view of an orthotic device according to one embodiment of the invention. Figure 2 is a perspective view of an orthotic device according to a second embodiment of the invention. Figure 3 is a perspective view of an orthotic device according to a third embodiment of the invention. . Figure 4 is a perspective view of an orthotic device according to a fourth embodiment of the invention. Figure 5 is a perspective view of an orthotic device according to a fifth embodiment of the invention. Figure 6 is a perspective view of an orthotic device according to a sixth embodiment of the invention. Figure 7 A is a perspective view of an orthotic device according to a seventh embodiment of the invention. Figure 7B is a front view along arrow A of the embodiment shown in Figure 7A. Figure 8 is a perspective view of an orthotic device according to an eighth embodiment of the invention. Figure 9 is a perspective view of an orthotic device according to a ninth embodiment of the invention. Figure 10A is a perspective view of an orthotic device according to a tenth embodiment of the invention. . Figure 10B is a front view along A of the embodiment shown in Figure 10A. WO 2006/072147 PCT/AU2006/000023 5 Figure 11 is a perspective view of an orthotic device according to an eleventh embodiment of the invention. Figure 12 is a perspective view of an orthotic device according to a twelfth embodiment of the invention. Figure 13 is a perspective view of an orthotic device according to a thirteenth embodiment of the invention. Figure 14 is a perspective view of an orthotic device according to a fourteenth embodiment of the invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS As used herein, the "mandibular surface" is taken to include all things of, pertaining to or attached to the anterior portion of the lower jaw. Non-limiting examples of anterior mandibular surfaces include bone, gingiva or gum, teeth, prosthetics and other fixed or removable appliances. As used herein, "maxillary surface" is taken to include all things of, pertaining to or attached to the upper jaw. Non-limiting examples of maxillary surfaces include bone, gum, teeth, prosthetics or other fixed or removable appliances. Referring to the drawings, the orthotic device 100 of the embodiment illustrated in Figure 1 incorporates an extraoral member 105 and an intraoral member 110 adapted to fit inside the mouth of the patient. The members 105 and 110 are made from stainless steel. Alternatively, such extraoral and intraoral members can be made from a rigid thermoplastic. Thermoplastic materials can be softened by heat to allow for manipulation of their shape, examples of suitable thermoplastic materials include . acrylic, hard durometer, polypropylene, methyl vinyl acetate, ethyl vinyl acetate, polyethylene and hard durometer urethane. A concave anterior maxillary abutment surface 115 is shown mounted to the member 105 by a threaded bolt 120. As illustrated, the anterior maxillary abutment surface 115 is slightly angled towards the lip to provide more uniform contact with the tissue covering the subnasal maxillary bone. The anterior maxillary abutment surface 115 is positioned such that it does not substantially impinge upon or obstruct flow of air through the nose. In other embodiments of the invention, such an anterior maxillary abutment surface may be adjustably mounted to the orthotic device by a slide arrangement or any other means known in the art. In yet. other embodiments, such an anterior maxillary abutment surface can be permanently affixed to the body of the orthotic. WO 2006/072147 PCT/AU2006/000023 6 In the embodiment of the invention shown in Figure 1, the anterior maxillary abutment surface 115 is made from an elastomeric material that is of a shape to fit comfortably upon the soft tissue and skin covering the subnasal maxillary bone. Examples of suitable thermoplastic materials include caprolactone, polycaprolactone, 1,4-dibutanediol polyester, 2-oxepanone or silicone rubber. The anterior mandibular abutment surface 125 of the embodiment of Figure 1 is a convex band and is attached to member 110 by member 130. The anterior mandibular abutment surface 125 pushes on the gingiva covering the mandible. This arrangement allows the orthotic device 100 to be applied to patients who have lost one or more of their anterior mandibular teeth. Further, by abutting the gingiva covering the mandible, the anterior mandibular abutment surface 125 avoids or minimizes the chance of mandibular teeth being undesirably relocated over time. In the embodiment of the invention illustrated in Figure 1, the member 110 includes a deviation 135 to give the tongue sufficient room for the comfort of the patient. The intraoral posterior maxillary abutment surfaces 140 and 140' are flat projections which make contact with the maxillary surface. The contact between the intraoral posterior maxillary abutment surfaces 140 and 140' and the maxillary surface helps resists rotation of the dental orthotic device 100 produced by the interaction of the anterior mandibular abutment surface 125 and the anterior maxillary abutment surface 115. The intraoral posterior maxillary abutment surfaces 140 and 140' are positioned such that they are unlikely to apply sufficient lateral force to the teeth to cause unwanted displacement of the teeth. The intraoral posterior maxillary abutment surfaces 140 and 140' are of a shape to comfortably conform to the patient's posterior maxillary characteristics. The two guide surfaces 150 and 150' are positioned to make loose contact with the maxillary surfaces, in other embodiments, the intraoral posterior maxillary abutment surfaces may make contact with the maxillary molars or premolars, to position the orthotic device in the mouth of the patient. The degree of protrusion or advancement of the mandible can depend upon clinical requirements. The relative displacement of the mandible can be seen to have both side-to-side or forward-to-back components. Protrusion of the mandible carries the tongue forward so that (particularly in sleep) there is a reduced tendency for the tongue to impinge on the pharynx. Referring to the second embodiment of the invention illustrated in Figure 2, the orthotic device 200 incorporates a concave anterior maxillary abutment surface 215 mounted via a threaded bolt 220 to the extraoral member 205. The intraoral member WO 2006/072147 PCT/AU2006/000023 7 210 has a member 230 and an anterior mandibular abutment surface 225. The intraoral posterior maxillary abutment surfaces 240 and 240' are fiat projections. The two guide surfaces may be positioned to make loose contact with the maxillary surfaces to resist lateral movement of the orthotic device 200. In yet further embodiments, such guide surfaces make loose contact with the maxillary molars or premolars. In other embodiments, the shape and configuration of such guide surfaces can be adjusted to fit the patient's requirements. Referring to the third embodiment of the invention illustrated in Figure 3, the orthotic device 300 incorporates a concave anterior maxillary abutment surface 315 mounted via a threaded bolt 320 to the extraoral member 305. The intraoral member 310 has a member 330, anterior mandibular abutment surface 325 and the two intraoral posterior maxillary abutment surfaces 340 and 340'. In this embodiment, the guide surfaces 350 and 350' are positioned to make loose contact with the maxillary surface. In other embodiments, such guide surfaces make contact with the maxillary molars or premolars to position and resist lateral movement of the orthotic device 300 in the mouth of the patient. Member 310 further forms a hole into which the patient's tongue may extend. Referring to the fourth embodiment of the invention illustrated in Figure 4, the orthotic device 400 incorporates a concave anterior maxillary abutment surface 415 mounted via a threaded bolt 420 to the extraoral member 405. The intraoral member 410 has a member 430, anterior mandibular abutment surface 425 and the two intraoral posterior maxillary abutment surfaces 440 and 440'. In this embodiment, the guide surfaces 450 and 450' are connected by a member 460 which is raised in order to give the tongue sufficient room for the comfort of the patient. Referring to the fifth embodiment of the invention illustrated in Figure 5, the orthotic device 500 incorporates a concave anterior maxillary abutment surface 515 mounted via a sliding arm 520 to the extraoral member 505. In this embodiment, the length of the arm is adjustable via the action of knob 560. In alternative embodiments, the knob may be substituted for another means for controlling the position of the concave anterior maxillary abutment surface. The other means may have facility for controlling the angle of an associated anterior maxillary abutment surface to suit the patient's needs and/or preference. As illustrated, the length of the extraoral member 505 can be adjusted by the extraoral adjustment means 555. Alternatively, the length of such an extraoral member can be customized to the patient's needs when, for example, manufacturing the orthotic. WO 2006/072147 PCT/AU2006/000023 8 The extraoral member 505 is connected to the intraoral body portion 565 of the orfliotic device by member 510. The length of member 510 can be adjusted to suit the patient's requirement(s). In this embodiment, air holes 570 and 570' are shown passing through intraoral portion 565 are positioned to improve the flow of air through and around the orthotic device 500. The incorporation of this feature has advantages for patients with breathing difficulties who, for example, may have nasal blockages or congestion. The anterior mandibular abutment surface 525 is connected to portion 565 by members 530 and 530'. This variation gives the user's tongue more comfortable stretch space. In the illustrated embodiment, arms 530 and 530' are permanently affixed to the body portion 565. Alternatively, such arms may be adjustably mounted by a slide arrangement or other means known in the art. As illustrated, the anterior mandibular abutment surface 525 is a convex band and pushes on the gingiva covering the mandible. In alternative embodiments, the anterior mandibular abutment surface is appropriately shaped to make contact with at least a portion of the anterior mandibular surface. The intraoral posterior maxillary abutment surfaces 540 and 540' are connected to intraoral body portion 565 by arms 535 and 535'. This arrangement of arms 535 and 535' is advantageous in that it gives the user's tongue more room which may improve the comfort of the device. As illustrated, the abutment surfaces 540 and 540' are flat projections which make contact with at least a portion of the maxillary surface. This contact resists rotation of the orfliotic device 500 produced by the interaction of the mandibular abutment surface 525 and the anterior maxillary abutment surface 515. Surfaces 540 and 540' are separated by soft palate abutment surface 550. In the illustrated embodiment, the surface is arch shaped to conform to or support the patient's soft palate. This arrangement is useful for patients whose soft palate can potentially collapse during sleep. By also supporting the soft palate, in some situations the effectiveness of the orthotic device may be improved. Referring to the sixth embodiment of the invention illustrated in Figure 6, the orthotic device 600 incorporates a concave anterior maxillary abutment surface 615 mounted via a sliding arm 620 to the extraoral member 605. In this embodiment, the length of the arm is adjustable via the action of knob 660. As illustrated, the length of the extraoral member 605 can be adjusted by the extraoral adjustment means 655. The extraoral member 605 is connected to the intraoral body portion 665 of the orthotic device by member 610. In this embodiment, air holes 670 and 670' passing through intraoral body portion 665 are positioned to improve the flow of air through WO 2006/072147 PCT/AU2006/000023 9 and around the orthotic device. The convex band shaped anterior mandibular abutment surface 625 is connected to body portion 665 by members 630 and 630'. The intraoral posterior maxillary abutment surfaces 640 and 640' are connected to intraoral body portion 665 by arms 635 and 635'. The abutment surfaces 640 and 640' are flat projections which make contact with at least a portion of the maxillary surface. This contact resists rotation of the orthotic device 600 produced by the interaction of the mandibular abutment surface 625 and the anterior maxillary abutment surface 615. Abutment surfaces 640 and 640' have guide surfaces 650 and 650' respectively, which are positioned to make contact with the maxillary surfaces and help position the orthotic in the patient's mouth. With this embodiment, there is no connecting member directly between the abutment surfaces 640 and 640'. This arrangement has the advantage that the user's tongue has more comfortable stretch space and is particularly useful for patients who do not have problems with the soft palate collapsing during sleep. Referring to the seventh embodiment of the invention illustrated in Figure 7A, the orthotic device 700 incorporates a concave anterior maxillary abutment surface 715 mounted via an adjustable arm 720 to the extraoral member 705. In this embodiment, the length of the arm 720 is adjustable via the action of knob 760. As illustrated, the length of the extraoral member 705 can be adjusted by the extraoral adjustment means 755. The extraoral member 705 is connected to the intraoral body portion 765 of the orthotic device by member 710. The convex band shaped anterior mandibular abutment surface 725 is connected to body portion 765 by members 730 and 730'. The body portion 765 may be adapted to comfortably conform to the user's anterior maxillary and mandibular surfaces. With the embodiment illustrated in Figure 7A, the body portion 765 has a cavity 770. As shown in Figure 7B, which is a view of the body portion 765 from direction A, the opening of the cavity 775 is which is adapted to allow the tongue an extended stretch space and is adapted to hold the tongue in a protrusive position. This arrangement advantageously improves the performance of the orthotic device in some patients. The intraoral posterior maxillary abutment surfaces 740 and 740' are connected to intraoral body portion 765 by arms 735 and 735'. The abutment surfaces 740 and 740' are flat projections which make contact with at least a portion of the maxillary surface. This contact resists rotation of the orthotic device 700 produced by the WO 2006/072147 PCT/AU2006/000023 10 interaction of the mandibular abutment surface 725 and the anterior maxillary abutment surface 715. Abutment surfaces 740 and 740' have guide surfaces 750 and 750' respectively, which axe positioned to make contact with the maxillary surfaces and help position the orthotic in the patient's mouth. With this embodiment, there is no connecting member directly between the abutment surfaces 740 and 740'. This arrangement has the advantage that the user's tongue has more comfortable stretch space and is particularly useful for patients who do not have problems with the soft palate collapsing during sleep. Referring to the eighth embodiment of the invention illustrated in Figure 8, the orthotic device 800 incorporates a concave anterior maxillary abutment surface 815 mounted via a sliding arm 820 to the extraoral member 805. In this embodiment, the length of the arm 820 is adjustable via the action of knob 860. The length of the extraoral member 805 can be adjusted by the extraoral adjustment means 855. The extraoral member 805 is connected to the intraoral body portion 865 of the orthotic device by member 810. The convex band shaped anterior mandibular abutment surface 825 is connected to body portion 865 by a single member 830. The intraoral posterior maxillary abutment surfaces 840 and 840' are connected to intraoral body portion 865 by single arm 835 and by connecting arms 870 and 870'. The length of arm 835 may be adjusted to suit the patient's requirements. The abutment • surfaces 840 and 840' are flat projections which make contact with at least a portion of the maxillary surface. This contact resists rotation of the orthotic device 800 produced by fee interaction of the mandibular abutment surface 825 and the anterior maxillary abutment surface 815. Abutment surfaces 840 and 840' have guide surfaces 850 and 850' respectively, which are positioned to make contact with the maxillary surfaces and help position the orthotic in the patient's mouth. Attached to arm 835 is a posterior tail shaped portion 875 which is adapted to depress the user's tongue during sleep. This has the advantage in some patients of improving the performance of the orthotic device for treating sleep apnoea. Referring to the ninth embodiment of the invention illustrated in Figure 9, the orthotic device 900 incorporates an intraoral concave anterior maxillary abutment surface 915 mounted on intraoral member 905. While being intraoral, member 905 is nevertheless extramaxillary as required by the invention, by being adapted for positioning between the patient's top lip and maxillary. As illustrated, the position of the intraoral member 905 can be adjusted by the adjustment means 960. WO 2006/072147 PCT/AU2006/000023 11 The intraoral member 905 is connected to the intraoral body portion 965 of the orthotic device by member 910. The convex band shaped anterior mandibular abutment surface 925 is connected to body portion 965 by members 930 and 930'. The position of the convex band shaped anterior mandibular abutment surface 925 can be adjusted by movement of body portion 965 along member 910. The angle and/or length of members 930 and 930' can also be adjusted to suit the user's requirements. As illustrated, an air hole 955 is shown passing through intraoral body portion 965 and is positioned to improve flow of air through and around the orthotic device. The incorporation of this feature has advantages for patients with breathing difficulties who, for example, may have nasal blockages or congestion. The intraoral posterior maxillary abutment surfaces 940 and 940' are connected to intraoral body portion 965 by single arm 935 and by connecting arms 970 and 970'. The length of arm 935 may be adjusted to suit the patient's requirements. The abutment surfaces 940 and 940' are flat projections which make contact with at least a portion of the maxillary surface. This contact resists rotation of the orthotic device 900 produced by the interaction of the mandibular abutment surface 925 and the anterior maxillary abutment surface 915. As illustrated, intraoral posterior maxillary abutment surfaces,940 and 940' have guide surfaces 950 and 950' respectively, which are positioned to make contact with the maxillary surfaces and help position the orthotic in the patient's mouth. In alternative embodiments, the guide surfaces are not need required. Referring to the tenth embodiment of the invention illustrated in Figure 10A, the orthotic device 1000 incorporates a concave anterior maxillary abutment surface 1015 mounted via an arm 1020 to the extraoral member 1005. In this embodiment, the length of the arm 1020 is adjustable via the action of knob 1060. Adjustability may also be provided by a turnbuckle mechanism (or jack screw mechanism) which can be operated by a turnbuckle key to advance or retract such an arm as desired. In this way, the appropriate treatment can be provided as determined by a clinician. In other embodiments, the length of such an arm is fixed. As illustrated, the length of the extraoral member 1005 can be adjusted by the extraoral adjustment means 1055. Alternatively, the length of such an arm may be fixed. The extraoral member 1005 is connected to intraoral arms 1035 and 1035' of the orthotic device by members 1010 and 1010'. In this embodiment, the intraoral body portion 1065 is made from an elastic band and is adapted such that the user's tongue can slip into cavity 1070, but not easily slip out of it. The cavity is shown in more detail in Figure 10B along direction of arrow A. The combined biting forces from the WO 2006/072147 PCT/AU2006/000023 12 anterior maxillary and mandibular surfaces and/or elastic tension can securely hold the tongue in a forward position. This can improve the effectiveness of the orthotic device in some patients. The intraoral posterior maxillary abutment surfaces 1040 and 1040' are connected to intraoral arms 1035 and 1035'. The abutment surfaces 1040 and 1040' are flat projections which make contact with at least a portion of the maxillary surface. The convex band shaped anterior mandibular abutment surface 1025 is connected to intraoral arms 1035 and 1035' by members 1030 and 1030'. Abutment surfaces 1040 and 1040' have guide surfaces 1050 and 1050' respectively, which are positioned to make contact with the maxillary surfaces and help position the orthotic in the patient's mouth. Referring to the eleventh embodiment of the invention illustrated in Figure 11, the orthotic device 1100 incorporates a concave anterior maxillary abutment surface 1115 mounted to the extraoral member 1105. The intraoral member 1110 has a positionally variable member 1130 and an attached anterior mandibular abutment surface 1125. The relative position of the surface 1125 can be varied by the action of knob 1170 and thread 1160. In alternative embodiments, the position of such a surface can be controlled by other means known in the art. By movement of the member 1125, the level of protrusion of the mandible can be controlled depending on the needs of the patient. The intraoral posterior maxillary abutment surfaces 1140 and 1140' are flat projections with two guide surfaces 1150 and 1150' positioned to make loose contact with the maxillary surfaces to resist lateral movement of the orthotic device 1100. Referring to the twelfth embodiment of the invention illustrated in Figure 12, the orthotic device 1200 incorporates a concave anterior maxillary abutment surface 1215 mounted via an arm 1220 to the extraoral member 1205. The length of the arm 1220 is adjustable via the action of knob 1260. As illustrated, the length of the extraoral member 1205 can be adjusted by the extraoral adjustment means 1255. The extraoral member 1205 is connected to the intraoral body portion 1265 of the orthotic device by member 1210. The convex band shaped anterior mandibular abutment surface 1225 is connected to arm 1235 by a single member 1230. The length of member 1230 may be adjusted by the action of means 1275 to suit the patient's requirement. The intraoral posterior maxillary abutment surfaces 1240 and 1240' are connected to intraoral body portion 1265 by single arm 1235 and by connecting arm 1270. The length of arm 1235 may be adjusted to suit the patient's requirements by the WO 2006/072147 PCT/AU2006/000023 13 action of means 1280. Abutment surfaces 1240 and 1240' are flat projections which make contact with at least a portion of the maxillary surface and are attached to arm 1235 by posterior arm 1270. Abutment surfaces 1240 and 1240' have guide surfaces 1250 and 1250' respectively, which are positioned to make contact with the maxillary surfaces and help position the orthotic in the patient's mouth. The distance between surfaces 1240 and 1240' is variable via the action of means 1290. Referring to the thirteenth embodiment of the invention illustrated in Figure 13, the orthotic device 1300 incorporates an intraoral concave anterior maxillary abutment surface 1315 mounted on intraoral member 1305. As illustrated, the position of the intraoral member 1305 can be adjusted by the adjustment means 1360. The intraoral member 1305 is connected to the intraoral body portion 1365 of the orthotic device by member 1310. The convex band shaped anterior mandibular abutment surface 1325 is connected to body portion 1365 by members 1330 and 1330'. The position of the convex band shaped anterior mandibular abutment surface 1325 can be adjusted by movement of body portion 1365 along member 910. The angle and/or length of members 1330 and 1330' can also be adjusted to suit the user's requirements. As illustrated, an air hole 1355 is shown passing through intraoral body portion 1365 and is positioned to improve flow of air through and around the orthotic device. The intraoral posterior maxillary abutment surfaces 1340 and 1340' are connected to intraoral body portion 1365 by single arm 1335 and by connecting arms 1370 and 1370'. The length of arm 1335 and connecting arms 1370 and 1370' can be adjusted to suit the patient's requirements. The abutment surfaces 1340 and 1340' are flat projections which make contact with at least a portion of the maxillary surface. This contact resists rotation of the orthotic device 1300 produced by the interaction of the mandibular abutment surface 1325 and the anterior maxillary abutment surface 1315. Referring to the fourteenth embodiment of the invention illustrated in Figure 14, the orthotic device 1400 incorporates a concave anterior maxillary abutment surface 1415 mounted via a sliding arm 1420 to the extraoral member 1405. In this embodiment, the length of the arm is adjustable via the action of adjustment means 1460. As illustrated, the length of the extraoral member 1405 can be adjusted by the extraoral adjustment means 1455. The extraoral member 1405 is connected to the intraoral body portion 1465 of the orthotic device by member 1410. The convex band shaped anterior mandibular abutment surface 1425 is connected to body portion 1465 by members 1430 and 1430'. The position of the convex band shaped anterior mandibular abutment surface 1425 can WO 2006/072147 PCT/AU2006/000023 14 be varied according to the user's requirements by movement of connecting web portion 1490. The intraoral posterior maxillary abutment surfaces 1440 and 1440' are connected to intraoral body portion 1465 by arms 1435 and 1435'. The abutment surfaces 1440 and 1440' make contact with at least a portion of the maxillary surface. This contact resists rotation of the orthotic device 1400 produced by the interaction of the mandibular abutment surface 1425 and the anterior maxillary abutment surface 1415, Abutment surfaces 1440 and 1440' have guide surfaces 1450 and 1450' respectively, which are positioned to make contact with the maxillary surfaces and help position the orthotic in the patient's mouth. With this embodiment, there is a connecting member 1470 linking the abutment surfaces 1440 and 1440'. This connecting member is adapted to contact and depress the user's tongue and has the advantage of improving the performance of the orthotic device for treating sleep apnoea in some patients. The position of connecting member 1470 can be adjusted by the action of adjustment means 1480 and/or 1480'. The orthotic device for retaining a patient's mandible in a protrusive position embodying the invention can have a number of beneficial uses, including as an early interceptive device to encourage mandibular growth, in the treatment of certain orthodontic problems, in the treatment of certain temporomandibular joint problems, in the management of bruxism, and/or in the treatment of snoring and obstructive sleep apnoea. The orthotic device can be formed from orthodontic materials such as acrylic, cobalt chromium, gold, silver, platinum or other acceptable materials. In some circumstances, it may be desirable to add a simple tooth-stabilising plate, such as a retainer fitted to the orthotic device. This may serve to resist movement of the teeth due to engagement of the respective abutment surfaces, and also may avoid a degree of discomfort. The inclusion of such a plate may help to stabilize the upper and/or lower dentition. It will be appreciated by persons skilled in the art that numerous variations and/or modifications may be made to the invention as shown in the specific embodiments without departing from the spirit or scope of the invention as broadly described. The present embodiments are, therefore, to be considered in all respects as illustrative and not restrictive. WO 2006/072147 PCT/AU2006/000023 15 THE CLAIMS DEFINING THE INVENTION ARE AS FOLLOWS:- 1. A dental orthotic device for retaining a patient's mandible in a protrusive position, the dental orthotic device comprising: an intraoral anterior mandibular abutment surface for resisting mandibular retraction by abutting the patient's gingiva covering the mandible; an extramaxillary anterior maxillary abutment surface against which the intraoral anterior mandibular abutment surface is braced; an intraoral posterior maxillary abutment surface to resist rotation of the dental orthotic produced by interaction of the intraoral anterior mandibular abutment surface and the extramaxillary anterior maxillary abutment surface. 2. The device according to claim 1, wherein the anterior maxillary abutment surface is concave. 3. The device according to claim 1 or 2, wherein the anterior maxillary abutment surface is of a shape to comfortably fit upon and conform to the shape of the tissue covering the maxillary bone. 4. The device according to any one of the preceding claims, wherein the anterior maxillary abutment surface is extraoral. 5. The device according to any one of the preceding claims, wherein the position of the anterior maxillary abutment surface is adjustable to give a variable extent of protrusion of the mandible. 6. The device according to claim 5, wherein the positional adjustment is achieved by a screw extension device. 7. The device according to any one of the preceding claims, wherein the device further comprises a posterior tongue abutment surface which depresses at least a portion of the patient's tongue to avoid or at least minimize occlusion of the patient's airway. WO 2006/072147 PCT/AU2006/000023 16 8. The device according to claim 7, wherein a position of the posterior tongue abutment surface is adjustable to give a variable extent of depression of at least a portion of the patient's tongue. 9. The device according to any one of the preceding claims, wherein the device has a cavity for accommodating at least a portion of the anterior section of the tongue. 10. The device according to claim 9, wherein the cavity is adapted to hold the tongue in a protrusive position. 11. The device according to claim 10, wherein the cavity comprises an upper tongue holding surface and a lower tongue holding surface. 12. The device according to claim 11, wherein a combined biting force from the anterior maxillary and mandibular surfaces causes the tongue holding surfaces to securely hold the tongue in a protrusive position. 13. The device according to any one of the preceding claims, wherein the intraoral anterior mandibular abutment surface is of a shape to fit comfortably upon the gingiva covering the mandible. 14. The device according to claim 13, wherein the intraoral anterior mandibular abutment surface is formed of an elastomeric material. 15. The device according to claim 14, wherein the intraoral anterior mandibular abutment surface is formed of an elastomeric thermoplastic material. 16. The device according to claim 15, wherein the elastomeric material is a silicone rubber. 17. The device according to any one of the preceding claims, wherein the device comprises at least one guide surface adapted to resist lateral movement of the orthotic device in the patient's mouth. WO 2006/072147 PCT/AU2006/000023 17 18. The device according to any one of the preceding claims, wherein the orthotic device comprises a soft palate abutment surface adapted to support the patient's soft palate. 19. The device according to claim 18, wherein the soft palate abutment surface is of a shape to conform to the surface of the soft palate. 20. The device according to any one of the preceding claims, wherein air holes are provided in the device to facilitate airflow through the patient's airway. 21. The device according to any one of the preceding claims, further comprising a tooth stabilizing plate adapted to be fitted to the lower dentition and/or upper dentition. 22. A method of retaining a patient's mandible in a protrusive position, the method comprising: resisting retraction of the mandible by abutting on the patient's gingiva covering the mandible an intraoral anterior mandibular abutment surface; bracing the intraoral anterior mandibular abutment surface against an extramaxillary anterior maxillary abutment surface; and bracing against rotation produced by the interaction of the intraoral anterior mandibular abutment surface and the extramaxillary anterior maxillary abutment surface, with an intraoral posterior maxillary abutment surface. 23. The method according to claim 22, further comprising depressing at least a portion of the patient's tongue to avoid or at least minimize occlusion of the patient's airway. 24. The method according to claim 22 or claim 23, further comprising holding the tongue a protrusive position. 25. The method according to any one of claims 22 to 24, further comprising supporting the patient's soft palate. 26. A method of treating obstructive sleep apnoea, comprising: WO 2006/072147 PCT/AU2006/000023 18 releasably fitting a dental orfhotic device according to any one of claims 1 to 21; and maintaining protrusion of the mandible to at least minimize occlusion of the patient's airway. 27. A method for the treatment of one or more orthodontic conditions, snoring, obstructive sleep apnoea and temporomandibular joint disorders, the method comprising: releasably fitting a dental orthotic device according to any one of claims 1 to 21; and causing protrusion of the mandible. 28. A kit of parts, or spare parts comprising an intraoral anterior mandibular abutment surface, and/or an extramaxillary anterior abutment surface and/or an intraoral posterior maxillary abutment surface. An orthotic device (100) for retaining a patient's mandible in an advanced or protrusive position comprises an intraoral anterior mandibular abutment surface (125) for resisting mandibular retraction by abutting the gingiva covering the mandible and an extramaxillary anterior maxillary abutment surface (115) against which the intraoral anterior mandibular abutment surface (125) is braced. In order to resist rotation of the dental orthotic produced by the interaction of the intraoral anterior mandibular abutment surface and the extramaxillary anterior maxillary abutment surface, the orthotic device is provided with an intraoral posterior maxillary abutment surface (140). The relative positions of the maxillary and/or mandibular abutment surfaces may be adjusted to suit the requirements of the user.

Full Text

WO 2006/072147 PCT/AU2006/000023
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METHOD AND DEVICE FOR MANDIBULAR ADVANCEMENT
CROSS-REFERENCE TO RELATED APPLICATIONS
The present application claims priority from Australian Provisional Patent
Application No. 2005900090 filed on 10 January 2005, the content of which is
incorporated herein by reference.
FIELD OF THE INVENTION
The present invention relates to a dental orthotic and methods of using a dental
orfhotic. In particular the present invention relates to a method and device for retaining
the mandible in protrusive position.
BACKGROUND TO THE INVENTION
During normal breathing, air passes, through the nose and past the flexible
structures in the back of the throat such as the soft palate, uvula and tongue. When an
individual is awake, muscles hold the airway open, but during sleep, these muscles
relax and can potentially cause problems. Sleep disordered breathing such as snoring,
upper airway resistance syndrome (UARS) and obstructive sleep apnoea (OSA) are
thought to occur when there is at least partial occlusion of the airway, with the tongue
often being associated with the occlusion. During OSA, the tongue is sucked against
the back of the throat, completely blocking the air flow. When oxygen levels in the
brain become low enough, the sleeper partially awakens and the muscles contract
opening the airway again. This cyclic occlusion of the airway can have serious
repercussions, including contributing to cardiovascular diseases potentially leading to
cardiac arrest and death.
There are a number of treatment options available including surgery, nasal
continuous positive airway pressure (CPAP) and the use of orfhotic devices. Orthotic
devices are becoming an increasingly favoured option as they are generally small and
easy to wear and relatively inexpensive. Another benefit of orthotic devices is that the
treatment is reversible and non-invasive.
Mandibular advancement device (MAD) is one type of orthotic device which is
used to hold the mandible in a protrusive position, which has proved effective in the
treatment of sleep disordered breathing. Retaining the mandible in a protruded position
has been found to help control the symptoms of sleep disordered breathing by clearing
the airways and reducing the likelihood of the tongue impacting on breathing.

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Boil and bite MADs are prefabricated and are lined with a soft, thermoplastic
material that is moulded to the patient's teeth in the patient's home. The MAD engages
the mandible mainly at the incisors and therefore applies the force of advancement
across only a couple of teeth. While these MADs are relatively cheap and easy to use,
they have the disadvantage in that they can potentially apply excessive force to the
lower anterior teeth in some patients and this can cause discomfort, movement of the
teeth and problems with the fit of the device over time. Another potential problem is
that they are not adjustable once moulded to the patient, limiting their applicability to a
wider range of patients. Furthermore, some patients may not have healthy gums and
teeth in both the upper and lower jaws upon which to brace the MAD in the mouth.
Another example is a laboratory fabricated MAD which requires the attendance
of a dentist to take mouth impressions which are used to make models of the teeth and
gums. These moulds are then used to make dental overlays to overlay all of the lower
and upper teeth, and protrude the mandible and help to clear the airways. A laboratory
fabricated MAD can also cause excessive force on the teeth, leading to pain and tooth
movement. Moreover, laboratory fabricated MADs can be problematic to customize to
the patient's dental requirements as they require both healthy gums and teeth.
Any discussion of documents, acts, materials, devices, articles or the like which
has been included in the present specification is solely for the purpose of providing a
context for the present invention. It is not to be taken as an admission that any or all of
these matters form part of the prior art base or were common general knowledge in the
field relevant to the present invention as it existed before the priority date of each claim
of this application.
Throughout this specification the word "comprise", or variations such as
"comprises" or "comprising", will be understood to imply the inclusion of a stated
element, integer or step, or group of elements, integers or steps, but not the exclusion of
any other element, integer or step, or group of elements, integers or steps.
SUMMARY OF THE INVENTION
According to a first aspect, the present invention provides a dental orthotic
device for retaining a patient's mandible in a protrusive position, the dental orthotic
device comprising:
an intraoral anterior mandibular abutment surface for resisting mandibular
retraction by abutting the patient's gingiva covering the mandible;
an extramaxillary anterior maxillary abutment surface against which the
intraoral anterior mandibular abutment surface is braced;

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an intraoral posterior maxillary abutment surface to resist rotation of the dental
orthotic produced by interaction of the intraoral anterior mandibular abutment surface
and the extramaxillary anterior maxillary abutment surface.
In another aspect, the present invention provides a method of retaining a
patient's mandible in a protrusive position, the method comprising:
resisting retraction of the mandible by abutting on the gingiva covering the
mandible an intraoral anterior mandibular abutment surface;
bracing the intraoral anterior mandibular abutment surface against an
extramaxillary anterior maxillary abutment surface; and
bracing against rotation produced by the interaction of the intraoral anterior
mandibular abutment surface and the extramaxillary anterior maxillary abutment
surface, with an intraoral posterior maxillary abutment surface.
In yet a further aspect, the present invention provides a kit of parts comprising
an intraoral anterior mandibular abutment surface, and/or an extramaxillary anterior
abutment surface and/or an intraoral posterior maxillary abutment surface.
In one embodiment of the invention, the anterior maxillary abutment surface is
concave and preferably the anterior maxillary abutment surface is of a shape to
comfortably fit upon and conform to the shape of the tissue covering the maxillary
bone. In another embodiment of the invention, the anterior maxillary abutment surface
is extraoral and pushes on the soft tissue covering the subnasal maxillary bone.
In another embodiment of the invention, the anterior maxillary abutment surface
is adjustably mounted on the orthotic device so (hat the extent of protrusion of the
mandible can be controlled.
In yet another embodiment of the invention, the orthotic device comprises a
tongue abutment surface which contacts the tongue when the mandible is in a protruded
position. The tongue abutment surface may be adapted to retain the tongue in an
anterior position, and/or a depressed position, to discourage the tongue from blocking
the airway. In an alternative embodiment of the invention, the orthotic device may be
shaped to give the tongue sufficient room for the comfort of the patient
In a further embodiment of the invention, the intraoral anterior mandibular
abutment surface is convex and in one embodiment, the abutment surface is formed of
an elastomeric thermoplastic material which is of a shape to fit comfortably upon the
gingiva covering the mandible. Preferably the intraoral anterior mandibular abutment
surface is made from a silicone rubber.
In another embodiment of the invention, the orthotic device comprises at least
one guide surface to resist lateral movement of the orthotic device in the patient's

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mouth. Preferably the orthotic device has at least two guide surfaces for positioning the
orthotic device.
In yet a further embodiment, the orthotic device further comprises a soft palate
abutment surface, adapted to support the patient's soft palate, preferably the soft palate
abutment surface is of a shape to conform to the surface of the soft palate.
In some preferred embodiments, the orthotic device is provided with air holes to
facilitate airflow through the device.
In one embodiment, the orthotic device further comprises a tooth stabilizing
plate adapted to be fitted to the lower dentition and/or upper dentition.
BRIEF DESCRIPTION OF THE DRAWINGS
Examples of the invention will now be described with reference to the
accompanying drawings in which:
Figure 1 is a perspective view of an orthotic device according to one
embodiment of the invention.
Figure 2 is a perspective view of an orthotic device according to a second
embodiment of the invention.
Figure 3 is a perspective view of an orthotic device according to a third
embodiment of the invention. .
Figure 4 is a perspective view of an orthotic device according to a fourth
embodiment of the invention.
Figure 5 is a perspective view of an orthotic device according to a fifth
embodiment of the invention.
Figure 6 is a perspective view of an orthotic device according to a sixth
embodiment of the invention.
Figure 7 A is a perspective view of an orthotic device according to a seventh
embodiment of the invention.
Figure 7B is a front view along arrow A of the embodiment shown in Figure 7A.
Figure 8 is a perspective view of an orthotic device according to an eighth
embodiment of the invention.
Figure 9 is a perspective view of an orthotic device according to a ninth
embodiment of the invention.
Figure 10A is a perspective view of an orthotic device according to a tenth
embodiment of the invention. .
Figure 10B is a front view along A of the embodiment shown in Figure 10A.

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Figure 11 is a perspective view of an orthotic device according to an eleventh
embodiment of the invention.
Figure 12 is a perspective view of an orthotic device according to a twelfth
embodiment of the invention.
Figure 13 is a perspective view of an orthotic device according to a thirteenth
embodiment of the invention.
Figure 14 is a perspective view of an orthotic device according to a fourteenth
embodiment of the invention.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
As used herein, the "mandibular surface" is taken to include all things of,
pertaining to or attached to the anterior portion of the lower jaw. Non-limiting
examples of anterior mandibular surfaces include bone, gingiva or gum, teeth,
prosthetics and other fixed or removable appliances.
As used herein, "maxillary surface" is taken to include all things of, pertaining
to or attached to the upper jaw. Non-limiting examples of maxillary surfaces include
bone, gum, teeth, prosthetics or other fixed or removable appliances.
Referring to the drawings, the orthotic device 100 of the embodiment illustrated
in Figure 1 incorporates an extraoral member 105 and an intraoral member 110 adapted
to fit inside the mouth of the patient. The members 105 and 110 are made from
stainless steel. Alternatively, such extraoral and intraoral members can be made from a
rigid thermoplastic. Thermoplastic materials can be softened by heat to allow for
manipulation of their shape, examples of suitable thermoplastic materials include .
acrylic, hard durometer, polypropylene, methyl vinyl acetate, ethyl vinyl acetate,
polyethylene and hard durometer urethane.
A concave anterior maxillary abutment surface 115 is shown mounted to the
member 105 by a threaded bolt 120. As illustrated, the anterior maxillary abutment
surface 115 is slightly angled towards the lip to provide more uniform contact with the
tissue covering the subnasal maxillary bone. The anterior maxillary abutment surface
115 is positioned such that it does not substantially impinge upon or obstruct flow of air
through the nose.
In other embodiments of the invention, such an anterior maxillary abutment
surface may be adjustably mounted to the orthotic device by a slide arrangement or any
other means known in the art. In yet. other embodiments, such an anterior maxillary
abutment surface can be permanently affixed to the body of the orthotic.

WO 2006/072147 PCT/AU2006/000023
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In the embodiment of the invention shown in Figure 1, the anterior maxillary
abutment surface 115 is made from an elastomeric material that is of a shape to fit
comfortably upon the soft tissue and skin covering the subnasal maxillary bone.
Examples of suitable thermoplastic materials include caprolactone, polycaprolactone,
1,4-dibutanediol polyester, 2-oxepanone or silicone rubber.
The anterior mandibular abutment surface 125 of the embodiment of Figure 1 is
a convex band and is attached to member 110 by member 130. The anterior
mandibular abutment surface 125 pushes on the gingiva covering the mandible. This
arrangement allows the orthotic device 100 to be applied to patients who have lost one
or more of their anterior mandibular teeth. Further, by abutting the gingiva covering
the mandible, the anterior mandibular abutment surface 125 avoids or minimizes the
chance of mandibular teeth being undesirably relocated over time.
In the embodiment of the invention illustrated in Figure 1, the member 110
includes a deviation 135 to give the tongue sufficient room for the comfort of the
patient. The intraoral posterior maxillary abutment surfaces 140 and 140' are flat
projections which make contact with the maxillary surface.
The contact between the intraoral posterior maxillary abutment surfaces 140 and
140' and the maxillary surface helps resists rotation of the dental orthotic device 100
produced by the interaction of the anterior mandibular abutment surface 125 and the
anterior maxillary abutment surface 115. The intraoral posterior maxillary abutment
surfaces 140 and 140' are positioned such that they are unlikely to apply sufficient
lateral force to the teeth to cause unwanted displacement of the teeth. The intraoral
posterior maxillary abutment surfaces 140 and 140' are of a shape to comfortably
conform to the patient's posterior maxillary characteristics. The two guide surfaces 150
and 150' are positioned to make loose contact with the maxillary surfaces, in other
embodiments, the intraoral posterior maxillary abutment surfaces may make contact
with the maxillary molars or premolars, to position the orthotic device in the mouth of
the patient.
The degree of protrusion or advancement of the mandible can depend upon
clinical requirements. The relative displacement of the mandible can be seen to have
both side-to-side or forward-to-back components. Protrusion of the mandible carries the
tongue forward so that (particularly in sleep) there is a reduced tendency for the tongue
to impinge on the pharynx.
Referring to the second embodiment of the invention illustrated in Figure 2, the
orthotic device 200 incorporates a concave anterior maxillary abutment surface 215
mounted via a threaded bolt 220 to the extraoral member 205. The intraoral member

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210 has a member 230 and an anterior mandibular abutment surface 225. The intraoral
posterior maxillary abutment surfaces 240 and 240' are fiat projections. The two guide
surfaces may be positioned to make loose contact with the maxillary surfaces to resist
lateral movement of the orthotic device 200. In yet further embodiments, such guide
surfaces make loose contact with the maxillary molars or premolars. In other
embodiments, the shape and configuration of such guide surfaces can be adjusted to fit
the patient's requirements.
Referring to the third embodiment of the invention illustrated in Figure 3, the
orthotic device 300 incorporates a concave anterior maxillary abutment surface 315
mounted via a threaded bolt 320 to the extraoral member 305. The intraoral member
310 has a member 330, anterior mandibular abutment surface 325 and the two intraoral
posterior maxillary abutment surfaces 340 and 340'. In this embodiment, the guide
surfaces 350 and 350' are positioned to make loose contact with the maxillary surface.
In other embodiments, such guide surfaces make contact with the maxillary molars or
premolars to position and resist lateral movement of the orthotic device 300 in the
mouth of the patient. Member 310 further forms a hole into which the patient's tongue
may extend.
Referring to the fourth embodiment of the invention illustrated in Figure 4, the
orthotic device 400 incorporates a concave anterior maxillary abutment surface 415
mounted via a threaded bolt 420 to the extraoral member 405. The intraoral member
410 has a member 430, anterior mandibular abutment surface 425 and the two intraoral
posterior maxillary abutment surfaces 440 and 440'. In this embodiment, the guide
surfaces 450 and 450' are connected by a member 460 which is raised in order to give
the tongue sufficient room for the comfort of the patient.
Referring to the fifth embodiment of the invention illustrated in Figure 5, the
orthotic device 500 incorporates a concave anterior maxillary abutment surface 515
mounted via a sliding arm 520 to the extraoral member 505. In this embodiment, the
length of the arm is adjustable via the action of knob 560. In alternative embodiments,
the knob may be substituted for another means for controlling the position of the
concave anterior maxillary abutment surface. The other means may have facility for
controlling the angle of an associated anterior maxillary abutment surface to suit the
patient's needs and/or preference.
As illustrated, the length of the extraoral member 505 can be adjusted by the
extraoral adjustment means 555. Alternatively, the length of such an extraoral member
can be customized to the patient's needs when, for example, manufacturing the orthotic.

WO 2006/072147 PCT/AU2006/000023
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The extraoral member 505 is connected to the intraoral body portion 565 of the
orfliotic device by member 510. The length of member 510 can be adjusted to suit the
patient's requirement(s). In this embodiment, air holes 570 and 570' are shown passing
through intraoral portion 565 are positioned to improve the flow of air through and
around the orthotic device 500. The incorporation of this feature has advantages for
patients with breathing difficulties who, for example, may have nasal blockages or
congestion.
The anterior mandibular abutment surface 525 is connected to portion 565 by
members 530 and 530'. This variation gives the user's tongue more comfortable stretch
space. In the illustrated embodiment, arms 530 and 530' are permanently affixed to the
body portion 565. Alternatively, such arms may be adjustably mounted by a slide
arrangement or other means known in the art.
As illustrated, the anterior mandibular abutment surface 525 is a convex band
and pushes on the gingiva covering the mandible. In alternative embodiments, the
anterior mandibular abutment surface is appropriately shaped to make contact with at
least a portion of the anterior mandibular surface.
The intraoral posterior maxillary abutment surfaces 540 and 540' are connected
to intraoral body portion 565 by arms 535 and 535'. This arrangement of arms 535 and
535' is advantageous in that it gives the user's tongue more room which may improve
the comfort of the device. As illustrated, the abutment surfaces 540 and 540' are flat
projections which make contact with at least a portion of the maxillary surface. This
contact resists rotation of the orfliotic device 500 produced by the interaction of the
mandibular abutment surface 525 and the anterior maxillary abutment surface 515.
Surfaces 540 and 540' are separated by soft palate abutment surface 550. In the
illustrated embodiment, the surface is arch shaped to conform to or support the patient's
soft palate. This arrangement is useful for patients whose soft palate can potentially
collapse during sleep. By also supporting the soft palate, in some situations the
effectiveness of the orthotic device may be improved.
Referring to the sixth embodiment of the invention illustrated in Figure 6, the
orthotic device 600 incorporates a concave anterior maxillary abutment surface 615
mounted via a sliding arm 620 to the extraoral member 605. In this embodiment, the
length of the arm is adjustable via the action of knob 660. As illustrated, the length of
the extraoral member 605 can be adjusted by the extraoral adjustment means 655.
The extraoral member 605 is connected to the intraoral body portion 665 of the
orthotic device by member 610. In this embodiment, air holes 670 and 670' passing
through intraoral body portion 665 are positioned to improve the flow of air through

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and around the orthotic device. The convex band shaped anterior mandibular abutment
surface 625 is connected to body portion 665 by members 630 and 630'.
The intraoral posterior maxillary abutment surfaces 640 and 640' are connected
to intraoral body portion 665 by arms 635 and 635'. The abutment surfaces 640 and
640' are flat projections which make contact with at least a portion of the maxillary
surface. This contact resists rotation of the orthotic device 600 produced by the
interaction of the mandibular abutment surface 625 and the anterior maxillary abutment
surface 615.
Abutment surfaces 640 and 640' have guide surfaces 650 and 650' respectively,
which are positioned to make contact with the maxillary surfaces and help position the
orthotic in the patient's mouth.
With this embodiment, there is no connecting member directly between the
abutment surfaces 640 and 640'. This arrangement has the advantage that the user's
tongue has more comfortable stretch space and is particularly useful for patients who
do not have problems with the soft palate collapsing during sleep.
Referring to the seventh embodiment of the invention illustrated in Figure 7A,
the orthotic device 700 incorporates a concave anterior maxillary abutment surface 715
mounted via an adjustable arm 720 to the extraoral member 705. In this embodiment,
the length of the arm 720 is adjustable via the action of knob 760. As illustrated, the
length of the extraoral member 705 can be adjusted by the extraoral adjustment means
755.
The extraoral member 705 is connected to the intraoral body portion 765 of the
orthotic device by member 710. The convex band shaped anterior mandibular
abutment surface 725 is connected to body portion 765 by members 730 and 730'. The
body portion 765 may be adapted to comfortably conform to the user's anterior
maxillary and mandibular surfaces.
With the embodiment illustrated in Figure 7A, the body portion 765 has a cavity
770. As shown in Figure 7B, which is a view of the body portion 765 from direction A,
the opening of the cavity 775 is which is adapted to allow the tongue an extended
stretch space and is adapted to hold the tongue in a protrusive position. This
arrangement advantageously improves the performance of the orthotic device in some
patients.
The intraoral posterior maxillary abutment surfaces 740 and 740' are connected
to intraoral body portion 765 by arms 735 and 735'. The abutment surfaces 740 and
740' are flat projections which make contact with at least a portion of the maxillary
surface. This contact resists rotation of the orthotic device 700 produced by the

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interaction of the mandibular abutment surface 725 and the anterior maxillary abutment
surface 715.
Abutment surfaces 740 and 740' have guide surfaces 750 and 750' respectively,
which axe positioned to make contact with the maxillary surfaces and help position the
orthotic in the patient's mouth.
With this embodiment, there is no connecting member directly between the
abutment surfaces 740 and 740'. This arrangement has the advantage that the user's
tongue has more comfortable stretch space and is particularly useful for patients who
do not have problems with the soft palate collapsing during sleep.
Referring to the eighth embodiment of the invention illustrated in Figure 8, the
orthotic device 800 incorporates a concave anterior maxillary abutment surface 815
mounted via a sliding arm 820 to the extraoral member 805. In this embodiment, the
length of the arm 820 is adjustable via the action of knob 860. The length of the
extraoral member 805 can be adjusted by the extraoral adjustment means 855.
The extraoral member 805 is connected to the intraoral body portion 865 of the
orthotic device by member 810. The convex band shaped anterior mandibular
abutment surface 825 is connected to body portion 865 by a single member 830.
The intraoral posterior maxillary abutment surfaces 840 and 840' are connected
to intraoral body portion 865 by single arm 835 and by connecting arms 870 and 870'.
The length of arm 835 may be adjusted to suit the patient's requirements. The abutment •
surfaces 840 and 840' are flat projections which make contact with at least a portion of
the maxillary surface. This contact resists rotation of the orthotic device 800 produced
by fee interaction of the mandibular abutment surface 825 and the anterior maxillary
abutment surface 815.
Abutment surfaces 840 and 840' have guide surfaces 850 and 850' respectively,
which are positioned to make contact with the maxillary surfaces and help position the
orthotic in the patient's mouth.
Attached to arm 835 is a posterior tail shaped portion 875 which is adapted to
depress the user's tongue during sleep. This has the advantage in some patients of
improving the performance of the orthotic device for treating sleep apnoea.
Referring to the ninth embodiment of the invention illustrated in Figure 9, the
orthotic device 900 incorporates an intraoral concave anterior maxillary abutment
surface 915 mounted on intraoral member 905. While being intraoral, member 905 is
nevertheless extramaxillary as required by the invention, by being adapted for
positioning between the patient's top lip and maxillary. As illustrated, the position of
the intraoral member 905 can be adjusted by the adjustment means 960.

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The intraoral member 905 is connected to the intraoral body portion 965 of the
orthotic device by member 910. The convex band shaped anterior mandibular
abutment surface 925 is connected to body portion 965 by members 930 and 930'. The
position of the convex band shaped anterior mandibular abutment surface 925 can be
adjusted by movement of body portion 965 along member 910. The angle and/or
length of members 930 and 930' can also be adjusted to suit the user's requirements.
As illustrated, an air hole 955 is shown passing through intraoral body portion 965 and
is positioned to improve flow of air through and around the orthotic device. The
incorporation of this feature has advantages for patients with breathing difficulties who,
for example, may have nasal blockages or congestion.
The intraoral posterior maxillary abutment surfaces 940 and 940' are connected
to intraoral body portion 965 by single arm 935 and by connecting arms 970 and 970'.
The length of arm 935 may be adjusted to suit the patient's requirements.
The abutment surfaces 940 and 940' are flat projections which make contact
with at least a portion of the maxillary surface. This contact resists rotation of the
orthotic device 900 produced by the interaction of the mandibular abutment surface 925
and the anterior maxillary abutment surface 915.
As illustrated, intraoral posterior maxillary abutment surfaces,940 and 940' have
guide surfaces 950 and 950' respectively, which are positioned to make contact with
the maxillary surfaces and help position the orthotic in the patient's mouth. In
alternative embodiments, the guide surfaces are not need required.
Referring to the tenth embodiment of the invention illustrated in Figure 10A, the
orthotic device 1000 incorporates a concave anterior maxillary abutment surface 1015
mounted via an arm 1020 to the extraoral member 1005. In this embodiment, the
length of the arm 1020 is adjustable via the action of knob 1060. Adjustability may
also be provided by a turnbuckle mechanism (or jack screw mechanism) which can be
operated by a turnbuckle key to advance or retract such an arm as desired. In this way,
the appropriate treatment can be provided as determined by a clinician.
In other embodiments, the length of such an arm is fixed. As illustrated, the
length of the extraoral member 1005 can be adjusted by the extraoral adjustment means
1055. Alternatively, the length of such an arm may be fixed.
The extraoral member 1005 is connected to intraoral arms 1035 and 1035' of the
orthotic device by members 1010 and 1010'. In this embodiment, the intraoral body
portion 1065 is made from an elastic band and is adapted such that the user's tongue
can slip into cavity 1070, but not easily slip out of it. The cavity is shown in more
detail in Figure 10B along direction of arrow A. The combined biting forces from the

WO 2006/072147 PCT/AU2006/000023
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anterior maxillary and mandibular surfaces and/or elastic tension can securely hold the
tongue in a forward position. This can improve the effectiveness of the orthotic device
in some patients.
The intraoral posterior maxillary abutment surfaces 1040 and 1040' are
connected to intraoral arms 1035 and 1035'. The abutment surfaces 1040 and 1040' are
flat projections which make contact with at least a portion of the maxillary surface.
The convex band shaped anterior mandibular abutment surface 1025 is
connected to intraoral arms 1035 and 1035' by members 1030 and 1030'.
Abutment surfaces 1040 and 1040' have guide surfaces 1050 and 1050'
respectively, which are positioned to make contact with the maxillary surfaces and help
position the orthotic in the patient's mouth.
Referring to the eleventh embodiment of the invention illustrated in Figure 11,
the orthotic device 1100 incorporates a concave anterior maxillary abutment surface
1115 mounted to the extraoral member 1105. The intraoral member 1110 has a
positionally variable member 1130 and an attached anterior mandibular abutment
surface 1125. The relative position of the surface 1125 can be varied by the action of
knob 1170 and thread 1160. In alternative embodiments, the position of such a surface
can be controlled by other means known in the art. By movement of the member 1125,
the level of protrusion of the mandible can be controlled depending on the needs of the
patient.
The intraoral posterior maxillary abutment surfaces 1140 and 1140' are flat
projections with two guide surfaces 1150 and 1150' positioned to make loose contact
with the maxillary surfaces to resist lateral movement of the orthotic device 1100.
Referring to the twelfth embodiment of the invention illustrated in Figure 12, the
orthotic device 1200 incorporates a concave anterior maxillary abutment surface 1215
mounted via an arm 1220 to the extraoral member 1205. The length of the arm 1220 is
adjustable via the action of knob 1260. As illustrated, the length of the extraoral
member 1205 can be adjusted by the extraoral adjustment means 1255.
The extraoral member 1205 is connected to the intraoral body portion 1265 of
the orthotic device by member 1210. The convex band shaped anterior mandibular
abutment surface 1225 is connected to arm 1235 by a single member 1230. The length
of member 1230 may be adjusted by the action of means 1275 to suit the patient's
requirement.
The intraoral posterior maxillary abutment surfaces 1240 and 1240' are
connected to intraoral body portion 1265 by single arm 1235 and by connecting arm
1270. The length of arm 1235 may be adjusted to suit the patient's requirements by the

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action of means 1280. Abutment surfaces 1240 and 1240' are flat projections which
make contact with at least a portion of the maxillary surface and are attached to arm
1235 by posterior arm 1270. Abutment surfaces 1240 and 1240' have guide surfaces
1250 and 1250' respectively, which are positioned to make contact with the maxillary
surfaces and help position the orthotic in the patient's mouth. The distance between
surfaces 1240 and 1240' is variable via the action of means 1290.
Referring to the thirteenth embodiment of the invention illustrated in Figure 13,
the orthotic device 1300 incorporates an intraoral concave anterior maxillary abutment
surface 1315 mounted on intraoral member 1305. As illustrated, the position of the
intraoral member 1305 can be adjusted by the adjustment means 1360.
The intraoral member 1305 is connected to the intraoral body portion 1365 of
the orthotic device by member 1310. The convex band shaped anterior mandibular
abutment surface 1325 is connected to body portion 1365 by members 1330 and 1330'.
The position of the convex band shaped anterior mandibular abutment surface 1325 can
be adjusted by movement of body portion 1365 along member 910. The angle and/or
length of members 1330 and 1330' can also be adjusted to suit the user's requirements.
As illustrated, an air hole 1355 is shown passing through intraoral body portion 1365
and is positioned to improve flow of air through and around the orthotic device.
The intraoral posterior maxillary abutment surfaces 1340 and 1340' are
connected to intraoral body portion 1365 by single arm 1335 and by connecting arms
1370 and 1370'. The length of arm 1335 and connecting arms 1370 and 1370' can be
adjusted to suit the patient's requirements.
The abutment surfaces 1340 and 1340' are flat projections which make contact
with at least a portion of the maxillary surface. This contact resists rotation of the
orthotic device 1300 produced by the interaction of the mandibular abutment surface
1325 and the anterior maxillary abutment surface 1315.
Referring to the fourteenth embodiment of the invention illustrated in Figure 14,
the orthotic device 1400 incorporates a concave anterior maxillary abutment surface
1415 mounted via a sliding arm 1420 to the extraoral member 1405. In this
embodiment, the length of the arm is adjustable via the action of adjustment means
1460. As illustrated, the length of the extraoral member 1405 can be adjusted by the
extraoral adjustment means 1455.
The extraoral member 1405 is connected to the intraoral body portion 1465 of
the orthotic device by member 1410. The convex band shaped anterior mandibular
abutment surface 1425 is connected to body portion 1465 by members 1430 and 1430'.
The position of the convex band shaped anterior mandibular abutment surface 1425 can

WO 2006/072147 PCT/AU2006/000023
14
be varied according to the user's requirements by movement of connecting web portion
1490.
The intraoral posterior maxillary abutment surfaces 1440 and 1440' are
connected to intraoral body portion 1465 by arms 1435 and 1435'. The abutment
surfaces 1440 and 1440' make contact with at least a portion of the maxillary surface.
This contact resists rotation of the orthotic device 1400 produced by the interaction of
the mandibular abutment surface 1425 and the anterior maxillary abutment surface
1415,
Abutment surfaces 1440 and 1440' have guide surfaces 1450 and 1450'
respectively, which are positioned to make contact with the maxillary surfaces and help
position the orthotic in the patient's mouth.
With this embodiment, there is a connecting member 1470 linking the abutment
surfaces 1440 and 1440'. This connecting member is adapted to contact and depress
the user's tongue and has the advantage of improving the performance of the orthotic
device for treating sleep apnoea in some patients. The position of connecting member
1470 can be adjusted by the action of adjustment means 1480 and/or 1480'.
The orthotic device for retaining a patient's mandible in a protrusive position
embodying the invention can have a number of beneficial uses, including as an early
interceptive device to encourage mandibular growth, in the treatment of certain
orthodontic problems, in the treatment of certain temporomandibular joint problems, in
the management of bruxism, and/or in the treatment of snoring and obstructive sleep
apnoea.
The orthotic device can be formed from orthodontic materials such as acrylic,
cobalt chromium, gold, silver, platinum or other acceptable materials.
In some circumstances, it may be desirable to add a simple tooth-stabilising
plate, such as a retainer fitted to the orthotic device. This may serve to resist movement
of the teeth due to engagement of the respective abutment surfaces, and also may avoid
a degree of discomfort. The inclusion of such a plate may help to stabilize the upper
and/or lower dentition.
It will be appreciated by persons skilled in the art that numerous variations
and/or modifications may be made to the invention as shown in the specific
embodiments without departing from the spirit or scope of the invention as broadly
described. The present embodiments are, therefore, to be considered in all respects as
illustrative and not restrictive.

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15
THE CLAIMS DEFINING THE INVENTION ARE AS FOLLOWS:-
1. A dental orthotic device for retaining a patient's mandible in a protrusive
position, the dental orthotic device comprising:
an intraoral anterior mandibular abutment surface for resisting mandibular
retraction by abutting the patient's gingiva covering the mandible;
an extramaxillary anterior maxillary abutment surface against which the
intraoral anterior mandibular abutment surface is braced;
an intraoral posterior maxillary abutment surface to resist rotation of the
dental orthotic produced by interaction of the intraoral anterior mandibular
abutment surface and the extramaxillary anterior maxillary abutment surface.
2. The device according to claim 1, wherein the anterior maxillary abutment
surface is concave.
3. The device according to claim 1 or 2, wherein the anterior maxillary abutment
surface is of a shape to comfortably fit upon and conform to the shape of the
tissue covering the maxillary bone.
4. The device according to any one of the preceding claims, wherein the anterior
maxillary abutment surface is extraoral.
5. The device according to any one of the preceding claims, wherein the position
of the anterior maxillary abutment surface is adjustable to give a variable extent
of protrusion of the mandible.
6. The device according to claim 5, wherein the positional adjustment is achieved
by a screw extension device.
7. The device according to any one of the preceding claims, wherein the device
further comprises a posterior tongue abutment surface which depresses at least a
portion of the patient's tongue to avoid or at least minimize occlusion of the
patient's airway.

WO 2006/072147 PCT/AU2006/000023
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8. The device according to claim 7, wherein a position of the posterior tongue
abutment surface is adjustable to give a variable extent of depression of at least
a portion of the patient's tongue.
9. The device according to any one of the preceding claims, wherein the device has
a cavity for accommodating at least a portion of the anterior section of the
tongue.
10. The device according to claim 9, wherein the cavity is adapted to hold the
tongue in a protrusive position.
11. The device according to claim 10, wherein the cavity comprises an upper tongue
holding surface and a lower tongue holding surface.
12. The device according to claim 11, wherein a combined biting force from the
anterior maxillary and mandibular surfaces causes the tongue holding surfaces
to securely hold the tongue in a protrusive position.
13. The device according to any one of the preceding claims, wherein the intraoral
anterior mandibular abutment surface is of a shape to fit comfortably upon the
gingiva covering the mandible.
14. The device according to claim 13, wherein the intraoral anterior mandibular
abutment surface is formed of an elastomeric material.
15. The device according to claim 14, wherein the intraoral anterior mandibular
abutment surface is formed of an elastomeric thermoplastic material.
16. The device according to claim 15, wherein the elastomeric material is a silicone
rubber.
17. The device according to any one of the preceding claims, wherein the device
comprises at least one guide surface adapted to resist lateral movement of the
orthotic device in the patient's mouth.

WO 2006/072147 PCT/AU2006/000023
17
18. The device according to any one of the preceding claims, wherein the orthotic
device comprises a soft palate abutment surface adapted to support the patient's
soft palate.
19. The device according to claim 18, wherein the soft palate abutment surface is of
a shape to conform to the surface of the soft palate.
20. The device according to any one of the preceding claims, wherein air holes are
provided in the device to facilitate airflow through the patient's airway.
21. The device according to any one of the preceding claims, further comprising a
tooth stabilizing plate adapted to be fitted to the lower dentition and/or upper
dentition.
22. A method of retaining a patient's mandible in a protrusive position, the method
comprising:
resisting retraction of the mandible by abutting on the patient's gingiva
covering the mandible an intraoral anterior mandibular abutment surface;
bracing the intraoral anterior mandibular abutment surface against an
extramaxillary anterior maxillary abutment surface; and
bracing against rotation produced by the interaction of the intraoral
anterior mandibular abutment surface and the extramaxillary anterior maxillary
abutment surface, with an intraoral posterior maxillary abutment surface.
23. The method according to claim 22, further comprising depressing at least a
portion of the patient's tongue to avoid or at least minimize occlusion of the
patient's airway.
24. The method according to claim 22 or claim 23, further comprising holding the
tongue a protrusive position.
25. The method according to any one of claims 22 to 24, further comprising
supporting the patient's soft palate.
26. A method of treating obstructive sleep apnoea, comprising:

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releasably fitting a dental orfhotic device according to any one of claims 1
to 21; and
maintaining protrusion of the mandible to at least minimize occlusion of
the patient's airway.
27. A method for the treatment of one or more orthodontic conditions, snoring,
obstructive sleep apnoea and temporomandibular joint disorders, the method
comprising:
releasably fitting a dental orthotic device according to any one of claims 1
to 21; and
causing protrusion of the mandible.
28. A kit of parts, or spare parts comprising an intraoral anterior mandibular
abutment surface, and/or an extramaxillary anterior abutment surface and/or an
intraoral posterior maxillary abutment surface.

An orthotic device (100) for retaining a patient's mandible in an advanced or protrusive position comprises an intraoral anterior mandibular abutment surface (125) for resisting mandibular retraction by abutting the gingiva covering the mandible
and an extramaxillary anterior maxillary abutment surface (115) against which the intraoral anterior mandibular abutment surface
(125) is braced. In order to resist rotation of the dental orthotic produced by the interaction of the intraoral anterior mandibular abutment surface and the extramaxillary anterior maxillary abutment surface, the orthotic device is provided with an intraoral posterior maxillary abutment surface (140). The relative positions of the maxillary and/or mandibular abutment surfaces may be adjusted to
suit the requirements of the user.

Documents:

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Patent Number

269506

Indian Patent Application Number

2810/KOLNP/2007

PG Journal Number

44/2015

Publication Date

30-Oct-2015

Grant Date

26-Oct-2015

Date of Filing

01-Aug-2007

Name of Patentee

YAN GUOPING

Applicant Address

6/19 BRISBANE STREET MURRUMBEENA, VICTORIA

Inventors:

#	Inventor's Name	Inventor's Address
1	YAN, GUOPING	6/19 BRISBANE STREET, MURRUMBEENA, VIC 3163

PCT International Classification Number

A61C 7/06,A61F 5/042

PCT International Application Number

PCT/AU2006/000023

PCT International Filing date

2006-01-09

PCT Conventions:

#	PCT Application Number	Date of Convention	Priority Country
1	2005900090	2005-01-10	Australia