ORAL APPLIANCE

Abstract

An oral appliance (10) for the treatment of sleep disorder breathing in a patient, the oral appliance comprising a U shaped appliance body with a front section (12) and two arms (14, 16), the appliance body (12) including an inner wall (18) and an outer wall (20). A web (22) interconnects the inner wall (18) and the outer wall (20) so as to define an upper dental arch receiving channel (24). The front section of the body has an air inlet opening (50) in the front section of the body (12) for intake of air during inhalation. The oral appliance (10) also comprises an air outlet member and an air flow passageway (71) communicating the air inlet opening (50) with the air outlet (56).

Claims

1. An oral appliance for the treatment of sleep disorder breathing in a patient, the oral appliance comprising; a U shaped appliance body with a front section and two arms, the appliance body including an inner wall and an outer wall; a web interconnecting the inner wall and the outer wall so as to define an upper dental arch receiving channel; an air inlet opening in the front section of the body for intake of air during inhalation; an air outlet member configured when in use in a patient's mouth locate above the tongue with an air outlet configured for directing inhaled air between the patient's tongue and hard palette towards the patient's posterior oral cavity; and an air flow passageway communicating the air inlet opening with the air outlet.

2. The oral appliance of claim 1, wherein the air inlet opening has a cross sectional area for breathing that allows a patient to breathe fully through the mouth.

3. The oral appliance of claim 1, wherein an air inlet member extends forward of the front of the appliance body such that the air inlet opening is spaced from the appliance body.

4. The oral appliance of claim 3, wherein the air inlet member is configured so as to allow a patient's lips to form a lip seal about the air inlet member.

5. The oral appliance of claim 4, wherein the air inlet member has an elliptic cylindrical shape.

6. The oral appliance of claim 4, wherein the air inlet member has an elliptic frustoconical shape with side walls that taper from the air inlet opening towards the appliance body.

7. The oral appliance of claim 5, wherein the air flow passageway has a constricted part between the air inlet member and the air outlet member.

8. The oral appliance of claim 5, wherein the cross sectional flow area of the air inlet member before the constricted part is between about 200 mm. to about 400 mm.

9. The oral appliance of claim 8, wherein the cross sectional flow area of the constricted part is between about 50 mm and about 100 mm.

10. The oral appliance of claim 1, wherein the air outlet member is configured to abut or be close to the hard palate.

11. The oral appliance of claim 10, wherein the air outlet member has a degree of reliance such that it resiliently contacts or presses against the hard palette so as to direct inhaled air flow above the tongue.

12. The oral appliance of claim 11 that further comprises a lower dental arch receiving channel and the upper and lower dental arch receiving channels are configured so that when the oral appliance is worn in the mouth, the patient's mandible is advanced.

13. The oral appliance of claim 12, wherein the mandible is advanced about 5 mm or less.

14. The oral appliance of claim 13, wherein the mandible is advanced about 1 mm to about 3 mm.

15. A combination comprising an oral appliance of claim 1 and an adapter having an air inlet and an air outlet and an air passage between the air inlet and the air outlet, wherein the air outlet is configured for fluid communication with the air inlet opening of the appliance and the air inlet is configured for fluid communication with an air supply.

16. A method of treating symptoms of SDB in a patient comprising the steps of; providing an oral appliance as disclosed claim 1 and causing the patient to wear the oral appliance whilst sleeping.

17. The method of claim 16, wherein the SBD is snoring or OSA and the appliance is worn during sleep for a minimum of three hours, suitably four hours, suitably five hours or more.

18. (canceled)

19. (canceled)

20. A method of treating symptoms of SDB in a patient comprising the steps of providing an oral appliance as claimed in claim 3, fluidly connecting the air inlet member of the oral appliance to a CPAP machine and causing air from to flow from the CPAP machine into the patient's mouth through the air inlet member and causing the patient to wear the oral appliance whilst sleeping.

21. The combination of claim 15, wherein the adapter comprises an air inlet member configured for fluid connection to a CPAP air outlet and an outlet member configured to received or be received by the air inlet member of the appliance.

22. The combination of claim 21, wherein the adapter incudes a flange between the inlet member and the outlet member that in use acts as a stop against a patient's lips.

Description

DESCRIPTION OF THE FIGURES

[0100] FIG. 1 is a top front perspective view of one aspect of an oral appliance as disclosed herein;

[0101] FIG. 2 is a rear top perspective view of the same oral appliance shown in FIG. 1;

[0102] FIG. 3 is a front view of the oral appliance shown in FIG. 1;

[0103] FIG. 4 is a rear view of the oral appliance shown in FIG. 1;

[0104] FIG. 5 is a side view of the oral appliance shown in FIG. 1;

[0105] FIG. 6 is a cross section of the appliance shown in FIG. 1

[0106] FIG. 7 is a top plan view of the oral appliance shown in FIG. 1;

[0107] FIG. 8 is a bottom plan view of the oral appliance shown in FIG. 1;

[0108] FIG. 9 is a top plan view of an oral appliance of a further disclosed aspect;

[0109] FIG. 10 is a schematic top plan view of the oral appliance shown in FIG. 1 and the relationship with the positions of the teeth of a patient's upper arch;

[0110] FIG. 11 is a schematic view of tongue position relative to the oral appliance of FIG. 1;

[0111] FIG. 12 is a front perspective view of an oral appliance of a still further disclosed aspect;

[0112] FIG. 13 is a rear perspective view of the oral appliance as shown in FIG. 12;

[0113] FIG. 14 is a front view of the oral appliance as shown in FIG. 12;

[0114] FIG. 15 is a rear view of the oral appliance as shown in FIG. 12;

[0115] FIG. 16 is a side view of the oral appliance as shown in FIG. 12;

[0116] FIG. 17 is a cross section view of the oral appliance as shown in FIG. 12;

[0117] FIG. 18 is a top view of the oral appliance as shown in FIG. 12;

[0118] FIG. 19 is a bottom view of the oral appliance as shown in FIG. 12;

[0119] FIG. 20 is a cross section of a still further oral appliance as disclosed herein;

[0120] FIG. 21 is a front perspective view of a CPAP adapter for use with the disclosed oral appliances;

[0121] FIG. 22 is a rear perspective view of the adapter shown in FIG. 21;

[0122] FIG. 23 is right end view of the adapter shown in FIG. 21;

[0123] FIG. 24 is a left end view of the adapter shown in FIG. 21;

[0124] FIG. 25 is a side view of the adapter shown in FIG. 21;

[0125] FIG. 26 is a cross section view of the adapter shown in FIG. 21;

[0126] FIG. 27 is a top plan view of the adapter shown in FIG. 21;

[0127] FIG. 28 is a front perspective view of the oral appliance as shown in FIG. 12 with the adapter as shown in FIG. 21 fitted thereto;

[0128] FIG. 29 is a side view of the oral appliance adapted combination as shown in FIG. 28;

[0129] FIG. 30 is a cross section view of the oral appliance adapted combination as shown in FIG. 28;

[0130] FIG. 31 is a front perspective view of another embodiment of an oral appliance as disclosed herein;

[0131] FIG. 32 is a side view of the oral appliance as shown in FIG. 31;

[0132] FIG. 33 is a front perspective view of the oral appliance as shown in FIG. 33 with a CPAP adapter fitted thereto and

[0133] FIG. 34 is a side view of the oral appliance as shown in FIG. 33 with the adapted shown in cross section.

DETAILED DESCRIPTION

[0134] An oral appliance and methods in accordance with this disclosure may manifest itself in a variety of forms. It will be convenient to hereinafter describe several embodiments of the invention in detail with reference to the accompanying drawings. The purpose of providing this detailed description is to instruct persons having an interest in the subject matter of the invention how to carry the invention into practical effect. However it is to be clearly understood that the specific nature of this detailed description does not supersede the generality of the preceding broad disclosure.

[0135] FIGS. 1 to 8 show a first aspect of an oral appliance 10. The appliance 10 may be made of medical grade silicone that is a rubber material that is flexible and comfortable in the mouth. The flexibility can also accommodate users of different oral dimensions. The flexibility still further allows some movement that not only can provide comfort but can accommodate movement of the TMJ so as to reduce strain on the joint.

[0136] The appliance may also be made from a dual moulded having a base member that does not substantially soften at temperatures below 100° C. and a layer of a thermoplastic material such as ethylene vinyl acetate (EVA) that is softenable below 100° C. over the base member.

[0137] The base member may be a polyolefin such as polyethylene (PE), polypropylene (PP) or blends thereof. One example of a suitable polyolefin blend is a PE/polyurethane (PU) blend.

[0138] The base member confers a suitable level of rigidity on the base member but does have some flexibility and this enables the appliance to accommodate arches of varying width.

[0139] It will be appreciated that the flexibility allows for better fit whilst the mouldable outer layer provides a degree of customisation.

[0140] The appliance 10 includes a U shaped appliance body for mounting over the upper arch of a user. The appliance body 10 has a front section 12 and two arms 14, 16.

[0141] The appliance 10 includes an inner wall 18 that is positioned on a lingual side of the patient's upper arch and an outer wall 20 that is positioned on the buccal side thereof.

[0142] The outer wall 20 is U shaped with a front 20f and two arms 20a. The inner wall 18 is U shaped with a front 18f and two arms 18a.

[0143] The appliance body 10 also includes a U shaped web 22 interconnecting the inner wall 18 and the outer wall 20. When the appliance 10 is in the mouth of a user, the web 22 lies in the occlusal plane between the dentition of the upper and the lower arches in use.

[0144] The inner 18, outer wall 20 and web 22 define upper 24 and lower 26 arch receiving channels within which respectively the upper arch and associated dentition and the lower arch and associated dentition can be received (most clearly seen in FIG. 4).

[0145] The inner wall 18 includes an upper portion 28 which projects up from the web 22 and a lower portion 30 which projects down from the web 22. Similarly the outer wall 20 comprises an upper portion 32 above the web 22 and a lower portion 34 below the web 22.

[0146] The inner wall 18 has a lingual surface 36 and a channel surface 38.

[0147] The outer wall 20 has a front buccal surface 40 that is dimensioned so that it substantially covers the buccal aspects of the upper and lower posterior teeth.

[0148] The oral appliance 10 includes an air inlet member 44 extending forwardly from the front buccal surface 40 of the outer wall 20. The air inlet member 44 is may be any suitable shape or configuration and may be elliptical or ovoid in cross section and is located generally centrally on the buccal surface 40. The air inlet member 44 has a curved upper wall 46 and a curved lower wall 48 and an elliptical inlet 50 (as can be seen in FIG. 3). The inlet 50 is surrounded by a lip 52 (as seen in FIG. 6).

[0149] In another aspect, the air inlet may be ovoid. The air inlet may also comprises a plurality of inlet aperatures.

[0150] The curvature of the upper and lower walls 46, 48 of the air inlet member 44 is designed for a user's lips to fit comfortably around so as to be able to form a lip-seal around the air inlet member 44. This means that the only way that air can pass into the mouth is through the air inlet 50. It will be appreciated that other shapes or configurations of the air inlet member may be suitable for the purpose.

[0151] As can be seen in the cross section in FIG. 6, the upper 46 and lower walls 48 define an air passage 54 that extends through the outer wall 20.

[0152] The frontal portion of the inner wall 18f inclines rearwardly away from the outer wall 20 as it extends up from the web 22 at an angle of about 30 to 40 degrees. This matches the curvature of the lingual side of the maxillary teeth.

[0153] The lower portion of the inner wall 18 includes a tongue elevator 70 (shown in FIGS. 2 and 4). The lower part 18l of the inner wall 18 has a lower terminal edge region that is thickened to form the tongue elevator 70. The tongue elevator 70 forces the tongue to hold an upwards position that further assists in bringing the tongue forward so as to open the airway.

[0154] At substantially centrally in the upper part 28 of the inner wall 18 there is a rearward facing extended part that forms an air outlet member 56. The air outlet member 56 has an outlet body 58. The outlet body 58 has an upper wall 60 that is concave in the transverse direction and a lower wall 62 that is also concave in the transverse direction.

[0155] The outlet body 58 further comprises opposing side edges 64, 66 and a posteriorly facing elliptical air outlet 68. As seen in FIG. 7, the side edges 64, 66 of the outlet body 58 diverge outwardly towards the air outlet 68. The elliptical outlet 68 has an upper edge 69 that is convex in the transverse direction and a lower edge 72 that is convex in the transverse direction. The outlet body 58 is also arcuate about a radial centre along the longitudinal axis of the body.

[0156] The air outlet member 56 is configured such that in use the air outlet locates horizontally adjacent or close to the hard palate at a position between the molars, suitably in the region of the second premolar PM and first molar M as shown in FIG. 10. This places the air outlet 68 above the tongue about the middle part of the hard palate.

[0157] The curvature of the upper wall 60 of the air outlet body 58 substantially corresponds to that of a user's hard palate for comfort.

[0158] The air outlet member 56 has a degree of resilience such that it may comfortably press against the patient's palate so as to prevent or obstruct air from passing above the air outlet member 56 and the palate during exhalation so as to optimise air flowing into the air outlet 68.

[0159] The air outlet 68 is configured to extend substantially across the width of the hard palate at that point. In this way air enters the oral cavity uniformly across the cavity.

[0160] An air flow passageway 71 is defined between the air inlet 50 and the air outlet 68. The air flow passageway 71 has an inlet part 73 defined by the air inlet member and an outlet part 75 defined by the air outlet member body 58. The oral appliance 10 includes a curved intermediate part of 74 of constant cross section. The part 74 has an inner facing part and an outer part. The inner part receives the tip of a user's tongue. The tongue is highly responsive to objects in the mouth and will haptically explore the air outlet member 56 and part 74. This further brings the tongue forward. Further advantages of this tongue placement will be described below.

[0161] The diameter of the intermediate part 74 is constant and about 6 mm to 8 mm. The width of the air inlet is about 23 mm to 26 mm.

[0162] Fluid flow through an abrupt constriction in a pipe results in a decrease in pressure of the fluid. Fluid flow also experiences a decrease in pressure when travelling through a bend in a pipe. Fluid pressure also drops when fluid flows through an abrupt expansion.

[0163] Whilst not wishing to be bound by theory, it is believed that the flow of air upon inhalation from the inlet member through the constriction in intermediate part 74 and the bend therein. This decrease in pressure results in a positive external pressure that may assist inhalation.

[0164] As discussed above, the oral appliance 10 encourages the tongue forward adjacent the air outlet member 56. This corresponds to the normal rest position nasal for breathing (subject to the thickness of the air outlet member). Under normal circumstances, such a tongue position would inhibit mouth breathing and the tongue would be forced into the lower position of a mouth breather in which the tip rests against the maxillary teeth. However, with the present appliance, air is delivered above the tongue at a position about half way along the hard palate and bypasses any such inhibition, whilst encouraging forward location of the tongue T. This is schematically shown in FIG. 11.

[0165] The air outlet member 56 is also flexible that allows the tongue to press up against it. A patient may be encouraged to do this so as to exercise and train the tongue to adopt the correct position, when the appliance is not being worn.

[0166] Whilst not wishing to be bound by theory it is believed that the positive pressure delivered to the mouth through the air outlet member 56 combined with shape and configuration of upper part of the air outlet member against the hard palette and further the activity of the tongue against the air outlet member 56 may assist in expansion of the maxilla. The lateral wall of each nasal cavity mainly consists of the maxilla. Thus expansion of the maxilla may increase the size of the nasal cavity, thereby reducing nasal obstruction. This in turn may over time alleviate at least partially the symptoms of OSA.

[0167] FIG. 9 shows an alternative oral appliance 110 in which the air inlet member 144 is tapered from the air inlet opening 150 towards the appliance 110.

[0168] Further the upper and lower arch receiving channels are configured for mandibular advancement (see FIG. 6). This physically brings the mandible and tongue forward and further opens the pharyngeal airway.

[0169] FIGS. 12 to 19 show an oral appliance 210 of another aspect of the disclosure. The same reference numbers will be used to define the same features.

[0170] The oral appliance 210 is substantially the same as the oral appliance of FIG. 1 with the addition of three compressible channels 212 in the web 22 of each arm 14, 16. The channels may be open or closed. The channels are compressible that further allows relative movement of the jaw so as to reduce strain on the TMJ.

[0171] The air outlet member body 256 and the air outlet 268 each have a different configuration that may best be seen by comparing the cross section views in FIGS. 11 and 17.

[0172] Air outlet member body 256 has an upper wall 260 and a lower wall 262 that are diverging rather than parallel. The air outlet member body 256 is also at an angle of about 30 to 45 degrees to the horizontal rather than parallel. The air outlet body 256 is shorter and extends back to the premolars.

[0173] The space S where the tip of the tongue sits is larger than that in FIG. 11 that may facilitate further correct tongue placement.

[0174] FIG. 20 shows yet a further oral appliance 340 similar to that of FIGS. 12 to 19 but having a singular air channel 350.

[0175] FIGS. 21 to 26 show an adapter 300 that may be used to connect the oral appliance to an outlet tube of a CPAP machine.

[0176] The adapter 300 has cylindrical air inlet member 302 with an inlet 304. The inlet member 302 is configured for fluid connection to a CPAP air outlet tube. The inlet member 302 may receive or be received by the CPAP tube.

[0177] The adapter 300 has an outlet member 306 of elliptical cross section that is configured for fluid connection to the air inlet member 44 of the oral appliances 10, 210. The air inlet member 44 may receive or be received by the air outlet member 306.

[0178] The inlet member 302 and outlet member 306 are separated by an elliptical flange 308 that in use acts as a stop against a patient's lips.

[0179] FIGS. 28 to 30 show the adapter 300 connected to the appliance 210. It will be appreciated that such an arrangement may be more comfortable to a user than a nasal of full face mask. Seals against the face and chin straps are not required.

[0180] As can be seen in FIG. 30 there is a sudden contraction C in the in-flow direction from the air inlet member 302 to the air outlet member 306. Sudden contractions in pipes cause a marked drop in pressure due to an increase in velocity and loss of energy to turbulence.

[0181] FIGS. 31 and 32 show an oral appliance 410 of another aspect of the disclosure. The same reference numbers will be used to define the same features.

[0182] The oral appliance 410 is substantially the same as the oral appliance of FIG. 1 with the addition of an upper tab 412 formed on the upper wall 46 of the air inlet 44, and a lower tab 414 formed on the lower wall 48 of the air inlet 44.

[0183] FIGS. 33 to 34 show an adapter 400 of another aspect connected to the appliance 410. The same reference numbers will be used to define the same features.

[0184] The adapter 400 is substantially the same as the adapter of FIGS. 21 to 26 with the addition of an upper groove 416 and a lower groove 418 formed on an internal surface of the outlet member 306, positioned adjacent to the elliptical flange 308. The upper recess 416 is configured to engage with the upper tab 412 of the oral appliance and the lower recess 428 is configured to engage with the lower tab 414 to thereby releasably secure the air inlet member 306 of the adapter 400 to the appliance 410. The walls of the adapter are sufficiently resilient so as to provide for a snap fit engagement with the appliance 410.

[0185] Mandibular advancement for a person having a normal bite will put some strain on the temporomandibular joints (TMJ). The flexibility of the silicone material or the material of a base member where the oral appliance is dual moulded allows some relative movement of the mandible that may at least partially alleviate such strain. However, this strain is significantly less than the art known MAD devices. Common side effects of art known MAD devices include TMJ discomfort or pain and myofascial pain. Long term advancement can cause TMJ damage and dysfunction.

[0186] The combination of forward tongue position and minimal mandibular advancement of the present appliances allows opening of the pharyngeal airway to extents comparable with known art MADs that significantly advance the mandible. Thus there is less strain on the TMJ with use of the present appliances than with art known MADs. This allows for more patient comfort which generally translates to higher patient compliance. This location of the tongue also reciprocates retrusive action of the maxilla.

[0187] The oral appliance may also be used in conjunction with a CPAP machine whereby the CPAP air tube is connected to the air outlet member.

[0188] It will be appreciated that the disclosed oral appliances do not require custom fabrication fitting by virtue of the flexibility of the thermoplastics material. The oral appliances may be easily manufactured by injection moulding at a fraction of the cost of custom made devices. Alternately, with the dual moulded ready-made device can be custom fitted with the above features.

[0189] The configuration of the air outlet member promotes voluntary forward positioning of the tongue that opens the airway. This may reduce the amount of mandibular advancement required. This in turn reduces stress on the TMJ. Stress on the TMJ is further reduced by the flexibility of the appliance.

[0190] It will be appreciated that various changes and modifications may be made to the appliances and methods as disclosed herein without departing from the spirit and scope thereof.