Oral appliance for treatment of snoring and sleep apnea

• US 20070292819A1
• Filed: 05/11/2007
• Published: 12/20/2007
• Est. Priority Date: 06/14/2006
• Status: Active Grant

• Current Assignee: Philips RS North America LLC (Koninklijke Philips N.V.)
• Original Assignee: RIC INVESTMENTS LLC (Respironics Incorporated)
• Inventors: Parks, Robert, Busch, Lance, Stygar, Christopher, Scarberry, Eugene, Lotz, Gary, Kemnitzer, Ronald
• Granted Patent: US 8,205,617 B2
• Time in Patent Office: Days
• US Class Current: 433/140
• CPC Class Codes: A61F 5/566 Intra-oral devices
• CPC Class Codes: B29C 33/3857 by making impressions of one or more parts of models, e.g. shaped articles and including possible subsequent assembly of the parts
• CPC Class Codes: B29C 39/003 characterised by the choice of material
• CPC Class Codes: B29C 39/02 for making articles of definite length, i.e. discrete articles
• CPC Class Codes: B29C 39/38 Heating or cooling
• CPC Class Codes: B29K 2023/083 EVA, i.e. ethylene vinyl acetate copolymer
• CPC Class Codes: B29K 2067/00 Use of polyesters or derivatives thereof, as moulding material
• CPC Class Codes: B29L 2031/753 Medical equipment; Accessories therefor bloodbags, medical bags B29L2031/7148; artificial eyes B29L2011/0008

Abstract

An oral appliance is provided for the treatment of snoring and obstructive sleep apnea. The oral appliance includes an upper tray adaptable to conform to a user'"'"'s maxillary dentition and a plurality of lower trays, each of the lower trays adaptable to conform to the user'"'"'s mandibular dentition. At least some of the lower trays are structured to engage the upper tray, each of the lower trays are structured to impart a different fixed amount of mandibular advancement.

Claims

1. An oral appliance system, comprising:

an upper tray adaptable to conform to a user'"'"'s maxillary dentition; and

a plurality of lower trays, each of the lower trays adaptable to conform to the user'"'"'s mandibular dentition, wherein at least some of the lower trays are structured to engage the upper tray, and wherein each of the lower trays are structured to impart a different fixed amount of mandibular advancement.

2. The oral appliance system of claim 1, wherein the upper tray comprises:

an upper moldable material; and

an upper support member structured to define an upper region adapted to carry a portion of the upper moldable material.

3. The oral appliance system of claim 2, wherein the upper support member includes a base with a bonding surface and an occlusal surface, an outer wall with a front surface and a rear surface, and an inner wall with a front surface and a rear surface, and wherein at least a portion of the upper region is defined by the bonding surface of the base, the rear surface of the outer wall, and the front surface of the inner wall.

4. The oral appliance system of claim 3, wherein the bonding surface of the upper support member is concave to accommodate the Curve of Spee of a user'"'"'s maxillary dentition.

5. The oral appliance system of claim 1, wherein the upper tray includes an upper moldable material with a channel structured to align the user'"'"'s dentition within the center thereof, the channel including a substantially V-shaped portion structured to engage an anterior portion of the user'"'"'s maxillary dentition and a substantially U-shaped portion structured to engage a posterior portion of the user'"'"'s maxillary dentition, and wherein at least one of the plurality of lower trays includes a lower moldable material with a channel structured to align the user'"'"'s dentition within the center thereof, the channel including a substantially V-shaped portion structured to engage an anterior portion of the user'"'"'s mandibular dentition and a substantially U-shaped portion structured to engage a posterior portion of the user'"'"'s mandibular dentition.

6. The oral appliance system of claim 5, wherein at least one of the upper moldable material and the lower moldable material includes an ethylene-vinyl acetate copolymer resin and an aliphatic polyester.

7. The oral appliance system of claim 1, wherein each of the lower trays comprises:

an lower moldable material; and

a lower support member structured to define a lower region adapted to carry a portion of the lower moldable material.

8. The oral appliance system of claim 7, wherein the lower support member includes a base with a bonding surface and an occlusal surface, an outer wall with a front surface and a rear surface, and an inner wall with a front surface and a rear surface, and wherein at least a portion of the lower region is defined by the bonding surface of the base, the rear surface of the outer wall, and the front surface of the inner wall.

9. The oral appliance system of claim 8, wherein the bonding surface of the lower support member is convex to accommodate the Curve of Spee of a user'"'"'s mandibular dentition.

10. The oral appliance system of claim 1, wherein the upper tray has a slotted engagement member extending therefrom and each of at least some of the lower trays has an elongated engagement member extending therefrom, and wherein the slotted engagement member is structured to receive the elongated engagement member of a selected one of the lower trays and releasably couple the upper tray to the selected one of the lower trays.

11. The oral appliance system of claim 10, wherein the upper tray has a single slotted engagement member extending from the occlusal surface of the base of the upper support member and wherein the at least some of the lower trays has an elongated engagement member extending from the occlusal surface of the base of the lower support member.

12. The oral appliance system of claim 10, wherein at least one of the slotted engagement member and the elongated engagement member includes a frangible portion.

13. The oral appliance system of claim 10, wherein the slotted engagement member and the elongated engagement member cooperate to permit a predetermined amount of lateral movement and a predetermined amount of vertical movement of the upper tray relative to the selected one of the lower trays.

14. The oral appliance system of claim 13, wherein the predetermined amount of vertical movement is at least approximately 0.1 millimeter.

15. The oral appliance system of claim 14, wherein the predetermined amount of lateral movement is approximately between 10 millimeters and 13 millimeters.

16. The oral appliance system of claim 1, wherein each of the lower trays, in combination with the upper tray, are structured to impart an amount of vertical spacing between the user'"'"'s maxillary dentition and mandibular dentition.

17. The oral appliance system of claim 16, wherein at least one of the lower trays, in combination with upper tray, is structured to impart approximately 0.394 inches (10 millimeters) of vertical spacing.

18. The oral appliance system of claim 1 further comprising a holding tray structured to engage at least one of the upper tray and some of the plurality of lower trays.

19. A method for effecting the patency of a user'"'"'s airway, comprising:

providing an oral appliance assembly comprising an upper tray adaptable to conform to a user'"'"'s maxillary dentition and a plurality of lower trays each adaptable to conform to the user'"'"'s mandibular dentition, wherein each of at least some of the lower trays is structured to couple with the upper tray to impart a different fixed amount of mandibular advancement;

selecting of at least one of the plurality of lower trays; and

coupling the upper tray with a selected one of the lower trays to form an oral appliance having a desired amount of mandibular advancement.

20. The method of claim 19, further comprising inserting the upper tray and the selected lower tray into the user'"'"'s mouth.

21. The method of claim 19, wherein providing an oral appliance assembly includes at least one of fitting the upper tray to conform to a user'"'"'s maxillary dentition and fitting at least one of the lower trays to a user'"'"'s mandibular dentition.

22. The method of claim 19, wherein providing an oral appliance assembly, further comprises:

providing an upper tray having an upper moldable material and an upper support member structured to define an upper region adapted to carry a portion of the upper moldable material; and

providing a lower tray having a lower moldable material and a lower support member structured to define lower region adapted to carry a portion of the lower moldable material.

23. The method of claim 22, wherein at least one of providing an oral appliance assembly, further comprises at least one of:

providing a number of electrodes extending from at least one of the upper support member, lower support member, the upper moldable material, and the lower moldable; and

structuring at least one of the upper support member and the lower support member to couple with and stabilize a patient interface device

24. The method of claim 19, wherein providing an oral appliance assembly, further comprises providing an upper tray and a lower tray which when engaged are structured to impart a desired amount of vertical spacing between the user'"'"'s maxillary dentition and mandibular dentition.

25. The method of claim 19, wherein providing an oral appliance assembly, further comprises providing an upper tray and a lower tray which when engaged are structured to impart approximately 0.394 inches (10 millimeters) of vertical spacing between the user'"'"'s maxillary dentition and mandibular dentition.

26. An oral appliance assembly, comprising:

an oral appliance tray adaptable to conform to a user'"'"'s dentition; and

a holding tray adapted to promote proper insertion of the oral appliance tray into a user'"'"'s mouth, the holding tray comprising;

a generally U-shaped frame structured to couple with the oral appliance tray, and

a handle located substantially at the vertex of the frame.

27. The oral appliance assembly of claim 26, wherein the frame has a base with an outer wall extending therefrom and wherein the handle projects from a front surface of the outer wall.

28. The oral appliance assembly of claim 26, wherein the holding tray includes a number of bite pads located on an occlusal surface thereof, wherein the bite pads are structured to distribute a user'"'"'s bite pressure across the occlusal surface of the holding tray.

29. The oral appliance assembly of claim 26, wherein the oral appliance tray is adaptable to conform to one of the user'"'"'s maxillary dentition and the user'"'"'s mandibular dentition.

30. A holding tray adapted to promote proper insertion of an oral appliance into a user'"'"'s mouth, the holding tray comprising:

a generally U-shaped frame structured to engage the oral appliance, the frame having a base with an outer wall extending therefrom; and

a handle projecting from a buccal surface of the outer wall, the handle substantially located with the vertex of the U-shaped frame.

31. The holding tray of claim 30, wherein at least one of a portion of the base and a portion of the outer wall define an aperture structured to receive an engagement member of the oral appliance therethrough.

32. The holding tray of claim 30, wherein an occlusal surface of the base includes a number of contact pads, wherein the contact pads are structured to distribute a user'"'"'s bite pressure across the occlusal surface of the base.

33. The holding tray of claim 30, wherein the contact pads are comprised of an elastomeric material.

34. A method of fitting an oral appliance, comprising:

coupling an oral appliance tray with a holding tray, the oral appliance tray having a moldable material and the holding tray having a handle;

submerging the oral appliance tray at least partially within a heating medium without submerging at least a portion of the handle;

removing of the oral appliance tray from the heating medium with the handle;

inserting of the oral appliance tray into a user'"'"'s mouth using the handle; and

making an impression of a portion of the user'"'"'s dentition.

35. The method of claim 34, wherein removing of the oral appliance tray from the heating medium with the handle is completed after the moldable material has reached a yielded state.

36. The method of claim 34, wherein making an impression of a portion of the user'"'"'s dentition includes the user biting into the moldable material while the molded material is in a yielded state.

37. A method of fitting an oral appliance, comprising:

taking an impression of a user'"'"'s dentition;

creating a casting of the user'"'"'s dentition using the impression;

heating the casting to a predetermined temperature; and

placing the heated casting in an oral appliance having a moldable material.

38. The method of claim 37, wherein the taking an impression includes at least one of taking an impression of a user'"'"'s maxillary dentition and taking an impression of a user'"'"'s mandibular dentition.

39. The method of claim 37, wherein heating the casting comprises heating the casting to at least 180 degrees Fahrenheit (82 degrees Celsius).

40. The method of claim 37, wherein the placing the heated casting in an oral appliance further comprises heating at least a portion of the oral appliance material until the moldable material yields.

41. The method of claim 37, wherein the placing the heated casting in an oral appliance comprises:

inserting the heated casing within an oral appliance tray, the oral appliance tray comprising;

a moldable material with a channel structured to align the heated casting within the center thereof, the channel having a substantially V-shaped portion structured to engage an anterior portion of the heated casting and a substantially U-shaped portion structured to engage a posterior portion of the heated casting; and

a support member structured to carry the moldable material thereon.

42. An oral appliance tray, comprising a generally U-shaped support member having a first width relative to a vertex thereof that is between approximately 0.30 inches (7.62 millimeters) and approximately 0.53 inches (13.46 millimeters) and having a second width relative to at least one of a first leg and a second leg thereof that is approximately between 0.50 inches (12.70 millimeters) and approximately 0.73 inches (18.54 millimeters).

43. The oral appliance tray of claim 42, wherein the first and second widths are selected such that the ratio between the first width and the second width is between approximately 0.60 and 0.73.

44. The oral appliance tray of claim 42, wherein the generally U-shaped support member has a third width relative to the distance between the first leg and the second leg, and wherein the third width is between approximately 2.0 inches (50.8 millimeters) and 2.80 inches (71.12 millimeters).

45. The oral appliance tray of claim 44, wherein the first and third widths are selected such that the ratio between the first width and the third width is between approximately 0.17 and 0.19.

46. The oral appliance tray of claim 42, wherein the generally U-shaped support member has a first height relative to the vertex that is between approximately 0.30 inches (7.62 millimeters) and approximately 0.50 inches (12.70 millimeters) and has a second height relative to at least one of a first leg and a second leg that is between approximately 0.025 inches (0.635 millimeters) and approximately 0.42 inches (10.67 millimeters).

47. The oral appliance tray of claim 46, wherein the first and second heights are selected such that the ratio between the second height and the first height is between approximately 0.083 and approximately 0.125.

48. The oral appliance tray of claim 42, wherein the generally U-shaped support member has a maximum height that is between approximately 0.30 inches (7.62 millimeters) and approximately 0.48 inches (12.19 millimeters).

49. The oral appliance tray of claim 42, wherein the generally U-shaped support member is constructed of a polycarbonate resin thermoplastic having a density of approximately 0.045 lb/in³, a volume of approximately 0.17 in³, and a weight of approximately 0.0076 lbs.

50. The oral appliance tray of claim 42, wherein the generally U-shaped support member is constructed of a polycarbonate resin thermoplastic having a density of approximately 0.045 lb/in³, a volume of approximately 0.18 in³, and a weight of approximately 0.0081 lbs.

51. The oral appliance tray of claim 42, wherein the generally U-shaped support member has a base, an outer wall, and an inner wall, wherein the base, the outer wall, and the inner wall define a region adapted to carry a moldable material thereon.

52. The oral appliance tray of claim 51, wherein the moldable material is an ethylene-vinyl acetate copolymer resin having a density of approximately 0.035 lb/in³, a volume of approximately 0.75 in³, and a weight of approximately 0.0263 lbs.

53. The oral appliance tray of claim 51, wherein the moldable material is an ethylene-vinyl acetate copolymer resin having a density of approximately 0.035 lb/in³, a volume of approximately 0.66 in³, and a weight of approximately 0.0231 lbs.

54. The oral appliance tray of claim 51, wherein a portion of the moldable material extends at least 0.00984 inches (0.25 millimeters) above a rear surface of the outer wall.

55. The oral appliance tray of claim 51, wherein a portion of the moldable material extends at least 0.0256 inches (0.65 millimeters) above a front surface of the inner wall.

56. The oral appliance tray of claim 51, wherein a portion of the moldable material extends at least 0.00394 inches (0.10 millimeters) from an end of a bonding surface of the base.

57. The oral appliance tray of claim 51, wherein at least one of the U-shaped support member and the moldable material has a number of electrodes extending therefrom.

58. The oral appliance tray of claim 51, wherein the U-shaped support member is structured to couple with and stabilize a patient interface device.

59. An oral appliance tray, comprising:

a moldable material; and

a support member structured to carry a portion of the moldable material, the support member having a ramp adapted to promote alignment of a user'"'"'s dentition relative to the moldable material.

60. The oral appliance tray of claim 59, wherein the support member comprises a base with a bonding surface and an occlusal surface, the bonding surface including the ramp and carrying the portion of the moldable material.

61. The oral appliance tray of claim 60, wherein the occlusal surface has one of a slotted engagement member with a frangible portion or an elongated engagement member with a frangible portion extending therefrom.

62. The oral appliance tray of claim 60, wherein the occlusal surface has a number of bite pads extending therefrom.

63. The oral appliance tray of claim 60, wherein the support member further comprises an outer wall with a front surface and a rear surface, and an inner wall with a front surface and a rear surface, and wherein the bonding surface of the base, the rear surface of the outer wall, and the front surface of the inner wall define a region structured to carry the portion of the moldable material.

64. The oral appliance tray of claim 59, wherein the moldable material is comprised of a number of layers including a layer of aliphatic polyester and a layer of ethylene-vinyl acetate copolymer resin.

65. The oral appliance tray of claim 59, wherein the moldable material is comprised of an ethylene-vinyl acetate copolymer resin with an aliphatic polyester suspended therein.

66. An oral appliance tray, comprising:

a moldable material; and

a support member having a base, an outer wall, and an inner wall, wherein the base, the outer wall, and the inner wall define a region adapted to couple with the moldable material, wherein a portion of the moldable material extends out of the region.

67. The oral appliance tray of claim 66, wherein a portion of the moldable material extends at least 0.00984 inches (0.25 millimeters) above the rear surface of the outer wall.

68. The oral appliance tray of claim 66, wherein a portion of the moldable material extends at least 0.0256 inches (0.65 millimeters) above the front surface of the inner wall.

69. The oral appliance tray of claim 66, wherein a portion of the moldable material extends at least 0.00394 inches (0.1 millimeters) from an end of the bonding surface of the base.

70. The oral appliance tray of claim 66, wherein the support member includes one of a single slotted engagement member with a frangible portion or an elongated engagement member with a frangible portion extending therefrom.

71. The oral appliance tray of claim 66, wherein the moldable material is adapted to conform to one of the user'"'"'s maxillary dentition and the user'"'"'s mandibular dentition.

72. An oral appliance tray, comprising:

a moldable material with a channel structured to align a user'"'"'s dentition within the center thereof, the channel having a substantially V-shaped portion structured to engage an anterior portion of a user'"'"'s dentition and a substantially U-shaped portion structured to engage a posterior portion of the user'"'"'s dentition; and

a support member structured to carry the moldable material thereon.

73. The oral appliance tray of claim 72, wherein the support member has a base, an outer wall, and an inner wall, wherein the base, the outer wall, and the inner wall define a region adapted to couple with the moldable material.

74. The oral appliance tray of claim 73, wherein a portion of the moldable material extends at least 0.00987 inches (0.25 millimeters) above a rear surface of the outer wall.

75. The oral appliance tray of claim 73, wherein a portion of the moldable material extends at least 0.0256 inches (0.65 millimeters) above a front surface of the inner wall.

76. The oral appliance tray of claim 73, wherein a portion of the moldable material extends at least 0.0394 inches (0.1 millimeters) from an end of a bonding surface of the base.

77. The oral appliance tray of claim 73, wherein the base has a bonding surface that is structured to accommodate the Curve of Spee of at least one of a user'"'"'s mandibular dentition and the user'"'"'s maxillary dentition.

78. The oral appliance tray of claim 72, wherein said support member is generally U-shaped and has a first width relative to a vertex thereof that is approximately between 0.30 inches (7.62 millimeters) and 0.53 inches (13.46 millimeters), has a second width relative to at least one of a first leg and a second leg thereof that is approximately between 0.50 inches (12.70 millimeters) and 0.73 inches (18.54 millimeters), has a third width relative to the distance between the first leg and the second leg that is approximately between 2.0 inches (50.8 millimeters) and 2.80 inches (71.12 millimeters), has a first height relative to the vertex that is between approximately 0.30 inches (7.62 millimeters) and 0.50 inches (12.70 millimeters), has a second height relative to at least one of a first leg and a second leg that is approximately between 0.025 inches (0.635 millimeters) and 0.42 inches (10.67 millimeters), and has a maximum height that is approximately between 0.30 inches (7.62 millimeters) and 0.48 inches (12.19 millimeters).

79. The oral appliance tray of claim 72, wherein the support member is constructed of a polycarbonate resin thermoplastic having a density that is approximately between 0.040 lb/in3 and 0.050 lb/in³, a volume that is between approximately 0.12 in³ and 0.22 in³ and a weight that is between approximately 0.0071 lbs and 0.0081 lbs.

80. The oral appliance tray of claim 72, wherein at least one of the support member and the moldable material has a number of electrodes extending therefrom.

81. The oral appliance tray of claim 72, wherein the support member is structured to couple with and stabilize a patient interface device.