Respiratory mask assembly with vent

• US 8,122,886 B2
• Filed: 12/27/2006
• Issued: 02/28/2012
• Est. Priority Date: 02/10/1997
• Status: Expired due to Fees

• Current Assignee: Resmed Limited (ResMed Incorporated)
• Original Assignee: Resmed Limited (ResMed Incorporated)
• Inventors: Kwok, Philip Rodney, Lithgow, Perry David
• Primary Examiner(s): Dixon, Annette
• Application Number:
  US11/645,582
• Publication Number:
  US 20070101998A1
• Time in Patent Office: 1,889 Days
• Field of Search: 128/857, 128/858, 128/863, 128/200.24, 12820122-20129, 128/204.18, 128/204.23, 128/204.25, 128/205.24, 12820621-20713, 604/126, 604/254, 604/247, 247/136, 246/62
• US Class Current: 128/206.21
• CPC Class Codes: A61M 16/06 Respiratory or anaesthetic masks
• CPC Class Codes: A61M 16/0683 Holding devices therefor
• CPC Class Codes: A61M 2202/0085 product washed out
• CPC Class Codes: A61M 2202/0225 Carbon oxides, e.g. Carbon dioxide
• CPC Class Codes: A61M 2205/0216 Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking
• CPC Class Codes: A61M 2205/42 Reducing noise
• CPC Class Codes: A62B 18/02 Masks gas-masks for animals A62B18/06; masks for welders A61F9/06
• CPC Class Codes: A62B 18/10 Valves

Abstract

A mask (10) for use with a system for supplying breathable gas pressurized above atmospheric pressure to a human or animal'"'"'s airways. The mask (10) includes a mask shell (12) which is, in use, in fluid communication with a gas supply conduit (30), and a gas washout vent assembly (20). At least the region of the mask shell (12) or conduit (30) surrounding or adjacent the vent assembly is formed from a relatively flexible elastomeric material.

Claims

1. A CPAP mask assembly for use with a system for supplying breathable gas pressurized above atmospheric pressure to a user for treatment of obstructive sleep apnea, the CPAP mask assembly comprising:

a mask having an inlet tube that is, in use, adapted to be in fluid communication with a gas supply conduit, said mask including a shell made from polycarbonate or another rigid plastic material, the shell being provided with a sealing membrane to provide a gas tight seal with the user in use; and

a vent including a plurality of gas washout orifices regularly separated and spaced from one another, each said orifice having an inner side that, in use, is positioned towards the user'"'"'s face, and an outer side that, in use, is positioned adjacent atmosphere, each said orifice being open in use at least during the inhalation and exhalation phases of the user'"'"'s breathing cycle, wherein

the vent includes an insert and the orifices are provided in the insert,

wherein the use of the insert in the mask reduces the decibel noise levels 1 meter from the mask.

2. A CPAP mask assembly as claimed in claim 1, wherein a cross-sectional size or area of each orifice at the inner side is larger than a cross-sectional size or area of the orifice at the outer side, and a transition portion between the inner and outer sides of each said orifice has a cross-sectional size or area that varies or tapers along at least a portion of a length thereof.

3. A CPAP mask assembly as claimed in claim 2, wherein the inner side of each orifice is larger than the outer side.

4. A CPAP mask assembly as claimed in claim 1, wherein the vent includes at least three orifices.

5. A CPAP mask assembly as claimed in claim 1, wherein the vent includes at least four orifices.

6. A CPAP mask assembly as claimed in claim 1, wherein the vent includes at least five orifices.

7. A CPAP mask assembly as claimed in claim 1, wherein the vent includes six orifices.

8. A CPAP mask assembly as claimed in claim 1, wherein a ratio of an inner diameter at the inner side of the orifice to an outer diameter at the outer side of the orifice is about 1.9.

9. A CPAP mask assembly as claimed in claim 1, wherein the length of each said orifice is greater than an inner diameter at the inner side of each said orifice.

10. A CPAP mask assembly as claimed in claim 1, wherein said orifices are separated from each other by at least a diameter of the orifice at the outer side.

11. A CPAP mask assembly as claimed in claim 1, wherein an axis defined within each orifice extends substantially linearly from the inner side to the outer side.

12. A CPAP mask assembly as claimed in claim 1, further comprising a headgear strap and a lug on each side of the shell for connecting the mask to the headgear strap to retain the mask in place relative to the user in use.

13. A CPAP mask assembly as claimed in claim 12, wherein the vent is provided generally between the lugs.

14. A CPAP mask assembly as claimed in claim 1, wherein the length of each orifice is about 3 times a thickness of the shell.

15. A CPAP mask assembly as claimed in claim 1, wherein the length of each said orifice is about 3.60 mm, and each said orifice has an inner diameter at the inner side of about 3.30 mm, and an outer diameter at the outer side of about 1.73 mm.

16. A CPAP mask assembly as claimed in claim 1, wherein the insert is constructed of an elastomeric material.

17. A CPAP mask assembly as claimed in claim 1, wherein the orifices form a pattern generally in the shape of a square or diamond.

18. A CPAP mask assembly as claimed in claim 1, further comprising the gas supply conduit, wherein the orifices are provided to the gas supply conduit.

19. A CPAP mask assembly as claimed in claim 1, wherein each said orifice is substantially cylindrical in shape.

20. A CPAP mask assembly as claimed in claim 1, wherein the orifices are provided to the shell.

21. A CPAP mask assembly as claimed in claim 20, wherein each said orifice extends from the inner side to the outer side of the shell.

22. A CPAP mask assembly as claimed in claim 1, wherein the orifices are substantially linearly aligned.

23. A CPAP mask assembly as claimed in claim 1, wherein the orifices are regularly spaced along an arc.

24. A CPAP mask assembly as claimed in claim 1, wherein the vent is in general vertical alignment with the inlet tube, the vent including six orifices.

25. A CPAP mask assembly as claimed in claim 1, wherein the insert includes a main body providing said orifices, and at least one portion of the insert includes an inner flange portion defining a first surface that engages an inner surface of the mask and an outer flange portion defining a second surface that engages an outer surface of the mask, and the main body, inner flange portion, and outer flange portion comprise one piece of a common material.

26. A CPAP mask assembly as claimed in claim 1, further comprising a rim and groove arrangement to attach the insert to the mask.

27. A CPAP mask assembly as claimed in claim 26, wherein the mask includes a rim adapted to engage a groove of the insert.

28. A CPAP mask assembly for use with a system for supplying breathable gas pressurized above atmospheric pressure to a user for treatment of obstructive sleep apnea, the CPAP mask assembly comprising:

a mask adapted to be in fluid communication with a gas supply conduit; and

a flexible elastic vent portion provided to the mask, the vent portion including at least four gas washout orifices regularly separated and spaced from one another,

each said orifice having an inner side and an outer side,

wherein a cross-sectional size or area of each orifice at the inner side is larger than a cross-sectional size or area of the orifice at the outer side,

wherein the use of the vent portion in the mask reduces the decibel noise levels 1 meter from the mask.

29. A CPAP mask assembly as claimed in claim 28, wherein the inner side, in use, is positioned towards the user'"'"'s face, and the outer side, in use, is positioned adjacent atmosphere, each said orifice being open in use at least during the inhalation and exhalation phases of the user'"'"'s breathing cycle.

30. A CPAP mask assembly as claimed in claim 29, wherein the inner side of the vent portion extends inside the mask and the outer side of the vent portion extends outside the mask.

31. A CPAP mask assembly as claimed in claim 28, wherein each orifice includes a transition portion between the inner and outer sides that has a cross-sectional size or area that varies or tapers along at least a portion of a length thereof.

32. A CPAP mask assembly as claimed in claim 28, wherein each said orifice has a substantially round cross section along its length.

33. A CPAP mask assembly as claimed in claim 28, wherein the mask includes a mask shell and at least a region of the mask shell surrounding the vent portion is formed from a flexible elastomeric material.

34. A CPAP mask assembly as claimed in claim 33, wherein the entire mask shell is formed from the relatively flexible elastomeric material.

35. A CPAP mask assembly as claimed in claim 33, wherein the relatively flexible elastomeric material includes one of SILASTIC™

and SANTOPRENE™

.

36. A CPAP mask assembly as claimed in claim 28, wherein a ratio of an inner diameter at the inner side of the orifice to an outer diameter at the outer side of the orifice is about 1.9.

37. A CPAP mask assembly as claimed in claim 28, wherein the length of each said orifice is greater than an inner diameter at the inner side of each said orifice.

38. A CPAP mask assembly as claimed in claim 28, wherein said orifices are separated from each other by at least a diameter of the orifice at the outer side.

39. A CPAP mask assembly as claimed in claim 28, wherein an axis defined within each orifice extends substantially linearly from the inner side to the outer side.

40. A CPAP mask assembly as claimed in claim 28, wherein the length of each said orifice is about 3.60 mm, and each said orifice has an inner diameter at the inner side of about 3.30 mm, and an outer diameter at the outer side of about 1.73 mm.

41. A CPAP mask assembly as claimed in claim 28, wherein the mask includes a mask shell and a sealing membrane provided to the mask shell.

42. A CPAP mask assembly as claimed in claim 41, wherein the vent portion is raised compared to an inner and outer surface of the mask shell.

43. A CPAP mask assembly as claimed in claim 28, wherein the arc is “

U”

or “

C”

shaped.

44. A CPAP mask assembly as claimed in claim 43, wherein the arc is oriented as an upside-down “

U”

relative to the patient in use.

45. A CPAP mask assembly as claimed in claim 44, wherein the arc is symmetrical about an axis, and three of the orifices are provided on one side of the axis and the other three of the orifices are provided on the other side of the axis.

46. A CPAP mask assembly as claimed in claim 45, wherein one of the orifices is provided at each end portion of the arc.

47. A CPAP mask assembly as claimed in claim 28, wherein the arc is U-shaped and includes two end portions and a central portion connecting the two end portions, and two of the orifices are provided at respective end portions of the arc and the other four of the orifices are regularly spaced and separated from one another along the central portion of the arc.

48. A CPAP mask assembly as claimed in claim 28, wherein the mask includes an inlet tube for connection to the gas supply conduit.

49. A CPAP mask assembly as claimed in claim 48, wherein the vent portion is in general vertical alignment with the inlet tube.

50. A CPAP mask assembly as claimed in claim 28, wherein pressurized gas is provided at a level suitable for CPAP treatment.

51. A CPAP mask assembly as claimed in claim 50, wherein pressurized gas is provided in the range of 4-18 cmH₂O.

52. A CPAP mask assembly as claimed in claim 28, wherein said orifices are separated from each other by at least 1.73 mm.

53. A CPAP mask assembly as claimed in claim 28, wherein the length of each said orifice is about 3.60 mm.

54. A CPAP mask assembly as claimed in claim 28, wherein the arc is U-shaped and a height of the arc is less than 19 mm.

55. A CPAP mask assembly as claimed in claim 28, wherein the arc is U-shaped and a width of the arc is less than 28.8 mm.

56. A CPAP mask assembly as claimed in claim 28, wherein each orifice has a volume less than about 30.8 mm³.

57. A CPAP mask assembly as claimed in claim 28, wherein each orifice has a volume of at least 8.5 mm³.

58. A CPAP mask assembly as claimed in claim 28, wherein a difference between an inner diameter at the inner side of the orifice to an outer diameter at the outer side of the orifice is about 1.6 mm.

59. A CPAP mask assembly as claimed in claim 28, wherein the pressurized gas is in the range of 4-18 cmH₂O.

60. A mask assembly for continuous positive airway pressure treatment of obstructive sleep apnea, comprising:

a flexible sealing membrane defining at least a portion of a breathing cavity and structured to provide a gas tight seal between the face of the wearer and the breathing cavity; and

a vent for washout of exhaled carbon dioxide gas from the breathing cavity, the vent comprising a plurality of orifices, each orifice defining a passage from the breathing cavity to atmosphere wherein the passage has a cross-sectional profile that includes a generally frusto-conical portion and a generally cylindrical portion adjacent the generally frusto-conical portion,

wherein the use of the vent in the mask assembly reduces the decibel noise levels 1 meter from the mask assembly.

61. A mask assembly as claimed in claim 60, wherein the generally frusto-conical portion has a length and with a larger-diameter end of the frusto-conical portion aligned towards the breathing cavity and a smaller-diameter end of the frusto-conical portion aligned towards atmosphere and the cylindrical portion.

62. A mask assembly as claimed in claim 61, wherein the generally cylindrical portion has a cylinder diameter approximately the same size as the smaller-diameter end of the frusto-conical portion.

63. The mask assembly as claimed in claim 62, further comprising a second generally cylindrical portion having a cylinder diameter approximately the same size as the larger-diameter end of the frusto-conical portion.

64. The mask assembly as claimed in claim 62, wherein the sum of the lengths of the generally frusto-conical portion and the generally cylindrical portion is greater than a surrounding thickness of the mask assembly.

65. The mask assembly as claimed in claim 62, wherein the cylinder diameter is approximately half the larger-diameter end of the frusto-conical portion.

66. The mask assembly as claimed in claim 62, wherein the diameter of an orifice adjacent atmosphere is approximately 1.73 mm.

67. The mask assembly as claimed in claim 62, wherein the diameter of an orifice adjacent the breathing cavity is approximately 3.3 mm.

68. The mask assembly as claimed in claim 60, wherein a thickness of the cross-sectional profile is approximately 3.6 mm.

69. The mask assembly as claimed in claim 60, wherein the vent comprises molded silicone.

70. The mask assembly as claimed in claim 60, wherein the vent is formed from a flexible elastomeric material.

71. The mask assembly as claimed in claim 60, wherein an end of the generally cylindrical portion is adjacent atmosphere.

72. The mask assembly as claimed in claim 60, wherein the orifices of the vent are arranged on an arc.

73. The mask assembly as claimed in claim 60, wherein the vent includes six orifices.

74. The mask assembly as claimed in claim 60, wherein the flexible sealing membrane includes nasal pillows.

75. The mask assembly as claimed in claim 60, wherein the vent is provided on one side of the mask assembly and the flexible sealing membrane is provided on the opposite side of the mask assembly.

76. The mask assembly as claimed in claim 60, further comprising a shell to support the flexible sealing membrane and define at least a portion of the breathing cavity, the vent being provided to the shell.

77. The mask assembly as claimed in claim 76, wherein the shell is formed from a flexible elastomeric material.

78. The mask assembly as claimed in claim 76, wherein the shell is formed from a relatively rigid material.

79. The mask assembly as claimed in claim 60, wherein the vent includes six orifices arranged on an arc.

80. A mask assembly as claimed in claim 79, wherein the arc is “

U”

or “

C”

shaped.

81. A mask assembly as claimed in claim 80, wherein the arc is oriented as an upside-down “

U”

relative to the patient in use.

82. A mask assembly as claimed in claim 81, wherein the arc is symmetrical about an axis, and three of the orifices are provided on one side of the axis and the other three of the orifices are provided on the other side of the axis.

83. A CPAP mask assembly for use with a system for supplying breathable gas pressurized above atmospheric pressure to a user for treatment of obstructive sleep apnea, the CPAP mask assembly comprising:

a mask having an inlet tube that is, in use, adapted to be in fluid communication with a gas supply conduit, said mask including a shell and a seal provided to the shell to provide a gas tight seal with the user in use; and

a vent provided to the mask, the vent including at least four gas washout orifices arranged in two or more columns,

each orifice being open in use and having a cross-sectional area at a first side that is larger than a cross-sectional area at a second side opposite the first side,

wherein the use of the vent in the mask reduces the decibel noise levels 1 meter from the mask.

84. A CPAP mask assembly as claimed in claim 83, wherein the seal includes nasal pillows.

85. A CPAP mask assembly as claimed in claim 83, wherein each orifice includes a transition portion between the first and second sides that has a cross-sectional area that vanes or tapers along at least a portion of a length thereof.

86. A CPAP mask assembly as claimed in claim 83, wherein the shell includes a lug on each side thereof for connecting the mask to a headgear strap to retain the mask in place relative to the user in use.

87. A CPAP mask assembly as claimed in claim 83, wherein the orifices form a pattern generally in the shape of a square.

88. A CPAP mask assembly as claimed in claim 83, wherein each said orifice has a substantially round cross section along its length.

89. A CPAP mask assembly as claimed in claim 83, wherein the vent includes an insert and the orifices are provided in the insert.

90. A CPAP mask assembly as claimed in claim 89, further comprising a rim and groove arrangement to attach the insert to the mask.

91. A CPAP mask assembly as claimed in claim 90, wherein the mask includes a rim adapted to engage a groove of the insert.

92. A CPAP mask assembly as claimed in claim 89, wherein the insert includes a main body providing said orifices, and at least one portion of the insert includes an inner flange portion defining a first surface that engages an inner surface of the mask and an outer flange portion defining a second surface that engages an outer surface of the mask, and the main body, inner flange portion, and outer flange portion comprise only a single piece of a common material.

93. A CPAP mask assembly for use with a system for supplying breathable gas pressurized above atmospheric pressure to a user for treatment of obstructive sleep apnea, the CPAP mask assembly comprising:

a mask having an inlet tube that is, in use, adapted to be in fluid communication with a gas supply conduit, said mask including a shell made from polycarbonate or another rigid plastic material, the shell being provided with a sealing membrane to provide a gas tight seal with the user in use;

a vent including at least four gas washout orifices regularly separated and spaced from one another, each said orifice having an inner side that, in use, is positioned towards the user'"'"'s face, and an outer side that, in use, is positioned adjacent atmosphere, wherein a cross-sectional size or area of each orifice at the inner side is larger than a cross-sectional size or area of the orifice at the outer side, and a transition portion between the inner and outer sides of each said orifice has a cross-sectional size or area that varies or tapers along at least a portion of a length thereof; and

a headgear strap and a lug on each side of the shell for connecting the mask to the headgear strap to retain the mask in place relative to the user in use,

wherein the vent is provided generally between the lugs and in general vertical alignment with the inlet tube,

wherein the use of the vent in the mask reduces the decibel noise levels 1 meter from the mask.

94. A CPAP mask assembly as claimed in claim 93, wherein the vent includes an insert and the orifices are provided in the insert.

95. A CPAP mask assembly as claimed in claim 94, further comprising a rim and groove arrangement to attach the insert to the mask.

96. A CPAP mask assembly as claimed in claim 95, wherein the mask includes a rim adapted to engage a groove of the insert.

97. A CPAP mask assembly as claimed in claim 94, wherein the insert includes a main body providing said orifices, and at least one portion of the insert includes an inner flange portion defining a first surface that engages an inner surface of the mask and an outer flange portion defining a second surface that engages an outer surface of the mask, and the main body, inner flange portion, and outer flange portion comprise one piece of a common material.

98. A CPAP mask assembly as claimed in claim 93, wherein the orifices are provided to the inlet tube.

99. A CPAP mask assembly as claimed in claim 93, wherein the orifices are arranged in two or more columns.

100. A mask assembly for continuous positive airway pressure treatment of obstructive sleep apnea, comprising:

a flexible sealing membrane defining at least a portion of a breathing cavity and structured to provide a gas tight seal between the face of the wearer and the breathing cavity; and

a vent for washout of exhaled carbon dioxide gas from the breathing cavity, the vent comprising at least four orifices,

each orifice defining a passage from the breathing cavity to atmosphere wherein the passage has a cross-sectional profile that includes a generally frusto-conical portion and a generally cylindrical portion adjacent the generally frusto-conical portion,

wherein the generally frusto-conical portion has a length and with a larger-diameter end of the frusto-conical portion oriented generally towards the breathing cavity and a smaller-diameter end of the frusto-conical portion oriented generally towards atmosphere and the cylindrical portion, and the generally cylindrical portion has a cylinder diameter approximately the same size as the smaller-diameter end of the frusto-conical portion,

wherein the use of the vent in the mask assembly reduces the decibel noise levels 1 meter from the mask assembly.

101. A CPAP mask assembly for use with a system for supplying breathable gas pressurized above atmospheric pressure to a user for treatment of obstructive sleep apnea, the CPAP mask assembly comprising:

a mask having an inlet tube that is, in use, adapted to be in fluid communication with a gas supply conduit, said mask including a shell made from polycarbonate or another rigid plastic material, the shell being provided with a flexible sealing membrane to provide a gas tight seal with the user in use;

strap attachment points provided to the shell to connect the mask to a head strap; and

a vent provided to the shell, the vent including at least four gas washout orifices,

wherein each orifice is open in use and has a cross-sectional area at a first side that is larger than a cross-sectional area at a second side opposite the first side,

wherein the use of the vent in the mask reduces the decibel noise levels 1 meter from the mask.

102. A CPAP mask assembly as claimed in claim 101, wherein each orifice includes a transition portion between the first and second sides that has a cross-sectional size or area that varies or tapers along at least a portion of a length thereof.

103. A CPAP mask assembly as claimed in claim 102, wherein each said orifice has a substantially round cross section along its length.

104. A CPAP mask assembly as claimed in claim 103, wherein the pressurized gas is in the range of 4-18 cmH₂O.

105. A CPAP mask assembly as claimed in claim 104, wherein the orifices are regularly spaced along an arc.

106. A CPAP mask assembly as claimed in claim 104, wherein the orifices are arranged in two or more columns, each column including at least two said orifices.