Respiratory mask assembly

• US 8,479,736 B2
• Filed: 09/23/2011
• Issued: 07/09/2013
• Est. Priority Date: 04/23/2002
• Status: Expired due to Term

• Current Assignee: ResMed Pty Ltd. (ResMed Incorporated)
• Original Assignee: Resmed Limited (ResMed Incorporated)
• Inventors: Ging, Anthony M., Nasr, Saad
• Primary Examiner(s): DOUGLAS, STEVEN O
• Application Number:
  US13/200,395
• Publication Number:
  US 20120017912A1
• Time in Patent Office: 655 Days
• Field of Search: 128/205.25, 12820611-20613, 128/206.18, 128/206.21, 128/206.24, 128/206.27, 128/206.28, 128/207.11, 128/207.13, 128/207.18, 217/1, 218/1, 2/4, 225/5
• US Class Current: 128/206.11
• CPC Class Codes: A61M 16/0057 Pumps therefor
• CPC Class Codes: A61M 16/0066 Blowers or centrifugal pumps
• CPC Class Codes: A61M 16/06 Respiratory or anaesthetic masks
• CPC Class Codes: A61M 16/0605 Means for improving the adaptation of the mask to the patient
• CPC Class Codes: A61M 16/0616 with face sealing means comprising a flap or membrane projecting inwards, such that sealing increases with increasing inhalation gas pressure
• CPC Class Codes: A61M 16/0622 having an underlying cushion
• CPC Class Codes: A61M 16/0633 with forehead support
• CPC Class Codes: A61M 16/0666 Nasal cannulas or tubing devices for improving normal breathing through the nose A61F5/08; nose filters A62B23/06; outside holding devices A61M25/02
• CPC Class Codes: A61M 16/0683 Holding devices therefor
• CPC Class Codes: A61M 16/0694 Chin straps
• CPC Class Codes: A61M 16/0816 Joints or connectors
• CPC Class Codes: A61M 16/0825 with ball-sockets
• CPC Class Codes: A61M 16/0875 Connecting tubes
• CPC Class Codes: A61M 16/22 Carbon dioxide-absorbing devices ; Other means for removing carbon dioxidecartridges with absorbing substances for respiratory apparatus A62B19/00
• CPC Class Codes: A61M 2206/14 Static flow deviators in tubes disturbing laminar flow in tubes, e.g. archimedes screws
• CPC Class Codes: A61M 2210/0618 Nose
• CPC Class Codes: A62B 18/084 Means for fastening gas-masks to heads or helmets

Abstract

A respiratory mask assembly for delivering breathable gas to a patient includes a frame having a main body and a side frame member provided on each lateral side of the main body. Each side frame member includes an integrally formed first connector portion. A headgear assembly is removably attachable to the frame. The headgear assembly has a second connector portion adapted to be removably coupled with the first connector portion provided on the frame. The second connector portion is manually movable to a releasing position to detach the headgear assembly from the frame. The headgear assembly is rotationally adjustable with respect to the frame.

Claims

1. A nasal mask-securing assembly to secure a mask to a patient'"'"'s head, the nasal mask-securing assembly comprising:

a strap assembly including a pair of upper strap portions and a pair of rear strap portions each of which is made of a relatively soft and flexible material and each having a foam and fabric construction, and

a relatively rigid support structure extending across the cheek regions of the patient in use, constructed of an outer layer of plastic material provided to an inner patient-contacting layer,

wherein said outer layer of plastic material has a thickness in the range of 0.3 to 2.0 mm,

wherein the support structure is adapted to attach a mask frame portion of a nasal mask to the strap assembly,

wherein a top end of the support structure includes a connector element adapted to connect with the strap assembly, and

wherein said nasal mask-securing assembly not having a forehead support.

2. A nasal mask assembly for nasal CPAP therapy of a patient comprising:

a frame supporting nasal pillows; and

a nasal mask-securing assembly comprising;

a strap assembly including an upper strap portion and a rear strap portion each of which is made of a relatively soft and flexible material, and

a relatively rigid support structure supported by the frame and extending across the cheek regions of the patient in use, constructed of an outer layer of plastic material provided to an inner patient-contacting layer.

3. A nasal mask assembly according to claim 2, wherein said outer layer of plastic material has a thickness in the range of 0.3 to 2.0 mm.

4. A nasal mask assembly according to claim 2, wherein the support structure is adapted to attach a mask frame portion of a nasal mask to the strap assembly.

5. A nasal mask assembly according to claim 4, wherein a top end of the support structure includes a connector element adapted to connect with the strap assembly.

6. A nasal mask assembly according to claim 2, said nasal mask-securing assembly not having a forehead support.

7. A nasal mask assembly for nasal CPAP therapy of a patient comprising:

(i) a seal including nasal pillows, said seal having a face-contacting side and a non-face contacting side, the non-face contacting side being engagable in a manner that allows the seal to be repeatedly detachable from and re-attachable to other portions of the mask assembly;

(ii) a nasal pillows engagement structure including an aperture; and

(iii) a mask-securing assembly to secure the nasal pillows engagement structure and nasal pillows to the patient'"'"'s head, comprising;

a strap assembly including relatively flexible straps, and

a support structure made of a relatively rigid material compared to the straps and having a degree of flexibility in one direction such that variations in patient physiology can be accommodated in use, said support structure being attached to the straps and in use attaching the strap assembly and the nasal pillows engagement structure.

8. The nasal mask assembly according to claim 7, wherein the support structure is constructed from a plastic material which is relatively more rigid than the soft material of the straps and has a thickness in the range of 0.3 mm to 2.0 mm.

9. The nasal mask assembly according to claim 8, wherein the plastic material is chosen from the group consisting of nylon and polypropylene.

10. The nasal mask assembly according to claim 7, wherein in use the support structure is spaced from contact with the patient'"'"'s cheeks by an inner patient-contacting layer.

11. The nasal mask assembly according to claim 7, wherein the straps are made of laminated fabric and foam.

12. The nasal mask assembly according to claim 7, wherein the thickness of the support structure varies across its profile to modify flexibility characteristics.

13. The nasal mask assembly according to claim 7, wherein a top end of the support structure includes a connector element adapted to connect with the strap assembly.

14. The nasal mask assembly according to claim 7, further including an elbow coupled to the nasal seal engagement structure and adapted to connect to a gas delivery tube in order to supply pressurized gas to an entrance of the patient'"'"'s airway via the aperture of the nasal pillows engagement structure.

15. The nasal mask assembly according to claim 14, the elbow including one or more vent openings open to atmosphere for washout of patient exhalation gases.

16. A mask-securing assembly for securing a seal arrangement to a patient'"'"'s head, comprising:

a strap assembly including relatively flexible straps having a relatively soft construction, and

a support structure that is relatively rigid compared to the straps and having a degree of flexibility in one direction such that variations in patient physiology can be accommodated in use, said support structure being attached to the straps and in use attaching the strap assembly and the seal arrangement, said mask-securing assembly not having a forehead support.

17. The mask-securing assembly according to claim 16, wherein the support structure has a thickness in the range of about 0.3 mm to about 2.0 mm.

18. The mask-securing assembly according to claim 17, wherein said support structure comprises a construction having only a single material.

19. The mask-securing assembly according to claim 16, wherein in use the support structure is spaced from contact with the patient'"'"'s cheeks by an inner patient-contacting layer.

20. The mask-securing assembly according to claim 16, wherein the support structure is configured such that, when fitted to the patient, a front end of the support structure is attached to the seal arrangement below the patient'"'"'s eyes.

21. The mask-securing assembly according to claim 16, wherein the support structure is attached to a front portion of the straps.

22. The mask-securing assembly according to claim 16, the support structure further including a relatively soft inner patient-contacting surface resting against the cheek regions of the patient in use.

23. The mask-securing assembly according to claim 16, wherein the support structure is stiffer in another direction generally orthogonal to the one direction to resist vertical rotation of the seal arrangement due to the weight of the seal arrangement and/or of components attached to the seal arrangement.

24. The mask-securing assembly according to claim 16, wherein the thickness of the support structure varies across its profile to modify flexibility characteristics.

25. The mask-securing assembly according to claim 16, wherein a top end of the support structure includes a connector element adapted to connect with the strap assembly.

26. A nasal mask assembly for nasal CPAP therapy of a patient comprising:

(i) a frame including an aperture;

(ii) a silicone nasal pillows selectively and repeatedly attachable to and detachable from the frame, the seal having a face-contacting side and a non-face contacting side, the non-face contacting side being engagable with the frame;

(iii) a rotatable elbow provided to the frame and including one or more vent openings open to atmosphere for gas washout of exhaled carbon dioxide, the elbow being adapted to connect to a gas delivery tube in order to supply pressurized air to the entrance of the patient'"'"'s airway;

(iv) a headgear assembly including relatively flexible headstraps; and

(v) a stiffening support structure extending from the frame to assist in the stabilization of the nasal seal, the stiffening support structure being formed of a relatively more rigid material in comparison to the relatively flexible headstraps, said stiffening support structure having a degree of flexibility in one direction such that variations in patient physiology can be accommodated, said stiffening support structure being stiffer in another direction generally orthogonal to the one direction to resist vertical rotation of the frame due to the weight of the mask frame and/or components supported by the frame, said stiffening support structure arranged to be positioned adjacent the cheek regions in use, said stiffening support structure having on an inside surface thereof, a layer of material arranged between the patient'"'"'s cheek and the stiffening support structure in use, and said layer having the same general shape as the stiffening support structure.

27. The nasal mask assembly of claim 26, wherein the layer is attached to the stiffening support structure by stitching.

28. The nasal mask assembly of claim 26, wherein the stiffening support structure is constructed from a plastics material having a thickness in the range of 0.3 mm to 2.0 mm.

29. The nasal mask assembly of claim 28, wherein the stiffening support structure is constructed from nylon or polypropylene.

30. The nasal mask assembly of claim 26, wherein a top end of the stiffening support structure includes a connector element adapted to connect with a free end of one of the headstraps.

31. The nasal mask assembly of claim 30, wherein the connector element includes a crossbar.

32. The nasal mask assembly of claim 31, wherein in use the free end of the headstrap is adapted to be threaded around the crossbar.

33. The nasal mask assembly of claim 32, wherein the free end of the headstrap is adapted for lengthwise adjustment by threading through the connector element of the stiffening support structure.

34. The nasal mask assembly of claim 26, wherein the headgear assembly includes only two connection points to support the frame.

35. The nasal mask assembly of claim 34, without a forehead support and without obstructing the patient'"'"'s field of view.

36. A nasal mask assembly for nasal CPAP therapy of a patient comprising:

(i) a frame including an aperture;

(ii) a silicone nasal pillows selectively and repeatedly attachable to and detachable from the frame in such a manner that, upon engagement, the seal forms a secure seal with the frame and is retained in releasable engagement with the frame without an additional retaining device, the seal having a face-contacting side and a non-face contacting side, the non-face contacting side being engagable with the frame;

(iii) a rotatable elbow provided to the frame and including one or more vent openings open to atmosphere for gas washout of exhaled carbon dioxide, the elbow being adapted to connect to a gas delivery tube in order to supply pressurized air to the entrance of the patient'"'"'s airway;

(iv) a headgear assembly including relatively flexible headstraps; and

(v) a stiffening support structure to assist in the stabilization of the nasal seal, the stiffening support structure being formed of a relatively more rigid material in comparison to the relatively flexible headstraps, said stiffening support structure arranged to be positioned adjacent the cheek regions in use, said stiffening support structure having on an inside surface arranged between the patient'"'"'s cheek and the stiffening support structure in use, wherein an end of the stiffening support structure, remote from the frame, includes a connector element adapted to be coupled with a free end of one of the headstraps, wherein the connector element is formed with the stiffening support structure and includes a crossbar, and wherein the free end of the one of the headstraps includes a strap loop wrapped around the crossbar.

37. The nasal mask assembly of claim 36, wherein the stiffening support structure is constructed from a plastics material having a thickness in the range of 0.3 mm to 2.0 mm.

38. The nasal mask assembly of claim 37, wherein the stiffening support structure is constructed from nylon or polypropylene.

39. The nasal mask assembly of claim 36, wherein the free end of the headstrap is adapted for lengthwise adjustment by threading through the crossbar of the stiffening support structure.

40. The nasal mask assembly of claim 36, wherein the headgear assembly includes only two connection points to support the frame.

41. The nasal mask assembly of claim 40, without a forehead support and without obstructing the patient'"'"'s field of view.

42. A mask assembly for CPAP therapy of a patient comprising:

(i) at least one seal arrangement;

(ii) a rotatable elbow including a plurality of vent openings open to atmosphere for gas washout of exhaled carbon dioxide, the elbow being adapted to connect to a gas delivery tube in order to supply pressurized air to at least one airway of the patient via the seal arrangement;

(iii) a headgear assembly including relatively flexible headstraps; and

(iv) a support structure to assist in the stabilization of the seal arrangement, the support structure being more rigid in comparison to the relatively flexible headstraps, said support structure having a degree of flexibility in a first direction such that variations in patient physiology can be accommodated, said support structure being stiffer in a second direction generally orthogonal to the first direction to resist vertical rotation of the seal arrangement due to the weight of the seal arrangement, said support structure arranged to be positioned adjacent the cheek regions in use, wherein the mask assembly does not include a chin strap and does not include a forehead support.

43. The nasal assembly of claim 42, further comprising a layer of relatively soft and flexible material provided to the support structure.

44. The mask assembly of claim 42, wherein the support structure has a thickness in the range of 0.3 mm to 2.0 mm.

45. The mask assembly of claim 42, wherein the support structure comprises only a single material construction.

46. The mask assembly of claim 42, wherein the support structure includes first and second upper ends, each said upper end of the support structure including a connector element, formed in one piece with the support structure, adapted to connect with a respective free end of one of the headstraps.

47. The mask assembly of claim 46, wherein each connector element includes a slot through which the respective free end of the headstrap is threaded in use.

48. The mask assembly of claim 47, wherein each connector element includes first and second cross bars between which is formed the slot.

49. The mask assembly of claim 47, wherein the free end of the headstrap is adapted for lengthwise adjustment via a hook and loop fastener.

50. The mask assembly of claim 42, wherein the support structure includes only two connection points to support the seal arrangement.

51. The mask assembly of claim 42, further comprising the gas delivery tube, wherein the gas delivery tube is directly connected to the elbow without a swivel connector.

52. The mask assembly of claim 42, wherein the elbow is connected to the mask assembly without the need for a C-clip, such that the elbow is detachable from the mask assembly without the need to access the C-clip.

53. The mask assembly of claim 42, wherein the support structure has a shape selected to extend along a curved arc below the patient'"'"'s eyes, to avoid interferences with the patient'"'"'s field of view.

54. A mask assembly for treatment of a patient having a sleeping disorder, said assembly including:

(i) a frame;

(ii) a nasal pillows supported by the frame;

(iii) a rotatable elbow provided to the frame and including a plurality of vent openings open to atmosphere for gas washout of exhaled carbon dioxide, the elbow being adapted to connect to a gas delivery tube in order to supply air pressurized in the range of 4-20 cm H2O to the entrance of the patient'"'"'s airway;

(iv) a headgear assembly including relatively flexible headstraps; and

(v) a stiffening support structure to assist in the stabilization of the nasal pillows, the stiffening support structure being formed of a relatively more rigid material in comparison to the relatively flexible headstraps, said stiffening support structure arranged to be positioned adjacent the cheek regions in use,

wherein an end of the stiffening support structure, remote from the frame, includes a connector element adapted to be coupled with a free end of one of the headstraps, wherein the connector element is formed with the stiffening support structure and includes a slot, and wherein the free end of at least one of the headstraps is threaded through the slot.

55. The mask assembly of claim 54, further comprising a layer of relatively soft and flexible material provided to the stiffening support structure.

56. The mask assembly of claim 54, wherein the stiffening support structure is constructed from a plastics material having a thickness in the range of 0.3 mm to 2.0 mm.

57. The mask assembly of claim 56, wherein the stiffening support structure is constructed from nylon or polypropylene.

58. The mask assembly of claim 54, wherein the free end of the headstrap is adapted for lengthwise adjustment by threading through the slot of the stiffening support structure.

59. The mask assembly of claim 54, wherein the headgear assembly includes only two connection points to support the frame.

60. The mask assembly of claim 59, without a forehead support and without obstructing the patient'"'"'s field of view.

61. The mask assembly of claim 54, wherein the elbow is connected to the frame without the need for a C-clip, such that the elbow is detachable from the frame without the need to access the C-clip.

62. The mask assembly of claim 61, wherein the stiffening support structure has a shape selected to extend along a curved arc below the patient'"'"'s eyes, to avoid interferences with the patient'"'"'s field of view.

63. A respiratory mask assembly for delivering gas to a person, comprising:

a rigid shell;

a resilient silicone cushion permanently attached to the rigid shell so as to form a co-molded unit defining a breathing chamber, the resilient silicone cushion being adapted to seal against a face of the person; and

a swivel elbow snap-fitted to the rigid shell in a releasable manner, thereby positioning the elbow in fluid communication with the breathing chamber, the elbow including a first end and a second end, with an approximately 90 degree bend between the first and the second end, the first end being received within the aperture of the rigid shell, the second end including a swivel connector adapted to connect with a gas delivery tube.

64. A respiratory mask assembly according to claim 63, wherein the elbow includes at least one portion that flexes in a generally radial direction relative to an axis of the aperture to allow releasable engagement between the elbow and the shell, during insertion of the first end of the elbow into the aperture.

65. A respiratory mask assembly according to claim 64, wherein a face contacting side of the cushion is configured to seal around the nose and mouth of the person.

66. A respiratory mask assembly according to claim 65, wherein snap-action engagement between the elbow and the shell results in an audible noise.

67. A respiratory mask assembly according to claim 66, wherein an outer surface of the elbow engages an inner circumferential surface of the aperture of the shell.

68. A respiratory mask assembly according to claim 67, wherein the outer surface of the elbow and the inner circumferential surface of the aperture are in engagement over a distance of between about 1 mm to 10 mm.

69. A respiratory mask assembly according to claim 68, further comprising headgear configured to stabilize the cushion against the face of the person, the headgear comprising a plurality of strap ends and a plurality of connectors provided to the strap ends configured to connect the headgear to the respiratory mask assembly.

70. A respiratory mask assembly according to claim 69, wherein the headgear includes a left strap and a right strap, which are minor images of each other and are formed from one piece comprising laminated fabric and foam, and the left and right straps are configured to extend below the person'"'"'s ears.

71. A respiratory mask assembly according to claim 70, further comprising a clip portion on each lateral side of the assembly configured to engage a connector of a headgear assembly.

72. A respiratory mask assembly according to claim 70, wherein the elbow assembly includes a plurality of vent openings to vent exhalation gases from the breathing chamber mask assembly.

73. A respiratory mask assembly according to claim 72, wherein a diameter of the aperture is configured to be larger than a diameter of the gas delivery tube connectable to the swivel elbow.

74. A respiratory mask assembly according to claim 73, wherein the aperture has an area of at least 180 mm².

75. A respiratory mask assembly according to claim 74, wherein the area is in the range of 200-600 mm².

76. A respiratory mask assembly according to claim 74, wherein the area is the range of 500-600 mm².

77. A respiratory mask assembly according to claim 74, wherein the aperture has a diameter in the range of 20-30 mm.

78. A respiratory mask assembly for delivering gas to a person, comprising:

a rigid shell;

a resilient silicone cushion permanently attached to the rigid shell, said resilient silicone cushion and said rigid shell comprising a co-molded unit including a breathing chamber, the resilient silicone cushion being adapted to seal against a face of the person; and

a swivel elbow snap-fitted to the rigid shell in a releasable manner, thereby positioning the elbow in fluid communication with the breathing chamber, the elbow including a first end and a second end, opposite the first end, the first end being rotatable relative to the aperture of the rigid shell, the second end including a swivel connector adapted to connect with a gas delivery tube, wherein;

the elbow includes at least one portion that flexes to allow engagement between the elbow and the shell, during insertion of the first end of the elbow into the aperture,

snap-fitting engagement between the elbow and the shell results in an audible noise thereby providing a signal to the person that the elbow has been securely attached to the shell, and

an outer circumferential surface of the elbow engages an inner circumferential surface of the aperture of the shell.

79. A respiratory mask assembly according to claim 78, wherein axes of first and second ends of the swivel elbow are arranged at an approximate 90 degree angle, and wherein the outer circumferential surface of the elbow and the inner circumferential surface of the aperture are in engagement over a distance of between about 1 mm to 10 mm.

80. A respiratory mask assembly according to claim 78, further comprising headgear configured to stabilize the cushion against the face of the person, the headgear comprising a plurality of strap ends and a plurality of connectors provided to the strap ends.

81. A respiratory mask assembly according to claim 80, wherein the headgear includes a left strap and a right strap, which are minor images of each other and are formed from one piece comprising laminated fabric and foam.

82. A respiratory mask assembly according to claim 81, further comprising a clip portion on each side configured to engage a connector of a headgear.

83. A respiratory mask assembly according to claim 78, wherein the elbow assembly includes a plurality of vent openings to vent exhalation gases from an interior of the respiratory mask assembly.

84. A respiratory mask assembly according to claim 78, wherein a diameter of the aperture is configured to be larger than a diameter of the gas delivery tube connectable to the swivel elbow.

85. A respiratory mask assembly according to claim 78, wherein the aperture has an area of at least 180 mm².

86. A respiratory mask assembly according to claim 85, wherein the area is in the range of 200-600 mm².

87. A respiratory mask assembly according to claim 85, wherein the area is the range of 500-600 mm².

88. A respiratory mask assembly according to claim 85, wherein the aperture has a diameter in the range of 20-30 mm.

89. A method for repeatably and detachably connecting a swivel elbow from a respiratory mask assembly for delivering gas to a person, said respiratory mask assembly having a rigid shell with an aperture, a resilient silicone cushion, attached to the rigid shell so as to form a co-molded unit, that together with the rigid shell defines a breathing chamber;

and a swivel elbow, the method comprising;

inserting an end portion of the swivel elbow into the aperture of the shell; and

connecting the swivel elbow and the shell via a snap-action connection without accessing an interior portion of the breathing chamber, thereby securely positioning the elbow in fluid communication with the breathing chamber.

90. The method according to claim 89, wherein the elbow includes at least one portion that flexes in a generally radial direction relative to an axis of the aperture when connecting and disconnecting the elbow from the shell.

91. The method according to claim 90, wherein the connecting results in an audible noise.

92. The method according to claim 91, wherein an outer circumferential surface of the elbow engages an inner circumferential surface of the aperture of the shell.

93. A respiratory mask assembly for delivering gas to a person, comprising:

a breathing chamber defined by a substantially rigid frame portion comprising a ring defining an aperture on one side for introduction of breathable gas into the breathing chamber and a resilient silicone cushion on a second side, opposite to the first side, which is adapted to seal against the face of the person;

an elbow swivelably coupled to the breathing chamber positioning the elbow in fluid communication with the breathing chamber, the elbow comprising an end portion which fits within the aperture of the frame portion and protrudes towards the breathing chamber, and the elbow comprises at least one protrusion configured to engage the ring upon insertion of the end portion of the elbow into the aperture to releasably engage the elbow, and the elbow having a further end portion, opposite the end portion, that is equipped with a swivel connector to connect with a gas delivery tube; and

a headgear assembly configured to stabilize the respiratory mask assembly against the face of a person, the headgear comprising a plurality of strap ends and a plurality of connectors provided to the strap ends configured to connect the headgear to the respiratory mask assembly.

94. A mask assembly according to claim 93, wherein the engagement of the at least one protrusion on the elbow and ring occurs during a snap-action connection of the elbow.

95. A mask assembly according to claim 93, wherein the elbow is quickly releasable from the ring.

96. A mask assembly according to claim 95, wherein engagement of the elbow assembly and the frame results in an audible noise.

97. A mask assembly according to claim 93, wherein the headgear assembly includes a left strap and a right strap, which are minor images of each other and are formed from one piece comprising laminated fabric and foam, and the left and right straps are configured to extend below the person'"'"'s ears.

98. A mask assembly according to claim 94, wherein an outer surface of the end portion of the elbow sealingly engages an inner surface of the ring in the rigid frame portion.

99. A mask assembly according to claim 98, wherein the outer surface of the end portion of the elbow and the inner surface of the ring in the rigid frame portion are in sealing engagement over a distance of between about 1 mm to 10 mm.

100. A mask assembly according to claim 98, wherein the outer surface of the end portion of the elbow and the inner surface of the ring in the rigid frame portion are in sealing engagement over a distance of approximately 6 mm.

101. A mask assembly according to claim 93, wherein the elbow assembly includes a plurality of vent openings to vent exhalation gases from an interior of the mask assembly.

102. A mask assembly according to claim 101, wherein the mask assembly comprises an integrally formed clip portion on each side configured to engage a clip of a headgear assembly.

103. A mask assembly according to claim 93, wherein a diameter of the aperture is dimensioned to be larger than a diameter of the gas delivery tube connectable to the swivel elbow.

104. A mask assembly according to claim 103, wherein the aperture has an area of at least 180 mm².

105. A mask assembly according to claim 103, wherein the aperture has an area in the range of 200-600 mm².

106. A mask assembly according to claim 103, wherein the aperture has an area in the range of 500-600 mm².

107. A mask assembly according to claim 103, wherein the aperture has a diameter in the range of 20-30 mm.

108. A mask assembly according to claim 103, wherein the aperture has a diameter of 27 mm.

109. A mask assembly according to claim 93, wherein the resilient silicone cushion is generally triangular in a face side view.

110. A mask assembly according to claim 109, wherein the resilient silicone cushion has a face contacting side and a non-face contacting side and the face contacting side comprises a sealing membrane configured to seal against the person'"'"'s face and a support structure that supports the sealing membrane.

111. A mask assembly according to claim 110, wherein the respiratory mask assembly comprises a full-face mask assembly, and wherein the face contacting side of the cushion is configured to seal around the nose and mouth of the person.

112. A respiratory mask assembly for delivering breathable gas to a patient, comprising:

a frame having a front surface and a rear surface adapted to face the patient, the frame including a main body providing an aperture therethrough for the introduction of breathable gas into a breathing cavity;

an elbow assembly swivelably coupled through the front surface of the frame, the elbow assembly including a swivel elbow inserted into the aperture, wherein the swivel elbow includes an end portion that allows quick release attachment and detachment, without accessing the breathing cavity while allowing the elbow to swivel; and

a headgear assembly, configured to stabilize the respiratory mask assembly against the face of a person, comprising a plurality of strap ends and a plurality of connectors provided to the strap ends configured to connect the strap ends to the respiratory mask assembly.

113. A respiratory mask assembly according to claim 112, wherein the main body is attachable to and releasable from the swivel elbow with a snap-action connection.

114. A respiratory mask assembly according to claim 113, wherein attachment of the main body to the swivel elbow results in an audible noise.

115. A respiratory mask assembly according to claim 114, wherein the elbow assembly includes a plurality of vent holes to vent exhalation gases from an interior of the respiratory mask assembly.

116. A respiratory mask assembly according to claim 115, further comprising a full-face silicone cushion extending from the main body.

117. A frame for use with a respiratory mask for delivering CPAP therapy to a patient at a pressure of 4 to 20 cm H2O to a patient, comprising:

i. a front surface;

ii. a rear surface adapted to face the patient;

iii. a circular flange defining an aperture through the front surface for the introduction of breathable gas into a breathing cavity at least partly defined by a cushion extending from the rear surface; and

iv. an elbow assembly swivelably coupled to the front surface, the elbow assembly including a swivel elbow, wherein the swivel elbow includes a mating portion that is releasably engagable with the flange and rotatable relative to the flange by inserting an end portion of the elbow through the aperture and pressing the front surface and the elbow towards one another.

118. A frame according to claim 117, wherein the frame comprises a full-face frame.

119. A frame according to claim 118, wherein the end portion of the swivel elbow extends at least partially into the breathing cavity.

120. A frame according to claim 119, wherein the mating portion of the swivel elbow comprises at least one protrusion configured to engage the flange upon insertion of the end portion of the elbow into the aperture to releasably engage the elbow to the front surface, and the mating portion comprises a collar.

121. A frame according to claim 120, wherein the engagement of the swivel elbow and the flange is a snap-action connection.

122. A frame according to claim 121, wherein the mating portion includes at least one protrusion having an incline such that upon engagement with the flange a resilient portion of the mating portion of the elbow flexes until the mating portion reaches an operative position in which the resilient portion returns to an unflexed state.

123. A frame according to claim 117, wherein the swivel elbow includes a bend.