Interchangeable mask assembly

• US 9,381,316 B2
• Filed: 01/30/2009
• Issued: 07/05/2016
• Est. Priority Date: 10/25/2005
• Status: Active Grant

• Current Assignee: ResMed Pty Ltd. (ResMed Incorporated)
• Original Assignee: Resmed Limited (ResMed Incorporated)
• Inventors: Ng, Eva, Henry, Robert Edward, Kwok, Philip Rodney, Selvarajan, Karthikeyan
• Primary Examiner(s): Yu, Justine
• Assistant Examiner(s): Stuart, Colin W
• Application Number:
  US12/320,663
• Publication Number:
  US 20090139527A1
• Time in Patent Office: 2,713 Days
• Field of Search: 128/206.26, 128/206.24, 128/201.22, 128/201.23, 128/202.27, 128/204.18, 128/205.25, 128/206.21, 128/206.28
• US Class Current: 1/1
• 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 16/0611 with a gusset portion
• 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 16/0638 in the form of a pivot
• CPC Class Codes: A61M 16/0644 having the means for adjusting its position
• CPC Class Codes: A61M 16/065 in the form of a pivot
• 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 16/0672 Nasal cannula assemblies for oxygen therapy
• 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: Y10T 29/49826 Assembling or joining

Abstract

A mask assembly for a user includes a frame having a main body and lateral connector portions and a cushion component provided to the frame and defining a breathing cavity configured to accommodate at least a portion of the user'"'"'s nose in use. The cushion component includes a face contacting seal portion adapted to sealingly engage with at least a portion of the user'"'"'s nose in use. The cushion component has an aperture to communicate pressurized gas from the breathing chamber to the user'"'"'s airways in use, and a main wall portion, opposite from the aperture, extending upwardly away from the frame. The main wall portion includes a stiffening portion.

Claims

1. An interchangeable mask system for delivering breathable gas to a patient, comprising:

at least first and second cushion components that are different structurally from one another in at least one aspect, each of the cushion components including a front portion and a cushion structured to engage a patient'"'"'s face, the front portion and the cushion of each of the at least first and second cushion components defining a mask interior breathing chamber, the front portion of each of the at least first and second cushion components having an opening by which the breathable gas is delivered to the mask interior breathing chamber thereof; and

a common frame configured to interchangeably interface with each of the at least first and second cushion components,

wherein the common frame is external to the mask interior breathing chamber defined by each of the at least first and second cushion components,

wherein the common frame does not define part of the mask interior breathing chamber defined by each of the at least first and second cushion components,

wherein the front portion, the cushion, and the mask interior breathing chamber thereof of each of the at least first and second cushion components form a unit that as a whole is interchangeable with the common frame,

wherein the common frame includes a first opening having a closed shape and a second opening having a closed shape that is spaced apart and superior to the first opening, and the front portion of each of the at least first and second cushion components includes a protrusion that is spaced apart and superior to the opening of each of the at least first and second cushion components, and the protrusion of each of the at least first and second cushion components is received within and exposed through the second opening of the common frame towards a front side of the common frame when each of the at least first and second cushion components is provided to the common frame to at least assist in preventing rotation between each of the at least first and second cushion components and the common frame, and

wherein each of the at least first and second cushion components is structured to engage with the common frame in a fixed, non-adjustable position to prevent any relative or adjustable movement between each of the at least first and second cushion components and the common frame.

2. An interchangeable mask system according to claim 1, wherein the common frame includes a forehead support.

3. An interchangeable mask system according to claim 2, wherein the forehead support is adjustably mounted to the common frame.

4. An interchangeable mask system according to claim 2, wherein the forehead support includes a bridge.

5. An interchangeable mask system according to claim 4, wherein the bridge includes a pair of connectors each structured to connect to a headgear strap of headgear.

6. An interchangeable mask system according to claim 4, wherein the bridge is structured to support forehead padding.

7. An interchangeable mask system according to claim 2, wherein the common frame includes a tapered neck.

8. An interchangeable mask system according to claim 7, wherein the common frame includes a nasal bridge region adapted to be positioned adjacent a nasal bridge region of the patient'"'"'s face, and wherein the tapered neck is between the nasal bridge region of the common frame and the forehead support.

9. An interchangeable mask system according to claim 8, wherein the forehead support includes a bridge provided to the tapered neck, the bridge structured to support forehead padding.

10. An interchangeable mask system according to claim 9, wherein the tapered neck includes a portion that tapers from a larger width adjacent the common frame to a smaller width adjacent the bridge.

11. An interchangeable mask system according to claim 1, further comprising a pair of lateral arms each extending from the common frame and structured to connect to a headgear strap of headgear.

12. An interchangeable mask system according to claim 1, further comprising an elbow provided to the common frame and structured to deliver a supply of breathable gas to each of the cushion components.

13. An interchangeable mask system according to claim 12, wherein the elbow includes a gas washout vent.

14. An interchangeable mask system according to claim 12, wherein the common frame includes the front side and a rear side, the elbow being provided to the front side and each of the cushion components being provided to the rear side.

15. An interchangeable mask system according to claim 12, wherein the elbow and each of the at least first and second cushion components communicate with one another through the first opening of the common frame.

16. An interchangeable mask system according to claim 1, wherein the front portion and the cushion of each of the cushion components are attached to one another.

17. An interchangeable mask system according to claim 1, wherein the front portion and the cushion of each of the cushion components are integrated with one another.

18. An interchangeable mask system according to claim 1, wherein at least one of the cushion components includes a gusset portion.

19. An interchangeable mask system according to claim 1, wherein the opening of each of the at least first and second cushion components is bounded by an annular flange, the opening of each of the at least first and second cushion components structured to align with the first opening of the common frame.

20. An interchangeable mask system according to claim 1, wherein each of the cushion components is in the form of a full-face cushion.

21. A CPAP system used for treatment of sleep disordered breathing, comprising:

the interchangeable mask system according to claim 1;

a blower to supply breathable gas at positive pressure; and

a conduit to pass the breathable gas from the blower to the interchangeable mask system.

22. An interchangeable mask system according to claim 1, wherein at least a portion of the front portion of each of the at least first and second cushion components forms an exterior surface exposed at a front side of the interchangeable mask system when each of the cushion components is provided to the common frame.

23. An interchangeable mask system according to claim 1, further comprising a pair of press-fit connectors structured to connect headgear straps of headgear to the common frame.

24. An interchangeable mask system according to claim 1, wherein the front portion of each of the at least first and second cushion components is oriented towards a front side of the interchangeable mask system and defines at least a portion of the mask interior breathing chamber of each of the at least first and second cushion components.

25. An interchangeable mask system according to claim 1, wherein the front portion of each of the at least first and second cushion components includes an engagement interface configured to interface with the common frame, and the engagement interfaces of the at least first and second cushion components are substantially similar to one another and configured to interface with the common frame in substantially the same manner.

26. An interchangeable mask system according to claim 1, wherein the front portion of each of the at least first and second cushion components is relatively harder than the cushion thereof and the opening thereof is bounded by an annular flange that protrudes forwardly therefrom, the annular flange of each of the at least first and second cushion components structured to interface with the first opening of the common frame.

27. An interchangeable mask system according to claim 1, wherein the front portion of each of the at least first and second cushion components is relatively harder than the cushion thereof.

28. An interchangeable mask system according to claim 1, wherein the front portion of each of the at least first and second cushion components comprises polycarbonate and the cushion thereof comprises silicone.

29. An interchangeable mask system according to claim 1, wherein the cushion of each of the at least first and second cushion components includes a bellows type arrangement in at least a nasal bridge region of the cushion of each of the at least first and second cushion components.

30. An interchangeable mask system according to claim 1, wherein the front portion of each of the at least first and second cushion components includes one or more gas washout vents.

31. An interchangeable mask system according to claim 1, wherein each of the at least first and second cushion components consists essentially of a one piece front wall and a one piece cushion that define the mask interior breathing chamber thereof.

32. An interchangeable mask system according to claim 1, further comprising headgear to support the interchangeable mask system on the patient'"'"'s head, the headgear including a buckle adapted to be positioned on a top of the patient'"'"'s head.

33. An interchangeable mask system for delivering breathable gas to a patient, comprising:

a common frame structured and arranged to interface with at least first and second cushion components that are different structurally from one another in at least one aspect, each of the at least first and second cushion components including an integrated unit having a front portion and a cushion structured to engage a patient'"'"'s face, the front portion and the cushion of each of the at least first and second cushion components defining a mask interior breathing chamber, wherein the front portion of each of the at least first and second cushion components is relatively harder than the cushion thereof, and the front portion of each of the at least first and second cushion components having an opening by which the breathable gas is delivered to the mask interior breathing chamber thereof,

wherein the common frame is external to the mask interior breathing chamber defined by each of the at least first and second cushion components,

wherein the common frame does not define part of the mask interior breathing chamber defined by each of the at least first and second cushion components,

wherein the front portion, the cushion, and the mask interior breathing chamber thereof of each of the at least first and second cushion components form a unit that as a whole is interchangeable with the common frame, and

wherein the front portion of each of the at least first and second cushion components is structured to engage with the common frame in a fixed, non-adjustable position to prevent any relative or adjustable movement between each of the at least first and second cushion components and the common frame,

wherein the common frame includes a first opening having a closed shape and a second opening having a closed shape that is spaced apart and superior to the first opening, and the front portion of each of the at least first and second cushion components includes a protrusion that is spaced apart and superior to the opening of each of the at least first and second cushion components, and

wherein each of the at least first and second cushion components is configured to be engaged with the common frame into the fixed, non-adjustable position by engaging the protrusion of each of the at least first and second cushion components with the second opening of the common frame substantially along an anterior-posterior axis.

34. An interchangeable mask system according to claim 33, wherein the front portion of each of the at least first and second cushion components includes an engagement interface configured to interface with the common frame, and the engagement interfaces of the at least first and second cushion components are substantially similar to one another and configured to interface with the common frame in substantially the same manner.

35. An interchangeable mask system according to claim 33, wherein the protrusion of each of the at least first and second cushion components is received in and exposed through the second opening of the common frame towards a front side of the common frame when each of the at least first and second cushion components is provided to the common frame to at least assist in preventing rotation between each of the at least first and second cushion components and the common frame, and wherein the front portion of each of the at least first and second cushion components includes a base wall from which the protrusion extends, and at least a portion of the base wall of each of the at least first and second cushion components is proximate an interior surface adjacent the second opening of the common frame when each of the at least first and second cushion components is provided to the common frame.

36. An interchangeable mask system according to claim 33, wherein the front portion of each of the at least first and second cushion components comprises polycarbonate and the cushion thereof comprises silicone.

37. A CPAP system used for treatment of sleep disordered breathing, comprising:

the interchangeable mask system according to claim 33;

a blower to supply breathable gas at positive pressure; and

a conduit to pass the breathable gas from the blower to the interchangeable mask system.

38. A method for configuring a mask system, comprising:

providing at least first and second cushion components that are different structurally from one another in at least one aspect, each of the at least first and second cushion components including an integrated unit having a front portion and a cushion structured to engage a patient'"'"'s face, the front portion and the cushion of each of the at least first and second cushion components defining a mask interior breathing chamber, wherein the front portion of each of the at least first and second cushion components is relatively harder than the cushion thereof, and the front portion of each of the at least first and second cushion components having an opening by which breathable gas is delivered to the mask interior breathing chamber thereof and a protrusion that is spaced apart and superior to the opening;

providing a common frame structured and arranged to interface with each of the at least first and second cushion components such that the common frame is external to the mask interior breathing chamber defined by each of the at least first and second cushion components and the common frame does not define part of the mask interior breathing chamber defined by each of the at least first and second cushion components, wherein the common frame includes a first opening having a closed shape and a second opening having a closed shape that is spaced apart and superior to the first opening; and

selectively engaging the protrusion of one of the at least first and second cushion components with the second opening of the common frame substantially along an anterior-posterior axis into a fixed, non-adjustable position to prevent any relative or adjustable movement between each of the at least first and second cushion components and the common frame, the front portion, the cushion, and the mask interior breathing chamber thereof of each of the at least first and second cushion components forming a unit that as a whole is interchangeable with the common frame.

39. A method according to claim 38, wherein the front portion of each of the at least first and second cushion components includes an engagement interface configured to interface with the common frame, and the engagement interfaces of the at least first and second cushion components are substantially similar to one another and configured to interface with the common frame in substantially the same manner.

40. A method according to claim 38, wherein the front portion of each of the at least first and second cushion components comprises polycarbonate and the cushion thereof comprises silicone.

41. An interchangeable mask system for delivering breathable gas to a patient, comprising:

at least first and second cushion components that are different structurally from one another in at least one aspect, each of the at least first and second cushion components including a front portion and a cushion structured to engage a patient'"'"'s face, the front portion of each of the at least first and second cushion components being relatively harder than the cushion thereof, and the front portion and the cushion of each of the at least first and second cushion components defining a mask interior breathing chamber;

a common frame configured to interchangeably interface with the front portion of each of the at least first and second cushion components; and

at least a first elbow structured to deliver a supply of breathable gas to each of the cushion components,

wherein each of the cushion components is in the form of a full-face cushion,

wherein the common frame includes a first opening having a closed shape through which the at least first elbow and each of the at least first and second cushion components communicate with one another, and the common frame includes a second opening having a closed shape that is spaced apart and superior to the first opening,

wherein the front portion, the cushion, and the mask interior breathing chamber thereof of each of the at least first and second cushion components form a unit that as a whole is interchangeable with the common frame,

wherein the front portion of each of the at least first and second cushion components includes a front wall that includes an opening bounded by an annular flange that protrudes forwardly from the front wall, the annular flange of each of the at least first and second cushion components structured to interface with the first opening of the common frame,

wherein the front portion of each of the at least first and second cushion components includes a protrusion that is spaced apart and superior to the opening and the annular flange thereof of each of the at least first and second cushion components, and the protrusion of each of the at least first and second cushion components is exposed through the second opening of the common frame towards a front side of the common frame when each of the at least first and second cushion components is provided to the common frame, and

wherein each of the at least first and second cushion components is structured to engage with the common frame in a fixed, non-adjustable position to prevent any relative or adjustable movement between each of the at least first and second cushion components and the common frame.

42. An interchangeable mask system according to claim 41, wherein the opening of each of the at least first and second cushion components is structured to align with the first opening provided to the common frame.

43. An interchangeable mask system according to claim 41, wherein the at least first elbow and each of the at least first and second cushion components attach with one another.

44. An interchangeable mask system according to claim 41, wherein the front portion of each of the at least first and second cushion components includes an engagement interface configured to interface with the common frame, and the engagement interfaces of the at least first and second cushion components are substantially similar to one another and configured to interface with the common frame in substantially the same manner.

45. An interchangeable mask system according to claim 41, wherein the front portion of each of the at least first and second cushion components comprises polycarbonate and the cushion thereof comprises silicone.

46. An interchangeable mask system for delivering breathable gas to a patient, comprising:

at least first and second cushion components that are different structurally from one another in at least one aspect, each of the at least first and second cushion components including a front portion and a cushion structured to engage a patient'"'"'s face, the front portion and the cushion of each of the at least first and second cushion components defining a mask interior breathing chamber, and the front portion of each of the at least first and second cushion components having an opening by which the breathable gas is delivered to the mask interior breathing chamber thereof and a protrusion that is spaced apart and superior to the opening; and

a common frame configured to interchangeably interface with the front portion of each of the at least first and second cushion components,

wherein the common frame is external to the mask interior breathing chamber defined by each of the at least first and second cushion components,

wherein the common frame includes a first opening having a closed shape and a second opening having a closed shape that is spaced apart and superior to the first opening,

wherein the protrusion of each of the at least first and second cushion components is structured to engage with the common frame adjacent the second opening substantially along an anterior-posterior axis and prevent rotation between the common frame and the front portion of each of the at least first and second cushion components,

wherein the front portion of each of the at least first and second cushion components is relatively harder than the cushion thereof,

wherein the front portion, the cushion, and the mask interior breathing chamber thereof of each of the at least first and second cushion components form a unit that as a whole is interchangeable with the common frame, and

wherein each of the at least first and second cushion components is structured to engage with the common frame in a fixed, non-adjustable position to prevent any relative or adjustable movement between each of the at least first and second cushion components and the common frame.

47. An interchangeable mask system according to claim 46, further comprising a forehead support assembly and a neck to connect the common frame to the forehead support assembly, the neck comprising at least one wall comprising a first edge and a second edge,

wherein lower ends of the first edge and the second edge converge towards one another in an upward direction.

48. An interchangeable mask system according to claim 47, wherein at least a portion of the neck is integrally molded with the common frame.

49. An interchangeable mask system according to claim 47, wherein a width of the neck as seen in front view is substantially larger than a thickness of the at least one wall.

50. An interchangeable mask system according to claim 47, wherein the neck blends with and has a continuous form with the common frame.

51. An interchangeable mask system according to claim 47, wherein the first edge and the second edge of the at least one wall join to an edge of the common frame in a smooth, congruous manner without sharp edges.

52. An interchangeable mask system according to claim 47, wherein the first edge and the second edge of the at least one wall are joined to a portion of the forehead support assembly in a congruous, smooth manner.

53. An interchangeable mask system according to claim 47, wherein the first edge and the second edge of the at least one wall both include a curvature.

54. An interchangeable mask system according to claim 47, wherein each cushion component is a full face cushion.

55. An interchangeable mask system according to claim 47, wherein at least a portion of the neck is integrally molded with the common frame,

wherein a width of the neck as seen in front view is substantially larger than a thickness of the at least one wall,

wherein the neck blends with and has a continuous form with the common frame,

wherein the first edge and the second edge of the at least one wall join to an edge of the common frame in a smooth, congruous manner without sharp edges,

wherein the first edge and the second edge of the at least one wall are joined to a portion of the forehead support assembly in a congruous, smooth manner,

wherein the first edge and the second edge of the at least one wall both include a curvature, and

wherein each cushion component is a full face cushion.

56. An interchangeable mask system according to claim 46, wherein the front portion of each of the at least first and second cushion components includes an engagement interface configured to interface with the common frame, and the engagement interfaces of the at least first and second cushion components are substantially similar to one another and configured to interface with the common frame in substantially the same manner.

57. An interchangeable mask system according to claim 46, wherein the front portion of each of the at least first and second cushion components comprises polycarbonate and the cushion thereof comprises silicone.

58. A CPAP system used for treatment of sleep disordered breathing, comprising:

the interchangeable mask system according to claim 46;

a blower to supply breathable gas at positive pressure; and

a conduit to pass the breathable gas from the blower to the interchangeable mask system.

59. An interchangeable mask system for delivering breathable gas to a patient, comprising:

at least first and second full-face cushion components that are different structurally from one another in at least one aspect, each of the at least first and second full-face cushion components including a front portion and a cushion structured to engage a patient'"'"'s face, the front portion and the cushion of each of the at least first and second full-face cushion components defining a mask interior breathing chamber; and

a common frame configured to interchangeably interface with each of the at least first and second full-face cushion components,

wherein the common frame is external to the mask interior breathing chamber defined by each of the at least first and second full-face cushion components, and the common frame does not define part of the mask interior breathing chamber defined by each of the at least first and second full-face cushion components,

wherein the common frame includes a forehead support,

wherein the forehead support includes a bridge provided with forehead padding, and the bridge includes a pair of connectors each structured to connect to a headgear strap of headgear,

at least a first elbow structured to deliver a supply of breathable gas to each of the at least first and second full-face cushion components, the at least first elbow including a gas washout vent,

wherein the common frame includes a first opening having a closed shape through which the at least first elbow and each of the at least first and second full-face cushion components communicate with one another, and the common frame includes a second opening having a closed shape that is spaced apart and superior to the first opening, and

a pair of lateral arms each extending from the common frame and structured to connect to a headgear strap of headgear,

wherein the front portion of each of the at least first and second full-face cushion components is relatively harder than the cushion thereof,

wherein the front portion, the cushion, and the mask interior breathing chamber thereof of each of the at least first and second full-face cushion components form a unit that as a whole is interchangeable with the common frame,

wherein each of the at least first and second full-face cushion components is structured to engage with the common frame in a fixed, non-adjustable position to prevent any relative or adjustable movement between each of the at least first and second full-face cushion components and the common frame,

wherein the front portion of each of the at least first and second full-face cushion components includes an opening that is aligned with the first opening of the common frame along a common longitudinal axis in the fixed, non-adjustable position, and wherein each of the at least first and second full-face cushion components and the common frame are attached to one another by moving each of the at least first and second full-face cushion components and the common frame towards one another substantially along the longitudinal axis, and

wherein the front portion of each of the at least first and second full-face cushion components includes a protrusion that is spaced apart and superior to the opening of each of the at least first and second full-face cushion components, and the protrusion of each of the at least first and second full-face cushion components is received within and exposed through the second opening of the common frame towards a front side of the common frame when each of the at least first and second full-face cushion components is provided to the common frame.

60. An interchangeable mask system according to claim 59, wherein the forehead support is adjustably mounted to the common frame.

61. An interchangeable mask system according to claim 59, wherein the front portion and the cushion of each of the at least first and second full-face cushion components are attached to one another.

62. An interchangeable mask system according to claim 59, wherein the front portion and the cushion of each of the at least first and second full-face cushion components are integrated with one another.

63. An interchangeable mask system according to claim 59, wherein at least one of the at least first and second full-face cushion components includes a gusset portion.

64. An interchangeable mask system according to claim 59, wherein the front portion of each of the at least first and second full-face cushion components includes an engagement interface configured to interface with the common frame, and the engagement interfaces of the at least first and second full-face cushion components are substantially similar to one another and configured to interface with the common frame in substantially the same manner.

65. An interchangeable mask system for delivering breathable gas to a patient, comprising:

at least a first cushion unit and a second cushion unit that are different structurally from one another in at least one aspect, each of the at least first and second cushion units as a whole including a front portion and a cushion structured to engage a patient'"'"'s face, the front portion of each of the at least first and second cushion units being relatively harder than the cushion thereof, and each of the at least first and second cushion units defining a mask interior breathing chamber; and

a common frame configured to interchangeably interface with each of the at least first and second cushion units,

wherein each of the at least first and second cushion units is structured to engage with the common frame in a fixed, non-adjustable position to prevent any relative or adjustable movement between each of the at least first and second cushion units and the common frame,

wherein each of the at least first and second cushion units is configured to be engaged with the common frame into the fixed, non-adjustable position by engaging each of the at least first and second cushion units with the common frame substantially along an anterior-posterior axis,

wherein the front portion of each of the at least first and second cushion units includes a front wall that is relatively harder than the cushion thereof and includes an opening bounded by an annular flange that protrudes forwardly from the front wall, the annular flange of each of the at least first and second cushion units structured to interface with the common frame,

wherein the common frame includes a first opening having a closed shape and a second opening having a closed shape that is spaced apart and superior to the first opening, and the front portion of each of the at least first and second cushion units includes a protrusion that is spaced apart and superior to the opening and the annular flange thereof of each of the at least first and second cushion units, and the protrusion of each of the first and second cushion unit is received within and exposed through the second opening of the common frame towards a front side of the common frame when each of the at least first and second cushion units is provided to the common frame to at least assist in preventing rotation between each of the at least first and second cushion units and the common frame, and

wherein each of the at least first and second cushion units is interchangeable with the common frame to optimize fit and comfort.

66. An interchangeable mask system according to claim 65, wherein the common frame includes a forehead support.

67. An interchangeable mask system according to claim 65, further comprising a pair of lateral arms each extending from the common frame and structured to connect to a headgear strap of headgear.

68. An interchangeable mask system according to claim 65, further comprising an elbow provided to the common frame and structured to deliver a supply of breathable gas to each of the at least first and second cushion units.

69. An interchangeable mask system according to claim 65, wherein the front portion and the cushion of each of the at least first and second cushion units are attached to one another.

70. An interchangeable mask system according to claim 65, wherein the front portion and the cushion of each of the at least first and second cushion units are integrated with one another.

71. An interchangeable mask system according to claim 65, wherein at least one of the at least first and second cushion units includes a gusset portion.

72. An interchangeable mask system according to claim 65, wherein the front portion of each of the at least first cushion unit and second cushion unit includes an engagement interface configured to interface with the common frame, and the engagement interfaces of the at least first cushion unit and second cushion unit are substantially similar to one another and configured to interface with the common frame in substantially the same manner.

73. A CPAP system used for treatment of sleep disordered breathing, comprising:

the interchangeable mask system according to claim 65;

a blower to supply breathable gas at positive pressure; and

a conduit to pass the breathable gas from the blower to the interchangeable mask system.

74. An interchangeable mask system according to claim 65, wherein each of the at least first and second cushion units is configured to be engaged with the common frame substantially along the anterior-posterior axis which passes through aligned openings of the common frame and the front portion of each of the at least first and second cushion units.

75. An interchangeable mask system for delivering breathable gas to a patient, comprising:

at least first and second cushion components that are different structurally from one another in at least one aspect, each of the at least first and second cushion components including a front portion and a cushion structured to engage a patient'"'"'s face, the front portion and the cushion of each of the at least first and second cushion components defining a mask interior breathing chamber; and

a common frame configured to interchangeably interface with each of the at least first and second cushion components,

wherein the common frame is external to the mask interior breathing chamber defined by each of the at least first and second cushion components,

wherein the common frame does not define part of the mask interior breathing chamber defined by each of the at least first and second cushion components,

wherein the front portion of each of the at least first and second cushion components is relatively harder than the cushion thereof,

wherein the mask interior breathing chamber of each of the at least first and second cushion components as a whole is interchangeable with the common frame,

wherein each of the at least first and second cushion components is structured to engage with the common frame in a fixed, non-adjustable position to prevent any relative or adjustable movement between each of the at least first and second cushion components and the common frame,

wherein the front portion of each of the at least first and second cushion components includes an opening having a closed shape that is aligned with a first opening having a closed shape of the common frame along a common longitudinal axis in the fixed, non-adjustable position, and wherein each of the at least first and second cushion components and the common frame are attached to one another by moving each of the at least first and second cushion components and the common frame towards one another substantially along the longitudinal axis, and

wherein the front portion of each of the at least first and second cushion components includes a protrusion that is spaced apart and superior to the opening of each of the at least first and second cushion components, and the common frame includes a second opening having a closed shape that is spaced apart and superior to the first opening, and the protrusion of each of the at least first and second cushion components is received within and exposed through the second opening of the common frame towards a front side of the common frame when each of the at least first and second cushion components is provided to the common frame.

76. An interchangeable mask system according to claim 75, wherein the front portion of each of the at least first and second cushion components includes an engagement interface configured to interface with the common frame, and the engagement interfaces of the at least first and second cushion components are substantially similar to one another and configured to interface with the common frame in substantially the same manner.

77. An interchangeable mask system according to claim 75, wherein the front portion of each of the at least first and second cushion components comprises polycarbonate and the cushion thereof comprises silicone.

78. A mask system for delivering breathable gas to a patient, comprising:

a cushion component including a front portion and a cushion structured to engage a patient'"'"'s face, the front portion and the cushion defining a mask interior breathing chamber, the front portion having an opening by which the breathable gas is delivered to the mask interior breathing chamber thereof; and

a frame configured to interface with the cushion component,

wherein the frame is external to the mask interior breathing chamber defined by the cushion component,

wherein the frame includes a first opening having a closed shape and a second opening having a closed shape that is spaced apart and superior to the first opening, and the front portion of the cushion component includes a protrusion that is spaced apart and superior to the opening of the cushion component, and the protrusion of the cushion component is received within and exposed through the second opening of the frame towards a front side of the frame when the cushion component is provided to the frame to at least assist in preventing rotation between the cushion component and the frame, and

wherein the cushion component is structured to engage with the frame in a fixed, non-adjustable position to prevent any relative or adjustable movement between the cushion component and the frame.

79. A mask system according to claim 78, further comprising a pair of lateral arms each extending from the frame and structured to connect to a headgear strap of headgear.

80. A mask system according to claim 78, wherein the opening of the cushion component is bounded by an annular flange, the opening of the cushion component structured to align with the first opening of the frame.

81. A mask system according to claim 78, wherein the cushion component is in the form of a full-face cushion.

82. A mask system according to claim 78, wherein at least a portion of the front portion of the cushion component forms an exterior surface exposed at a front side of the mask system when the cushion component is provided to the frame.

83. A mask system according to claim 78, wherein the front portion of the cushion component is relatively harder than the cushion thereof and the opening thereof is bounded by an annular flange that protrudes forwardly therefrom, the annular flange of the cushion component is structured to interface with the first opening of the frame.

84. A mask system according to claim 78, wherein the front portion of the cushion component is relatively harder than the cushion thereof.

85. A CPAP system used for treatment of sleep disordered breathing, comprising:

the mask system according to claim 78;

a blower to supply breathable gas at positive pressure; and

a conduit to pass the breathable gas from the blower to the mask system.