Mask system

• US 9,027,556 B2
• Filed: 01/23/2013
• Issued: 05/12/2015
• Est. Priority Date: 03/04/2008
• Status: Active Grant

• Current Assignee: Resmed Limited (ResMed Incorporated)
• Original Assignee: Resmed Limited (ResMed Incorporated)
• Inventors: Ng, Eva, Lockwood, David James, Wehbeh, Jamie Graeme, Valcic, Zoran, D'souza, Errol Savio Alex, Eves, Matthew, Sari, Mahsita
• Primary Examiner(s): MATTER, KRISTEN CLARETTE
• Application Number:
  US13/747,701
• Publication Number:
  US 20130133660A1
• Time in Patent Office: 839 Days
• Field of Search: 128/205.25, 128/206.21, 128/206.24, 128/206.28, 128/207.11, 128/207.13
• US Class Current: 128/206.28
• 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 16/0611 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 16/0683 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 16/0841 for sampling
• CPC Class Codes: A61M 16/0858 Pressure sampling ports
• CPC Class Codes: A61M 16/0875 Connecting tubes
• CPC Class Codes: A61M 16/20 Valves specially adapted to medical respiratory devices
• CPC Class Codes: A61M 16/208 Non-controlled one-way valves, e.g. exhalation, check, pop-off non-rebreathing valves
• CPC Class Codes: A61M 2016/0661 with customised shape
• 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 2209/06 Packaging for specific medical equipment

Abstract

A cushion module provided to a frame module for delivery of a supply of gas at positive pressure to be delivered to a patient'"'"'s airways, the cushion module comprising a main body and a cushion, the main body defining a breathing chamber and having an exterior surface adapted to directly engage with a surface of the frame module, wherein the main body and the cushion together comprise a co-molded, integrated component, the main body comprising a molded polycarbonate material adapted to directly contact the frame module and the cushion comprises a molded silicone material adapted to interface with patient'"'"'s face, and wherein the molded polycarbonate material of the main body is a more rigid material than the molded silicone material of the cushion.

Claims

1. A mask system for delivery of a supply of gas at positive pressure to a patient for medical treatment, the mask system comprising:

a frame module;

a cushion module provided to the frame module and adapted to form a seal with the patient'"'"'s face;

an elbow module rotatably attached to the frame module such that the frame module acts as a carrier and bearing surface for the elbow module, the elbow module being rotatably attached to the frame module such that the elbow module is rotatable 360°

relative to the frame module in use, and the elbow module being adapted to be connected to an air delivery tube that delivers breathable gas to the patient; and

headgear removably attachable to the frame module to assist in maintaining the mask system in a desired adjusted position on the patient'"'"'s face, wherein;

the cushion module includes a main body and a cushion, the main body at least partly defining a breathing chamber,

the frame module and the main body having shapes that prevent relative rotation when the frame module is attached to the main body,

an outer portion of the main body is exposed and remains uncovered by the frame module when the frame module and the main body are attached, and

the main body and cushion together comprise an integrated component, the main body comprising a molded material that interfaces with the frame module and the cushion comprises a molded silicone material adapted to interface with patient'"'"'s face, and the molded material of the main body is a more rigid material than the molded silicone material of the cushion.

2. The mask system according to claim 1, wherein:

the cushion provides a sealing portion adapted to form a seal with the patient'"'"'s nose and mouth, and wherein the cushion is adapted to engage the patient'"'"'s face generally along nasal bridge, cheek, and chin regions of the patient'"'"'s face, and

the cushion includes a base wall provided to the main body.

3. The mask system according to claim 1, wherein:

the elbow module includes an elbow,

a vent arrangement is provided for gas washout,

an anti-asphyxia valve is provided to the elbow,

the elbow includes a first end portion and a second end portion, the first end portion being attached to the frame module, the second end portion being provided to a swivel joint adapted to be connected to the air delivery tube, and

the elbow includes a port that is selectively closed by a flap portion of the anti-asphyxia valve depending on the presence of pressurized gas, and a structure to attach the anti-asphyxia valve.

4. The mask system according to claim 1, wherein:

the frame module is structured to maintain the elbow module in an operative position with respect to the patient'"'"'s face, with the frame module and elbow module being connected with a mechanical interlock.

5. The mask system according to claim 1, wherein:

the frame module includes a forehead support,

the frame module includes four headgear connectors to connect with the headgear,

a pair of arms are provided, each of the pair of arms having a slot at a free end of the arm adapted to receive a respective headgear strap of the headgear, each arm being at least semi-rigid to stabilize the mask system on the patient'"'"'s face,

each arm is removably coupled to the frame module, each said arm including clip structure adapted to removably engage with a corresponding portion provided to the frame module,

the headgear is removably attachable to the headgear connectors of the frame module to maintain the mask system in a desired position on the patient'"'"'s face, and

the headgear includes a pair of upper and lower straps with the upper straps removably attached to respective upper headgear connectors and the lower straps removably attached to respective lower headgear connectors, a free end of each strap including a hook and loop tab structured to adjustably engage the remainder of the strap to secure the strap in place.

6. The mask system according to claim 1, further comprising a concertina section provided in a nasal bridge region of the cushion, the concertina section including one or more folds that provide a higher degree of flexibility or increased movement relative to the main body.

7. The mask system according to claim 1, wherein the mask system is provided with a number of differently sized cushion modules each having a cushion and main body joined together, the main body of each cushion module including a common configuration for interfacing with the frame module, thus providing a modular arrangement that allows the frame module to be selectively and removably coupled to each of the number of cushion modules,

wherein the differently sized cushion modules include different size cushions, including small, medium, and large.

8. The mask system according to claim 1, wherein:

the cushion provides a sealing portion adapted to form a seal with the patient'"'"'s nose and mouth, and wherein the cushion is adapted to engage the patient'"'"'s face generally along nasal bridge, cheek, and chin regions of the patient'"'"'s face,

the cushion includes a base wall provided to the main body,

the elbow module includes an elbow,

a vent arrangement is provided for gas washout,

an anti-asphyxia valve is provided to the elbow,

the elbow includes a first end portion and a second end portion, the first end portion being attached to the frame module, the second end portion being provided to a swivel joint adapted to be connected to the air delivery tube,

the elbow includes a port that is selectively closed by a flap portion of the anti-asphyxia valve depending on the presence of pressurized gas, and a structure to attach the anti-asphyxia valve,

the frame module is structured to maintain the elbow module in an operative position with respect to the patient'"'"'s face, with the frame module and elbow module being connected with a mechanical interlock,

the frame module includes a forehead support,

the frame module includes four headgear connectors to connect with the headgear,

a pair of arms are provided, each of the pair of arms having a slot at the free end of the arm adapted to receive a respective headgear strap of the headgear, each arm being at least semi-rigid to stabilize the mask system on the patient'"'"'s face,

each arm is removably coupled to the frame module, each said arm including clip structure adapted to removably engage with a corresponding portion provided to the frame module,

the headgear is removably attachable to the headgear connectors of the frame module to maintain the mask system in a desired position on the patient'"'"'s face,

the headgear includes a pair of upper and lower straps with the upper straps removably attached to respective upper headgear connectors and the lower straps removably attached to respective lower headgear connectors, a free end of each strap including a hook and loop tab structured to adjustably engage the remainder of the strap to secure the strap in place,

a concertina section is provided in a nasal bridge region of the cushion, the concertina section including one or more folds that provide a higher degree of flexibility or increased movement relative to the main body,

the mask system is provided with a number of differently sized cushion modules, the main body of each cushion module including a common configuration for interfacing with the frame module, thus providing a modular arrangement that allows the frame module to be selectively and removably coupled to each of the number of cushion modules, and

the differently sized cushion modules include different size cushions, including small, medium, and large.

9. The mask system according to claim 1, wherein a co-molded connection is provided between the molded material and the molded silicone material, the molded material being a molded polycarbonate material.

10. The mask system according to claim 9, wherein the co-molded connection between the molded polycarbonate material of the main body and the molded silicone material of the cushion extends around the respective perimeters of the main body and the cushion such that the cushion is oriented to extend from the connection towards the patient'"'"'s face and the main body extends away from the connection and towards the frame module.

11. The mask system according to claim 9, wherein said co-molded connection does not include a mechanical interlock.

12. The mask system according to claim 9, wherein said co-molded connection does not necessarily form a mechanical interlock.

13. The mask system according to claim 12, wherein the co-molded connection further comprises a co-molded joint between the molded polycarbonate material of the main body and the molded silicone material of the cushion extends around the respective perimeters of the main body and the cushion such that the cushion is adapted to extend from the joint towards the patient'"'"'s face and the main body extends away from the joint and towards the frame module.

14. A mask system for delivery of a supply of gas at positive pressure to a patient for medical treatment, the mask system comprising:

a frame module;

a cushion module snap-fit to the frame module and adapted to form a seal with the patient'"'"'s face; and

an elbow module provided to the frame module, the frame module including a carrier having a bearing surface, the elbow module being rotatably attached to the bearing surface of the carrier such that, in use, the elbow module is rotatable 360°

relative to the frame module, and adapted to be connected to an air delivery tube that delivers breathable gas to the patient,

wherein the cushion module includes a main body and a cushion, the main body at least partly defining a breathing chamber,

wherein the main body and the cushion together comprise an integrated component, the main body comprising a molded material adapted to directly contact the frame module and the cushion comprises a molded silicone material adapted to interface with patient'"'"'s face,

wherein the frame module and the main body have complementary shapes that provide for non-rotatable engagement relative to one another, and

wherein the molded material of the main body is a more rigid material than the molded silicone material of the cushion.

15. The mask system According to claim 14, wherein the cushion provides a sealing portion adapted to form a seal with the patient'"'"'s nose and mouth, and wherein the cushion is adapted to engage the patient'"'"'s face generally along nasal bridge, cheek, and chin regions of the patient'"'"'s face.

16. The mask system according to claim 15, wherein the main body includes an opening that is adapted to communicate with the elbow module.

17. The mask system according to claim 14, wherein a concertina section is provided in a nasal bridge region of the cushion of the cushion module, the concertina section including one or more folds that provide a degree of flexibility or movement relative to the main body.

18. The mask system according to claim 14, wherein:

the cushion provides a sealing portion adapted to form a seal with the patient'"'"'s nose and mouth, and wherein the cushion is adapted to engage the patient'"'"'s face generally along nasal bridge, cheek, and chin regions of the patient'"'"'s face,

the main body includes an opening that is adapted to communicate with an elbow module,

the cushion includes a base wall provided to the main body,

at least a portion of the main body is exposed when the cushion module and the frame module are attached, and

a concertina section is provided in a nasal bridge region of the cushion of the cushion module, the concertina section including one or more folds that provide a degree of flexibility or movement relative to the main body.

19. The mask system according to claim 14, wherein at least a portion of the main body is exposed when the cushion module and the frame module are attached.

20. The mask system according to claim 14, wherein a co-molded joint is provided between the molded material and the molded silicone material, the molded material being a molded polycarbonate material.

21. The mask system according to claim 20, wherein the co-molded joint between the molded polycarbonate material of the main body and the molded silicone material of the cushion extends around the respective perimeters of the main body and the cushion such that when worn the cushion is oriented to extend from the joint towards the patient'"'"'s face and the main body is oriented to extend away from the joint and towards the frame module.

22. A mask system for delivery of a supply of gas at positive pressure to a patient for medical treatment, the mask system comprising:

a frame module having a carrier with a bearing surface;

a cushion module provided to the frame module and adapted to form a seal with the patient'"'"'s face;

an elbow module directly attached to the carrier of the frame module and adapted to be connected to an air delivery tube that delivers breathable gas to the patient, the elbow module being 360°

rotatable relative to the bearing surface; and

headgear removably attachable to the frame module to assist in maintaining the mask system in a desired adjusted position on the patient'"'"'s face, wherein;

the cushion module includes a main body and a cushion, the main body at least partly defining a breathing chamber and having an exterior surface directly proximate to a surface of the frame module,

the main body comprises a molded material that interfaces with the frame module and the cushion comprises a molded silicone material adapted to interface with patient'"'"'s face, and the molded material of the main body is a more rigid material than the molded silicone material of the cushion,

headgear connectors to connect with the headgear are provided only on the frame module,

the main body being shaped complementary to the frame module such that the main body and the frame module are not rotatable relative to one another,

the mask system is provided with a plurality of differently sized cushion modules each having a cushion and a main body joined together, the main body of each cushion module including a universal configuration for interfacing with the frame module, thus providing a modular arrangement that allows the frame module to be selectively and removably coupled to each of the plurality of differently sized cushion modules, and

the plurality of differently sized cushion modules include different size cushions, including small, medium, and large.

23. The mask system according to claim 22, wherein:

the cushion provides a sealing portion adapted to form a seal with the patient'"'"'s nose and mouth, and wherein the cushion is adapted to engage the patient'"'"'s face generally along nasal bridge, cheek, and chin regions of the patient'"'"'s face,

wherein the cushion includes a base wall provided to the main body.

24. The mask system according to claim 22, wherein:

the elbow module includes an elbow,

a vent arrangement is provided for gas washout,

an anti-asphyxia valve is provided to the elbow,

the elbow includes a first end portion and a second end portion, the first end portion being attached to the frame module, the second end portion being provided to a swivel joint adapted to be connected to the air delivery tube, and

the elbow includes a port that is selectively closed by a flap portion of the anti-asphyxia valve depending on the presence of pressurized gas, and a structure to attach the anti-asphyxia valve.

25. The mask system according to claim 22, wherein:

the frame module is structured to maintain the elbow module in an operative position with respect to the patient'"'"'s face, with the frame module and elbow module being mechanically interlocked.

26. The mask system according to claim 22, wherein:

the frame module includes a forehead support,

a pair of the headgear connectors each includes an arm and a slot at a free end of the arm adapted to receive a respective headgear strap of the headgear, each arm being at least semi-rigid to stabilize the mask system on the patient'"'"'s face,

each arm is removably coupled to the frame module, each said arm including clip structure adapted to removably engage with a corresponding portion provided to the frame module,

the headgear is removably attachable to the headgear connectors of the frame module to maintain the mask system in a desired position on the patient'"'"'s face, and

the headgear includes a pair of upper and lower straps with the upper straps removably attached to respective upper headgear connectors and the lower straps removably attached to respective lower headgear connectors, a free end of each strap including a hook and loop tab structured to adjustably engage the remainder of the strap to secure the strap in place.

27. The mask system according to claim 22, further comprising a concertina section provided in a nasal bridge region of the cushion, the concertina section including one or more folds that provide a higher degree of flexibility or increased movement relative to the main body.

28. The mask system according to claim 22, wherein:

the cushion provides a sealing portion adapted to form a seal with the patient'"'"'s nose and mouth, and wherein the cushion is adapted to engage the patient'"'"'s face generally along nasal bridge, cheek, and chin regions of the patient'"'"'s face,

the cushion includes a base wall provided to the main body

the elbow module includes an elbow,

a vent arrangement is provided to the elbow for gas washout,

an anti-asphyxia valve is provided to the elbow,

the elbow includes a first end portion and a second end portion, the first end portion being attached to the frame module, the second end portion being provided to a swivel joint adapted to be connected to the air delivery tube,

the elbow includes a port that is selectively closed by a flap portion of the anti-asphyxia valve depending on the presence of pressurized gas, and a structure to attach the anti-asphyxia valve,

the frame module is structured to maintain the elbow module in an operative position with respect to the patient'"'"'s face, with the frame module and elbow module being mechanically interlocked,

the frame module includes a forehead support,

a pair of the headgear connectors each includes an arm and a slot at the free end of the arm adapted to receive a respective headgear strap of the headgear, each arm being at least semi-rigid to stabilize the mask system on the patient'"'"'s face,

each arm is removably coupled to the frame module, each said arm including clip structure adapted to removably engage with a corresponding portion provided to the frame module,

the headgear is removably attachable to the headgear connectors of the frame module to maintain the mask system in a desired position on the patient'"'"'s face,

the headgear includes a pair of upper and lower straps with the upper straps removably attached to respective upper headgear connectors and the lower straps removably attached to respective lower headgear connectors, a free end of each strap including a hook and loop tab structured to adjustably engage the remainder of the strap to secure the strap in place, and

a concertina section is provided in a nasal bridge region of the cushion, the concertina section including one or more folds that provide a higher degree of flexibility or increased movement relative to the main body.

29. The mask system according to claim 22, wherein at least a portion of the main body is exposed when the cushion module and the frame module are attached.

30. The mask system according to claim 22, wherein a co-molded connection is provided between the molded material and the molded silicone material, the molded material being a molded polycarbonate material.

31. The mask system according to claim 30, wherein the co-molded connection between the molded polycarbonate material of the main body and the molded silicone material of the cushion extends around the respective perimeters of the main body and the cushion such that the cushion is oriented to extend from the co-molded connection towards the patient'"'"'s face and the main body extends away from the co-molded connection and towards the frame module.

32. A mask system for a patient, the mask system comprising:

a cushion module comprising a cushion of one material adapted to form a seal with the patient'"'"'s face, and a main body of a different, more rigid material, the main body having a main body opening to receive pressurized breathable gas;

an elbow module having an elbow adapted to be connected to an air delivery tube that delivers breathable gas to the patient via the cushion module; and

a frame module connected to the main body of the cushion module with a snap-fit connection,

wherein the frame module and the cushion module are not rotatable relative to one another when connected,

wherein the frame module retains the elbow module, and acts as a carrier and a bearing surface for the elbow module, and

wherein the elbow module is rotatably attached to the frame module so that the elbow module is rotatable 360 degrees relative to the frame module.

33. The mask system of claim 32, wherein the frame module includes a portion to provide forehead support.

34. The mask system of claim 33, wherein the main body includes a lower portion having the main body opening, and an upper portion having a vent arrangement.

35. The mask system of claim 34, wherein the frame module includes:

a frame-opening aligned with the main body opening, and

a headgear connector on each side of the frame-opening.

36. The mask system of claim 32, wherein the main body is provided without upper headgear connectors and the main body is free of lower headgear connectors.

37. The mask system of claim 32, wherein the cushion module includes a concertina section having one or more folds.

38. The mask system of claim 37, wherein a nasal bridge region of the cushion module includes the one or more folds to provide the mask system, in use, with a higher level of adaptability or flexibility in the nasal bridge region of the cushion module relative to another region of the cushion module.

39. The mask system of claim 38, wherein the flexibility of the concertina section is variable by varying at least one of a number of folds, a wall thickness of each fold, and a depth of each fold.

40. The mask system of claim 37, wherein the cushion is configured to form a seal along a nasal bridge region, a cheek region, and a lower lip/chin region of the patient'"'"'s face in use.

41. The mask system of claim 37, wherein the concertina section is provided to a nasal bridge region of the main body.

42. The mask system of claim 37, wherein the concertina section is provided in selected regions of the cushion module.

43. The mask system of claim 32, wherein the cushion is a full-face cushion.

44. The mask system of claim 32, wherein the cushion is co-molded to the main body.

45. The mask system of claim 32, wherein the frame module includes headgear connectors adapted to removably attach to respective headgear straps of headgear.

46. The mask system of claim 32, wherein the frame module includes upper and lower headgear connectors on each side of the frame module.

47. The mask system of claim 46, wherein each upper headgear connector includes a slot adapted to receive a respective headgear strap in use.

48. The mask system of claim 47, wherein each lower headgear connector is adapted to be removably interlocked with a headgear clip associated with a respective headgear strap.

49. The mask system of claim 32, wherein the frame module includes an open construction.

50. The mask system of claim 32, wherein the elbow module includes an anti-asphyxia valve.

51. The mask system of claim 50, wherein the anti-asphyxia valve includes a flap portion adapted to selectively close a port provided in the elbow module.

52. The mask system of claim 32, wherein connection between the elbow module and the frame module is independent of releasable connection between frame module and the main body.

53. The mask system of claim 32, wherein the frame module includes a portion to provide forehead support,

wherein the main body includes a lower portion having the main body opening, and an upper portion having a vent arrangement,

wherein the main body is provided without upper headgear connectors and the main body is free of lower headgear connectors,

wherein the cushion module includes a concertina section having one or more folds,

wherein a nasal bridge region of the cushion module includes the one or more folds to provide the mask system, in use, with a higher level of adaptability or flexibility in the nasal bridge region of the cushion module relative to another region of the cushion module,

wherein the cushion is configured to form a seal along a nasal bridge region, a cheek region, and a lower lip/chin region of the patient'"'"'s face in use,

wherein the cushion is a full-face cushion,

wherein the frame module includes headgear connectors adapted to removably attach to respective headgear straps of headgear,

wherein the frame module includes an open construction, and

wherein connection between the elbow module and the frame module is independent of releasable connection between frame module and the main body.

54. An oro-nasal mask system for treatment of respiratory disorder with Continuous Positive Airway Pressure equipment suitable to generate a supply of gas at positive pressure to be delivered to a patient'"'"'s airways, the mask system comprising:

a frame module;

a cushion module having (i) a cushion adapted to form a seal with the patient'"'"'s nose and mouth and (ii) a main body;

an elbow module adapted to be connected to an air delivery tube to deliver breathable gas to the patient; and

headgear removably attachable to the frame module, wherein;

the frame module includes two headgear connectors to connect with the headgear,

the main body comprises a relatively harder material and the cushion comprises relatively softer material provided to the main body,

the cushion is an oro-nasal cushion adapted to engage the patient'"'"'s face generally along nasal bridge, cheek, and chin regions of the patient'"'"'s face,

a vent arrangement is provided for gas washout,

the elbow module includes a first end portion and a second end portion, the first end portion being attached to the frame module, the second end portion being provided to a swivel joint adapted to be connected to the air delivery tube,

the elbow module includes an elbow and an anti-asphyxia valve provided to the elbow,

the elbow includes a port that is selectively closed by a flap portion of the anti-asphyxia valve depending on the presence of pressurized gas, and a structure to attach the anti-asphyxia valve,

the elbow module is rotatably attached to the frame module,

the elbow module and the frame module are mechanically interlocked to form a combined elbow and frame module that is releasably snap-fitted to the cushion module, in a non-rotatable manner, with a snap-fit attachment mechanism.

55. The mask system according to claim 54, wherein the frame module includes a forehead support.

56. The mask system according to claim 55, further comprising a concertina section provided in a nasal bridge region of the cushion of the cushion module, the concertina section including one or more folds that provide a degree of flexibility or movement.

57. The mask system according to claim 54, wherein the main body includes a universal configuration adapted to interface with the frame module, the main body being adapted to connect with a plurality of cushions of different sizes, thus providing a modular arrangement that allows the frame module to be selectively and removably coupled to each of a plurality of differently sized cushion modules.

58. The mask system according to claim 57, wherein the differently sized cushion modules include different size cushions, including small, medium, and large.

59. The mask system according to claim 58, wherein the main body and cushion are co-molded with one another to form an integrated co-molded component, a polycarbonate material of the main body comprising a first molded material adapted to interface with the frame module, and a silicone material of the cushion comprises a second molded material adapted to interface with patient'"'"'s face.

60. The mask system according to claim 54, wherein:

the elbow module is permitted to be rotated 360 degrees relative to the frame module,

the frame module includes a forehead support,

a concertina section is provided in a nasal bridge region of the cushion of the cushion module, the concertina section including one or more folds that provide a degree of flexibility or movement,

the main body includes a universal configuration adapted to interface with the frame module, the main body being adapted to connect with a plurality of cushions of different sizes, thus providing a modular arrangement that allows the frame module to be selectively and removably coupled to each of a plurality of differently sized cushion modules, and

the differently sized cushion modules include different size cushions, including small, medium, and large.

61. A full-face mask system for delivering a supply of breathable gas at positive pressure to a patient'"'"'s airways to treat a respiratory disorder, the mask system comprising:

a frame module;

a cushion module that engages the frame module, the cushion module including a main body and a full-face cushion adapted to engage the patient'"'"'s face generally along nasal bridge, cheek, and chin regions of the patient'"'"'s face, the main body at least partly defining a breathing chamber;

an elbow directly attached to the frame module in a rotatable manner such that the elbow and the frame module are 360°

rotatable, the elbow being adapted to be connected to an air delivery tube to deliver breathable gas to the patient; and

headgear directly or indirectly attachable to the frame module in a removable manner, wherein;

the frame module and the main body are joined with a snap-fit,

the frame module includes an opening, the elbow including a distal end inserted into the opening of the frame module to retain the elbow with the frame module, and

the frame module and the main body having shapes that prevent relative rotation when the frame module is snap-fitted to the main body.

62. The mask system according to claim 61, wherein:

a vent arrangement is provided for gas washout,

the elbow includes a swivel joint adapted to be connected to the air delivery tube, and

the elbow includes an anti-asphyxia valve and a port that is selectively closed by a flap portion of the anti-asphyxia valve depending on the presence of pressurized gas.

63. The mask system according to claim 61, wherein:

the frame module includes a forehead support and four headgear connectors that are attached to the frame module to connect with the headgear.

64. The mask system according to claim 61, wherein the mask system is provided with a plurality of differently sized cushion modules each having a full-face cushion and a main body, the main body of each cushion module including a universal configuration for interfacing with the frame module, thus providing a modular arrangement that allows the frame module to be selectively and removably coupled to each of the plurality of differently sized cushion modules, and

wherein the plurality of differently sized cushion modules include different size full-face cushions, including small, medium, and large.

65. The mask system according to claim 61, wherein the main body and full-face cushion together comprise an integrated component, the main body comprising a molded polycarbonate material that interfaces with the frame module and the full-face cushion comprises a molded elastomeric material adapted to interface with patient'"'"'s face.

66. The mask system according to claim 61, wherein:

a vent arrangement is provided for gas washout,

the elbow includes a swivel joint adapted to be connected to the air delivery tube,

the elbow includes an anti-asphyxia valve and a port that is selectively closed by a flap portion of the anti-asphyxia valve depending on the presence of pressurized gas,

the frame module includes a forehead support and four headgear connectors that are attached to the frame module to connect with the headgear,

the mask system is provided with a plurality of differently sized cushion modules each having a full-face cushion and a main body, the main body of each cushion module including a universal configuration for interfacing with the frame module, thus providing a modular arrangement that allows the frame module to be selectively and removably coupled to each of the plurality of differently sized cushion modules,

the plurality of differently sized cushion modules include different size full-face cushions, including small, medium, and large, and

the main body and full-face cushion together comprise an integrated component, the main body comprising a molded polycarbonate material that interfaces with the frame module and the full-face cushion comprises a molded elastomeric material adapted to interface with patient'"'"'s face.