MASK SYSTEM

• US 20130327333A1
• Filed: 08/12/2013
• Published: 12/12/2013
• Est. Priority Date: 03/04/2008
• Status: Active Grant

• Current Assignee: Resmed Limited (ResMed Incorporated)
• Original Assignee: Resmed Limited (ResMed Incorporated)
• Inventors: NG, Eva, D'SOUZA, Errol Savio Alex, LOCKWOOD, David James, WEHBEH, Jamie Graeme, VALCIC, Zoran, EVES, Matthew, SARI, Mahsita
• Granted Patent: US 9,757,533 B2
• Time in Patent Office: Days
• US Class Current: 128/205.25
• 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 full-face mask system for delivery of a supply of gas at positive pressure to a patient for medical treatment includes a shroud, a cushion module adapted to form a seal with the patient'"'"'s nose and mouth, an elbow, and headgear. The cushion module includes a frame and a cushion. The frame includes an opening that releasably receives a distal end of the elbow with a snap-fit, wherein an inner edge of the opening and the distal end of the elbow together form a retention structure to retain the elbow to the frame.

Claims

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

a shroud module;

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

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

headgear to maintain the mask system in a desired adjusted position on the patient'"'"'s face, wherein;

the shroud module includes an engaging portion structured to engage the cushion module,

the mask system includes headgear connectors to connect with the headgear,

the cushion module is structured to interface with the shroud module, and the cushion module is structured to form a seal with the patient'"'"'s nose and mouth in use,

the cushion module includes a frame and a cushion, the frame defining a breathing chamber and being adapted to interface with the shroud module, the frame including an opening,

the cushion provides a sealing portion adapted to form a seal with the patient'"'"'s nose and mouth,

the cushion is 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 cushion includes a base wall extending from the frame, an undercushion layer extending away from the base wall, and a membrane to substantially cover the undercushion layer,

the undercushion layer is provided in a nasal bridge region of the cushion,

the undercushion layer is not provided in at least a part of a chin region of the cushion,

the shroud module is structured and shaped to hold the cushion module in an operative position with respect to the patient'"'"'s face, the engaging portion including an interfacing structure adapted to interface with the frame of the cushion module, the elbow module includes an elbow, a vent arrangement provided to the elbow for gas washout, and an anti-asphyxia valve provided to the elbow,

the elbow includes a first end portion and a second end portion, the first end portion providing an interfacing structure structured to engage to the shroud module, the second end portion including a swivel joint adapted to be connected to the air delivery tube,

the vent arrangement comprises a vent insert that is adapted to be supported within an outlet opening in the elbow, the vent insert having a plurality of vent holes,

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, the port being positioned between the swivel joint and the vent arrangement,

the first end portion of the elbow includes a series of circumferentially spaced tangs adapted to releasably engage with the opening of the frame of the cushion module with a snap-fit that provides retention, the tangs holding the elbow in place and permitting rotation of the elbow with respect to the frame, wherein the retention between the elbow and the frame maintains engagement between the shroud module and the frame, the shroud and the frame being prevented from rotation when the elbow is snap-fitted to the frame, and

the elbow module is rotatably engaged with the shroud module, the elbow module being adapted to be rotated 360 degrees relative to the shroud module.

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

the headgear includes a pair of upper and lower straps and a rear strap adapted to pass behind the patient'"'"'s head, 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

the shroud module includes a forehead support, and the shroud module includes four of said headgear connectors.

3. The mask system according to claim 2, further comprising a concertina section provided in the 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 frame.

4. The mask system according to claim 3, wherein the concertina section is provided around the entire perimeter of the cushion module.

5. The mask system according to claim 2, wherein flexibility of the concertina section is varied in different regions of the cushion module.

6. The mask system according to claim 3, wherein the concertina section in the nasal bridge region has a different flexibility compared to the concertina section in the chin region.

7. The mask system according to claim 6, wherein the flexibility of the concertina section is varied by varying a wall length of the one or more folds.

8. The mask system according to claim 1, wherein the frame is configured to be coupled with a plurality of differently sized cushions which results in a plurality of differently sized cushion modules, the frame of each cushion module including a universal configuration for interfacing with the shroud module, thus providing a modular arrangement that allows the shroud module to be selectively and removably coupled to each of the plurality of cushion modules.

9. The mask system according to claim 8, wherein the differently sized cushion modules include small, medium, and large cushions.

10. The mask system according to claim 1, wherein said headgear connectors include two upper and two lower headgear connectors, each said lower headgear connector including a semi-rigid stabilizing arm with a slot at a free end of the arm adapted to receive a respective one of the lower straps.

11. The mask system according to claim 10, wherein each arm extends outward of the cushion module and is oriented to retain the respective lower strap in spaced relation under the patient'"'"'s ear.

12. The mask system according to claim 1, wherein the frame and the cushion comprise a co-molded construction, the frame comprising a first molded material adapted to interface with the shroud module, and the cushion comprises a second molded material co-molded with the frame and adapted to interface with patient'"'"'s face.

13. The mask system according to claim 12, wherein the cushion is constructed of a relatively soft elastomeric material for sealing and the frame is constructed of a more rigid material than the cushion for interfacing with the shroud module, wherein the co-molded construction comprises a chemical bond.

14. The mask system according to claim 1, wherein the frame of the cushion module includes an exterior surface from which a hollow, cylindrical member that surrounds the opening protrudes.

15. The mask system according to claim 1, wherein the opening of the frame is adapted to receive the elbow.

16. The mask system according to claim 1, wherein the tangs are provided at a distal end of the first end portion, said tangs being adapted to extend under an edge of the opening of the frame to retain the elbow to the frame.

17. The mask system according to claim 16, wherein the frame is structured to maintain the elbow in an operative position with respect to the patient'"'"'s face, with the frame acting as a bearing surface for the elbow.

18. The mask system according to claim 17, wherein the opening is at least partially surrounded by a collar, and an inner circumferential surface of the collar comprises said bearing surface.

19. The mask system according to claim 18, wherein the elbow module includes an outwardly extending shoulder surface that engages with a distal end surface of the collar when fully connected.

20. The mask system according to claim 19, wherein the shoulder surface and the bearing surface are generally perpendicular.

21. The mask system according to claim 20, wherein the distal end surface is slightly rounded.

22. The mask system according to claim 21, wherein the elbow module is connected to both the shroud module and the frame of the cushion module.

23. The mask system according to claim 18, wherein the elbow module includes an annular outwardly extending protrusion that engages with a radially inwardly projecting tab of the shroud module, to thereby position the tab between the protrusion and the collar.

24. The mask system according to claim 23, wherein the tab is structured to utilize elbow-to-frame retention structure to retain the shroud module in engagement with the frame.

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

said collar includes a distal end that projects away from an exterior surface of the frame,

the shroud module includes a shroud module opening through which the first end portion of the elbow is inserted for retaining by the frame,

the shroud module includes an exterior surface adjacent the shroud module opening and an interior surface adjacent the shroud module opening, the exterior surface including a recess in which an outwardly extending protrusion of the elbow module is recessed, the protrusion engaging a portion of the shroud module that projects radially inwardly relative to the shroud module opening, and

the distal end of the collar terminates within the shroud module, proximate the interior surface.

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

a shroud module;

a cushion module provided to the shroud module and adapted to form a seal with the patient'"'"'s nose and mouth;

an elbow module engaged with the shroud module and adapted to be connected to an air delivery tube that delivers breathable gas to the patient; and

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

the cushion module includes a frame and a cushion, the frame defining a breathing chamber and having an exterior surface directly engaged with a surface of the shroud module,

the frame includes a collar at least partly defining an opening that releasably receives a first end of the elbow module with a snap-fit that provides retention, the elbow module having an exterior surface rotatable relative to a bearing surface formed on an inner circumferential surface of the collar, the collar including a distal end that projects outwardly away from the exterior surface of the frame, the distal end having a distal end surface, perpendicular to the bearing surface, that rotatably engages an outwardly extending surface of an annular protrusion of the elbow module when fully connected, whereby the retention between the elbow and the frame assists in maintaining engagement between the shroud module and the exterior surface of the frame, the frame and the shroud being non-rotatable relative to one another when the elbow is snap-fitted to the frame.

26. The mask system according to claim 25, wherein the cushion includes 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.

27. The mask system according to claim 26, wherein the cushion includes a base wall provided to the frame, an undercushion layer extending away from the base wall, and a membrane provided to cover the undercushion layer.

28. The mask system according to claim 27, wherein the undercushion layer is provided in a nasal bridge region of the cushion.

29. The mask system according to claim 28, wherein the undercushion layer is not provided in at least a portion of a chin region of the cushion.

30. The mask system according to claim 25, wherein the elbow module includes an elbow, a vent arrangement provided to the elbow for gas washout, and an anti-asphyxia valve provided to the elbow.

31. The mask system according to claim 30, wherein the elbow includes a first end portion and a second end portion, the first end portion providing an interfacing structure structured to engage the shroud module, the second end portion having a swivel joint adapted to be connected to the air delivery tube.

32. The mask system according to claim 31, wherein the vent arrangement comprises a vent insert that is adapted to be supported within an outlet opening in the elbow, the vent insert having more than one vent hole.

33. The mask system according to claim 32, wherein 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, the port being positioned between a swivel joint and the vent arrangement.

34. The mask system according to claim 25, wherein the shroud module is structured to maintain the elbow module in an operative position with respect to the patient'"'"'s face, with the shroud module and elbow module being connected with a mechanical interlock.

35. The mask system according to claim 34, wherein the elbow module is rotatably engaged with the shroud module, the elbow module being rotatable 360 degrees relative to the shroud module.

36. The mask system according to claim 25, further comprising four headgear connectors to connect with the headgear, two of the headgear connectors including 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.

37. The mask system according to claim 36, wherein each arm is removably coupled to the shroud module, each said arm including clip structure adapted to removably engage with a corresponding portion provided to the shroud module.

38. The mask system according to claim 37, wherein the headgear is removably attachable to the headgear connectors to maintain the mask system in a desired position on the patient'"'"'s face.

39. The mask system according to claim 38, wherein 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.

40. The mask system according to claim 39, wherein the shroud module includes a forehead support.

41. The mask system according to claim 25, 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 higher degree of flexibility or increased movement relative to the frame.

42. The mask system according to claim 41, wherein the concertina section is provided around the entire perimeter of the cushion module.

43. The mask system according to claim 42, wherein flexibility of the concertina section is varied in different regions of the cushion module.

44. The mask system according to claim 43, wherein the concertina section in the nasal bridge region has a different flexibility compared to the concertina section in a chin region.

45. The mask system according to claim 44 wherein the flexibility of the concertina section is varied by varying a wall length and/or a depth of the one or more folds.

46. The mask system according to claim 25, wherein the mask system is provided with a plurality of differently sized cushion modules each having a differently sized cushion, the frame of each cushion module including a common configuration for interfacing with the shroud module, thus providing a modular arrangement that allows the shroud module to be selectively and removably coupled to each of the plurality of cushion modules.

47. The mask system according to claim 46, wherein the differently sized cushion modules include differently sized cushions, including small, medium, and large.

48. The mask system according to claim 25, wherein the frame and the cushion together comprise a co-molded, integrated component, the frame comprising a first molded material that interfaces with the shroud module and the cushion comprises a second molded material adapted to interface with patient'"'"'s face.

49. The mask system according to claim 48, wherein the cushion is constructed of a relatively more soft elastomeric material for sealing and the frame is constructed of a relatively more rigid material than the cushion for interfacing with the shroud module, wherein said co-molded integrated component includes a chemical bond that chemically bonds the frame to the cushion.

50. The mask system according to claim 49, wherein a co-molded joint between the relatively more rigid material of the frame and the relatively more soft material of the cushion extends around the respective perimeters of the frame and the cushion such that the cushion is adapted to extend from the joint towards the patient'"'"'s face and the frame extends away from the joint and towards the shroud module.

51. The mask system according to claim 25, wherein the shroud module includes headgear connectors, each said headgear connector includes a semi-rigid arm with a slot at a free end of the arm adapted to receive a respective strap.

52. The mask system according to claim 51, wherein each arm extends outward of the cushion module and is oriented to retain the respective lower strap in spaced relation under the patient'"'"'s ear.

53. The mask system according to claim 25, wherein a rotatable and substantially airtight connection between the elbow module and the frame of the cushion module is established due to engagement between:

(1) the bearing surface of the collar and the exterior surface of the elbow module,

(2) the distal end surface of the collar and the outwardly extending surface of the annular protrusion of the elbow module, and

(3) a distal end of the elbow module and an inner edge of the opening.

54. The mask system according to claim 53, wherein each of the frame and the elbow module comprises polycarbonate.

55. The mask system according to claim 54, wherein the distal end surface is slightly rounded.

56. The mask system according to claim 55, wherein the distal end of the elbow module includes a distal shoulder adapted to extend under the inner edge of the opening of the frame to retain the elbow module to the frame.

57. The mask system according to claim 56, wherein a leading end of the distal shoulder of the elbow module includes a first ramped portion adapted to slide over the slightly rounded distal end surface of the collar when the elbow module is releasably inserted into the opening of the frame.

58. The mask system according to claim 57, wherein a trailing end of the distal shoulder of the elbow module includes a second ramped portion adapted to engage the inner edge of the opening, the inner edge being oriented towards the breathing chamber.

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

a shroud;

a cushion module proximate to the shroud, the cushion module being adapted to form a seal with the patient'"'"'s nose and mouth;

an elbow engaged with the shroud and adapted to be connected to an air delivery tube that delivers breathable gas to the patient; and

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

the cushion module includes a frame and a cushion, the frame and the cushion defining a breathing chamber,

the frame includes an opening that releasably receives a distal end of the elbow with a snap-fit, wherein an inner edge of the opening and the distal end of the elbow together form a retention structure to retain the elbow to the frame, the elbow having an exterior surface rotatable relative to a bearing surface formed on an inner circumferential surface of the opening, the elbow having an annular protrusion that abuts the frame of the cushion module when the distal end of the elbow is fully inserted into the opening, whereby the retention structure to retain the elbow to the frame maintains engagement between the shroud and the frame, the cushion module and the shroud being non-rotatable relative to one another when the elbow is snap-fitted to the frame.

61. The mask system according to claim 60, wherein the cushion includes 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.

62. The mask system according to claim 61, wherein the cushion includes a base wall provided to the frame, an undercushion layer extending away from the base wall, and a membrane provided to cover the undercushion layer.

63. The mask system according to claim 62, wherein the undercushion layer is provided in a nasal bridge region of the cushion.

64. The mask system according to claim 63, wherein the undercushion layer is not provided in at least a portion of a chin region of the cushion.

65. The mask system according to claim 60, wherein the elbow includes a vent arrangement and an anti-asphyxia valve.

66. The mask system according to claim 65, wherein the elbow is structured to engage the shroud, and the elbow includes a swivel joint adapted to be connected to the air delivery tube.

67. The mask system according to claim 66, wherein the vent arrangement comprises a vent insert that is adapted to be supported within an outlet opening in the elbow, the vent insert having more than one vent hole.

68. The mask system according to claim 67, wherein 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, the port being positioned between a swivel joint and the vent arrangement.

69. The mask system according to claim 60, wherein the shroud is structured to maintain the elbow in an operative position with respect to the patient'"'"'s face, with the shroud and elbow being connected with a mechanical interlock.

70. The mask system according to claim 69, wherein the elbow is rotatably engaged with the shroud, the elbow being rotatable 360 degrees relative to the shroud.

71. The mask system according to claim 60, wherein the elbow is rotatable 360 degrees relative to the shroud and the cushion module.

72. The mask system according to claim 60, further comprising four headgear connectors to connect with the headgear, two of the headgear connectors including 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.

73. The mask system according to claim 72, wherein each arm is removably coupled to the shroud, each said arm including clip structure adapted to removably engage with a corresponding portion provided to the shroud.

74. The mask system according to claim 73, wherein the headgear is removably attachable to the headgear connectors to maintain the mask system in a desired position on the patient'"'"'s face.

75. The mask system according to claim 74, wherein 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.

76. The mask system according to claim 75, wherein the shroud includes a forehead support.

77. The mask system according to claim 60, further comprising at least one fold provided in at least a nasal bridge region of the cushion of the cushion module, the at least one fold providing a higher degree of flexibility or increased movement relative to the frame.

78. The mask system according to claim 77, wherein the at least one fold is provided around the entire perimeter of the cushion module.

79. The mask system according to claim 60, wherein the shroud is engagable with a plurality of differently sized cushion modules each having a differently sized cushion, the frame of each cushion module including a common configuration for interfacing with the shroud, thus providing a modular arrangement that allows the shroud to be selectively and removably coupled to each of the plurality of cushion modules.

80. The mask system according to claim 79, wherein the differently sized cushion modules include differently sized cushions, including small, medium, and large.

81. The mask system according to claim 60, wherein the frame and the cushion together comprise a co-molded, integrated component, the frame comprising a first molded material that interfaces with the shroud and the cushion comprises a second molded material adapted to interface with patient'"'"'s face.

82. The mask system according to claim 81, wherein the cushion is constructed of a relatively more soft elastomeric material for sealing and the frame is constructed of a relatively more rigid material than the cushion for interfacing with the shroud, wherein said co-molded integrated component includes a chemical bond that chemically bonds the frame to the cushion.

83. The mask system according to claim 82, wherein a co-molded joint between the relatively more rigid material of the frame and the relatively more soft material of the cushion extends around the respective perimeters of the frame and the cushion such that the cushion is adapted to extend from the joint towards the patient'"'"'s face and the frame extends away from the joint and towards the shroud.

84. The mask system according to claim 60, wherein the shroud includes headgear connectors, each said headgear connector includes a semi-rigid arm with a slot at a free end of the arm adapted to receive a respective strap.

85. The mask system according to claim 84, wherein each arm extends outward of the cushion module and is oriented to retain the respective lower strap in spaced relation under the patient'"'"'s ear.

86. The mask system according to claim 60, wherein a rotatable and substantially airtight connection between the elbow and the frame of the cushion module is established due to engagement between:

(1) the exterior surface of the elbow and the bearing surface formed on the inner circumferential surface of the opening,

(2) the annular protrusion of the elbow and the frame, and

(3) the distal end of the elbow and the inner edge of the opening.

87. The mask system according to claim 86, wherein each of the frame and the elbow comprises polycarbonate.

88. The mask system according to claim 87, wherein the distal end of the elbow includes a distal shoulder adapted to extend under the inner edge of the opening of the frame to retain the elbow to the frame.

89. The mask system according to claim 88, wherein a leading end of the distal shoulder of the elbow includes a first ramped portion adapted to slide over a surface surrounding the opening when the elbow is releasably inserted into the opening of the frame.

90. The mask system according to claim 89, wherein a trailing end of the distal shoulder of the elbow includes a second ramped portion adapted to engage the inner edge of the opening, the inner edge being oriented towards the breathing chamber.