Ergonomic and adjustable respiratory mask assembly with frame

• US 8,371,302 B2
• Filed: 05/26/2010
• Issued: 02/12/2013
• Est. Priority Date: 04/23/2002
• Status: Expired due to Term

• Current Assignee: ResMed Pty Ltd. (ResMed Incorporated)
• Original Assignee: Resmed Limited (ResMed Incorporated)
• Inventors: Ging, Anthony Michael, Nasr, Saad, Kwok, Philip Rodney, Moore, Rachael Elizabeth, Price, Andrew Martin
• Primary Examiner(s): Dixon, Annette
• Application Number:
  US12/787,751
• Publication Number:
  US 20100229869A1
• Time in Patent Office: 993 Days
• Field of Search: 128/200.24, 128/205.25, 128/206.21, 128/206.24, 128/206.27, 128/207.13
• US Class Current: 128/206.24
• 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 16/0616 with face sealing means comprising a flap or membrane projecting inwards, such that sealing increases with increasing inhalation gas pressure
• CPC Class Codes: A61M 16/0622 having an underlying cushion
• CPC Class Codes: A61M 16/0633 with forehead support
• CPC Class Codes: A61M 16/0666 Nasal cannulas or tubing devices for improving normal breathing through the nose A61F5/08; nose filters A62B23/06; outside holding devices A61M25/02
• CPC Class Codes: A61M 16/0683 Holding devices therefor
• CPC Class Codes: A61M 16/0694 Chin straps
• CPC Class Codes: A61M 16/0816 Joints or connectors
• CPC Class Codes: A61M 16/0825 with ball-sockets
• CPC Class Codes: A61M 16/0875 Connecting tubes
• CPC Class Codes: A61M 2016/0661 with customised shape
• CPC Class Codes: A61M 2206/14 Static flow deviators in tubes disturbing laminar flow in tubes, e.g. archimedes screws
• CPC Class Codes: A61M 2210/0618 Nose
• CPC Class Codes: A62B 18/084 Means for fastening gas-masks to heads or helmets

Abstract

A respiratory mask assembly for delivering breathable gas to a patient includes a frame having a front surface and a rear surface, opposite the front surface, and adapted in use to face the patient. The frame defines an inner wall and an outer wall extending from the rear surface, the inner and outer walls being spaced to define a channel therebetween. A cushion is removably attachable to the frame such that the cushion and frame are repeatably engagable with and disengagable from one another. The cushion includes a side wall to be inserted into the channel of the frame, the side wall having a first interlocking surface that engages a second interlocking surface provided in the channel when the cushion and frame are engaged with one another. The first and second interlocking surfaces interlock with one another to removably attach the cushion to the frame.

Claims

1. A frame for a respiratory mask assembly that delivers breathable gas to a patient, the frame comprising:

a main body having a front surface and a rear surface adapted in use to face the patient, the main body having an aperture extending through the front surface for the introduction of breathable gas into a nasal breathing cavity defined by the frame; and

an inner wall and an outer wall each extending rearwardly from the rear surface, the inner and outer walls being spaced to define a channel therebetween that is structured to receive a side wall of a cushion such that the cushion may be repeatedly attached to and detached from the frame, wherein the main body and the inner and outer walls are formed in one piece and the inner and outer walls are spaced in parallel, wherein a length of the inner wall is different than a length of the outer wall such that the inner wall protrudes away from the rear surface a distance that is different than a distance the outer wall protrudes away from the rear surface,

wherein at least a portion of the channel is shaped and dimensioned to generally follow a contour of the patient'"'"'s face, and

wherein the channel has a generally triangular shape, and wherein the side wall of the cushion is adapted to be positioned between the inner and outer walls when attached to the frame.

2. A frame according to claim 1, further comprising a headgear assembly removably attachable to the frame, wherein the main body accommodates the cushion and a side frame member provided on each lateral side of the main body, each side frame member including an integrally formed first connector portion adapted to be removably coupled with a second connector portion provided on the headgear assembly.

3. A frame according to claim 1, wherein the channel includes a first surface to engage the cushion, to allow selective removal of the cushion from the frame.

4. A frame according to claim 3, wherein the first surface includes a protrusion on the inner wall.

5. A frame according to claim 4, wherein the channel further comprises a floor that extends between the inner and outer walls, each of the inner and outer walls includes a first end connected to the floor and a second end spaced from the first end, and the protrusion on the inner wall is spaced from the first end of the inner wall.

6. A frame according to claim 5, wherein the protrusion is configured to engage the side wall of the cushion so that a force required to attach the cushion to the frame is lower than a force required to detach the cushion from the frame.

7. A frame according to claim 5, wherein the floor of the channel is non-planar.

8. A frame according to claim 1, wherein the channel has a width in the range of about 2-10 mm.

9. A frame according to claim 8, wherein the width of the channel is 5 mm.

10. A frame according to claim 1, wherein the main body comprises an alignment feature on an outer surface configured to align with an alignment feature on the cushion.

11. A frame according to claim 10, wherein the channel includes an upper section dimensioned to be positioned over the patient'"'"'s nasal bridge region, a generally horizontal lower section, and side sections to join the upper and lower sections.

12. A frame according to claim 11, wherein the length of the inner wall is greater than the length of the outer wall such that the inner wall protrudes further away from the rear surface.

13. A frame according to claim 1, wherein the channel is structured such that an engagement force for engagement of the cushion to the frame is less than the disengagement force.

14. A frame according to claim 13, wherein the channel is structured such that the disengagement force is greater than a force asserted upon the mask assembly at a maximum treatment pressure.

15. A frame according to claim 1, wherein a length of the side wall is at least equal to a depth of the channel such that the cushion may contact a bottom surface of the channel.

16. A frame according to claim 15, wherein the cushion is retained and sealed without an interior or exterior member.

17. A combination, comprising:

a frame according to claim 1; and

a plurality of cushions, each cushion being configured to be removably attachable to the frame, wherein the cushions are different sizes.

18. A combination according to claim 17, wherein each cushion is configured to accommodate a percentage of a patient population such that the plurality of cushions together accommodate up to 95-100% of the patient population.

19. A frame for a respiratory mask assembly that delivers breathable gas to a patient, the frame comprising:

a base having a front side, a rear side, and an aperture therethrough for the introduction of breathable gas into a nasal breathing cavity;

an elbow assembly movably supported on the front side of the base; and

an inner wall and an outer wall having a generally triangular or trapezoidal channel therebetween that is structured to receive a side wall of a cushion so as to allow repeated attaching and detaching of the cushion and the base, at least a portion of the channel being shaped and dimensioned to generally follow a contour of the patient'"'"'s face, wherein

the inner wall includes a protrusion configured to contact the side wall of the cushion so as to removably attach the cushion to the base;

the channel has a width in the range of about 2-10 mm;

the base comprises an alignment feature configured to align with an alignment feature on the cushion;

the cushion can be attached to the frame to substantially simultaneously retain the cushion to the frame and form a seal with the frame; and

a depth of the channel is selected such that at least a portion of an end of the side wall of the cushion may contact a bottom surface of the channel; and

wherein each of the inner and outer walls extends from the rear side, and the inner wall extends a different distance than the outer wall, and wherein the side wall of the cushion is adapted to be positioned between the inner and outer walls when attached to the frame.

20. A frame according to claim 19, wherein each of the inner wall and outer wall has a thickness of about 1-2 mm.

21. A frame according to claim 19, wherein the width of the channel is 5 mm.

22. A frame according to claim 19, wherein the channel is structured such that an engagement force for engagement of the cushion to the frame is less than the disengagement force.

23. A frame according to claim 19, wherein the channel is structured such that a disengagement force is greater than a force asserted upon the mask assembly at a maximum treatment pressure.

24. A frame according to claim 19, wherein the cushion is retained and sealed without an interior or exterior member.

25. A frame according to claim 19, wherein the channel includes an upper section dimensioned to be positioned over the patient'"'"'s nasal bridge region, a generally horizontal lower section, and side sections to join the upper and lower sections.

26. A combination, comprising:

a frame according to claim 19; and

a plurality of cushions, each cushion being configured to be repeatedly and removably attachable to and detachable from the frame, wherein the cushions are different sizes.

27. A combination according to claim 26, wherein each cushion is configured to accommodate a percentage of a patient population such that the plurality of cushions together accommodate up to 95-100% of the patient population.

28. A frame according to claim 19, wherein the inner wall and the outer wall each extend rearwardly from the rear side, the inner and outer walls being spaced in parallel to define the channel therebetween.

29. A frame according to claim 19, wherein the inner and outer walls each extend rearwardly from the rear side in a direction of engagement and disengagement of the cushion side wall with the channel.

30. A frame according to claim 29, wherein the direction of engagement and disengagement of the cushion side wall with the channel is parallel to a longitudinal axis of the aperture.

31. A frame according to claim 19, wherein the channel has a symmetrical shape.

32. A frame according to claim 19, wherein the channel has an asymmetrical shape.

33. A frame according to claim 19, wherein the channel has a trapezoidal shape.

34. A frame according to claim 19, wherein the width of the channel is constant.

35. A frame according to claim 19, further comprising at least one receptacle provided to the frame that is configured to receive a locking clip of a headgear.

36. A frame according to claim 19, wherein the outer wall defines a perimeter of the base.

37. A frame according to claim 19, wherein the elbow assembly includes at least one vent opening.

38. A frame according to claim 19, wherein the nasal breathing cavity is configured to encompass at least the patient'"'"'s nose.

39. A frame for a respiratory mask assembly that delivers breathable gas to a patient, the frame comprising:

a substantially rigid main body, the main body comprising;

a front surface and a rear surface adapted in use to face the patient, and

an aperture provided therethrough for the introduction of breathable gas into a nasal breathing cavity defined by the frame;

a generally triangular or trapezoidal channel extending from the rear surface of the main body, the channel being structured to receive a side wall of a cushion so to removably attach the cushion to the frame, the channel comprising;

an inner wall and an outer wall spaced from and extending parallel to each other, and

a channel floor extending between the inner and outer walls, wherein the outer wall defines at least a portion of the outer perimeter of the main body, the channel having a generally horizontal upper section dimensioned to be positioned over the patient'"'"'s nasal bridge region, a generally horizontal lower section that is generally parallel to the upper section, and side section to join the upper and lower sections; and

wherein each of the inner and outer walls extends from the rear surface, and the inner wall extends a different distance than the outer wall, and wherein the side wall of the cushion is adapted to be positioned between the inner and outer walls when attached to the frame.

40. A frame according to claim 39, wherein the channel includes a first surface to frictionally engage a second surface of the side wall of the cushion to allow selective removal of the cushion from the frame.

41. A frame according to claim 40, wherein a depth of the channel is such that the side wall of the cushion may contact the channel floor when the first surface frictionally engages the second surface.

42. A frame according to claim 41, wherein the channel is structured to retain the cushion and form a seal without an interior or exterior member.

43. A frame according to claim 39, wherein the channel has a width in the range of about 2-10 mm.

44. A frame according to claim 43, wherein the inner wall has a thickness of about 1-2 mm.

45. A frame according to claim 44, wherein the outer wall has a thickness of about 1-2 mm.

46. A frame according to claim 39, wherein the channel is structured such that the disengagement force greater than a force asserted upon the mask assembly at a maximum treatment pressure.

47. A frame according to claim 45, wherein the channel is structured such that an engagement force for engagement of the cushion to the frame is less than the disengagement force.

48. A frame according to claim 39, wherein the inner and outer walls each extend in a direction of engagement and disengagement of the cushion side wall with the channel.

49. A frame according to claim 48, wherein the direction of engagement and disengagement of the cushion side wall with the channel is parallel to a longitudinal axis of the aperture.

50. A frame according to claim 49, wherein the width of the channel is constant.

51. A frame according to 39, wherein the inner and outer walls are parallel to a longitudinal axis of the aperture.

52. A frame according to claim 39, further comprising a swivel elbow coupled to the front surface of the main body.

53. A frame according to claim 52, wherein the swivel elbow comprises at least one vent.

54. A frame according to claim 39, further comprising a headgear connector provided at each of a first end of the frame and a second end of the frame opposite the first end.

55. A combination, comprising:

a frame according to claim 39; and

a plurality of cushions, each cushion being configured to be repeatedly and removably attached to and detachable from the frame, wherein the cushions are different sizes.

56. A frame according to claim 39, wherein interior surfaces of the inner and outer walls are tapered.

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

a rigid frame having a front surface and a rear surface, opposite the front surface, and adapted in use to face the patient, the frame defining an outer wall and an inner wall with at least the inner wall extending from the rear surface, the inner and outer walls being rigid and spaced to define a generally triangular or trapezoidal channel therebetween, the channel including a bottom surface defined by the frame and having a shape including a top region adapted to face the patient'"'"'s nasal bridge, a bottom region, and two cheek regions that connect the top region and the bottom region, the inner wall having at least a first protruding portion that protrudes into the channel, wherein the frame, the inner wall, the outer wall, the channel bottom and the first protruding portion are formed in one piece; and

a cushion being removably attachable to the frame such that the cushion and frame are repeatably engagable with and disengagable from one another, the cushion including a flexible and generally triangular or trapezoidal side wall to be inserted into the channel of the frame and is positioned between the rigid inner and outer walls of the frame, thereby forming a sealed connection therewith, the side wall having a shape that matches the shape of the channel, the side wall having an interior surface that engages the first protruding portion provided on the inner wall of the channel when the cushion and frame are engaged with one another, wherein, during assembly of the cushion and the frame, the interior surface and the first protruding portion engage one another to deform or compress the side wall in the vicinity of the interior surface and provide a retaining force to help maintain the sealed connection between the cushion and the frame such that the cushion is sealed and retained relative to the frame without an additional retaining member, and wherein each of the inner and outer walls include an end, and the inner wall end projects a different distance than the outer wall end.

58. A respiratory mask assembly according to claim 57, wherein the frame and cushion are configured to cover the patient'"'"'s nose and mouth.

59. A respiratory mask assembly according to claim 58, wherein a width of the channel is between about 2-10 mm.

60. A respiratory mask assembly according to claim 59, wherein a length of the outer wall of the channel is different from a length of the inner wall of the channel.

61. A respiratory mask assembly according to claim 60, further comprising:

an elbow connected to the frame.

62. A respiratory mask assembly according to claim 61, further comprising:

a headgear connected to the frame.

63. A respiratory mask assembly according to claim 57, wherein the channel includes a shoulder or ledge that defines the maximum insertion depth of the cushion within the channel.

64. A respiratory mask assembly according to claim 63, further comprising an empty space positioned below the shoulder or ledge.

65. A respiratory mask assembly according to claim 57, further comprising a sealing lip extending outward from an exterior surface of the side wall to sealingly engage the outer wall of the frame.

66. A respiratory mask assembly according to claim 57, wherein the cushion comprises a frame contacting side and a patient contacting side, the frame contacting side comprises the side wall which has a first aperture, the patient contacting side comprises a second aperture, and the first aperture is larger than the second aperture.

67. A respiratory mask assembly according to claim 57, wherein the bottom region is configured to engage the patient'"'"'s upper lip.

68. A respiratory mask assembly according to claim 57, wherein the bottom region is configured to engage the patient'"'"'s bottom lip.

69. A frame for a respiratory mask assembly that delivers breathable gas to a patient, the frame comprising:

a substantially rigid main body having a generally triangular or trapezoidal shape and having a curvature adapted to generally follow at least a part of the facial contour of the patient'"'"'s face, the main body comprising a front surface and a rear surface adapted in use to face the patient, and an aperture provided therethrough for the introduction of breathable gas into a nasal breathing cavity defined by the frame;

a channel structured to receive a side wall of a cushion so to removably attach the cushion to the frame, the channel comprising an inner wall and an outer wall spaced from and extending generally parallel to each other, and a channel floor extending between the inner and outer walls, wherein the outer wall defines at least a portion of the outer perimeter of the main body and the inner wall extends from the rear surface and is formed in one piece with the outer wall, the main body and the channel floor, at least a portion of the channel having a curvature adapted to generally follow at least a portion of the facial contour of the patient'"'"'s face and a generally triangular or generally trapezoidal shape; and

wherein the inner wall extends a different distance than the outer wall, and

wherein the channel is structured to retain the cushion and form a seal without an interior or exterior member, and wherein the side wall of the cushion is adapted to be positioned between the inner and outer walls when attached to the frame.

70. A frame according to claim 69, wherein the channel includes a first surface to frictionally engage a second surface of the side wall of the cushion to allow selective removal of the cushion from the frame.

71. A frame according to claim 70, wherein a depth of the channel is such that at least a portion of the side wall of the cushion may contact the channel floor when the first surface frictionally engages the second surface.

72. A frame according to claim 69, wherein the channel has a width in the range of about 2-10 mm.

73. A frame according to claim 72, wherein the inner wall has a thickness of about 1-2 mm.

74. A frame according to claim 73, wherein the outer wall has a thickness of about 1-2 mm.

75. A frame according to claim 74, wherein the inner and outer walls each extend in a direction of engagement and disengagement of the cushion side wall with the channel.

76. A frame according to claim 75, wherein the direction of engagement and disengagement of the cushion side wall with the channel is parallel to a longitudinal axis of the aperture.

77. A frame according to claim 76, wherein the width of the channel is generally constant.

78. A frame according to claim 69, further comprising a swivel elbow coupled to the front surface of the main body, wherein the swivel elbow comprises a plurality of vent holes.

79. A combination, comprising:

a frame according to claim 69; and

a plurality of cushions, each cushion being configured to be repeatedly and removably attached to and detachable from the frame, wherein the cushions are different sizes.

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

a frame having a main body, an outer wall, and an inner wall extending from the main body, the inner and outer walls having different extended lengths so as to establish a relative distance, said inner and outer walls being spaced to define a channel therebetween, the channel having a generally triangular or trapezoidal shape, wherein the inner wall includes a retaining element that protrudes into the channel, and wherein the main body, the inner wall, outer wall and retaining element are formed in one piece; and

at least one silicone cushion being removably attachable to the frame such that the cushion and frame are repeatably engagable with and disengagable from one another, the cushion including a deformable side wall to be inserted into the channel of the frame and being retained between the inner and outer walls of the frame, wherein the side wall frictionally contacts the inner and outer walls,

the side wall including at least one sealing lip positioned at or adjacent an end of the side wall, the sealing lip extending outward from an exterior surface of the side wall and running around the periphery of the side wall, thereby forming a sealed connection with the outer wall of the frame, the side wall having a shape that matches the shape of the channel,

wherein, during assembly, the relative distance between said extended lengths of the inner and outer walls of the frame assists in initial alignment of the side wall and the channel,

wherein the retaining element provided on the inner wall of the channel is positioned below a top edge of the inner wall such that during initial engagement between the cushion and the frame, the side wall begins to frictionally contact the inner and outer walls, before an interior surface of the side wall engages the retaining element provided on the inner wall of the channel,

wherein, after the cushion and frame are initially engaged with one another, and upon further insertion of the cushion into the channel, the interior surface and the retaining element engage one another to deform or compress the side wall in the vicinity of the interior surface to at least partially provide a retaining force to help maintain the sealed connection between the cushion and the frame, and

wherein the cushion is both sealed and retained relative to the frame without the need for a strap, an interior or exterior clip, or an additional retaining device.

81. A respiratory mask assembly according to claim 80, wherein the frame and cushion are configured to cover the patient'"'"'s nose and mouth.

82. A respiratory mask assembly according to claim 81, wherein a width of the channel is between about 2-10 mm.

83. A respiratory mask assembly according to claim 80, wherein the end of the side wall is generally linearly aligned with the side wall so as to project away from the main body at a substantially right angle when assembled, and a sealing membrane curls inwardly from a top end of the side wall.

84. A respiratory mask assembly according to claim 83, wherein the end and the side wall have a thickness that is able to withstand buckling forces applied when the cushion and frame are engaged with one another.

85. A respiratory mask assembly according to claim 83, wherein the membrane has a thickness of 0.1 to 2 mm, and the sidewall has a thickness of 2-10 mm.

86. A respiratory mask assembly according to claim 85, wherein the membrane thickness is 0.35 mm.

87. A respiratory mask assembly according to claim 80, wherein the channel includes a shoulder or ledge that defines the maximum insertion depth of the cushion within the channel.

88. A respiratory mask assembly according to claim 80, wherein only one said sealing lip is provided, and said sealing lip is only provided to the exterior surface of the side wall of the cushion, and the retaining element is provided only to the inner wall of the channel of the frame.

89. A respiratory mask assembly according to claim 80, wherein the cushion and frame include matching alignment indicators that align only when the cushion and frame are properly positioned for initial engagement.

90. A respiratory mask assembly according to claim 80, wherein the relative distance is between 0.5-10 mm.

91. A respiratory mask assembly according to claim 80, wherein the inner and/or outer walls have a taper to ease assembly of the cushion and the frame.

92. A respiratory mask assembly according to claim 80, further comprising:

an elbow connected to the frame.

93. A respiratory mask assembly according to claim 92, wherein the elbow defines an intake port and an exhaust port separated by a baffle having a generally planar configuration, the exhaust port being in communication with a plurality of gas washout ports.

94. A respiratory mask assembly according to claim 93, wherein the elbow is releasably detachable from the frame without accessing an interior portion of a breathing cavity defined between the cushion and frame.

95. A respiratory mask assembly according to claim 94, further comprising:

a headgear connected to the frame.

96. A respiratory mask assembly according to claim 80, wherein the cushion comprises a frame contacting side and a patient contacting side, the frame contacting side comprises the side wall which has a first aperture, the patient contacting side comprises a second aperture, and the first aperture is larger than the second aperture.

97. A respiratory mask assembly according to claim 80, wherein the at least one cushion comprises a plurality of cushions, each cushion being configured to be repeatedly and removably attached to and detachable from the frame, wherein the cushions are different sizes.