Respiratory mask

• US 10,265,492 B2
• Filed: 04/29/2011
• Issued: 04/23/2019
• Est. Priority Date: 04/30/2010
• Status: Active Grant

• Current Assignee: ResMed Pty Ltd. (ResMed Incorporated)
• Original Assignee: Resmed Limited (ResMed Incorporated)
• Inventors: Amarasinghe, Amal Shirley, Ozolins, Angelene Marie, Veliss, Lee James, Wells, Alicia Kristianne, Siu, Eric, Johnson, Ian Fredrick, Norcott, Alison Ruth
• Primary Examiner(s): Stuart, Colin W
• Assistant Examiner(s): Sul, Douglas Y
• Application Number:
  US13/097,501
• Publication Number:
  US 20110265796A1
• Time in Patent Office: 2,916 Days
• Field of Search: 12820122, 12820123, 12820128, 12820525, 12820621, 12820623, 12820628, 12820711, 12820714, 12820716, 12820717, 12820718, 2424, 2443, 2450, 2452, 24359, 24458, 24369, 24265 H, 24199, 24318, 403 38, 403119, 403120, 403150, 403348, D11210
• 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 16/0633 with forehead support
• CPC Class Codes: A61M 16/0683 Holding devices therefor
• CPC Class Codes: A61M 16/0816 Joints or connectors
• CPC Class Codes: A61M 16/0858 Pressure sampling ports
• CPC Class Codes: A61M 2210/0618 Nose

Abstract

A respiratory mask assembly for use with a patient, and that is suited for use with children ranging in age from about 2-7 years, includes a flexible patient interface structure arranged to interface with and deliver air to the patient'"'"'s nose, the patient interface structure including cylindrical protrusions extending from respective opposite sides of the patient interface structure adjacent the patient'"'"'s nares; a frame configured to support the patient interface structure, the frame including a pair of cylinders, each cylinder configured to receive a respective cylindrical protrusion of the patient interface structure; headgear arranged for releasable attachment to the frame; an air delivery tube connected to either one of the cylindrical protrusions; and a plug connected to the other one of the cylindrical protrusions.

Claims

1. A patient interface system for delivering breathable gas to a patient, comprising:

a flexible patient interface structure configured to interface with and deliver air to a nose of the patient, the patient interface structure comprising cylindrical protrusions extending from respective opposite sides of the patient interface structure, the cylindrical protrusions being dimensioned and configured to be adjacent the patient'"'"'s nares when the flexible patient interface structure is engaged with the patient'"'"'s face;

a frame configured to support the patient interface structure, the frame comprising a pair of cylinders, each cylinder having an inner circumferential surface configured to receive a respective cylindrical protrusion of the patient interface structure;

headgear arranged for releasable attachment to the frame; and

an air delivery tube connected to either one of the cylindrical protrusions, the air delivery tube being configured to be assembled to the cylindrical protrusion in an assembly direction,

wherein each of the cylindrical protrusions of the flexible patient interface structure comprises a shoulder having a diameter larger than a diameter of each of said cylinders of the frame, each of the shoulders being configured to prevent movement of the respective cylindrical protrusion relative to the corresponding cylinder in the assembly direction of the air delivery tube when the air delivery tube is assembled to the respective cylindrical protrusion.

2. A patient interface system according to claim 1, wherein the patient interface structure is formed of elastomeric material.

3. A patient interface system according to claim 2, wherein the elastomeric material comprises silicone or foam.

4. A patient interface system according to claim 2, wherein the elastomeric material has a Shore A hardness of about 35 to 50.

5. A patient interface system according to claim 4, wherein the elastomeric material has a Shore A hardness of about 39 to 45.

6. A patient interface system according to claim 2, wherein the patient interface structure is compression moulded.

7. A patient interface system according to claim 6, wherein the patient interface structure is post cured.

8. A patient interface system according to claim 7, wherein the patient interface structure is post cured at about 130°

C. to 150°

C.

9. A patient interface system according to claim 8, wherein the patient interface structure is post cured at about 140°

C.

10. A patient interface system according to claim 7, wherein the patient interface structure is post cured for about 20 to 40 minutes.

11. A patient interface system according to claim 10, wherein the patient interface structure is post cured for about 30 minutes.

12. A patient interface system according to claim 1, wherein the patient interface structure is translucent, transparent, or water clear.

13. A patient interface system according to claim 1, wherein the patient interface structure comprises:

a base wall on a front side; and

at least one flexible membrane extending from the base wall towards a rear side, the rear side being configured to engage a face of the patient, the base wall and the at least one flexible membrane forming an air chamber for receiving the air delivered by the air delivery tube, the at least one flexible membrane comprising a sealing area configured to sealingly engage the face of the patient.

14. A patient interface system according to claim 13, wherein the base wall and the at least one flexible membrane are separated by a parting line.

15. A patient interface system according to claim 14, wherein the at least one flexible membrane is polished.

16. A patient interface system according to claim 13, wherein the base wall is generally trapezoidally shaped and a top side of the trapezoid is configured to bridge the nose of the patient, a bottom side of the trapezoid is configured to be adjacent the patient'"'"'s nares, and lateral sides of the trapezoid are configured to be adjacent the patient'"'"'s nostrils when the patient interface structure is engaged with the patient'"'"'s face.

17. A patient interface system according to claim 13, wherein the at least one flexible membrane consists of one membrane.

18. A patient interface system according to claim 13, wherein the base wall and the at least one flexible membrane form side walls of the air chamber and the at least one flexible membrane defines an aperture to receive the patient'"'"'s nose.

19. A patient interface system according to claim 18, wherein the aperture has a trapezoidal shape similar to the trapezoidal shape of the base wall.

20. A patient interface system according to claim 13, wherein the at least one flexible membrane has a varying thickness in the sealing area ranging from about 0.10 mm to 0.70 mm.

21. A patient interface system according to claim 20, wherein the thickness ranges from about 0.20 mm to 0.58 mm.

22. A patient interface system according to claim 13, wherein the at least one flexible membrane comprises a sealing lip.

23. A patient interface system according to claim 22, wherein the sealing lip has a thickness of about 0.10 mm to 0.20 mm.

24. A patient interface system according to claim 23, wherein the sealing lip has a thickness of about 0.15 mm.

25. A patient interface system according to claim 13, wherein the base wall comprises an exhalation vent comprising at least one aperture.

26. A patient interface system according to claim 25, wherein the at least one aperture comprises at least one array of apertures.

27. A patient interface system according to claim 26, wherein the exhalation vent comprises two arrays of apertures.

28. A patient interface system according to claim 27, wherein the two arrays of apertures comprise generally parallel rows of apertures.

29. A patient interface system according to claim 28, wherein the two arrays of apertures provide a predetermined vent flow to the patient interface structure.

30. A patient interface system according to claim 29, wherein the predetermined vent flow is between about 30.7-41.0 L/min at 12 cm H₂O.

31. A patient interface system according to claim 26, wherein the apertures have a diameter of about 1.50 mm.

32. A patient interface system according to claim 26, wherein the apertures have a diameter of about 1.60 mm.

33. A patient interface system according to claim 32, wherein the apertures have a length of about 5.0 mm and an aspect ratio of about 0.32.

34. A patient interface system according to claim 25, wherein the exhalation vent is disposed on a thickened portion of the base wall.

35. A patient interface system for delivering breathable gas to a patient according to claim 34,

wherein the thickened portion of the flexible patient interface structure is shaped to conform to the shape of an aperture of the frame so that the flexible patient interface structure is correctly assembled to the frame when the aperture of the frame receives the thickened portion of the flexible patient interface structure.

36. A patient interface system according to claim 25, further comprising a stopper disposed on the frame, a tether adapted to connect the stopper to the patient interface structure or to the frame, retention lugs disposed on the tether, and a rib disposed on the tether adjacent to the retention lugs, the stopper adapted to engage with the rib to prevent the tether from being rotated in the aperture to a position over the exhalation vent.

37. A patient interface system according to claim 1, wherein each cylindrical protrusion comprises:

an outer cylindrical protrusion;

an inner cylindrical protrusion; and

a flexible cylindrical protrusion membrane connecting the outer and inner cylindrical protrusions to permit relative movement between the outer and inner cylindrical protrusions.

38. A patient interface system according to claim 37, wherein the air delivery tube is connected to the inner cylindrical protrusion.

39. A patient interface system according to claim 37, wherein a portion of the inner cylindrical protrusion extends beyond an end of the outer cylindrical protrusion.

40. A patient interface system according to claim 37, wherein each outer cylindrical protrusion comprises the shoulder.

41. A patient interface system according to claim 1, further comprising:

an elbow connected between the air delivery tube and the patient interface structure.

42. A patient interface system according to claim 41, wherein the elbow comprises a bend having an angle of about 35°

to 55°

.

43. A patient interface system according to claim 42, wherein the angle is about 39.5°

to 49.5°

.

44. A patient interface system according to claim 41, wherein the elbow has an inner diameter of about 7.0 mm to 10.0 mm.

45. A patient interface system according to claim 44, wherein the inner diameter is about 8.5 mm.

46. A patient interface system according to claim 1, wherein the frame comprises a pair of wing portions extending in opposite directions, each wing portion including a respective one of the cylinders, and a bridge that connects the wing portions.

47. A patient interfaces system according to claim 46, wherein the bridge is arranged above the wing portions.

48. A patient interface system according to claim 46, further comprising a cross bar extending between the wing portions generally parallel to the bridge.

49. A patient interface system according to any claim 46, further comprising a reinforcing rib on the bridge.

50. A patient interface system according to claim 49, wherein the reinforcing rib is on a rear side of the bridge.

51. A patient interface system according to claim 1, wherein the headgear comprises:

a pair of side straps, each side strap extending from a region adjacent a wing portion of the frame and configured to extend along the patient'"'"'s cheek to above the patient'"'"'s ear when the patient interface system is engaged with the patient'"'"'s face;

a pair of top straps, each top strap extending from a respective side strap and configured to extend at least to a top of the patient'"'"'s head;

a pair of upper rear straps, each upper rear strap extending from a respective side strap and configured to extend at least to a back of the patient'"'"'s head;

a pair of reinforcing structures, each reinforcing structure having a forward finger extending from a respective wing portion of the frame and configured to extend generally along the patient'"'"'s cheek when the patient interface system is engaged with the patient'"'"'s face, an upper finger extending from the forward finger and configured to extend to above the patient'"'"'s ear when the patient interface system is engaged with the patient'"'"'s face, and a lower finger extending from the forward finger and configured to extend to below the patient'"'"'s ear; and

a lower rear strap connected at each end to a respective lower finger of a respective reinforcing structure.

52. A patient interface system according to claim 51, further comprising a quick release buckle configured to connect one end of the lower rear strap to allow quick release of the lower rear strap.

53. A patient interface system according to claim 52, wherein the quick release buckle comprises a tab and a hook, the hook being configured to connect the lower rear strap to a respective lower finger of a respective reinforcing structure.

54. A patient interface system according to claim 53, wherein the hook comprises a thinned section.

55. A patient interface system according to claim 51, wherein each wing portion of the frame comprises a connector portion and each forward finger of each reinforcing structure comprises an aperture configured to receive a respective connector portion.

56. A patient interface system according to claim 55, wherein the connector portion of one wing portion of the frame is larger than the connector portion of the other wing portion and the aperture of the forward finger of one of the reinforcing structures is larger than the aperture of the forward finger of the other reinforcing structure so that the reinforcing structures can only be connected to the connector portions in correct orientation of the headgear.

57. A patient interface system according to claim 55, wherein one wing portion comprises at least one indicia and one reinforcing structure comprises an indicia so that connection of the one reinforcing structure to the one wing portion results in correct orientation of the headgear.

58. A patient interface system according to claim 57, wherein the at least one indicia is provided on the connector portion of the one wing portion.

59. A patient interface system according to claim 51, wherein the forward fingers of the reinforcing structures are configured to be at an angle to the respective wing portions of the frame when the headgear is attached to the frame to increase a force applied to a nasal bridge region of the flexible patient interface structure.

60. A patient interface system according to claim 59, wherein the angle does not exceed about 20°

.

61. A patient interface system according to claim 60, wherein the angle is about 15°

.

62. A patient interface system according to claim 60, wherein the angle is about 10°

.

63. A patient interface system according to claim 60, wherein the angle is about 7.5°

.

64. A patient interface system according to claim 60, wherein the angle is about 5°

.

65. A patient interface system according to claim 60, wherein the angle is about 2.5°

.

66. A patient interface system according to claim 1, further comprising a plug sealingly connectable to the cylindrical protrusions of the patient interface structure.

67. A patient interface system according to claim 66, further comprising a circumferential rib disposed on each of the cylindrical protrusions, and a circumferential groove disposed on the plug, the circumferential rib adapted to engage the circumferential groove to retain the plug in the respective cylindrical protrusion.

68. A patient interface system according to claim 67, further comprising a bevelled flange disposed on the plug, the bevelled flange adapted to aid insertion of the plug into the respective cylindrical protrusion.

69. A patient interface system according to claim 67, further comprising an elbow connected between the air delivery tube and one of the cylindrical protrusions, the elbow having a circumferential groove, the circumferential rib adapted to engage the circumferential groove to retain the elbow in the respective cylindrical protrusion.

70. A patient interface system according to claim 69, further comprising a bevelled flange disposed on the elbow, the bevelled flange adapted to aid insertion of the elbow into the respective cylindrical protrusion.

71. A patient interface system according to claim 66, further comprising a tether adapted to connect the plug to the patient interface structure or to the frame.

72. A patient interface system according to claim 71, wherein the tether is integrally formed with at least one of the patient interface structure, the frame and the plug.

73. A patient interface system according to claim 71, further comprising an aperture formed in the frame, and retention lugs disposed on the tether, the retention lugs configured to engage with the aperture on the frame to attach the tether to the frame.

74. A patient interface system according to claim 73, wherein the retention lugs are angled towards the tether.

75. A patient interface system according to claim 73, wherein the retention lugs each include a first surface facing the tether and a second surface facing away from the tether, wherein the first surface is substantially parallel to a lower surface of the tether, and the second surface is angled with respect to the lower surface of the tether.

76. A patient interface system according to claim 73, further comprising a guide disposed on the frame, and a rib disposed on the tether adjacent to the retention lugs, the guide adapted to engage with the rib to prevent the tether from being rotated in the aperture upward beyond a horizontal position.

77. A patient interface system according to claim 71, wherein the plug includes a handle and the tether includes a first flange and a second flange separated by a recessed groove, the handle being disposed in the recessed groove between the first flange and the second flange to secure the plug to the tether.

78. A patient interface system according to claim 71, wherein the tether includes a connector having an opening, wherein a portion of the frame is disposed within the opening to secure the tether to the frame.

79. A patient interface system according to claim 71, wherein the tether is integrally formed with the plug and the tether includes a connector adapted to connect the tether to the frame.

80. A patient interface system according to claim 79, further comprising an aperture on each of the pair of cylinders of the frame, the aperture on each of the pair of cylinders adapted to receive the connector of the tether to connect the tether to the frame.

81. A patient interface system according to claim 80, wherein the aperture on each of the pair of cylinders includes a wide portion and a narrow portion.

82. A patient interface system according to claim 81, wherein the connector of the tether includes a wide portion, wherein the wide portion of the aperture is adapted to receive the wide portion of the tether.

83. A patient interface system according to claim 81, wherein the wide portion of the tether is retained beneath the narrow portion of the aperture to secure the tether to the frame.

84. A patient interface system according to claim 81, wherein the wide portion of the aperture on each of the pair of cylinders is offset from the narrow portion of the aperture on each of the pair of cylinders with respect to an axis of the cylinders.

85. A patient interface system according to claim 66, wherein the plug includes a handle having a plurality of ribs, the ribs being adapted to be gripped by a user.

86. A patient interface system according to claim 85, further comprising a connector disposed on an end of the handle and a headgear connector disposed on the frame, wherein the connector disposed on the end of the handle is adapted to connect the plug to the headgear connector on the frame.

87. A patient interface system according to claim 86, further comprising a post disposed on the headgear connector, the post having a head, and an aperture formed in the connector on the end of the handle, wherein the aperture is adapted to receive the head of the post to secure the plug to the frame.

88. A patient interface system according to claim 87, wherein the aperture formed in the connector on the end of the handle includes a small aperture portion and a large aperture portion, wherein the large aperture portion is adapted to receive the head of the post, and the small aperture portion is adapted to retain the head of the post to secure the plug to the frame.

89. A patient interface system according to claim 66, further comprising a post extending laterally from a front surface of the frame, the post adapted to receive and retain the plug when the plug is removed from the cylinder.

90. A patient interface system according to claim 89, wherein the plug includes a handle and a connector of the post includes a first flange and a second flange separated by a recessed groove, the handle being adapted to be received in the recessed groove between the first flange and the second flange to secure the plug to the post.

91. A patient interface system according to claim 89, wherein the plug includes a groove, and the post includes a connector having an aperture and an inner circumferential edge, the inner circumferential edge of the connector being adapted to receive the groove of the plug to secure the plug to the post.

92. A patient interface system according to claim 1, further comprising a valve in each of the cylindrical protrusions of the patient interface structure.

93. A patient interface system according to claim 92, wherein each valve is integrally formed with the patient interface structure and comprises a plurality of flaps configured to seal the cylindrical protrusion.

94. A patient interface system according to claim 92, wherein the valve is provided in a plug sealingly connectable to the cylindrical protrusions.

95. A patient interface system according to claim 94, wherein the plug is integrally connected to the patient interface structure.

96. A patient interface system according to claim 1, further comprising a port configured to permit pressure measurement or administration of gas into the patient interface structure, the port being configured to be inserted into a respective cylindrical protrusion.

97. A patient interface system according to claim 96, wherein the port is releasably connected to the patient interface structure by one of a barb, a slot, a port tether, or at least one snap arm.

98. A patient interface system according to claim 97, wherein the port tether comprises a first portion configured to extend around an elbow connected to one of the cylindrical protrusions and the air delivery tube.

99. A patient interface system according to claim 98, wherein the port tether comprises a second portion configured to extend around an outlet of the port.

100. A patient interface system according to claim 99, wherein the second portion is configured to snap into a space between the outlet of the port and an outer circumference of the port.

101. A patient interface system according to claim 99, wherein the outlet of the port is provided between the elbow and the cylindrical protrusion.

102. A patient interface system according to claim 99, wherein the outlet extends perpendicularly between a first end of the port connected to the cylindrical protrusion and a second end connected to the elbow.

103. A patient interface system according to claim 97, wherein the port tether is connected to the headgear.

104. A patient interface system according to claim 103, wherein the headgear comprises at least one flexible strap and at least one reinforcing structure provided to the flexible strap, and the port tether is connected at least to the at least one reinforcing structure.

105. A patient interface system according to claim 104, wherein the port tether is connected to the at least one flexible strap.

106. A patient interface system according to claim 96, further comprising a tube configured to be connected to the port.

107. A patient interface system according to claim 106, wherein the tube is connected to the port by an adaptor.

108. A patient interface system according to claim 106, further comprising a tube retainer connected to the port.

109. A patient interface system according to claim 108, wherein the tube retainer comprises a collar configured to extend around the tube and a tether configured to be connected to the port.

110. A patient interface system according to claim 1, further comprising at least one orientation element adapted to indicate a correct orientation between the frame and the patient interface structure.

111. A patient interface system according to claim 110, wherein the at least one orientation element comprises indicia on the patient interface structure.

112. A patient interface system according to claim 110, wherein the at least one orientation element comprises a post on the patient interface structure.

113. A patient interface system according to claim 110, wherein the at least one orientation element comprises a thickened portion of the patient interface structure and an aperture provided in the frame, wherein the thickened portion of the patient interface structure is shaped be received by the aperture of the frame.

114. A patient interface system according to claim 110, wherein the patient interface structure is a cushion.

115. A patient interface system according to claim 1, wherein the patient interface structure has a generally trapezoidal shape and the cylindrical protrusions extend from respective opposite sides of the generally trapezoidal shape of the patient interface structure.

116. A patient interface system according to claim 1, wherein the shoulder is continuous.

117. A patient interface system according to claim 1, wherein an outer diameter of the shoulder is larger than an inner diameter of each of said cylinders of the frame.

118. A headgear for use with a patient interface system, comprising:

a pair of side straps, each side strap extending from a region adjacent a wing portion of a patient interface frame and configured to extend along the patient'"'"'s cheek to above the patient'"'"'s ear when the patient interface system is engaged with the patient'"'"'s face;

a pair of top straps, each top strap extending from a respective side strap and configured to extend at least to a top of the patient'"'"'s head;

a pair of upper rear straps, each upper rear strap extending from a respective side strap and configured to extend at least to a back of the patient'"'"'s head;

a pair of reinforcing structures, each reinforcing structure having a forward finger extending from a respective wing portion of the frame and configured to extend generally along the patient'"'"'s cheek when the patient interface system is engaged with the patient'"'"'s face, an upper finger extending from the forward finger and configured to extend to above the patient'"'"'s ear, and a lower finger extending from the forward finger and configured to extend to below the patient'"'"'s ear;

a lower rear strap connected at each end to a respective lower finger of a respective reinforcing structure; and

a quick release buckle comprising a tab, the quick release buckle being configured to connect one end of the lower rear strap to a respective lower finger and release the lower rear strap from the respective lower finger when a pulling force is applied to the tab,

wherein the quick release buckle is configured so that the pulling force causes the quick release buckle to move directly from a secured position to a fully released position,

wherein the quick release buckle is in the secured position when the lower rear strap is secured to the respective lower finger,

wherein the quick release buckle is in the fully released position when the lower rear strap is fully removed from the respective lower finger,

wherein the quick release buckle further comprises a hook that is configured to connect the lower rear strap to the respective lower finger of a respective reinforcing structure, and

wherein the hook is configured so that a predetermined amount of tension in the lower rear strap bends the hook enough to release the hook from the respective lower finger.

119. A headgear according to 118, wherein the quick release buckle further comprises a slot configured to accept the lower rear strap, the hook and the lower rear strap being positioned at opposite ends of the quick release buckle.

120. A headgear according to claim 119, wherein the tab is configured to be accessible to a user'"'"'s fingers.

121. A headgear according to claim 120, wherein the quick release buckle is configured so that a pulling force applied to the tab will cause the hook to be separated from the respective lower finger of the respective reinforcing structure.

122. A headgear according to claim 118, wherein the quick release buckle comprises a substantially planar body and the tab extends from the substantially planar body at an angle.

123. A headgear according to claim 118, wherein the tab is configured to extend outwardly away from the patient'"'"'s head when the headgear is positioned on the patient'"'"'s head.

124. A headgear according to claim 118, wherein the quick release buckle is configured so that the pulling force is in a direction away from the patient'"'"'s head when the patient interface system is engaged with the patient'"'"'s face.

125. A headgear according to claim 118, wherein the hook is configured so that a pulling force in either a first or a second direction releases the hook from the respective lower finger.

126. A headgear according to claim 125, wherein the first direction and the second direction are substantially opposite directions.

127. A headgear according to claim 118, wherein the quick release buckle is configured to release the lower rear strap from the respective lower finger in one motion when the pulling force is applied to the tab.

128. A headgear according to claim 118, wherein the quick release buckle is configured to release the lower rear strap from the respective lower finger in one step when the pulling force is applied to the tab.