RESPIRATORY MASK

• US 20100313891A1
• Filed: 02/29/2008
• Published: 12/16/2010
• Est. Priority Date: 03/02/2007
• Status: Active Grant

• Current Assignee: ResMed Pty Ltd. (ResMed Incorporated)
• Original Assignee: Resmed Limited (ResMed Incorporated)
• Inventors: Johnson, Ian Frederick, Sokolov, Richard, Siu, Eric, Caffin, Bart Jeremy, Harrington, Carmel Therese, Veliss, Lee James, Kwok, Philip Rodney, Gunning, Philip John, Gudiksen, Joshua Adam
• Granted Patent: US 9,981,102 B2
• Time in Patent Office: Days
• US Class Current: 128/206.26
• 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 16/0683 Holding devices therefor
• CPC Class Codes: A61M 16/0816 Joints or connectors
• CPC Class Codes: A61M 16/0825 with ball-sockets
• CPC Class Codes: A61M 2210/0618 Nose
• CPC Class Codes: A61M 2240/00 Specially adapted for neonatal use

Abstract

A respiratory mask for use with a patient, and that is suited for use with children, includes a flexible cushion arranged to interface with and deliver air to the patient'"'"'s nose. The cushion has a tube connection portion at one or both sides adjacent the patient'"'"'s nares, the tube connection portion being arranged to connect to an air delivery tube. This location, plus the very low profile of the mask, allows a patient (e.g. an infant) to sleep on their face more comfortably. A more rigid support structure adjacent the cushion is provided to stabilize the cushion and prevent it from collapsing. Headgear is also provided and arranged for releasable attachment to the support structure.

Claims

1. A respiratory mask for use with a patient, comprising:

a flexible cushion arranged to interface with and deliver air to the patient'"'"'s nose and having a tube connection portion at one or both sides adjacent the patient'"'"'s nares, the tube connection portion being arranged to connect to an air delivery tube,

a rigid support structure adjacent the cushion, and

headgear arranged for releasable attachment to the support structure.

2. A respiratory mask according to claim 1, wherein the cushion is overmolded to the support structure.

3. A respiratory mask according to claim 1, wherein the cushion is co-molded with the support structure.

4. A respiratory mask according claim 1, wherein the cushion is formed of elastomeric material.

5. A respiratory mask according claim 1, wherein the cushion is translucent, transparent or water clear.

6. A respiratory mask according claim 1, wherein the cushion is generally trapezoidally shaped and, in use, a top side of the trapezoid is configured to bridge a nose of a 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.

7. A respiratory mask according to claim 6, wherein a length of the top side of the trapezoid is between about 10-50 mm, a length of the bottom side of the trapezoid is between about 20-90 mm, and a length of each lateral side of the trapezoid is between about 20-60 mm.

8. A respiratory mask according to claim 7, wherein a length of the top side of the trapezoid is about 28.4 mm, a length of the bottom side of the trapezoid is about 55.4 mm, and a length of each lateral side of the trapezoid is about 36.5 mm.

9. A respiratory mask according to claim 6, wherein top corners between the top side and the lateral sides are rounded and have a radius of up to 30 mm and bottom corners between the bottom side are rounded and have a radius up to 20 mm.

10. A respiratory mask according to claim 9, wherein the top corners have a radius of 13 mm and the bottom corners have a radius of 5 mm.

11. A respiratory mask according to claim 1, wherein the cushion comprises a dome portion on a front side and a base wall and a flexible membrane extending from the base wall on a rear side, the rear side being configured to engage the patient'"'"'s face, and the dome portion, the base wall and the membrane forming an air chamber for receiving the air delivered by the air delivery tube.

12. A respiratory mask according to claim 11, wherein the base wall and the membrane form side walls of the air chamber, the membrane defining an aperture to receive the patient'"'"'s nose.

13. A respiratory mask according to claim 12, wherein the aperture has a trapezoidal shape similar to the trapezoidal shape of the cushion.

14. A respiratory mask according to claim 13, wherein a length of a top side of the aperture is about 18.5 mm, a length of a bottom side of the aperture is about 40.2 mm, and a length of each lateral side of the aperture is about 28.1 mm.

15. A respiratory mask according to claim 11, wherein the membrane has a substantially C-shaped cross section.

16. A respiratory mask according to claim 15, wherein top and bottom portions of the membrane have a larger curvature than lateral side portions.

17. A respiratory mask according to claim 11, wherein the bottom portion of the flexible membrane is thicker than the top and lateral side portions.

18. A respiratory mask according to claim 11, wherein top and bottom portions of the base wall are wider than lateral side portions of the base wall.

19. A respiratory mask according to claim 18, wherein a width of the top and bottom portions of the base wall is about 8 mm, a width of the lateral side portions of the base wall is about 5 mm, and transition zones of tapered width are provided between the lateral side portions and the top and bottom portions.

20. A respiratory mask according to claim 11, wherein a thickness of the top, bottom and lateral side portions of the base wall is about 0.9 mm, and the thickness of the top and bottom portions tapers to about 0.5 mm in a transition region between the base wall and the membrane.

21. A respiratory mask according to claim 11, wherein the membrane is visco-elastic foam.

22. A respiratory mask according to claim 21, wherein the membrane has a variable cross section.

23. A respiratory mask according to claim 1, wherein the cushion is triangular, rectangular, circular or square shaped.

24. A respiratory mask according to claim 1, wherein the cushion is formed by injection molding.

25. A respiratory mask according to claim 1, wherein the cushion comprises an exhalation vent comprising at least one aperture.

26. A respiratory mask according to claim 25, wherein the at least one aperture comprises at least one array of apertures.

27. A respiratory mask according to claim 26, wherein the exhalation valve comprises two arrays of apertures.

28. A respiratory mask according to claim 27, wherein the arrays of apertures converge toward each other in the bottom portion of the cushion and diverge away from each other toward a top portion of the cushion.

29. A respiratory mask according to claim 26, wherein diameters of the apertures vary.

30. A respiratory mask according to claim 29, wherein the diameters of the apertures are between about 0.8-1.1 mm.

31. A respiratory mask according to claim 1, wherein the tube connection portion comprises a hollow cylindrical protrusion, the hollow cylindrical protrusion comprising an outer cylinder, an inner cylinder, and a flexible membrane connecting the outer and inner cylinders to permit relative movement between the inner and outer cylinders.

32. A respiratory mask according to claim 31, wherein an inner diameter of the inner cylinder is between about 5-20 mm, an outer diameter of the inner cylinder is between about 7-22 mm, an inner diameter of the outer cylinder is between about 9-21 mm, and an outer diameter of the outer cylinder is between about 11-26 mm.

33. A respiratory mask according to claim 31, wherein the inner diameter of the inner cylinder is about 9.1 mm, the outer diameter of the inner cylinder is about 11.2 mm, the inner diameter of the outer cylinder is about 13.1 mm, and the outer diameter of the outer cylinder is about 15.3 mm.

34. A respiratory mask according to claim 31, wherein a portion of the inner cylinder extends beyond an end of the outer cylinder.

35. A respiratory mask according to claim 31, wherein the inner cylinder comprises a circumferential rib configured to engage a groove of an elbow configured to connect the air delivery hose to the mask.

36. A respiratory mask according to claim 31, wherein the cushion further comprises a resilient flap biased to seal the hollow cylindrical protrusion.

37. A respiratory mask according to claim 1, further comprising a plug configured to be received in the tube connection portion.

38. A respiratory mask according to claim 1, wherein the support structure comprises two wing portions extending in opposite directions, and a bridge that connects the two wing portions.

39. A respiratory mask according to claim 38, wherein the bridge is arranged above the two wing portions.

40. A respiratory mask according to claim 38, wherein the bridge is arranged in line with the two wing portions.

41. A respiratory mask according to claim 38, wherein the bridge is arranged below the two wing portions.

42. A respiratory mask according to claim 1, wherein the support structure includes a cylindrical portion configured to support the tube connection portion of the cushion.

43. A respiratory mask according to claim 1, wherein the support structure comprises pads configured, in use, to contact cheeks of the patient.

44. A respiratory mask according to claim 43, wherein the pads comprise a protrusion received in a slot in the support structure.

45. A respiratory mask according to claim 44, wherein the protrusion is retained in the slot by friction and/or adhesive.

46. A respiratory mask according to claim 1, further comprising a connection arrangement for releasably attaching the headgear to the support structure, the connection arrangement comprising

a thin, plate-like female portion having a substantially triangular or trapezoidal aperture, and

a male portion comprising a body and a cooperating substantially triangular or trapezoidal lug extending from the body, the lug having a body portion and a lip overhanging at least a portion of the body portion, wherein the connection arrangement is such that when the lip of the lug is inserted through the aperture of the female portion and the male portion is pulled towards the apex of the aperture, an edge of the aperture locates between an under-surface of the lip and the body of the male portion to form a releasable connection.

47. A respiratory mask according to claim 46, wherein both the female and male portions are relatively rigid.

48. A respiratory mask according to claim 1, wherein the support structure extends over the patient'"'"'s nasal bridge but not over the apex of the patient'"'"'s nose, such that the support structure substantially stops the cushion from collapsing when a force is applied to a front side of the mask.

99. A respiratory mask according to claim 1, wherein the rigid support structure is covered in a material that is less rigid than the rigid support structure.

100. A breathing apparatus, comprising:

a flow generator configured to generate a flow of breathable air;

an air delivery hose configured to deliver the flow of breathable air; and

a mask according to claim 1.

101. A breathing apparatus according to claim 100, further comprising:

a humidifier configured to humidify the flow of breathable air.

102. A breathing apparatus according to claim 100, wherein the air delivery hose comprises a first air delivery hose having a first diameter and a second air delivery hose having a second diameter, the second hose being configured to be connected to the mask, and the second diameter is smaller than the first diameter.

103. A breathing apparatus according to claim 102, wherein the first air delivery hose has a diameter of about 15 mm or about 19 mm and the second air delivery hose has a diameter of about 6 mm or about 8 mm.

104. A breathing apparatus according to claim 100, wherein the air delivery hose comprises a first air delivery hose having a first diameter, a second air delivery hose having a second diameter, and a third air delivery hose having a third diameter, the third delivery hose being configured to be connected to the mask, the first diameter being larger than the second diameter and the third diameter, and the second diameter being larger than the third diameter.

105. A breathing apparatus according to claim 104, wherein the first air delivery hose has a diameter of about 22 mm, the second air delivery hose has a diameter of about 15 mm, and the third delivery hose has a diameter of about 7 mm.

106. A breathing apparatus according to claim 105, wherein the second hose has a length of about 10 cm-1 m, and the third hose has a length of about 20 cm-1 m.

107. A breathing apparatus according to claim 100, wherein the flow generator is configured to generate a flow of about 12-15 l/min.

108. A respiratory mask according to claim 4, wherein the elastomeric material is silicone or foam.

49. A connection arrangement for connecting a respiratory mask to headgear, the connection arrangement comprising:

a thin, plate-like female portion having a substantially triangular or apezoidal aperture, and

a male portion comprising a body and a cooperating, substantially triangular or trapezoidal lug extending from the body, the lug having a body portion and a lip overhanging at least a portion of the body portion,

wherein when the lip of the lug is inserted through the aperture of the female portion and the male portion is pulled towards an apex of the aperture, an edge of the aperture locates between an under-surface of the lip and the body of the male portion to form a releasable connection.

50. A connection arrangement as claimed in claim 49, wherein both the female and male portions are relatively rigid.

51. A connection portion of a respiratory mask for receiving an air delivery tube, the connection portion comprising:

a relatively thin-walled flexible portion having an aperture configured to substantially sealingly receive an air delivery tube, and

a relatively rigid surround to which the flexible portion is connected,

wherein when the air delivery tube is inserted into the aperture, a seal is formed and the mask is substantially decoupled from movement of the tube.

52. A connection portion according to claim 51, wherein the relatively thin-walled flexible portion and the relatively rigid surround are concentric and connected by a flexible membrane.

53. A connection portion according to claim 52, wherein the relatively thin-walled flexible portion comprises a circumferential rib configured to engage a circumferential groove in the air delivery tube.

54. A connection portion according to claim 51, wherein a portion of the relatively thin-walled flexible portion extends beyond an end of the relatively rigid surround.

55. A connection portion according to claim 51, further comprising a resilient flap that covers the aperture.

56. A respiratory mask for use with a patient, comprising:

a flexible cushion arranged to interface with and deliver air to the patient'"'"'s nose;

a more rigid support structure adjacent the cushion; and

headgear arranged for releasable attachment to the support structure,

wherein the support structure extends over the patient'"'"'s nasal bridge but not over the apex of the patient'"'"'s nose, such that the support structure substantially stops the cushion from collapsing when a force is applied to a front side of the mask.

57. A respiratory mask according to claim 56, wherein the cushion is at least translucent to the extent that the patient'"'"'s nares can be inspected through the cushion.

58. A respiratory mask according to claim 56, wherein the cushion is transparent or water clear.

59. A respiratory mask according to claim 56, wherein the cushion is overmolded to the support structure.

60. A respiratory mask according to claim 56, wherein the cushion is co-molded with the support structure.

61. A respiratory mask according to claim 60, wherein the support structure and the cushion are formed of silicone.

62. A respiratory mask according to claim 56, wherein the support structure is translucent, transparent, or water clear.

63. A respiratory mask according to claim 56, wherein the support structure is formed of nylon or polypropylene.

64. A respiratory mask according to claim 56, wherein the support structure is formed by injection molding.

65. A respiratory mask according to claim 56, wherein the headgear comprises a strap configured for attachment and to the support structure and extend around the back of the patient'"'"'s head.

66. A respiratory mask according to claim 65, wherein the strap is configured to extend below the patient'"'"'s ears.

67. A respiratory mask according to claim 65, wherein the strap is configured to extend above the patient'"'"'s ears.

68. A respiratory mask according to claim 66, further comprising a support strap attached to the headgear at a position on a side of the patient'"'"'s face, the support strap being configured to support a delivery tube configured to deliver air to the cushion.

69. A respiratory mask according to claim 65, further comprising a stiffening element attached to the strap.

70. A respiratory apparatus according to claim 69, wherein the support strap is connected to the stiffening element.

71. A respiratory apparatus according to claim 67, further comprising a second strap connected to the first strap and configured to extend around a front of the patient'"'"'s head.

72. A respiratory apparatus according to claim 71, further comprising third straps extending from junctions of the first and second straps on both sides of the patient'"'"'s head.

73. A respiratory apparatus according to claim 72, further comprising a fourth strap connected to the third straps and configured to encircle a top of the patient'"'"'s head.

74. An air delivery tube, for interconnection between a CPAP device and a patient interface, the air delivery tube having an internal diameter of between 4 mm and 8 mm.

75. A respiratory mask for delivering a flow of pressurized breathable gas to a patient, comprising:

a flexible cushion arranged to interface with and deliver air to the patient'"'"'s nose; and

a more rigid support structure adjacent the cushion, wherein the flexible cushion is pivotably supported by the support structure.

76. A respiratory mask according to claim 75, wherein the support structure comprises an aperture for introduction of the flow, the cushion comprises an aperture configured to receive the flow from the support structure aperture, and the cushion is pivotably supported on the support structure on a pivot axis that is coincident with an axis of the apertures.

77. A respiratory mask according to claim 75, wherein the support structure comprises a projection configured to engage one of a plurality of recesses in the cushion to select a position of the cushion with respect to the support structure.

78. A respiratory mask according to claim 77, wherein the plurality of recesses are spaced equidistantly from the pivot axis.

79. A respiratory mask according to claim 75, wherein the support structure comprises a slot and the cushion comprises an adjustment member extending through the slot and configured to be engagable by fingers for pivoting the cushion.

80. A respiratory mask according to claim 79, wherein the slot comprises a plurality of indentations configured to frictionally engage the adjustment member.

81. A respiratory mask according to claim 79, wherein the adjustment member is made of the same material as the cushion.

82. A respiratory mask according to claim 75, wherein the cushion comprises a membrane configured to sealingly engage the patient'"'"'s face.

83. A respiratory mask according to claim 75, further comprising a headgear configured to hold the respiratory mask in contact with the patient'"'"'s face.

84. A respiratory mask according to claim 83, further comprising a stiffening element attached to at least a portion of the headgear.

85. A respiratory mask according to claim 83, wherein the stiffening element is attached to the support structure.

86. A respiratory mask for delivering a flow of pressurized breathable gas to a patient, comprising a one piece flexible membrane, the membrane having a rear surface configured to engage the patient'"'"'s face and a front surface opposite the rear surface, and a connector formed on the front surface, the connector defining an aperture through the mask and configured to be connected to a source of the flow, wherein the rear surface defines a nasal breathing cavity configured to receive the flow through the aperture.

87. A respiratory mask according to claim 86, wherein the flexible membrane is formed of transparent material.

88. A respiratory mask according to claim 86, wherein the flexible membrane is formed of silicone rubber.

89. A respiratory mask according to claim 86, further comprising ribs formed on the front surface of the flexible membrane.

90. A respiratory mask according to claim 89, further comprising two stiffening elements, each stiffening element configured to be connected to a corresponding end of the flexible membrane to connect the respiratory mask to a headgear system.

91. A respiratory mask according to claim 90, wherein each end of the flexible membrane comprises at least one projection configured to be received in at least one aperture in each stiffening element.

92. A respiratory mask according to claim 91, wherein the at least projection comprises two projections and the at least one aperture comprises two apertures.

93. A respiratory mask according to claim 90, wherein each end of the flexible membrane comprises an aperture configured to receive an end of a corresponding stiffening element.

94. A respiratory mask according to claim 86, wherein the connector comprises walls having a thickness that is less than a thickness of the flexible membrane.

95. A respiratory mask according to claim 94, wherein the walls are V-shaped.

96. A respiratory mask according to claim 94, wherein the connector includes a recess configured to receive a seal.

97. A respiratory mask according to claim 86, wherein the flexible membrane comprises a structure configured to decouple a force applied to an end portion of the flexible membrane from a middle portion of the membrane.

98. A respiratory mask according to claim 97, wherein the structure comprises a projection formed on a first edge of membrane between the middle portion and the end portion, and a notch formed on a second edge opposite the first edge.