Mask system

• US 8,505,535 B2
• Filed: 12/23/2009
• Issued: 08/13/2013
• Est. Priority Date: 05/02/2003
• Status: Active Grant

• Current Assignee: ResMed Pty Ltd. (ResMed Incorporated)
• Original Assignee: Resmed Limited (ResMed Incorporated)
• Inventors: Jones, Michael Andrew, Amarasinghe, Amal Shirley, Fu, Timothy Tsun-Fai, Lithgow, Perry David, Saada, Jim, Sweeney, Fiachra Marcus
• Primary Examiner(s): DOUGLAS, STEVEN O
• Application Number:
  US12/654,595
• Publication Number:
  US 20110030692A1
• Time in Patent Office: 1,329 Days
• Field of Search: 128/206.21, 128/206.24, 128/206.27, 128/206.28, 128/207.13, 128/205.25
• US Class Current: 128/204.21
• CPC Class Codes: A61M 16/0057 Pumps therefor
• 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 16/0633 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 16/0825 with ball-sockets
• CPC Class Codes: A61M 16/0858 Pressure sampling ports
• CPC Class Codes: A61M 2210/0618 Nose
• CPC Class Codes: A62B 18/02 Masks gas-masks for animals A62B18/06; masks for welders A61F9/06

Abstract

A mask system for treating sleep disordered breathing, comprising headgear, a shell/cushion including a channel adjacent a front aperture, a frame, an elbow including at least one undercut on a proximal end, a retaining ring including a rear flange adapted to be retainably insertable in the channel of the shell/cushion, and a front flange adapted to retainably engage with the at least one undercut of the elbow.

Claims

1. A mask system for treating sleep disordered breathing, comprising:

a shell and cushion unit including a cushion portion and a shell portion, the cushion portion having two walls and a rear aperture surrounded by a face contacting portion adapted to form a seal with the patient'"'"'s face, the face contacting portion including a nasal bridge region and side regions extending from the nasal bridge region, the shell portion including a centrally located front aperture opposite the cushion portion and a projection located adjacent the front aperture and oriented towards an interior of a breathing chamber, the shell and cushion unit being a single integral component defining the breathing chamber;

a rigid, generally triangularly-shaped frame with rounded lower corners, the frame engaging the shell portion of the shell and cushion unit, the frame having at least one opening leaving at least a portion of the shell portion uncovered, and the frame being secured to and positively located relative to the shell and cushion unit;

a rigid ring-shaped member with an annular flange, at least a portion of which is adjacent to the front aperture of the shell and cushion unit;

a rotatable elbow having a first end and a second end, the first end engaging with and being rotatable relative to the rigid ring-shaped member and engaging with and being rotatable relative to the shell and cushion unit, a portion of the first end extending through and beyond the ring-shaped member and engaging the shell portion projection;

a swivel attached to the second end of the rotatable elbow and adapted to engage an air delivery conduit;

headgear to support the shell and cushion unit on the user'"'"'s face; and

anchor points for the headgear formed on the frame, the anchor points including a first anchor point provided on a first side portion of the frame, and a second anchor point provided on a second side portion of the frame so that the centrally located front aperture on the shell portion is positioned between the first and second anchor points.

2. The mask system according to claim 1, wherein the headgear comprises a multi-layered one-piece construction.

3. The mask system according to claim 2, wherein the elbow includes an approximately 90°

bend between the first and second ends thereof.

4. The mask system according to claim 3, wherein the first and second anchor points are proximate to the rounded lower corners of the frame.

5. The mask system according to claim 4, wherein the ring-shaped member and the frame comprise a common material.

6. The mask system according to claim 5, wherein the elbow comprises polycarbonate.

7. The mask system according to claim 5, wherein the ring-shaped member, the elbow and the frame comprise polycarbonate.

8. The mask system according to claim 1, wherein the shell and cushion unit include a continuous rear flange, a continuous front flange and a continuous channel between the rear flange and the front flange.

9. The mask system according to claim 8, wherein a contour of a rear portion of the frame substantially matches a contour of the rear flange.

10. The mask system according to claim 9, wherein the continuous channel has a different thickness at different regions of the shell and cushion unit.

11. The mask system according to claim 1, wherein a shoulder of the elbow abuts the annular flange of the ring-shaped member.

12. The mask system according to claim 1, further including third and fourth anchor points, wherein the headgear includes four straps structured to be anchored to the first, second, third and fourth anchor points, respectively.

13. The mask system according to claim 1, wherein the frame is an exoskeletal frame.

14. The mask system according to claim 1, wherein the rotatable elbow includes a passage wall and a vent wall that extends away from the passage wall, the vent wall including at least one aperture therethrough, the at least one aperture lying at an angle to an outlet direction of air flowing out of the elbow.

15. The mask system according to claim 14, wherein the frame has a rearwardly projecting rib that engages the shell and cushion unit.

16. The mask system according to claim 15, further comprising a securing mechanism to secure the shell and cushion unit and the frame.

17. The mask system according to claim 16, wherein the shell and cushion unit is sandwiched between the securing mechanism and the frame.

18. The mask system according to claim 17, wherein the securing mechanism passes through a portion of the shell and cushion unit.

19. The mask system according to claim 1, wherein the elbow is freely rotatable when mounted on the mask system.

20. The mask system according to claim 1, wherein the cushion portion comprises a nasal or full face cushion.

21. A mask system for treating sleep disordered breathing, comprising:

headgear;

a shell and cushion unit adapted to form a seal with a patient and defining an interior breathing chamber, the cushion portion having two walls and the shell portion including an opening with front and rear sides, and a projection oriented on the rear side of the opening towards the breathing chamber;

a frame shaped and adapted to be engaged with the shell portion of the shell and cushion unit, the frame being attachable to the headgear to position the mask system on a patient'"'"'s head; and

a rotatable elbow having a proximal end adapted to engage with the shell and cushion unit, an end of the rotatable elbow being rotatably received within the breathing chamber and engaging the shell portion projection.

22. The mask system according to claim 21, wherein the shell and cushion unit includes a centrally located front aperture and the shell portion projection is located adjacent the front aperture.

23. The mask system according to claim 22, wherein the frame includes a plurality of anchor points for the headgear and the shell and cushion unit aperture is provided generally between the anchor points.

24. The mask system according to claim 21, wherein the elbow includes an approximately 90°

bend between the first and second ends thereof, and the elbow is rotatable in any position.

25. The mask system according to claim 24, further comprising a swivel attached to the rotatable elbow and adapted to engage an air delivery conduit.

26. The mask system according to claim 25, wherein the elbow comprises polycarbonate.

27. The mask system according to claim 21, further comprising a ring member that receives the elbow.

28. The mask system according to claim 27, wherein the ring member and the frame comprise polycarbonate.

29. The mask system according to claim 28, wherein the ring member includes an annular flange.

30. The mask system according to claim 29, wherein the annular flange is symmetrical in shape.

31. The mask system according to claim 30, wherein the rotatable elbow includes a shoulder that abuts the annular flange.

32. The mask system according to claim 21, wherein the frame includes at least one opening through which at least a portion of the shell and cushion unit is exposed.

33. The mask system according to claim 32, wherein the frame is of a generally triangular shape with rounded apexes.

34. The mask system according to claim 33, wherein the frame includes anchor points for the headgear.

35. The mask system according to claim 34, wherein the frame includes two anchor points for the headgear, and the mask system further comprises two additional anchor points for the headgear.

36. The mask system according to claim 21, wherein the headgear comprises a multi-layered one-piece construction.

37. The mask system according to claim 21, wherein the shell and cushion unit has a generally triangular shape.

38. The mask system according to claim 37, wherein the shell and cushion unit includes at least one flange extending away from an outer surface and surrounding the shell and cushion unit, and the frame is generally shaped to substantially match a shape of the at least one flange of the shell and cushion unit.

39. The mask system according to claim 21, wherein the rotatable elbow includes a passage wall and a vent wall that extends away from the passage wall, the vent wall including at least one aperture therethrough, the at least one aperture lying at an angle to an outlet direction of air flowing out of the elbow.

40. The mask system according to claim 39, wherein the frame has a rearwardly projecting rib that engages the shell and cushion unit.

41. The mask system according to claim 40, further comprising a securing mechanism to secure the shell and cushion unit and the frame.

42. The mask system according to claim 21, wherein the cushion portion is either a full face cushion or a nasal cushion.

43. The mask system according to claim 21, wherein the elbow is freely rotatable when mounted on the mask system.

44. A mask system for treating sleep disordered breathing, comprising:

headgear;

a shell and cushion unit adapted to form a seal with a patient and defining an interior breathing chamber, the cushion portion being a full face cushion and having two walls and the shell portion including an opening with front and rear sides, and a projection oriented on the rear side of the opening towards the breathing chamber;

a frame shaped and adapted to be engaged with the shell and cushion unit, the frame being attachable to the headgear to position the mask system on a patient'"'"'s head; and

a rotatable elbow having a proximal end adapted to engage with the shell portion of the shell and cushion unit, an end of the rotatable elbow being rotatably received within the breathing chamber and engaging the shell portion projection.

45. The mask system according to claim 44, wherein the shell and cushion unit includes a centrally located front aperture and the shell portion projection is located adjacent the front aperture.

46. The mask system according to claim 45, wherein the frame includes a plurality of headgear anchor points and the shell and cushion unit aperture is provided generally between the headgear anchor points.

47. The mask system according to claim 44, wherein the elbow includes an approximately 90°

bend between the first and second ends thereof.

48. The mask system according to claim 47, further comprising a swivel attached to the rotatable elbow and adapted to engage an air delivery conduit.

49. The mask system according to claim 48, wherein the elbow comprises either a polycarbonate or polypropylene material.

50. The mask system according to claim 44, further comprising a ring member that receives the elbow.

51. The mask system according to claim 50, wherein the ring member and the frame are formed from a common material.

52. The mask system according to claim 51, wherein the ring member includes an annular flange.

53. The mask system according to claim 52, wherein the annular flange is symmetrical in shape.

54. The mask system according to claim 53, wherein the rotatable elbow includes a shoulder that abuts the annular flange.

55. The mask system according to claim 44, wherein the frame includes at least one opening through which at least a portion of the shell and cushion unit is exposed.

56. The mask system according to claim 55, wherein the frame is of a generally triangular shape with rounded apexes.

57. The mask system according to claim 56, wherein the frame includes anchor points for the headgear.

58. The mask system according to claim 57, wherein the frame includes two anchor points for the headgear.

59. The mask system according to claim 44, wherein the headgear comprises a multi-layered one-piece construction.

60. The mask system according to claim 44, wherein the shell and cushion unit has a generally triangular shape.

61. The mask system according to claim 60, wherein the shell and cushion unit includes at least one flange extending away from an outer surface and surrounding the shell and cushion unit, and the frame is generally shaped to substantially match a shape of the at least one flange of the shell and cushion unit.

62. The mask system according to claim 44, wherein the rotatable elbow includes a passage wall and a vent wall that extends away from the passage wall, the vent wall including at least one aperture therethrough, the at least one aperture lying at an angle to an outlet direction of air flowing out of the elbow.

63. The mask system according to claim 62, wherein the frame has a rearwardly projecting rib that engages the shell and cushion unit.

64. The mask system according to claim 63, further comprising a securing mechanism to secure the shell and cushion unit and the frame.

65. The mask system of claim 44, wherein the elbow is freely rotatable when mounted on the mask system.

66. A mask system for treating sleep disordered breathing, comprising:

headgear;

a combination shell and cushion unit defining an interior breathing chamber, adapted to form a seal with a face of a patient, and including a front aperture and a projection located adjacent a rear side of the front aperture such that the projection is oriented towards an interior of the breathing chamber;

a frame with a plurality of anchor points for anchoring the headgear to the frame and positioning the shell and cushion unit onto the patient'"'"'s head;

a rotatable elbow engaging the projection and including an inlet, an outlet, a passage wall and a vent wall that extends away from the passage wall and is in the vicinity of the outlet between the outlet and the inlet, the vent wall including at least one aperture therethrough the elbow being freely rotatable when mounted; and

a securing device that secures the frame to the shell and cushion unit, a portion of the shell and cushion unit being sandwiched between the securing device and the frame when the shell and cushion unit is secured to the frame.

67. The mask system according to claim 66, wherein the securing device passes through the portion of the shell and cushion unit to secure the shell and cushion unit to the frame.

68. The mask system according to claim 67, wherein the frame further comprises a rearwardly projecting rib.

69. The mask system according to claim 66, wherein the securing device is independent from the anchor points.

70. The mask system according to claim 69, wherein the securing device allows rotation of the elbow relative to the frame and the shell and cushion unit.

71. The mask system according to claim 66, wherein the at least one aperture lies at an oblique angle to a direction of air flowing through the outlet.

72. The mask system according to claim 71, wherein the angle is approximately 35 degrees.

73. The mask system according to claim 66, wherein the front aperture is provided generally between the anchor points.

74. The mask system according to claim 73, wherein the frame includes two anchor points for the headgear, and the mask system further comprises two additional anchor points for the headgear.

75. The mask system according to claim 66, further comprising a swivel attached to the rotatable elbow and adapted to engage an air delivery conduit.

76. The mask system according to claim 66, wherein the combination shell and cushion unit includes at least one flange extending away from an outer surface and surrounding the combination shell and cushion, and the frame having a shape which substantially matches the contours of the at least one flange.

77. The mask system according to claim 66, wherein the frame includes at least one opening through which at least a portion of the combination shell and cushion is exposed.

78. The mask system according to claim 67, wherein the frame is of a generally triangular shape with rounded apexes.

79. The mask system according to claim 66, wherein a sealing structure of the combination shell and cushion has two walls.

80. The mask system according to claim 66, wherein the frame is an exoskeletal frame.

81. The mask system according to claim 66, wherein a cushion portion of the shell and cushion unit comprises a nasal or full face cushion.

82. A mask system for treating sleep disordered breathing, comprising:

headgear;

a frame having a plurality of anchor points to connect the headgear;

a combined shell and cushion coupled to the frame and defining an interior breathing chamber, the combined shell and cushion comprising a cushion adapted to form a seal on the patient'"'"'s face and, on the opposing side, a shell defining a centrally located front aperture having a rigid retaining ring with a raised rim; and

an elbow rotatably directly connected to the retaining ring and having a first end fitted with a swivel connector for connecting a conduit providing air flow to the mask and a second end, a portion of the second end extending into the breathing chamber beyond the raised rim, the elbow including at least one undercut proximal the second end, the at least one undercut to retainably engage the raised rim of the retaining ring.

83. The mask system according to claim 82, wherein the headgear comprises a multi-layered one-piece construction.

84. The mask system according to claim 83, wherein the elbow includes an approximately 90°

bend between the first and second ends thereof.

85. The mask system according to claim 84, further comprising two anchor points to anchor the headgear.

86. The mask system according to claim 85, wherein the retaining ring and the frame comprise polycarbonate.

87. The mask system according to claim 86, wherein the elbow comprises polycarbonate.

88. The mask system according to claim 86, wherein the retaining ring, the elbow and the frame comprise a common material.

89. The mask system according to claim 82, wherein the frame includes first and second anchor points, and the mask system further comprises third and fourth anchor points, wherein the headgear includes four straps structured to be anchored to the anchor points.

90. The mask system according to claim 82, wherein the frame is an exoskeletal frame.

91. The mask system according to claim 82, wherein the elbow includes a passage wall and a vent wall that extends away from the passage wall, the vent wall including at least one aperture therethrough, the at least one aperture lying at an angle to an outlet direction of air flowing out of the elbow.

92. The mask system according to claim 91, wherein the frame has a rearwardly projecting rib that engages the combined shell and cushion.

93. The mask system according to claim 92, further comprising a securing mechanism to secure the combined shell and cushion and the frame.

94. The mask system according to claim 93, wherein a portion of the combined shell and cushion is sandwiched between the securing mechanism and the frame.

95. The mask system according to claim 94, wherein the securing mechanism passes through the portion of the combined shell and cushion.

96. The mask system according to claim 82, wherein the elbow is freely rotatable.

97. The mask system according to claim 82, wherein the cushion comprises a nasal or full face cushion.

98. A mask system for treating sleep disordered breathing, comprising:

headgear;

a mask comprising;

a frame having a plurality of anchor points to connect the headgear; and

a combined shell and cushion coupled to the frame and defining an interior breathing chamber, the combined shell and cushion comprising a cushion adapted to form a seal on the patient'"'"'s face and, on the opposing side, a shell defining a centrally located front aperture having positioned therein a rigid retaining ring with a raised rim; and

an elbow rotatably directly connected to the mask and having a first end fitted with a swivel connector for connecting a conduit providing air flow to the mask and a second end, a portion of the second end extending into the breathing chamber beyond the raised rim, the elbow including at least one undercut proximal the second end, the at least one undercut to retainably engage the raised rim of the retaining ring.

99. The mask system according to claim 98, wherein the headgear comprises a multi-layered one-piece construction.

100. The mask system according to claim 99, wherein the elbow includes an approximately 90°

bend between the first and second ends thereof.

101. The mask system according to claim 100, wherein the anchor points are proximate to lower rounded corners of the frame.

102. The mask system according to claim 101, wherein the retaining ring and the frame comprise a common material.

103. The mask system according to claim 102, wherein the elbow comprises polycarbonate.

104. The mask system according to claim 102, wherein the retaining ring, the elbow and the frame comprise polycarbonate.

105. The mask system according to claim 98, wherein the frame includes first and second anchor points, and the mask system further comprises third and fourth anchor points, wherein the headgear includes four straps structured to be anchored to the first, second, third and fourth anchor points, respectively.

106. The mask system according to claim 98, wherein the frame is an exoskeletal frame.

107. The mask system according to claim 98, wherein the elbow includes a passage wall and a vent wall that extends away from the passage wall, the vent wall including at least one aperture therethrough, the at least one aperture lying at an angle to an outlet direction of air flowing out of the elbow.

108. The mask system according to claim 107, wherein the frame has a rearwardly projecting rib that engages the combined shell and cushion.

109. The mask system according to claim 108, further comprising a securing mechanism to secure a portion of the combined shell and cushion and the frame.

110. The mask system according to claim 109, wherein the portion of the combined shell and cushion is sandwiched between the securing mechanism and the frame.

111. The mask system according to claim 110, wherein the securing mechanism passes through a portion of the combined shell and cushion.

112. The mask system according to claim 98, wherein the elbow is freely rotatable.

113. The mask system according to claim 98, wherein the cushion comprises a nasal or full face cushion.

114. A mask system for treating sleep disordered breathing, comprising:

headgear;

a mask comprising;

a frame having a plurality of anchor points to connect the headgear; and

a combined shell and cushion coupled to the frame and defining an interior breathing chamber, the combined shell and cushion comprising a cushion adapted to form a seal on the patient'"'"'s face and, on the opposing side, a shell having positioned therein a centrally located rigid retaining ring with a raised rim; and

an elbow rotatably directly connected to the mask and having a first end fitted with a swivel connector for connecting a conduit providing air flow to the mask and a second end, a portion of the second end extending into the breathing chamber beyond the raised rim, the elbow including at least one undercut proximal the second end, the at least one undercut to retainably engage the raised rim of the retaining ring.

115. The mask system according to claim 114, wherein the headgear comprises a multi-layered one-piece construction.

116. The mask system according to claim 115, wherein the elbow includes an approximately 90°

bend between the first and second ends thereof.

117. The mask system according to claim 116, wherein the anchor points are proximate to lower rounded corners of the frame.

118. The mask system according to claim 117, wherein the retaining ring and the frame comprise a common material.

119. The mask system according to claim 118, wherein the elbow comprises polycarbonate.

120. The mask system according to claim 118, wherein the retaining ring, the elbow and the frame comprise a common material.

121. The mask system according to claim 114, wherein the frame includes first and second anchor points, and the mask system further comprises third and fourth anchor points, wherein the headgear includes four straps structured to be anchored to the first, second, third and fourth anchor points, respectively.

122. The mask system according to claim 114, wherein the frame is an exoskeletal frame.

123. The mask system according to claim 114, wherein the elbow includes a passage wall and a vent wall that extends away from the passage wall, the vent wall including at least one aperture therethrough, the at least one aperture lying at an angle to an outlet direction of air flowing out of the elbow.

124. The mask system according to claim 123, wherein the frame has a rearwardly projecting rib that engages the combined shell and cushion.

125. The mask system according to claim 124, further comprising a securing mechanism to secure the combined shell and cushion and the frame.

126. The mask system according to claim 125, wherein a portion of the combined shell and cushion is sandwiched between the securing mechanism and the frame.

127. The mask system according to claim 126, wherein the securing mechanism passes through the portion of the combined shell and cushion.

128. The mask system according to claim 114, wherein the elbow is freely rotatable when mounted on the mask system.

129. The mask system according to claim 114, wherein the cushion comprises a nasal or full face cushion.

130. A mask system for treating sleep disordered breathing, comprising:

headgear;

a frame having a plurality of anchor points to connect the headgear;

a combined shell and cushion coupled to the frame and defining an interior breathing chamber, the combined shell and cushion comprising a cushion adapted to form a seal on the patient'"'"'s face and, on the opposing side, a shell having an integrally formed and centrally located rigid retaining ring with a raised rim; and

an elbow rotatably directly connected to the retaining ring and having a first end fitted with a swivel connector for connecting a conduit providing air flow to the mask and a second end, a portion of the second end extending into the breathing chamber beyond the raised rim, the elbow including at least one undercut proximal the second end, the at least one undercut to retainably engage the raised rim of the retaining ring.

131. The mask system according to claim 130, wherein the headgear comprises a multi-layered one-piece construction.

132. The mask system according to claim 131, wherein the elbow includes an approximately 90°

bend between the first and second ends thereof.

133. The mask system according to claim 132, wherein the anchor points are proximate to lower rounded corners of the frame.

134. The mask system according to claim 133, wherein the retaining ring and the frame comprise a common material.

135. The mask system according to claim 134, wherein the elbow comprises polycarbonate.

136. The mask system according to claim 134, wherein the retaining ring, the elbow and the frame comprise a common material.

137. The mask system according to claim 130, wherein the frame includes first and second anchor points, and the mask system further comprises third and fourth anchor points, wherein the headgear includes four straps structured to be anchored to the anchor points.

138. The mask system according to claim 130, wherein the frame is an exoskeletal frame.

139. The mask system according to claim 130, wherein the elbow includes a passage wall and a vent wall that extends away from the passage wall, the vent wall including at least one aperture therethrough, the at least one aperture lying at an angle to an outlet direction of air flowing out of the elbow.

140. The mask system according to claim 139, wherein the frame has a rearwardly projecting rib that engages the combined shell and cushion.

141. The mask system according to claim 140, further comprising a securing mechanism to secure the combined shell and cushion and the frame.

142. The mask system according to claim 141, wherein the combined shell and cushion is sandwiched between the securing mechanism and the frame.

143. The mask system according to claim 142, wherein the securing mechanism passes through a portion of the combined shell and cushion.

144. The mask system according to claim 130, wherein the elbow is freely rotatable when mounted on the mask system.

145. The mask system according to claim 130, wherein the cushion comprises a nasal or full face cushion.