Nasal assembly

• US 7,874,293 B2
• Filed: 02/20/2004
• Issued: 01/25/2011
• Est. Priority Date: 02/21/2003
• Status: Active Grant

• Current Assignee: ResMed Pty Ltd. (ResMed Incorporated)
• Original Assignee: Resmed Limited (ResMed Incorporated)
• Inventors: Hitchcock, Robin Garth, Lynch, Susan Robyn, Veliss, Lee James, Guney, Memduh, Lithgow, Perry David, Sokolov, Richard, Kwok, Philip Rodney, Darkin, Donald, Gunaratnam, Michael Kassipillai
• Primary Examiner(s): Douglas; Steven O
• Assistant Examiner(s): Ostrup; Clinton
• Application Number:
  US10/546,305
• Publication Number:
  US 20060137690A1
• Time in Patent Office: 2,531 Days
• Field of Search: 128/207.18, 128/202.27, 128/204.18, 128/205.25, 128/206.21, 128/206.24, 128/207.13, 128/207.17, 128/206.18, 128/207.11
• US Class Current: 128/207.18
• CPC Class Codes: A61M 16/0611 with a gusset portion
• CPC Class Codes: A61M 16/0622 having an underlying cushion
• CPC Class Codes: A61M 16/0633 with forehead support
• CPC Class Codes: A61M 16/0644 having the means for adjusting its position
• 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 16/08 Bellows; Connecting tubes having means for taking samples G01N1/22; Water traps; Patient circuits
• CPC Class Codes: A61M 16/0816 Joints or connectors
• CPC Class Codes: A61M 16/0825 with ball-sockets
• CPC Class Codes: A61M 16/0833 T- or Y-type connectors, e.g. Y-piece
• CPC Class Codes: A61M 2016/0661 with customised shape

Abstract

A nasal assembly for delivering breathable gas to a patient includes a frame having an integrally formed first connector portion. A nozzle assembly includes a gusset or base portion and a pair of nozzles. At least one inlet conduit is structured to deliver breathable gas into the frame and nozzle assembly for breathing by the patient. A pair of second connector portions are removably and rotatably connected to respective first connector portions of the frame and are in communication with respective inlet conduits, e.g., directly or via angle connectors. A headgear assembly is removably connected to the pair of second connector portions and/or the angle connectors so as to maintain the frame and the nozzle assembly in a desired adjusted position on the patient'"'"'s face.

Claims

1. A nasal assembly for delivering breathable gas to a patient, comprising:

a rigid frame having a main body 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;

a flexible nozzle assembly including flexible base portion and a pair of flexible nozzles movable relative to the flexible base portion, the base portion including side walls adapted to sealingly engage with the frame, and a central wall, the pair of nozzles being attached to the central wall, the nozzle assembly being coupled with the main body of the frame with the pair of nozzles structured to sealingly engage with nasal passages of a patient'"'"'s nose in use;

at least one inlet conduit structured to deliver breathable gas into the frame and nozzle assembly for breathing by the patient;

a pair of second connector portions connected to a respective first connector portion of the frame; and

a headgear assembly removably connected to at least one of the pair of second connector portions so as to maintain the frame and the nozzle assembly in a desired adjusted position on the patient'"'"'s face.

2. The nasal assembly according to claim 1, wherein the frame is rotatable with respect to the pair of second connector portions so as to adjust a position of the nozzles with respect to the patient'"'"'s nose in use, without detaching the first and second connector portions.

3. The nasal assembly according to claim 1, wherein the pair of second connector portions are releasably interlockable with the headgear assembly.

4. The nasal assembly according to claim 3, wherein the pair of second connector portions include respective grooves that are engagable with retaining members provided on yokes of the headgear assembly.

5. The nasal assembly according to claim 4, wherein the retaining members are ring shaped members.

6. The nasal assembly according to claim 5, further comprising an angle connector provided to each said second connector portion, each said angle connector including a first locking member and the headgear includes a second locking member.

7. The nasal assembly according to claim 1, wherein each of the second connector portions includes an interlock for engagement with an angle connector.

8. The nasal assembly according to claim 7, wherein the interlock is an undercut.

9. The nasal assembly according to claim 1, wherein the at least one inlet conduit includes a plurality of channels.

10. The nasal assembly according to claim 9, further comprising an angle connector provided to each said second connector portion, each said angle connector including elongated connectors structured to engage each of the channels of the respective inlet conduit.

11. The nasal assembly according to claim 10, wherein the elongated connectors have a tapered configuration to facilitate connection.

12. The nasal assembly according to claim 1, wherein the headgear assembly helps retain the second connector portions on the frame.

13. The nasal assembly according to claim 12, wherein the headgear assembly includes a pair of retaining members engaged with respective second connector portions so as to transfer headgear force to the frame and thereby help prevent inadvertent detachment of the second connector portions from the frame.

14. The nasal assembly according to claim 1, wherein the headgear assembly is connected to both the second connector portions and associated angle connectors.

15. The nasal assembly according to claim 1, wherein the headgear assembly is structured to transfer a tube force to the headgear assembly or the frame, to avoid application of the tube force to the nozzle assembly.

16. The nasal assembly according to claim 15, wherein the headgear assembly includes a pair of retaining or locking members engaged with respective second connector portions and/or angle connectors, so as to transfer the headgear force to the frame.

17. The nasal assembly according to claim 1, wherein the headgear assembly allows symmetrical adjustment.

18. The nasal assembly according to claim 17, wherein the headgear assembly includes a pair of headgear yokes coupled to one another by a headgear buckle, the headgear buckle structured to allow symmetrical adjustment of the headgear assembly.

19. The nasal assembly according to claim 18, wherein the headgear buckle includes a first locking portion adapted to be removably and adjustably coupled with one of the pair of headgear yokes and a second locking portion adapted to be removably and adjustably coupled with the other of the pair of headgear yokes.

20. The nasal assembly according to claim 1, wherein each second connector portion is formed with an adjustment portion that allows relative movement between the second connector portion and an angle connector.

21. The nasal assembly according to claim 20, wherein the adjustment portion comprises a flexible corrugation in the second connector portion.

22. The nasal assembly according to claim 1, further comprising a flow generator connector structured to interconnect the at least one inlet conduit with a pressurized supply.

23. The nasal assembly according to claim 22, wherein the flow generator connector includes a first elongated connector structured to engage the at least one inlet conduit and a second elongated connector structured to engage the another said at least one inlet conduit.

24. The nasal assembly according to claim 23, wherein the flow generator connector has a general Y-shape with the first elongated connectors angled with respect to the second elongated connectors.

25. The nasal assembly according to claim 23, wherein the first and second elongated connectors have a tapered configuration to facilitate connection.

26. The nasal assembly according to claim 1, wherein the nozzle assembly wraps around the main body of the frame.

27. The nasal assembly according to claim 1, wherein the nozzle assembly is secured to the frame with a clip.

28. The nasal assembly according to claim 27, wherein the nozzle assembly includes a pair of opposing spaced apart end portions, the end portions being secured between the frame and the clip.

29. The nasal assembly according to claim 1, wherein the frame is secured to the nozzle or nasal assembly such that the frame is angled away from an upper lip of the patient in use.

30. The nasal assembly according to claim 1, wherein the nozzle assembly is easily removable from the frame to facilitate cleaning of the nozzle assembly.

31. The nasal assembly according to claim 1, wherein the nozzle assembly is accessible for cleaning.

32. The nasal assembly according to claim 31, wherein the nozzle assembly has a generally tubular configuration with a longitudinal opening.

33. The nasal assembly according to claim 1, wherein the nozzle assembly has a generally tubular configuration with a longitudinal opening to facilitate manufacturing.

34. The nasal assembly according to claim 1, wherein the inlet conduits provide low impedance.

35. The nasal assembly according to claim 34, wherein the inlet conduits provide impedance less than about 3 cm H₂O, for a given flow rate.

36. The nasal assembly according to claim 1, wherein the second connector portions are flexible to dampen tube drag forces.

37. The nasal assembly according to claim 1, wherein the inlet conduits have a low profile.

38. The nasal assembly according to claim 1, wherein the second connector portions are flexible without obstructing airflow.

39. The nasal assembly according to claim 1, wherein the nozzle assembly is contoured to accommodate a patient'"'"'s septum.

40. The nasal assembly according to claim 1, wherein the headgear assembly includes stiffeners to add rigidity to the headgear assembly.

41. The nasal assembly according to claim 1, wherein the at least one inlet conduit is constructed with kink and/or occlusion resistant tubing.

42. The nasal assembly according to claim 1, wherein the second connector portions include a seal ring provided to one said first connector portion and a plug provided to another said first connector portion, said at least one inlet conduit being provided to the seal ring.

43. The nasal assembly according to claim 42, wherein the plug and the seal ring are non-rotatably mounted on the headgear.

44. The nasal assembly according to claim 43, wherein the headgear includes a yoke arranged to non-rotatably mate with respect to at least one of the plug and the seal ring.

45. The nasal assembly according to claim 1, further comprising a tube retainer including a first portion provided to a portion of the headgear, and a second portion constructed to receive the at least one inlet conduit.

46. The nasal assembly according, to claim 45, wherein the second portion includes at least one slot to receive a ribbed portion of the inlet conduit.

47. The nasal assembly according to claim 1, wherein the at least one conduit is rotatably provided to one of the second connector portions, wherein rotation is limited to a predetermined angular extent.

48. The nasal assembly according to claim 47, wherein said one second connector portion is a seal ring provided with at least one stop to define said angular extent.

49. The nasal assembly according to claim 1, wherein said at least one inlet conduit includes an elbow connector provided to one of said second connector portions, said elbow connector having first and second legs that are angled at more than 90 degrees from one another.

50. The nasal assembly according to claim 1, wherein the frame and nozzle assembly are rotatable with respect to the second connector portions so as to adjust the nozzle relative to the patient in use.

51. The nasal assembly according to claim 50, wherein the nozzle assembly includes a plurality of visual indicators which can be selectively matched with a reference indicator provided adjacent the visual indicators.

52. The nasal assembly according to claim 51, wherein the reference indicator is provided on a yoke of the headgear.

53. A nasal assembly according to claim 1, wherein at least one of the second connector portions is in communication with the at least one inlet conduit.

54. A nasal assembly for delivering breathable gas to a patient, including:

i) a frame;

ii) a nozzle assembly including a base portion and a pair of nozzles, the pair of nozzles being structured to sealingly engage around the openings of a patient'"'"'s nose in use;

iii) at least one inlet conduit structured to deliver breathable gas into the frame and nozzle assembly for breathing by the patient;

iv) a mount arrangement to allow the nozzle assembly to be repeatedly detachable from and reattachable to the frame;

v) a headgear assembly for securing the frame and nozzle assembly in a desired adjusted position on the patient'"'"'s face, said headgear assembly being detachably mountable to the frame, and including;

first and second relatively flexible generally Y-shaped straps constructed from a soft, flexible composite material, the first and second Y-shaped straps having;

respective first and second rear strap portions in use extending from above the patient'"'"'s ears around the back of the patient'"'"'s head and passing through and being adjustably coupled together via a rear strap buckle,

respective first and second upper strap portions in use extending over the top of the patient'"'"'s head and passing through and being adjustably coupled together via a top strap buckle, and

respective first and second side strap portions in use extending along the patient'"'"'s cheeks towards the frame and nozzle assembly;

each of the side strap portions including a stiffening support structure extending from above the patient'"'"'s ears along the lengths thereof, the stiffening support structure being arranged to assist in stabilizing the nasal assembly on the head of the patient during use.

55. A nasal assembly according to claim 54 wherein the stiffening support structure does not extend along the first and second rear and upper strap portions.

56. A nasal assembly according to claim 54, wherein the rear and top strap buckles are structured to allow symmetrical adjustment of the headgear assembly, and are arranged to be centrally located on the head of the patient.

57. A nasal assembly according to claim 54, which includes a breathable gas delivery tube movably coupled to said at least one inlet conduit by an elbow.

58. A nasal assembly according to claim 57, wherein at least one tube retainer in the form of a hook and loop fastener is provided for detachably connecting the gas delivery tube to one of the strap portions of the headgear assembly.

59. A nasal assembly according to claim 54, wherein the first and second upper strap portions are structured to adjust a sealing force of the nozzle assembly by pulling the frame and nozzle assembly up towards and the pair of nozzles up into the patient'"'"'s nose, and the first and second rear strap portions are structured to adjust the stability of the nasal assembly by pulling the frame and nozzle assembly back into the patient'"'"'s face against the top lip of the patient.

60. A nasal assembly for delivering breathable gas to a patient, comprising:

a frame, the frame comprising a main body comprising two opposed ends, each end having a first connector portion integrally formed with the main body, each first connector portion having a recess on an inner surface thereof, the main body further comprising opposed side walls between the opposed ends that define a central opening;

a nozzle assembly comprising a base portion and a pair of nozzles structured to sealingly engage with nasal passages of a patient'"'"'s nose in use, the nozzle assembly being detachably coupled to the main body of the frame at the central opening to sealingly engage the opposed side walls of the central opening;

a tube to deliver the breathable gas to the frame and nozzle assembly for breathing by the patient, the tube having a first end and a second end;

an elbow connected to the first end of the tube, the elbow comprising a first end being detachably pivotably connectable to either one of the opposed ends of the main body of the frame by inserting the first end of the elbow into one of the recesses of the first connector portions, the first end of the elbow having a head portion having a larger diameter than a diameter of the recesses of the first connector portion, the elbow further comprising at least one slot to allow the head portion to resiliently flex to reduce its diameter upon insertion into one of the recesses of the first connector portions;

a headgear assembly detachably connectable to the frame to maintain the frame and the nozzle assembly in a desired adjusted position on the patient'"'"'s face, the headgear assembly comprising

a pair of Y-shaped straps, each Y-shaped strap comprising a side strap having a first end adjacent the frame and extending in use along the patient'"'"'s cheek to a second end above the patient'"'"'s ear, an upper strap extending from the second end of the side strap and in use passing over a top of the patient'"'"'s head, and a rear strap extending from the second end of the side strap and in use passing around the rear of the patient'"'"'s head,

an upper strap buckle configured to couple the upper straps together,

a rear strap buckle configured to couple the rear straps together, the buckled upper straps and rear straps encircling the crown of the patient'"'"'s head in use, and

a yoke connected to each side strap of each Y-shaped strap, each yoke comprising a second connector portion configured to detachably connect the yoke to a respective first connector portion of the frame, the second connector portion of each yoke rotatably connecting the yoke and the frame relative to each other; and

a plug configured to be inserted into the recess of the other first connector portion of the frame not connected to the swivel elbow.

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

a tube retainer configured to be connected to the headgear assembly.

62. A nasal assembly according to claim 61, wherein the tube retainer comprises a loop having a first end and a second end, and the first end and the second end comprising hook and loop material, respectively.

63. A nasal assembly according to claim 62, wherein the tube comprises at least one rib disposed around an outer surface thereof.

64. A nasal assembly according to claim 63, wherein the tube has a length of about 200 mm-400 mm.

65. A nasal assembly according to claim 64, wherein the tube has a length of about 250 mm-350 mm.

66. A nasal assembly according to claim 64, wherein the tube further comprises a swivel connector at a second end.

67. A nasal assembly according to claim 66, wherein the second connector portions of the yokes comprises rings configured to receive the first connector portions of the frame.

68. A nasal assembly according to claim 67, wherein the yoke rings comprise a plurality of alignment marks and the nozzle assembly includes a plurality of alignment markers that can be selectively aligned with the alignment marks.

69. A nasal assembly according to claim 68, wherein each of the upper straps and the rear straps are constructed from a soft, flexible composite material and ends of the upper straps and lower straps comprise hooks configured to engage the soft, flexible composite material to fasten the ends to the straps.

70. A nasal assembly for delivering breathable gas to a patient, comprising:

a main conduit portion including a central portion, a first side inlet opening and a side second inlet opening;

a nozzle assembly provided to the central portion of the main conduit portion, said nozzle assembly including a pair of nozzles adapted to form a seal with the patient'"'"'s nares in use;

a gas washout vent provided to the nozzle assembly, the gas washout vent including a plurality of openings for gas washout;

first and second connectors engaged with the first and second inlet openings;

an inlet conduit in fluid communication with the main conduit portion via the first or second connector;

a headgear assembly to support the nozzle assembly in a desired position of the patient'"'"'s face in use, the headgear assembly including two generally Y-shaped straps made of a soft, flexible material, each of said Y-shaped straps defining a side strap configured to extend between the eye and ear and along the cheek of the patient in use, an upper strap configured to pass over the top of the patient'"'"'s head in use and rear strap configured to pass around the rear portion of the patient'"'"'s head in use; and

a stiffener provided along at least a portion of the length of each said side strap, each said stiffener having an end portion including a ring-shaped retainer or circular filling integrally formed therewith, each of the first and second connectors being engaged with a respective first or second side inlet opening of the main conduit portion and being oriented and arranged such that the ring-shaped retainer surrounds a portion of the respective first or second connector in a connected position.

71. A nasal assembly according to claim 70, wherein each nozzle includes a hollow, generally cone-shaped portion coupled to a base portion via a hollow stem portion of reduced cross-section.

72. A nasal assembly according to claim 71, wherein each nozzle has a distal opening with a generally oval shape having a major diameter and a minor diameter.

73. A nasal assembly according to claim 72, wherein the nozzles are constructed of flexible material.

74. A nasal assembly according to claim 73, wherein the flexible material includes a silicone elastomer.

75. A nasal assembly according to claim 74, wherein the main conduit portion is rotatable to allow an infinite amount of settings for alignment of the nozzles with respect to the nasal passages of the patient.

76. A mask nasal assembly according to claim 75, wherein the upper straps have length-adjustable ends coupled to one another via a top buckle, and the rear straps have length-adjustable ends coupled to one another via a rear buckle.

77. A mask nasal assembly according to claim 76, wherein the upper and rear straps include hook and loop fasteners.

78. A mask nasal assembly according to claim 77, wherein a width of each stiffener is less than a width of each side strap.

79. A nasal assembly according to claim 78, wherein the retainer ring is formed in a plane that is generally orthogonal to a longitudinal plane of the stiffener, with the stiffener being positioned along only a limited circumference of the retainer ring.

80. A nasal assembly according to claim 79, wherein each retainer ring, side inlet opening and connector share a common longitudinal axis in the coupled position.

81. A nasal assembly according to claim 80, wherein the stiffener is made of a plastic material.

82. A nasal assembly according to claim 81, wherein the first connector is in the form of an elbow.

83. A nasal assembly according to claim 82, wherein the second connector is in the form of a plug.

84. A nasal assembly according to claim 83, wherein the stiffener retains at least a partial portion of the basic shape of the headgear assembly.

85. A nasal assembly according to claim 84, wherein the inlet conduit may be selectively routed in either first or second positions relative to the patient.

86. A nasal assembly according to claim 85, wherein, in the first position, the inlet conduit is to extend upwardly over the head of the patient in use.

87. A nasal assembly according to claim 86, wherein, in the second position, the inlet conduit is routed downwardly under the chin of the patient in use.

88. A nasal assembly according to claim 87, further comprising hook and loop fasteners to fasten the inlet conduit to the respective Y-shaped straps.

89. A nasal assembly for delivering pressurized breathable gas to a user, comprising:

a support frame having a central portion and a pair of lateral support arms extending laterally away from the central portion, each lateral support arm including an integrally formed connector slot;

a silicone pillows cushion including a base portion and a pair of nozzles formed in one piece with the base portion, the pillows cushion being removably coupled with the central portion of the support frame with the pair of nozzles structured to sealingly engage with nasal passages of a user'"'"'s nose in use, wherein the nozzles, as a unit, are rotatably adjustable between a plurality of positions to align the nozzles with the nasal passages of the user;

an inlet tube having a first end provided with a connector to be connected to a source of pressurized breathable gas via an air delivery tube, and a second end provided to deliver the gas into the support frame for breathing by the user via the pillows cushion; and

headgear including a back strap to pass around the rear portion of the user'"'"'s head, a top strap to pass over the top of the user'"'"'s head, and a pair of depending side straps each of which is suspended from a junction between the back and top straps, said depending side straps being configured to extend forwardly of the ear along the user'"'"'s face, each of said depending side straps having an end received in a respective one of said connector slots of said lateral support arms.

90. A nasal assembly according to claim 89, not including a support for the bridge of the user'"'"'s nose or the user'"'"'s forehead.

91. A nasal assembly according to claim 90, further comprising an exhalation port provided to the pillows cushion and including a plurality of orifices for CO₂ washout.

92. A nasal assembly according to claim 91, wherein the base portion includes opposed side walls that interlock with respective lateral side walls of the support frame.

93. A nasal assembly according to claim 92, wherein an opening of each nozzle is in the form of an ellipse having a major axis and a minor axis.

94. A nasal assembly according to claim 93, wherein each of the pair of nozzles has a first portion integrally formed with the base portion in communication with a respective outlet opening provided in the base portion, and a second portion integrally formed with the first portion to sealingly engage with the nasal passages of the user'"'"'s nose in use.

95. A nasal assembly according to claim 94, wherein the first portion is necked down relative to the second portion.

96. A nasal assembly according to claim 95, wherein the second portion is in the form of a hollow, truncated cone.

97. A nasal assembly according to claim 96, wherein the second portion has one portion to seal on the underside of the nostrils and another portion to enter into the nasal passage of the user in use.

98. A nasal assembly according to claim 97, wherein side walls of the first and second portions are concave.

99. A nasal assembly according to claim 98, wherein the pillows cushion is rotatable relative to the headgear about an axis positioned below the user'"'"'s nose in use.

100. A nasal assembly according to claim 99, wherein the axis extends substantially transverse to and below the nozzles.

101. A nasal assembly according to claim 100, wherein the pillows cushion is structured to be rotatable about an axis that extends generally parallel to the user'"'"'s lips.