Ergonomic and adjustable respiratory mask assembly with headgear assembly

• US 20070119458A1
• Filed: 01/26/2007
• Published: 05/31/2007
• Est. Priority Date: 04/23/2002
• Status: Active Grant

• Current Assignee: ResMed Pty Ltd. (ResMed Incorporated)
• Original Assignee: Resmed Limited (ResMed Incorporated)
• Inventors: Nasr, Saad, Ging, Anthony
• Granted Patent: US 7,341,060 B2
• Time in Patent Office: Days
• US Class Current: 128/206.260
• CPC Class Codes: A61M 16/0057 Pumps therefor
• CPC Class Codes: A61M 16/0066 Blowers or centrifugal pumps
• CPC Class Codes: A61M 16/06 Respiratory or anaesthetic masks
• CPC Class Codes: A61M 16/0605 Means for improving the adaptation of the mask to the patient
• CPC Class Codes: A61M 16/0616 with face sealing means comprising a flap or membrane projecting inwards, such that sealing increases with increasing inhalation gas pressure
• CPC Class Codes: A61M 16/0622 having an underlying cushion
• CPC Class Codes: A61M 16/0633 with forehead support
• CPC Class Codes: A61M 16/0666 Nasal cannulas or tubing devices for improving normal breathing through the nose A61F5/08; nose filters A62B23/06; outside holding devices A61M25/02
• CPC Class Codes: A61M 16/0683 Holding devices therefor
• CPC Class Codes: A61M 16/0694 Chin straps
• CPC Class Codes: A61M 16/0816 Joints or connectors
• CPC Class Codes: A61M 16/0825 with ball-sockets
• CPC Class Codes: A61M 16/0875 Connecting tubes
• CPC Class Codes: A61M 16/22 Carbon dioxide-absorbing devices ; Other means for removing carbon dioxidecartridges with absorbing substances for respiratory apparatus A62B19/00
• CPC Class Codes: A61M 2206/14 Static flow deviators in tubes disturbing laminar flow in tubes, e.g. archimedes screws
• CPC Class Codes: A61M 2210/0618 Nose
• CPC Class Codes: A62B 18/084 Means for fastening gas-masks to heads or helmets
• CPC Class Codes: Y10T 24/1959 Magnetic, adhesive, or snap type fastener connects tie to shirt
• CPC Class Codes: Y10T 24/32 having magnetic fastener

Abstract

A respiratory mask assembly for delivering breathable gas to a patient includes a frame having a main body and a side frame member provided on each lateral side of the main body. Each side frame member includes an integrally formed first connector portion. A headgear assembly is removably attachable to the frame. The headgear assembly has a second connector portion adapted to be removably coupled with the first connector portion provided on the frame. The second connector portion is manually movable to a releasing position to detach the headgear assembly from the frame. The headgear assembly is rotationally adjustable with respect to the frame.

Claims

1-20. -20. (canceled)

21. A nasal pillows assembly for nasal CPAP therapy of a patient comprising:

(i) a frame including a first alignment indicator, an aperture and a channel having an inner wall, an outer wall and a channel floor;

(ii) silicone nasal pillows selectively and repeatedly attachable to and detachable from the frame, the seal having a face-contacting side and a non-face contacting side, the non-face contacting side being engagable between the inner and outer walls of the frame, the nasal pillows including a second alignment indicator on an outer surface of the nasal pillows adapted to align with the first alignment indicator on the frame as the cushion and frame are engaged with one another;

(iii) a rotatable elbow adapted to engage the aperture provided in the frame including one or more vent openings open to atmosphere for gas washout of exhaled carbon dioxide, the elbow assembly being adapted to connect to a gas delivery tube in order to supply pressurized air to the entrance of the patient'"'"'s airway; and

(iv) a headgear assembly to provide added stability to the nasal pillows including a pair of front straps having a layered fabric and foam structure and having attached by stitching thereto at least one yoke portion, each said yoke portion being constructed of a somewhat rigid material and having a relative stiffness that helps to position the frame and nasal pillows in the correct position on the patient, each said yoke portion being narrower than each front strap so that when the yoke portion and strap are attached together the softer material of the front straps extends beyond the more rigid material of the yoke portion, thereby preventing or at least reducing the opportunity for contact between the patient and the more rigid material of the yoke portion, the yoke portion being further adapted to add to the rigidity of the straps in certain planes and directions to assist in stabilizing the nasal pillows assembly on the head of the patient during use, and when fitted the front end of the yoke portion is connected to the frame below the patient'"'"'s eyes.

22. The assembly of claim 21, wherein the thickness of the yoke portion varies across its profile to modify the flexibility characteristics.

23. The assembly of claim 21, wherein the width of the channel between the upstanding surfaces of the inner and outer walls that face each other is in the range of about 2-10 mm.

24. The assembly of claim 21, wherein the first alignment indicator includes an arrow.

25. The assembly of claim 21, wherein the channel forms a groove of a tongue and groove arrangement.

26. The assembly of claim 21, not including a forehead support.

27. The assembly of claim 21, wherein the yoke has a thickness in the range of 0.3 to 2 mm.

28. The assembly of claim 21, wherein the headgear further includes strap structure adapted to engage the occiputal portion of the patient'"'"'s head.

29. The assembly of claim 28, wherein a lower strap of the strap structure engages a lower region of the occiputal portion of the patient'"'"'s head.

30. A headgear assembly for a patient interface for nasal continuous positive airway pressure therapy of sleep disordered breathing of a patient, the patient interface being in the form of a nose and mask assembly, nasal cushions, or a nasal prongs or pillow assembly, the headgear assembly including head straps and at least one layer which imparts a degree of stiffness to the head straps to assist in the stabilization of the patient interface, the layer being constructed from a plastic material and having a thickness in the range of 0.3 to 2.0 mm, the layer having different flexibilities in different directions and being attached to a head strap by stitching, the layer having a width that is narrower than the head strap to prevent or at least reduce the opportunity for contact between the patient and the more rigid material of the layer.

31. The headgear assembly of claim 30, wherein the head straps further include strap structure adapted to engage the occiputal portion of the patient'"'"'s head.

32. The headgear assembly of claim 30, wherein the headgear assembly maintains stability of the mask in use without a forehead support.

33. The headgear assembly of claim 30, wherein the headstraps are constructed from a layered fabric and foam structure.

34. The headgear assembly of claim 30, including a pair of front straps.

35. The headgear assembly of claim 33, wherein the pair of front straps includes left and right front straps.

36. The headgear assembly of claim 35, wherein the left and right front straps are mirror images of each other.

37. The headgear assembly of claim 34, wherein the layer is attached to each of the front straps.

38. The headgear assembly of claim 34, wherein the front ends of the layer are adapted to be connected to the frame below the patient'"'"'s eyes in use.

39. The headgear assembly of claim 38, wherein the layer is adapted to extend along a curved arc resting across the cheek regions in use.

40. The headgear assembly of claim 30, wherein the layer is a yoke portion.

41. The headgear assembly of claim 34, wherein the front straps have top strap ends.

42. The headgear assembly of claim 41, wherein the layer has a top end and the top end does not extend as far as the top strap ends.

43. The headgear assembly of claim 34, wherein due to the rigidity provided by the layer, the front straps are better able to maintain a predetermined shape.

44. The headgear assembly of claim 30, wherein the thickness of the layer varies to modify flexibility characteristics.

45. The headgear assembly of claim 30, wherein the layer has a thicker region.

46. The headgear assembly of claim 45, wherein the thicker region of the layer is stiffer.

47. The headgear assembly of claim 30, wherein the layer is constructed from nylon 11 or propylene.

48. The headgear assembly of claim 30, wherein fastening of the straps is assisted by use of a hook and loop material.

49. The headgear assembly of claim 30, wherein the layer is constructed from a plastic material.

50. The headgear assembly of claim 30, wherein the layer has different flexibilities in different directions.

51. The headgear assembly of claim 30, wherein the layer is attached to a headstrap by stitching.

52. The headgear assembly of claim 30, wherein the layer has a width that is narrower than the headstrap to prevent or at least reduce the opportunity for contact between the patient and the more rigid material of the layer.

53. A nasal mask assembly for nasal CPAP therapy of a patient comprising:

(i) a mask frame including a first alignment indicator, an aperture and a channel having an inner wall, an outer wall and a channel floor;

(ii) a silicone nasal seal having a face-contacting side and a non-face contacting side, the non-face contacting side being engagable between the inner and outer walls of the frame in a manner that allows the nasal seal to be repeatedly detachable from and re-attachable to the frame, the nasal seal including a second alignment indicator on an outer surface of the nasal seal that aligns with the first alignment indicator of the frame as the nasal seal and the frame are engaged with one another;

(iii) an elbow rotatably coupled to the frame and adapted to connect to a gas delivery tube in order to supply pressurized gas to the entrance of the patient'"'"'s airway via the aperture of the frame, the elbow including one or more vent openings open to atmosphere for washout of patient exhalation gases; and

(iv) a headgear assembly to generally secure the frame and nasal seal to the patient'"'"'s head, said headgear assembly including a pair of relatively flexible, generally Y-shaped straps having a relatively soft fabric and foam material construction, and a stiffening support structure made of a relatively rigid material compared to the strap material, said stiffening support structure being stitched to an outside surface of at least a front portion of the pair of straps, said stiffening support structure providing added stability to the nasal seal on the patient'"'"'s face in use, said stiffening support structure being narrower than the strap portion to which it is stitched so that when the stiffening support structure and strap are attached together the relatively softer material of the strap extends beyond the relatively rigid material of the stiffening support structure, thereby preventing or at least reducing the opportunity for contact between the patient and the relatively rigid material of the stiffening support structure in use.

54. The nasal mask assembly of claim 53, said nasal mask assembly not having a forehead support.

55. The nasal mask assembly of claim 54, wherein the stiffening support structure is constructed from a plastic material and has a thickness in the range of about 0.3 mm to about 2.0 mm.

56. The nasal mask assembly of claim 53, wherein the stiffening support structure forms a connection with the frame and, when fitted, a front end of the stiffening support structure is connected to the frame below the patient'"'"'s eyes.

57. The nasal mask assembly of claim 53, wherein the nasal seal comprises nasal pillows.

58. A headgear assembly for securing a mask frame and nasal seal of a nasal mask assembly to a patient'"'"'s head, said headgear assembly including a pair of relatively flexible, generally Y-shaped straps having a relatively soft fabric and foam material construction, and a stiffening support structure made of a relatively rigid material compared to the strap material, said stiffening support structure being stitched to an outside surface of at least a front portion of the pair of straps, said stiffening support structure providing added stability to the nasal seal on the patient'"'"'s face in use, said stiffening support structure being narrower than the strap portion to which it is stitched so that when the stiffening support structure and strap are attached together the relatively softer material of the strap extends beyond the relatively rigid material of the stiffening support structure, thereby preventing or at least reducing the opportunity for contact between the patient and the relatively rigid material of the stiffening support structure in use.

59. The headgear assembly of claim 58, said headgear assembly not having a forehead support.

60. The headgear assembly of claim 59, wherein the stiffening support structure is constructed from a plastic material and has a thickness in the range of about 0.3 mm to about 2.0 mm.

61. The headgear assembly of claim 60, wherein said plastic material is nylon or polypropylene.

62. The headgear assembly of claim 58, wherein the stiffening support structure is adapted to form a connection with the frame and, when fitted, a front end of the stiffening support structure is connected to the frame below the patient'"'"'s eyes.

63. A headgear assembly to generally secure a mask to a patient'"'"'s head, the headgear assembly comprising:

a strap assembly including a pair of front strap portions and a rear strap portion each of which is made of a relatively soft and flexible material and each having a foam and fabric construction,

each front strap portion being structured and dimensioned to be positioned towards the front of the patient'"'"'s face, adjacent the mask, in use, the rear strap portion being structured and dimensioned to be positioned generally in the region of the rear of the patient'"'"'s head, away from the mask, in use,

at least a selected portion of at least one of the front strap portions being selectively reinforced compared to the rear portion of the strap assembly to provide added rigidity to further stabilize the mask in use.

64. A headgear assembly as claimed in claim 63, wherein the selected portion includes a relatively rigid reinforcing support structure constructed of a plastic material stitched to an outside surface of the selected portion, away from the patient in use.

65. A headgear assembly as claimed in claim 63, wherein said reinforcing support structure has a thickness in the range of 0.3 to 2.0 mm.

66. A headgear assembly as claimed in claim 63, wherein the strap assembly includes a pair of upper end portions each coupled to a buckle portion, each upper end portion being adapted to be independently length-adjustable by threading through the buckle portion and being fastened by a hook and loop fastener.

67. A headgear assembly as claimed in claim 63, wherein each front strap portion includes a said selected portion.

68. A nasal mask assembly for nasal CPAP therapy of a patient comprising:

(i) a mask frame including an aperture;

(ii) a silicone nasal seal having a face-contacting side and a non-face contacting side, the non-face contacting side being engagable with the frame in a manner that allows the nasal seal to be repeatedly detachable from and re-attachable to the frame;

(iii) an elbow coupled to the frame and adapted to connect to a gas delivery tube in order to supply pressurized gas to an entrance of the patient'"'"'s airway via the aperture of the frame, the elbow including one or more vent openings open to atmosphere for washout of patient exhalation gases; and

(v) a headgear assembly to generally secure the frame and nasal seal to the patient'"'"'s head, said headgear assembly including a pair of soft and flexible generally Y-shaped straps, and a stiffening layer attached to an outside surface of a portion of the pair of straps resting against the cheek regions in use, said stiffening layer providing added stability to the nasal seal on the patient'"'"'s face in use, said stiffening layer having a width that is narrower than the strap portion to which it is attached so that when the stiffening layer and strap are attached together the soft material of the strap extends beyond the stiffening layer, thereby preventing or at least reducing the opportunity for contact between the patient'"'"'s cheek and the stiffening layer in use.

69. The nasal mask assembly of claim 68, wherein the stiffening layer is constructed from a plastic material which is relatively more rigid than the soft material of the strap and has a thickness in the range of 0.3 mm to 2.0 mm.

70. The nasal mask assembly of claim 69, wherein the plastic material is chosen from the group consisting of nylon and polypropylene.

71. The nasal mask assembly of claim 68, wherein the straps are made of laminated fabric and foam.

72. The nasal mask assembly of claim 68, wherein the thickness of the stiffening layer varies across its profile to modify flexibility characteristics.

73. A headgear assembly for securing a mask frame and nasal seal of a nasal mask assembly to a patient'"'"'s head, said headgear assembly including a pair of soft and flexible generally Y-shaped, and a stiffening layer attached to an outside surface of a portion of the pair of straps resting against the cheek regions in use, said stiffening layer providing added stability to the nasal seal on the patient'"'"'s face in use, said stiffening layer having a width that is narrower than the strap portion to which it is attached so that when the stiffening layer and strap are attached together the soft material of the strap extends beyond the stiffening layer, thereby preventing or at least reducing the opportunity for contact between the patient'"'"'s cheek and the stiffening layer in use.

74. The headgear assembly of claim 73, wherein the stiffening layer is constructed from a plastic material which is relatively more rigid than the soft material of the strap and has a thickness in the range of 0.3 mm to 2.0 mm.

75. The headgear assembly of claim 74, wherein the plastic material is chosen from the group consisting of nylon and polypropylene.

76. The headgear assembly of claim 75, wherein the straps are made of laminated fabric and foam.

77. The headgear assembly of claim 73, wherein the thickness of the stiffening layer varies across its profile to modify flexibility characteristics.

78. Headgear to generally secure a frame and nasal seal of a nasal mask assembly to a patient'"'"'s head, said headgear assembly including:

a pair of relatively flexible, generally Y-shaped straps having a relatively soft fabric and foam material construction, and

a stiffening layer made of a relatively rigid material compared to the strap material,

said stiffening layer being attached to an outside surface of a portion of the pair of straps resting against the cheek regions of the patient in use, said stiffening layer providing added stability to the nasal seal on the patient'"'"'s face in use, and said attached stiffening layer and strap having a degree of flexibility in one direction such that variations in patient physiology can be accommodated.

79. The headgear of claim 78, said stiffening layer having a width that is narrower than said strap portion to which it is attached, the relatively softer material of the strap extending laterally beyond each side of the stiffening layer.

80. The headgear of claim 78, wherein the attached stiffening layer and strap is stiffer in another direction generally orthogonal to the one direction to resist vertical rotation of the frame due to the weight of the mask frame and of components attached to the frame.

81. The headgear of claim 80, wherein each Y-shaped strap includes a front strap portion, a rear strap portion and a top strap portion all formed in one piece.

82. The headgear of claim 81, wherein the thickness of the stiffening layer varies across its profile to modify flexibility characteristics.

83. A nasal mask assembly for nasal CPAP therapy of a patient comprising:

a mask frame;

a silicone nasal seal having a face-contacting side and a non-face contacting side, the non-face contacting side being engagable with the frame in a manner that allows the nasal seal to be repeatedly detachable from and re-attachable to the frame;

an elbow coupled to the frame and adapted to connect to a gas delivery tube in order to supply pressurized gas to an entrance of the patient'"'"'s airway via the frame, the elbow including one or more vent openings open for washout of patient exhalation gases;

a headgear assembly to generally secure the frame and nasal seal to the patient'"'"'s head, said headgear assembly including a pair of relatively flexible straps having a relatively soft fabric and foam material construction, and a stiffening support structure made of a relatively rigid material compared to the strap material, said stiffening support structure being attached to an outside surface of a portion of the pair of straps resting against the cheek regions in use, said stiffening support structure providing added stability to the nasal seal on the patient'"'"'s face in use; and

a headgear mount integral with the stiffening support structure to detachably mount the headgear assembly relative to the frame.

84. The headgear assembly of claim 83, wherein the headgear mount includes a mounting aperture to receive and engage with a retaining tab provided to the frame.

85. The headgear assembly of claim 83, wherein the stiffening support structure is connected to the frame at a fixed angle via the headgear mount.

86. The headgear assembly of claim 83, wherein the frame includes a channel and the non-face contacting side of the seal includes an edge that is retained in the channel of the frame based solely on frictional and/or locking engagement between the channel and the seal without the need for an additional retaining device.

87. The headgear assembly of claim 83, wherein the headgear mount extends forwardly of the combined stiffening support structure and strap to support the seal and frame on the patient'"'"'s head in use, and wherein the headgear mount includes a recess and the frame includes a latch hook to detachably retain the headgear assembly on the frame.

88. A nasal mask assembly for nasal CPAP therapy of a patient comprising:

a mask frame;

a silicone nasal seal having a face-contacting side and a non-face contacting side, the non-face contacting side being engagable with the frame in a manner that allows the nasal seal to be repeatedly detachable from and re-attachable to the frame; and

a headgear assembly to generally secure the frame and nasal seal to the patient'"'"'s head, said headgear assembly including a pair of relatively flexible straps having a relatively soft fabric and foam material construction, and a stiffener made of a relatively rigid material compared to the strap material, said stiffener being attached to or formed as part of a portion of the pair of straps resting against the cheek regions in use, said stiffener providing added stability to the nasal seal on the patient'"'"'s face in use;

said stiffener and straps having a degree of flexibility in one direction such that variations in patient physiology can be accommodated in use,

said stiffener and strap being stiffer in another direction generally orthogonal to the one direction to resist deformation of the straps due to undesirable force applied to the mask assembly.

89. The headgear assembly of claim 88, further including an elbow coupled to the frame and adapted to connect to a gas delivery tube in order to supply pressurized gas to an entrance of the patient'"'"'s airway via the frame.

90. The headgear assembly of claim 89, wherein the elbow includes one or more vent openings open for washout of patient exhalation gases.

91. The headgear assembly of claim 88, wherein the stiffener is attached to the straps and has a thickness in the range of 0.3-2.0 mm, said thickness being substantially less than a width of the stiffener.

92. The headgear assembly of claim 88, further including a headgear mount integral with the stiffener to detachably mount the headgear assembly relative to the frame.

93. The headgear assembly of claim 88, wherein the undesirable force is attributable to tube drag and/or weight of components attached to the mask assembly.