Sealing lip device for a respiratory mask, respiratory mask and a method and mould for producing the same

• US 20090139526A1
• Filed: 01/27/2009
• Published: 06/04/2009
• Est. Priority Date: 02/25/2000
• Status: Active Grant

• Current Assignee: ResMed Humidification Technologies GmbH (ResMed Incorporated)
• Original Assignee: MAP Medizin-Technologie GMBH (ResMed Incorporated)
• Inventors: Melidis, Paris, Lauboeck, Theodor
• Granted Patent: US 8,931,484 B2
• Time in Patent Office: Days
• US Class Current: 128/206.260
• 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 16/0611 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 16/0683 Holding devices therefor
• CPC Class Codes: A61M 2016/0661 with customised shape
• CPC Class Codes: A61M 2202/0085 product washed out
• CPC Class Codes: A61M 2202/0225 Carbon oxides, e.g. Carbon dioxide
• CPC Class Codes: A61M 2205/0216 Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking
• CPC Class Codes: A61M 2205/42 Reducing noise
• CPC Class Codes: A61M 2210/0618 Nose
• CPC Class Codes: B29C 45/1676 using a soft material and a rigid material, e.g. making articles with a sealing part
• CPC Class Codes: B29L 2031/4835 Masks

Abstract

A sealing lip device for a breathing mask includes a receiving opening for receiving at least the nose tip region of a mask wearer, a sealing lip which is formed from an elastomeric material and which surrounds the receiving opening and which is configured to cross the bridge of the nose and which has a contact zone provided for bearing against the face of a mask wearer in use. The sealing lip is elastically and yieldingly arranged in such a way that a first sealing lip zone which in use seals the region of the bridge of the nose has a higher degree of flexibility than a second sealing lip zone which in use is adjacent to at least one of the nostrils and the upper lip of the mask wearer in the application position of the breathing mask. The sealing lip includes a folding bellows structure that suspends the sealing lip in the region of the first zone provided for sealing of the region of the bridge of the nose. The folding bellows structure includes a fold indentation having zones of differing wall thickness.

Claims

1-46. -46. (canceled)

47. A sealing lip device for a breathing mask having a receiving opening for receiving at least the nose tip region of a mask wearer, a sealing lip which is formed from an elastomeric material and which surrounds the receiving opening and which is configured to cross the bridge of the nose and which has a contact zone provided for bearing against the face of a mask wearer in use, wherein the sealing lip is elastically and yieldingly arranged in such a way that a first sealing lip zone which in use seals the region of the bridge of the nose has a higher degree of flexibility than a second sealing lip zone which in use is adjacent to at least one of the nostrils and the upper lip of the mask wearer in the application position of the breathing mask, and

wherein the sealing lip includes a folding bellows structure that suspends the sealing lip in the region of the first zone provided for sealing of the region of the bridge of the nose, the folding bellows structure including a fold indentation having zones of differing wall thickness.

48. A sealing lip device as set forth in claim 47, wherein the bellows structure forms an abutment device.

49. A sealing lip device as set forth in claim 47, wherein the bellows structure has a hinge characteristic defined by different wall thicknesses.

50. A sealing lip device as set forth in claim 47, wherein the bellows structure has a plurality of fold indentations.

51. A sealing lip device as set forth in claim 47, wherein at least one fold indentation is structured to extend from the nose bridge region into a region adjacent to the nostrils in the position of use of the mask.

52. A sealing lip device as set forth in claim 47, wherein at least one fold indentation extends around the entire periphery of the sealing lip device.

53. A sealing lip device as set forth in claim 47, wherein the flexibility of the sealing lip, which is related to an application direction, is structured to define an articulation axis in the nostril or upper lip region in use.

54. A sealing lip device as set forth in claim 47, wherein zones of higher load-bearing capability are provided in the region of the sealing lip and are configured in use to be positioned adjacent to the nostrils or the upper lip.

55. A sealing lip device as set forth in claim 54, wherein the zones of higher load-bearing capability are formed by locally thickened zones of the sealing lip.

56. A sealing lip device as set forth in claim 55, wherein the locally thickened zones are supported on a mask frame zone by way of a support structure which is formed in the sealing lip.

57. A sealing lip device as set forth in claim 54, wherein the zones of higher load-bearing capability are of a pad-like configuration.

58. A sealing lip device as set forth in claim 54, wherein the zones of higher load-bearing capability are each of a substantially crescent moon-shaped configuration in the region of the face-contact zone.

59. A sealing lip device as set forth in claim 54, wherein a zone of high flexibility in and in opposite relationship to an application direction is provided in the region of the upper lip in use in a region which is between the zones of higher load-bearing capability.

60. A sealing lip device as set forth in claim 47, wherein the sealing lip device is adapted to be mounted to a mask base body.

61. A sealing lip device as set forth in claim 60, wherein the mask base body is formed by a hard shell.

62. A sealing lip device as set forth in claim 61, wherein the hard shell has a conduit connection which faces towards a forehead region in use.

63. A sealing lip device as set forth in claim 47, further comprising a coupling structure for coupling the sealing lip device to a hard shell.

64. A sealing lip device as set forth in claim 61, further comprising structure to fix the position of the sealing lip device with respect to the hard shell in the peripheral direction.

65. A sealing lip device as set forth in claim 61, wherein there is imparted to the sealing lip device a prestressing which is achieved by elastic deformation upon coupling to the hard shell.

66. A sealing lip device as set forth in claim 47, further comprising a frame portion extending substantially in one plane.

67. A sealing lip device as set forth in claim 66, wherein the frame portion is of a configuration which advances in a region of an articulation axis relative to a zone of high load-bearing capability.

68. A sealing lip device as set forth in claim 47, wherein a wall thickness of a thin zone of the sealing lip is in the range of between 0.65 and 1.85 mm.

69. A sealing lip device as set forth in claim 47, wherein the zone of high load-bearing capability is of a different color from the thinner-wall zone.

77. A mold for producing a sealing lip device as set forth in claim 47, wherein a mold core device which in conjunction with an outer mold defines a mold cavity with a fold portion for forming a portion of the sealing lip device having a varying degree of flexibility.

78. A mold as set forth in claim 77, wherein the outer mold is of a multi-part configuration.

79. A mold as set forth in claim 77, wherein the outside of a sealing lip, which in use is towards the mask wearer, is formed by an outer mold portion in conjunction with the mold core device, wherein the outer mold portion has a peripherally extending mold cavity channel which defines the outside of the sealing lip.

80. A mold as set for in claim 79, wherein the outer edge of the mold cavity channel extends in the region of the outer peripheral edge of the sealing lip.

88. A sealing lip device as set forth in claim 47, wherein the elastomeric material comprises silicone rubber.

70. A breathing mask comprising a mask base body, a sealing lip device with a receiving opening for receiving at least the nose tip region of a mask wearer, a sealing lip which is formed from an elastomeric material and which surrounds the receiving opening and which is configured to cross the bridge of the nose and which has a contact zone provided for bearing against the face of a mask wearer, wherein the sealing lip is elastically and yieldingly arranged in such a way that in use there is a higher level of flexibility in the region of the bridge of the nose than in the region of at least one of the nostrils and the upper lip, and

wherein the sealing lip includes a folding bellows structure that suspends the sealing lip in the region of the first zone provided for sealing of the region of the bridge of the nose, the folding bellows structure including a fold indentation having zones of differing wall thickness.

71. A breathing mask as set forth in claim 70, further comprising a hard shell injection molded to the sealing lip device.

72. A method of producing a sealing lip device for a breathing mask comprising:

introducing an elastomeric material into a mold cavity formed by a mold,

at least partially setting the material in the mold cavity; and

opening of the mold and removing the material from the mold;

wherein the step of introducing the elastomeric material into the mold cavity includes introducing the material in two discrete steps which occur in succession in respect of time to form various portions of the sealing lip device having varying degrees of flexibility.

73. A method as set forth in claim 72, further comprising forming a support structure of the sealing lip device and a thin-wall zone of the sealing lip in steps which are separate in respect of time.

74. A method as set forth in claim 73, further comprising forming the support structure in a first injection step and the thin-wall zone in a subsequent second injection step.

75. A method as set forth in claim 73, wherein to form the thin-wall zone a mold which delimits the outside of the sealing lip is lifted off a core which delimits the inside of the sealing lip.

76. A method as set forth in claim 73, wherein the support structure is formed by a mold cavity which is defined by a core delimiting the inside of a sealing lip and an outer mold, and wherein to form the thin-wall zone of the sealing lip the outer mold is changed and then the material provided for forming the thin zone sets in the mold cavity provided for the thin-wall zone.

81. A breathing mask comprising a mask body and a sealing pad device which is formed from an elastomeric material and which in conjunction with the mask body delimits a mask internal space, and an outlet device for the discharge of at least partially consumed respiratory gas from the mask internal space, wherein the outlet device has a flow path portion which is at least partially defined by the sealing pad device.

82. A breathing mask as set forth in claim 81, wherein the mask body is formed by a hard shell.

83. A breathing mask as set forth in claim 81, wherein the sealing pad device is formed from a silicone rubber material.

84. A breathing mask as set forth in claim 81, wherein the flow path portion is formed by an opening formed in the sealing pad device.

85. A breathing mask as set forth in claim 81, wherein the flow path portion is formed by a channel which is formed in the mask body.

86. A breathing mask as set forth in claim 81, wherein the flow path portion is in a region above a peripheral bead of the mask body and is at least partially aligned with an opening in the mask body.

87. A breathing mask as set forth in claim 81, wherein provided at the sealing pad device is a portion which extends inwardly into the mask internal space and in which there is provided at least one outlet opening.

89. An elastomeric cushion for a breathing mask, comprising:

a sealing lip;

a frame;

a mid-cushion section provided between the sealing lip and the frame; and

a folding bellows structure provided about at least a portion of the mid-cushion section,

wherein the folding bellows structure includes one or more fold indentations each having an indentation depth that is variable in different regions of the folding bellows structure.

90. A cushion as set forth in claim 89, wherein the cushion has a generally triangular-shaped cross-section including an apex zone, a pair of side zones extending from the apex zone, and a bottom zone interconnected between the pair of side zones.

91. A cushion as set forth in claim 90, wherein the folding bellows structure includes a bottom folding bellows structure extending along the bottom zone.

92. A cushion as set forth in claim 89, wherein the sealing lip includes an apex zone having a length, a pair of side zones having a length, and a bottom zone having a length.

93. A cushion as set forth in claim 92, wherein the length of the apex zone is longer than the length of the bottom zone.

94. A cushion as set forth in claim 89, wherein the sealing lip has a thickness, the frame has a thickness, and the mid-cushion section has a thickness.

95. A cushion as set forth in claim 96, wherein the thickness of the sealing lip is less than the thickness of the frame.