Full-face mask and mask cushion therefor

• US 6,701,927 B2
• Filed: 06/11/2002
• Issued: 03/09/2004
• Est. Priority Date: 07/26/1996
• Status: Expired due to Term

• Current Assignee: Resmed Limited (ResMed Incorporated)
• Original Assignee: Resmed Limited (ResMed Incorporated)
• Inventors: Smart, Gregory Scott, Kwok, Philip Rodney, Styles, Robert Edward
• Primary Examiner(s): DONELS, JEFFREY
• Application Number:
  US10/166,282
• Publication Number:
  US 20020174868A1
• Time in Patent Office: 637 Days
• Field of Search: 128/205.25, 128/206.24, 128/207.11, 128/207.13
• US Class Current: 128/207.13
• CPC Class Codes: A61B 5/097 Devices for facilitating collection of breath or for directing breath into or through measuring devices
• CPC Class Codes: A61B 5/6819 Nose
• CPC Class Codes: A61B 5/682 Mouth, e.g., oral cavity; tongue; Lips; Teeth
• CPC Class Codes: A61M 16/06 Respiratory or anaesthetic masks
• CPC Class Codes: A61M 16/0616 with face sealing means comprising a flap or membrane projecting inwards, such that sealing increases with increasing inhalation gas pressure
• CPC Class Codes: A61M 16/0622 having an underlying cushion
• CPC Class Codes: A61M 16/0633 with forehead support
• CPC Class Codes: A61M 16/0683 Holding devices therefor
• CPC Class Codes: A61M 2016/0661 with customised shape
• CPC Class Codes: A61M 2210/0618 Nose

Abstract

A full-face cushion (30B) comprises a substantially triangularly shaped frame (32) from which extends a membrane (34). The frame (32) has a scalloped edge (36) by which the cushion (30B) is affixed to a mask body (46) to form a full-face mask (60B). The membrane (34) has an aperture (38) into which the wearer'"'"'s nose is received. The member (34) is spaced away from the rim (40) of the frame (32), and its outer surface (41) is of substantially the same shape as the rim (40). Respective notches (42, 44) receive the bridge of the wearer'"'"'s nose. The wearer'"'"'s nose and lips are received through the aperture (38) into the chamber within the mask body (46). The seal forming portion (45) thus contacts both the surface of the wearer'"'"'s nose and a portion of the wearer'"'"'s face in the region between the bottom lip and the chin, and around the sides and over the bridge of the nose. The shape of the seal forming portion (45) is particularly suited to effectively seal the difficult region of the facial contour that is the crease between the sides of the nose and the face.

Claims

1. A full-face mask cushion to sealingly connect a mask to a wearer'"'"'s face, the cushion comprising:

a nasal bridge region, a cheek region and a chin region;

first membrane comprising a substantially triangularly-shaped frame of resilient material having a first molded inwardly curved rim of said first membrane;

a second membrane of resilient material, said second membrane being thinner and more flexible than said first membrane, said second membrane having a second molded inwardly curved rim, said second membrane curved rim spaced a distance from said first membrane curved rim, said distance greater than a thickness of the first molded inwardly curved rim, said distance measured when the mask is not in use, a portion of said second membrane curved rim forming a face contacting seal structured to present a convex sealing surface with the wearer'"'"'s face.

2. A cushion as claimed in claim 1, wherein said second molded rim and said first molded rim have a co-located notch to accommodate the bridge of a wearer'"'"'s nose.

3. A cushion as claimed in claim 2, wherein said first membrane molded rim and said second membrane molded rim are substantially saddle-shaped.

4. A cushion as claimed in claim 3, wherein said second membrane is shaped so that said seal portion, in use, contacts at least a wearer'"'"'s nose.

5. A cushion as claimed in claim 4, wherein said seal portion, in use, contacts the facial tissue around the sides and over the bridge of the nose, and between the bottom lip and the chin.

6. A cushion as claimed in claim 1, wherein said second rim and seal portion are shaped to generally match facial contours in the region of facial tissue around the sides and over the bridge of the nose, and between the bottom lip and the chin.

7. A cushion as claimed in claim 1, wherein the first and second membranes comprise one molded piece, without being adhered together by an adhesive.

8. A cushion as claimed in claim 1, wherein the first molded inwardly curved rim of said first membrane is approximately 1.5 mm thick.

9. A cushion as claimed in claim 1, wherein the second molded inwardly curved rim of the second membrane is approximately 0.35 mm thick.

10. A cushion as claimed in claim 1, wherein only the second membrane forms the face contacting seal.

11. A cushion as claimed in claim 1, wherein the second membrane is longer than the first membrane.

12. A cushion as claimed in claim 1, wherein the first molded inwardly curved rim of the first membrane is approximately 1.5 mm thick, and the second molded inwardly curved rim of the second membrane is approximately 0.35 mm thick.

42. A cushion as claimed in claim 1, wherein the face contacting seal has a convex shape.

13. A full-face mask for connection to a wearer'"'"'s face comprising:

a mask body for connection with a supply of breathable gas; and

a cushion secured to said mask body, the body and cushion forming a nose and mouth receiving cavity, said cushion including;

a nasal bridge region, a cheek region and a chin region;

a substantially triangularly-shaped first membrane of resilient material having a first molded inwardly curved rim to surround wearer'"'"'s nose; and

a second membrane also of resilient material, said second membrane being relatively more flexible than said first membrane, said second membrane having a second molded inwardly curved rim, said second molded rim being of the same general shape as said first molded rim and fixed to and extending away from said first membrane so as to have a second membrane inner surface spaced a distance from an outer surface of said first molded rim, said distance greater than a thickness of the first molded inwardly curved rim, said first distance measured when the mask is not in use, a portion of said second molded rim forming a face contacting seal, wherein only the second membrane forms the face contacting seal,

wherein said seal portion is substantially coterminous with respect to said second molded rim and is resiliently deformable towards said first membrane in use of said mask.

14. A mask as claimed in claim 13, wherein said mask body includes attachment points.

15. A mask as claimed in claim 14, further comprising securing straps fixed to said attachment points.

16. A mask as claimed in claim 15, wherein said second membrane molded rim and said first membrane molded rim each have a co-located notch to accommodate the bridge of a nose.

17. A mask as claimed in claim 16, wherein said first and second molded rims are substantially saddle-shaped.

18. A mask as claimed in claim 17, wherein said second membrane is shaped so that said seal portion, in use, contacts at least the wearer'"'"'s nose.

19. A mask as claimed in claim 17, wherein said seal portion, in use, contacts the facial tissue around the sides and over the bridge of the nose, and between the bottom lip and the chin.

20. mask as claimed in claim 13, wherein said rim and said seal portion are shaped to generally match facial contours in the region of facial tissue around the sides and over the bridge of the nose, and between the bottom lip and the chin.

21. A mask as claimed in claim 13, wherein the first molded inwardly curved rim of said first membrane is approximately 1.5 mm thick.

22. A mask as claimed in claim 13, wherein the second molded inwardly curved rim of the second membrane is approximately 0.35 mm thick.

23. A CPAP treatment apparatus comprising:

a flow generator for the supply of gas at a pressure elevated above atmospheric pressure;

a gas delivery conduit coupled to said flow generator; and

a full-face mask in turn coupled to said conduit, said full-face mask including;

a mask body for connection with a supply of breathable gas; and

a cushion secured to said mask body, the body and cushion forming a nose and mouth receiving cavity, the cushion including;

a nasal bridge region, a cheek region and a chin region;

a substantially triangularly-shaped first membrane of resilient material having a first membrane having a first molded inwardly curved rim;

a second membrane having a second molded inwardly curved rim also of resilient material, said second membrane being relatively more flexible and longer than said first membrane, and being of the same general shape as said first molded inwardly curved rim and fixed to and extending away from said first membrane so as to have an inner surface spaced a distance from said first molded rim, wherein

said distance is greater than a thickness of the first inwardly curved rim, said distance is measured when the mask is not in use, and a portion of said second molded rim forms a face contacting seal, and

wherein said seal portion is generally coterminous with respect to said second molded rim and is resiliently deformable towards said first membrane in use of said mask.

24. The CPAP treatment apparatus as claimed in claim 23, wherein said mask body includes attachment points.

25. The CPAP treatment apparatus as claimed in claim 24, further comprising securing straps fixed to said attachment points.

26. The CPAP treatment apparatus as claimed in claim 25, wherein said first and second molded rims each have a co-located notch to accommodate the bridge of a nose.

27. The CPAP treatment apparatus as claimed in claim 26, wherein said first and second molded rims are substantially saddle-shaped.

28. The CPAP treatment apparatus as claimed in claim 27, wherein said second membrane is shaped so that said seal portion, in use, contacts at least wearer'"'"'s nose.

29. The CPAP treatment apparatus as claimed in claim 28, wherein said seal portion, in use, contacts the facial tissue around the sides and over the bridge of the nose, and between the bottom lip and the chin.

30. The CPAP treatment apparatus as claimed in claim 23, wherein said second molded rim and said seal portion are shaped to generally match facial contours in the region of facial tissue around the sides and over the bridge of the nose, and between the bottom lip and the chin.

31. The CPAP treatment apparatus as claimed in claim 23, wherein the first molded inwardly curved rim of said first membrane is approximately 1.5 mm thick.

32. The CPAP treatment apparatus as claimed in claim 23, wherein the second molded inwardly curved rim of the second membrane is approximately 0.35 mm thick.

33. A full-face mask cushion for sealingly connecting a mask to a wearer'"'"'s face, comprising:

a substantially triangularly-shaped frame of resilient material having a first membrane, the first membrane including a first molded inwardly curved rim; and

a second membrane of resilient material, said second membrane being more flexible and longer than said first membrane, said second membrane having a second molded inwardly curved rim, said second membrane curved rim spaced a distance from said first membrane curved rim, said distance greater than a thickness of the first molded inwardly curved rim, said distance measured when the mask is not in use, a portion of said second membrane curved rim forming a face contacting seal.

34. A cushion as claimed in claim 33, wherein said second molded rim and said first molded rim have a co-located notch to accommodate a bridge of a wearer'"'"'s nose.

35. A cushion as claimed in claim 34, wherein said first membrane molded rim and said second membrane molded rim are substantially saddle-shaped.

36. A cushion as claimed in claim 35, wherein said second membrane is shaped so that said seal portion, in use, contacts at least a wearer'"'"'s nose.

37. A cushion as claimed in claim 36, wherein said seal portion, in use, contacts the facial tissue around the sides and over the bridge of the nose, and between the bottom lip and the chin.

38. A cushion as claimed in claim 33, wherein said second rim and seal portion are shaped to generally match facial contours in the region of facial tissue around the sides and over the bridge of the nose, and between the bottom lip and the chin.

39. A cushion as claimed in claim 33, wherein the first and second membranes comprise one molded piece, without being adhered together by an adhesive.

40. A cushion as claimed in claim 33, wherein the first molded inwardly curved rim of said first membrane is approximately 1.5 mm thick.

41. A cushion as claimed in claim 33, wherein the second molded inwardly curved rim of the second membrane is approximately 0.35 mm thick.

43. A full-face mask cushion to sealingly connect a mask to a wearer'"'"'s face, the cushion comprising:

a nasal bridge region, a cheek region and a chin region;

a first membrane comprising a substantially triangularly-shaped frame of resilient material having a first molded inwardly curved rim of said first membrane; and

a second membrane of resilient material, said second membrane being thinner and more flexible than said first membrane, said second membrane having a second molded inwardly curved rim, a portion of said second membrane curved rim forming a face contacting seal, wherein only the second membrane forms the face contacting seal, said second membrane curved rim spaced a sufficient distance from said first membrane curved rim such that under a normal tightening force of the mask to the wearer'"'"'s face, the second membrane curved rim remains spaced from the first membrane curved rim in at least one of the nasal bridge region, the cheek region and the chin region.

44. A cushion as claimed in claim 43, wherein said second molded rim and said first molded rim have a co-located notch to accommodate the bridge of a wearer'"'"'s nose.

45. A cushion as claimed in claim 44, wherein said first membrane molded rim and said second membrane molded rim are substantially saddle-shaped.

46. A cushion as claimed in claim 45, wherein said second membrane is shaped so that said seal portion, in use, contacts at least a wearer'"'"'s nose.

47. A cushion as claimed in claim 46, wherein said seal portion, in use, contacts the facial tissue around the sides and over the bridge of the nose, and between the bottom lip and the chin.

48. A cushion as claimed in claim 43, wherein said second rim and seal portion are shaped to generally match facial contours in the region of facial tissue around the sides and over the bridge of the nose, and between the bottom lip and the chin.

49. A cushion as claimed in claim 43, wherein the first and second membranes comprise one molded piece, without being adhered together by an adhesive.

50. A cushion as claimed in claim 43, wherein the first molded inwardly curved rim of said first membrane is approximately 1.5 mm thick.

51. A cushion as claimed in claim 43, wherein the second molded inwardly curved rim of the second membrane is approximately 0.35 mm thick.

52. A full-face mask for connection to a wearer'"'"'s face comprising:

a mask body for connection with a supply of breathable gas; and

a cushion secured to said mask body, the body and cushion forming a nose and mouth receiving cavity, said cushion including;

a nasal bridge region, a cheek region and a chin region;

a substantially triangularly-shaped first membrane of resilient material having a first molded inwardly curved rim to surround wearer'"'"'s nose; and

a second membrane also of resilient material, said second membrane being relatively more flexible than said first membrane, said second membrane having a second molded inwardly curved rim, said second molded rim being of the same general shape as said first molded rim and fixed to and extending away from said first membrane so as to have a second membrane inner surface spaced a distance from an outer surface of said first molded rim, a portion of said second molded rim forming a face contacting seal, wherein only the second membrane forms the face contacting seal,

wherein said seal portion is substantially coterminous with respect to said second molded rim and is resiliently deformable towards said first membrane in use of said mask, the second molded rim remaining spaced from the first molded rim in at least one of the nasal bridge region, the cheek region and the chin region when the mask is connected to the wearer'"'"'s face.

53. A mask as claimed in claim 52, wherein said mask body includes attachment points.

54. A mask as claimed in claim 53, further comprising securing straps fixed to said attachment points.

55. A mask as claimed in claim 54, wherein said second membrane molded rim and said first membrane molded rim each have a co-located notch to accommodate the bridge of a nose.

56. A mask as claimed in claim 55, wherein said first and second molded rims are substantially saddle-shaped.

57. A mask as claimed in claim 56, wherein said second membrane is shaped so that said seal portion, in use, contacts at least the wearer'"'"'s nose.

58. A mask as claimed in claim 57, wherein said seal portion, in use, contacts the facial tissue around the sides and over the bridge of the nose, and between the bottom lip and the chin.

59. A mask as claimed in claim 52, wherein said rim and said seal portion are shaped to generally match facial contours in the region of facial tissue around the sides and over the bridge of the nose, and the bottom lip and the chin.

60. A mask as claimed in claim 52, wherein the first molded inwardly curved rim of said first membrane is approximately 1.5 mm thick.

61. A mask as claimed in claim 52, wherein the second molded inwardly curved rim of the second membrane is approximately 0.35 mm thick.

62. A CPAP treatment apparatus comprising:

a flow generator for the supply of gas at a pressure elevated above atmospheric pressure;

a gas delivery conduit coupled to said flow generator; and

a full-face mask in turn coupled to said conduit, said full-face mask including;

a mask body for connection with a supply of breathable gas; and

a cushion secured to said mask body, the body and cushion forming a nose and mouth receiving cavity, the cushion including;

a nasal bridge region, a cheek region and a chin region;

a substantially triangularly-shaped first membrane of resilient material having a first membrane having a molded inwardly curved rim; and

a second membrane having a second molded inwardly curved rim also of resilient material, said second membrane being relatively more flexible and longer than said first membrane, and being of the same general shape as said first molded inwardly curved rim and fixed to and extending away from said first membrane so as to have an inner surface spaced a distance from said first molded rim, a portion of said second molded rim forming a face contacting seal,

wherein said seal portion is generally coterminous with respect to said second molded rim and is resiliently deformable towards said first membrane in use of said mask, the second molded rim remaining spaced from the first molded rim in at least one of the nasal bridge region, the cheek region and the chin region when the mask is connected to a wearer'"'"'s face.

63. The CPAP treatment apparatus as claimed in claim 62, wherein said mask body includes attachment points.

64. The CPAP treatment apparatus as claimed in claim 63, further comprising securing straps fixed to said attachment points.

65. The CPAP treatment apparatus as claimed in claim 64, wherein said first and second molded rims each have a co-located notch to accommodate the bridge of a nose.

66. The CPAP treatment apparatus as claimed in claim 65, wherein said first and second molded rims are substantially saddle-shaped.

67. The CPAP treatment apparatus as claimed in claim 66, wherein said second membrane is shaped so that said seal portion, in use, contacts at least wearer'"'"'s nose.

68. The CPAP treatment apparatus as claimed in claim 67, wherein said seal portion, in use, contacts the facial tissue around the sides and over the bridge of the nose, and between the bottom lip and the chin.

69. The CPAP treatment apparatus as claimed in claim 62, wherein said second molded rim and said seal portion are shaped to generally match facial contours in the region of facial tissue around the sides and over the bridge of the nose, and between the bottom lip and the chin.

70. The CPAP treatment apparatus as claimed in claim 62, wherein the first molded inwardly curved rim of said first membrane is approximately 1.5 mm thick.

71. The CPAP treatment apparatus as claimed in claim 62, wherein the second molded inwardly curved rim of the second membrane is approximately 0.35 mm thick.

72. A full-face mask cushion for sealingly connecting a mask to a wearer'"'"'s face, comprising:

a substantially triangularly-shaped frame of resilient material having a first membrane, the first membrane including a first molded inwardly curved rim; and

a second membrane of resilient material, said second membrane being more flexible than said first membrane, said second membrane having a second molded inwardly curved rim, said second membrane curved rim spaced a distance from said first membrane curved rim, measured when the mask is not in use, a portion of said second membrane curved rim forming a face contacting seal, wherein only the second membrane forms the face contacting seal, said second membrane curved rim spaced a sufficient distance from said first membrane curved rim such that under a normal tightening force of the mask to the wearer'"'"'s face, the second membrane curved rim remains spaced from the first membrane curved rim around at least a portion of a circumference of the first membrane curved rim.

73. A cushion as claimed in claim 72, wherein said second molded rim and said first molded rim have a co-located notch to accommodate a bridge of a wearer'"'"'s nose.

74. A cushion as claimed in claim 73, wherein said first membrane molded rim and said second membrane molded rim are substantially saddle-shaped.

75. A cushion as claimed in claim 74, wherein said second membrane is shaped so that said seal portion, in use, contacts at least a wearer'"'"'s nose.

76. A cushion as claimed in claim 75, wherein said seal portion, in use, contacts the facial tissue around the sides and over the bridge of the nose, and between the bottom lip and the chin.

77. A cushion as claimed in claim 72, wherein said second rim and seal portion are shaped to generally match facial contours in the region of facial tissue around the sides and over the bridge of the nose, and between the bottom lip and the chin.

78. A cushion as claimed in claim 72, wherein the first and second membranes comprise one molded piece, without being adhered together by an adhesive.

79. A cushion as claimed in claim 72, wherein the first molded inwardly curved rim of said first membrane is approximately 1.5 mm thick.

80. A cushion as claimed in claim 72, wherein the second molded inwardly curved rim of the second membrane is approximately 0.35 mm thick.