Full-face mask and mask cushion therefor

• US 8,056,561 B2
• Filed: 05/12/2006
• Issued: 11/15/2011
• Est. Priority Date: 07/26/1996
• Status: Expired due to Fees

• 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): Yu; Justine
• Assistant Examiner(s): YOUNG, RACHEL T
• Application Number:
  US11/432,436
• Publication Number:
  US 20060201515A1
• Time in Patent Office: 2,013 Days
• Field of Search: 128/206.24, 128/205.25, 128/207.11, 128/206.21, 128/206.28
• US Class Current: 128/206.24
• 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 mask assembly for delivery of a supply of gas to an entrance to the airways of a patient, said patient having a nasal bridge region, a cheek region and a lip region, said mask assembly comprising:

a headstrap system to secure the mask assembly relative to the patient'"'"'s head;

a mask body defining a cavity to receive a nose of the patient; and

a nasal cushion, said nasal cushion comprising;

a first cushion portion secured to the mask body,

a second cushion portion adapted to confront a face of a patient in use, and

a wall-portion located between said first and second cushion portions, wherein;

said second cushion portion comprises first and second membranes, each of said first and second membranes having respective first ends located adjacent said wall-portion, and each of said first and second membranes having respective second ends forming respective rims defining an aperture through which the patient'"'"'s nose is received in use,

said second membrane is more flexible and/or thinner than said first membrane,

said second membrane is pre-formed with a shape adapted to be substantially complementary to a patient'"'"'s facial contour,

said second membrane defines a seal-forming portion on an outer surface thereof, said seal-forming portion having an inner periphery and an outer periphery, the inner periphery of said seal-forming portion is constructed and arranged to be positioned in use adjacent a nasal bridge region, along sides of the nose, and between a top lip and a base of a nose to effect a seal,

the seal forming portion is structured such that it is not required to turn in on itself to conform with the patient'"'"'s face, in use,

said first membrane provides a supporting structure for the second membrane, and

said second membrane covering said first membrane.

2. The mask assembly of claim 1, wherein the second membrane is substantially unsupported by the first membrane where the cushion is adapted to seal with the nasal bridge region in use.

3. The mask assembly of claim 1, wherein, in a portion of the cushion adapted to contact the lip region in use, the rims of the first and second membranes extend a lip region distance towards the aperture, the lip region distances of the rims being generally equal.

4. The mask assembly of claim 3, wherein, in a portion of the cushion adapted to contact the cheek region in use, the second membrane extends a cheek region distance towards the aperture that is greater than the lip region distance of the second membrane.

5. The mask assembly of claim 3, wherein, in the nasal bridge region, the second membrane extends a nasal bridge region distance that is greater than the lip region distance of the second membrane.

6. The mask assembly of claim 5, wherein in the nasal bridge region, the second membrane extends towards the aperture to a degree relative to the first membrane that is greater than that of the second membrane relative to the first membrane in the cheek region.

7. The mask assembly of claim 1, wherein, in the nasal bridge region, the shape between the first and second membranes is different from one another such that the nasal bridge is able to be inserted into a space where there is substantially no first membrane, with the second membrane stretching across a gap in the first membrane.

8. The mask assembly of claim 1, wherein the first cushion portion has a scalloped edge by which the cushion is attached to the mask body.

9. The mask assembly of claim 8, wherein the first cushion portion and the first and second membranes comprise integrally formed resilient material.

10. The mask assembly of claim 9, wherein the resilient material includes silicone.

11. The mask assembly of claim 1, wherein the second membrane is spaced away from the rim of the first membrane and the outer surface of the second membrane has substantially the same shape as the rim of the second membrane.

12. The mask assembly of claim 1, further comprising a notch in both the first and second membranes to receive the bridge of the wearer'"'"'s nose in use.

13. The mask assembly of claim 1, wherein the first membrane provides an end limit structure for deformation of the second membrane.

14. The mask assembly of claim 1, wherein the first membrane has a thickness at its rim of about 1.5 mm and the second membrane has a thickness at its rim of about 0.35 mm.

15. The mask assembly of claim 1, wherein the rim of the first membrane extends a first distance towards the aperture in the nasal bridge region, and a second distance towards the aperture in the lip region, wherein said first distance is less than said second distance.

16. The mask assembly of claim 15, wherein the rim of the first membrane does not curl inwardly in a portion of the cushion adapted to contact the nasal bridge region in use.

17. The mask assembly of claim 1, wherein the second membrane surrounds a nose region.

18. The mask assembly of claim 1, wherein the seal-forming portion depends on tension from first and second fastening straps associated with the headstrap system.

19. The mask assembly of claim 1, wherein a curled edge of the first membrane is positioned on either side of the nose in use, with a non-curled portion therebetween.

39. A mask assembly as claimed in claim 1, wherein the seal forming portion is preshaped to closely imitate the contours of the patient'"'"'s face.

40. A mask assembly as claimed in claim 1, wherein the seal forming portion is structured to enable contact with the patient'"'"'s face without folds or creases.

41. A mask assembly as claimed in claim 1, wherein the membrane is less stiff than the frame, to conform with the patient'"'"'s facial structure with minimum force, without a tendency to fold or crease.

20. A mask assembly for delivery of a supply of gas to an entrance to the airways of a patient, said patient having a nasal bridge region, a cheek region and a chin region, said mask assembly comprising:

a headstrap system to secure the mask assembly relative to the patient'"'"'s head;

a mask body defining a cavity to receive a nose of the patient; and

a nasal cushion, said nasal cushion comprising;

a first cushion portion adapted to be secured to the mask body in use,

a second cushion portion adapted to confront a face of a patient in use, and

a wall-portion located between said first and second cushion portions, wherein;

said second cushion portion comprises first and second membranes, each of said first and second membranes having respective first ends located adjacent said wall-portion, and each of said first and second membranes having respective second ends forming respective rims defining an aperture through which the patient'"'"'s nose and mouth are received in use,

said second membrane is more flexible and/or thinner than said first membrane,

said second membrane is pre-formed with a shape substantially complementary to a patient'"'"'s facial contour,

said second membrane defines a seal-forming portion on an outer surface thereof, said seal-forming portion having an inner periphery and an outer periphery, the inner periphery of said seal-forming portion is constructed and arranged to be positioned in use adjacent a nasal bridge region, along sides of the nose, and below lips or on a chin to effect a seal,

the seal forming portion is structured such that it is not required to turn in on itself to conform with the patient'"'"'s face, in use,

said first membrane provides a supporting structure for the second membrane, and

said second membrane covering said first membrane.

21. The mask assembly of claim 20, wherein the second membrane is substantially unsupported by the first membrane wherein the cushion is adapted to seal with the nasal bridge region in use.

22. The mask assembly of claim 20, wherein, a portion of the cushion adapted to contact in the chin region, the rims of the first and second membranes extend a chin region distance towards the aperture, the chin region distance of the second membrane being greater than the chin region distance of the first membrane.

23. The mask assembly of claim 22, wherein, in a portion of the cushion adapted to contact the cheek region, the second membrane extends a cheek region distance towards the aperture that is greater than the chin region distance of the second membrane.

24. The mask assembly of claim 22, wherein, in the nasal bridge region, the second membrane extends a nasal bridge region distance that is greater than the chin or cheek region distances of the second membrane.

25. The mask assembly of claim 24, wherein in the nasal bridge region, the second membrane extends towards the aperture to a degree relative to the first membrane that is greater than that of the second membrane relative to the first membrane in the cheek and chin regions.

26. The mask assembly of claim 20, wherein, in the nasal bridge region, the shape between the first and second membranes is different from one another such that the nasal bridge is able to be inserted into a space where there is substantially no first membrane, with the second membrane stretching across a gap in the first membrane.

27. The mask assembly of claim 20, wherein the first cushion portion has a scalloped edge by which the cushion is attached to the mask body.

28. The mask assembly of claim 27, wherein the first cushion portion and the first and second membranes comprise integrally formed resilient material.

29. The mask assembly of claim 28, wherein the resilient material includes silicone.

30. The mask assembly of claim 20, wherein the second membrane is spaced away from the rim of the first membrane and the outer surface of the second membrane has substantially the same shape as the rim of the second membrane.

31. The mask assembly of claim 20, further comprising a notch in both the first and second membranes to receive the bridge of the wearer'"'"'s nose in use.

32. The mask assembly of claim 20, wherein the first membrane provides an end limit structure for deformation of the second membrane.

33. The mask assembly of claim 20, wherein the first membrane has a thickness at its rim of about 1.5 mm and the second membrane has a thickness at its rim of about 0.35 mm.

34. The mask assembly of claim 20, wherein the rim of the first membrane extends a first distance towards the aperture in the nasal bridge region, and a second distance towards the aperture in the chin or cheek region, wherein said first distance is less than said second distance.

35. The mask assembly of claim 34, wherein the rim of the first membrane does not curl inwardly in a portion of the cushion adapted to contact the nasal bridge region in use.

36. The mask assembly of claim 20, wherein the second membrane surrounds a nose and mouth region.

37. The mask assembly of claim 20, wherein the seal-forming portion depends on tension from first and second fastening straps associated with the headstrap system.

38. The mask assembly of claim 20, wherein a curled edge of the first membrane is positioned on either side of the nose in use, with a non-curled portion therebetween.