Cushion for a respiratory mask assembly

• US 7,971,590 B2
• Filed: 06/15/2005
• Issued: 07/05/2011
• Est. Priority Date: 06/16/2004
• Status: Active Grant

• Current Assignee: ResMed Pty Ltd. (ResMed Incorporated)
• Original Assignee: Redmed Limited
• Inventors: Davidson, Aaron Samuel, Hitchcock, Robin Garth, Drew, Joanne Elizabeth, Kwok, Philip Rodney, Gunaratnam, Michael Kassipillai, McAuliffe, Patrick John, Frater, Robert Henry
• Primary Examiner(s): Yu; Justine R
• Assistant Examiner(s): SKORUPA, VALERIE LYNN
• Application Number:
  US11/628,714
• Publication Number:
  US 20070215161A1
• Time in Patent Office: 2,211 Days
• Field of Search: 128/201.23, 128/201.24, 128/203.29, 128/205.25, 128/206.12, 128/206.21, 12820624-20713
• US Class Current: 128/206.24
• CPC Class Codes: A61M 16/0057 Pumps therefor
• CPC Class Codes: A61M 16/06 Respiratory or anaesthetic masks
• 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 16/0622 having an underlying cushion
• CPC Class Codes: A61M 16/0638 in the form of a pivot
• CPC Class Codes: A61M 16/0644 having the means for adjusting its position
• CPC Class Codes: A61M 16/065 in the form of a pivot
• CPC Class Codes: A61M 16/0655 in the form of a linear or curvilinear slide
• CPC Class Codes: A61M 16/0683 Holding devices therefor
• CPC Class Codes: A61M 16/0825 with ball-sockets

Abstract

A respiratory mask assembly for delivering breathable gas to a patient includes a frame and a cushion. The cushion has a non-face contacting portion structured to be connected to the frame, a face-contacting portion structured to engage the patient'"'"'s face, and a central portion that interconnects the non-face contacting portion and the face contacting portion. The frame may be structured to allow a forehead support to assume multiple positions, to compensate for replacement cushions that may have a different profile, shape or size. The cushion is structured to compensate for variations in strap tension, treatment pressure and/or movement of the patient. Headgear may be provided with a strap assembly in which one or more straps is provided with selectively adjustable elasticity or extensibility that may be automatically changed in dependence of treatment pressure and/or treatment type.

Claims

1. A cushion for a respiratory mask assembly that delivers breathable gas in a range of operating pressures to a patient, the cushion comprising:

a non-face contacting portion adapted to contact a frame;

a face-contacting or interacting portion adapted to form a contact seal with the patient'"'"'s face in use and including a first footprint area on the patient'"'"'s face; and

a central portion that interconnects the non-face contacting portion and the face-contacting portion,

the central portion being structured to automatically adjust a component of force applied to the patient'"'"'s face through the face-contacting portion in accordance with operating pressure, while maintaining the contact seal throughout the range of operating pressures,

the central cushion portion comprising a gusset portion and a ring-shaped reinforcement portion provided between the gusset portion and the face-contacting cushion portion,

wherein the gusset portion includes a second footprint area on the patient'"'"'s face, and

wherein an inner edge of the second footprint area is located substantially adjacent an outer edge of the first footprint area, and an outer edge of the second footprint area is located radially inwardly of a line of contact between the non face-contacting cushion portion and the frame.

2. The cushion according to claim 1, further comprising a spring structure.

3. The cushion according to claim 2, wherein the spring structure includes a concertina portion with a spring portion.

4. The cushion according to claim 3, wherein the concertina spring portion includes an embedded wire spring.

5. The cushion according to claim 2, wherein the spring structure includes a T-shaped spring having a first anchored end and a second end structured to engage an internal shoulder portion of the face contacting portion.

6. The cushion according to claim 1, wherein the central portion includes an outwardly projecting gusset portion.

7. The cushion according to claim 6, further comprising a spring positioned on an inside of the outward gusset portion.

8. The cushion according to claim 1, wherein the gusset portion is reinforced with an embedded spring member, a wire rim provided along a transition between the face contacting portion and the gusset portion, and a prong embedded within the fact contacting portion.

9. The cushion according to claim 8, wherein the prong is provided to an underlying rim of the face contacting portion, below a membrane of the face contacting portion.

10. The cushion according to claim 8, wherein the spring member and the prong are connected to the wire rim.

11. The cushion according to claim 8, wherein the wire rim extends substantially transverse to the prong.

12. The cushion according to claim 1, wherein cushion is substantially triangular and the gusset portion includes relatively larger projected area portions at at least one apice, and relatively smaller projected area portions along at least one portion between the apices.

13. The cushion according to claim 12, wherein each apice includes a relatively larger projected area portion and each said portion between the apices includes a relatively smaller projected area portion.

14. The cushion according to claim 1, wherein the non-face contacting portion and at least a portion of the central portion are made of a relatively more rigid material having an inherent springiness, and the face-contacting portion is made of a relatively compliant material.

15. The cushion according to claim 14, wherein the relatively rigid material comprises polypropylene and the relatively compliant material comprises silicone rubber.

16. The cushion according to claim 1, wherein the face contacting portion includes a membrane and an underlying rim, the underlying rim including an inflatable chamber structured to receive a fluid.

17. The cushion according to claim 16, wherein the fluid comprises gel and/or air.

18. The cushion according to claim 1, further comprising an elastic cuff provided between the gusset portion and the face contacting portion.

19. The cushion according to claim 1, wherein the central portion includes a side wall portion that deforms, moves and/or flexes in response to pressure and/or force variation, to thereby create a variable projected area.

20. The cushion according to claim 19, wherein the side wall portion comprises at least one of a cut-out, a groove, a thin walled portion, and a predetermined area of weakness prone to deformation that can be resiliently restored to its original shape.

21. The cushion according to claim 1, wherein the central portion includes a spring-biased thin-walled portion structured to resiliently kink in response to changes in air delivery pressure.

22. The cushion according to claim 1, wherein the central portion includes an intermediate adapter portion to connect with the non-face contacting portion.

23. The cushion according to claim 22, wherein the intermediate adapter portion includes the gusset portion to create a variable projected area that changes with pressure.

24. The cushion according to claim 1, wherein at least one of the face contacting portion, the central portion and the non-face contacting portion is filled with a gel and/or flowable liquid.

25. The cushion according to claim 24, wherein each of the face contacting portion, non-face contacting portion and the central portion is filled with a gel and/or flowable liquid.

26. The cushion according to claim 24, wherein the central portion includes a gel filled section that at least partially decouples transmission of force between the face contacting portion and the non-face contacting portion.

27. The cushion according to claim 1, wherein the reinforcement portion comprises at least one of an elastic flap and a gel filled pocket that resists overstretching of the gusset portion at high pressure.

28. The cushion according to claim 1, wherein the gusset portion has an outer perimeter, and the outer perimeter of the gusset portion can be varied in size in different regions of the patient'"'"'s face to thereby vary the contact force applied in different regions of the patient'"'"'s face in use.

29. The cushion according to claim 28, wherein the gusset portion tapers as it approaches an apex of the cushion over the bridge of the nose.

30. The cushion according to claim 29, wherein the apex forms substantially fixed portion about which a lower portion of the cushion may resiliently move with changes in operating pressure.

31. The cushion according to claim 28, wherein the cushion includes a nasal bridge region and an upper lip region having reduced gusset portions compared to a remainder of the mask.

32. The cushion according to claim 31, wherein at least one cutout is provided in the gusset portion in the region adjacent the lip and/or each eye of the patient'"'"'s eyes in use.

33. The cushion according to claim 28, further comprising at least one clamp provided to the gusset portion, the clamp being positionable to allow adjustment of the radial width of the gusset portion along any perimeter portion of the cushion.

34. The cushion according to claim 28, wherein the gusset potion includes a linear fastener portion provided along at least a portion of the gusset portion, the linear fastener being provided to adjust the size and/or profile of the gusset portion and/or to selectively enable and/or disable operation of the gusset potion.

35. The cushion according to claim 1, wherein the non-face contacting portion includes a thin membrane section structured to be stretched over a frame portion including a preformed gusset portion that defines a projected area.

36. A method for barriatric treatment of a patient using a mask assembly including a cushion according to claim 1.

37. The cushion according to claim 1, wherein the reinforcement portion is constructed and arranged to limit distendability or extension of the face-contacting portion.

38. A cushion for a respiratory mask assembly, comprising:

a face-contacting cushion portion adapted to form a contact seal with a region of the patient'"'"'s face in use and defining a first footprint area therewith;

a non face-contacting cushion portion adapted to connect to a frame in use; and

a central cushion portion that interconnects the non face-contacting cushion portion and the face-contacting cushion portion,

the central cushion portion being structured to allow the face-contacting cushion portion to travel through a travel range away from and towards the frame,

the central cushion portion comprising a gusset portion located in use adjacent the non face-contacting cushion portion and a ring-shaped reinforcement portion located in use adjacent the face-contacting cushion portion,

wherein the gusset portion defines a second footprint area on the face, and

wherein an inner edge of the second footprint area is located adjacent an outer edge of the first footprint area, and an outer edge of the second footprint area is located radially inwardly of a line of connection between the non face-contacting cushion portion and the frame.

39. A cushion according to claim 38, wherein the central cushion portion is constructed and arranged to automatically adjust a component of force applied to the patient'"'"'s face through the face-contacting cushion portion in accordance with operating pressure, while maintaining the contact seal throughout a range of operating pressures.

40. A cushion according to claim 38, wherein the face-contacting cushion portion includes a membrane and an underlying rim.

41. A respiratory mask assembly for delivery of a supply of air to a patient at a positive operating pressure in a range of about 4 to 20 cm H₂O, comprising:

a frame having a forehead support and a forehead pad;

headgear; and

a cushion according to claim 38 connected to the frame.

42. A cushion for a respiratory mask assembly, comprising:

a face-contacting cushion portion adapted to form a contact seal with a region of the patient'"'"'s face in use and including a first footprint area on the patient'"'"'s face;

a non face-contacting cushion portion adapted to contact a frame in use; and

a central cushion portion that interconnects the non face-contacting cushion portion and the face-contacting cushion portion,

the central cushion portion being structured to allow the face-contacting cushion portion to travel through a travel range away from and towards the frame in use,

the central cushion portion comprising a gusset portion and a ring-shaped reinforcement portion provided between the gusset portion and the face-contacting cushion portion,

wherein the gusset portion includes a second footprint area on the patient'"'"'s face, and

wherein an inner edge of the second footprint area is located adjacent an outer edge of the first footprint area, and an outer edge of the second footprint area is located radially inwardly of a line of contact between the non face-contacting cushion portion and the frame.

43. A cushion according to claim 42, wherein the central cushion portion is constructed and arranged to automatically adjust a component of force applied to the patient'"'"'s face through the face-contacting cushion portion in accordance with operating pressure, while maintaining the contact seal throughout a range of operating pressures.

44. A cushion according to claim 42, wherein the face-contacting cushion portion includes a membrane and an underlying rim.

45. A cushion according to claim 42, wherein cushion is substantially triangular and the gusset portion includes relatively larger projected area portions at least one apice, and relatively smaller projected area portions along at least one portion between the apices.

46. A cushion according to claim 45, wherein each apice includes a relatively larger projected area portion and each said portion between the apices includes a relatively smaller projected area portion.

47. A cushion according to claim 42, wherein the gusset portion has an outer perimeter, and the outer perimeter of the gusset portion can be varied in size in different regions of the patient'"'"'s face to thereby vary the contact force applied in different regions of the patient'"'"'s face in use.

48. A cushion according to claim 42, wherein the reinforcement portion is constructed and arranged to limit distendability or extension of the face-contacting portion.

49. A respiratory mask assembly for delivery of a supply of air to a patient at a positive operating pressure in a range of about 4 to 20 cm H₂O, comprising:

a frame having a forehead support and a forehead pad;

headgear; and

a cushion according to claim 42 provided to the frame.

50. A cushion for a respiratory mask assembly, comprising:

a face-contacting portion adapted to contact a patient'"'"'s face in use;

a non face-contacting portion adapted to connect to a frame; and

a gusset portion that interconnects the non face-contacting portion and the face-contacting portion, the gusset portion projecting radially outwardly from the face-contacting portion,

wherein the non-face contacting portion is adapted to connect to the frame radially outwardly of the gusset portion.

51. A cushion according to claim 50, further comprising a ring-shaped reinforcement portion provided between the gusset portion and the face-contacting portion.

52. A cushion according to claim 50, wherein the face-contacting portion includes a first footprint area on the patient'"'"'s face and the gusset portion includes a second footprint area on the patient'"'"'s face.

53. A cushion according to claim 52, wherein an inner edge of the second footprint area is located adjacent an outer edge of the first footprint area.

54. A cushion according to claim 52, wherein an outer edge of the second footprint area is located radially inwardly of the non face-contacting portion.