Cushion and mask therefor

• US 7,950,392 B2
• Filed: 07/13/2007
• Issued: 05/31/2011
• Est. Priority Date: 07/26/1996
• Status: Expired due to Fees

• Current Assignee: Resmed Limited (ResMed Incorporated)
• Original Assignee: Resmed Limited (ResMed Incorporated)
• Inventors: Styles, Robert Edward, Kwok, Philip Rodney
• Primary Examiner(s): MATTER, KRISTEN CLARETTE
• Application Number:
  US11/826,267
• Publication Number:
  US 20070261697A1
• Time in Patent Office: 1,418 Days
• Field of Search: 128/205.25, 128/206.12, 128/206.18, 128/206.21, 128/206.24, 128/207.11, 128/207.13
• 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 16/0057 Pumps therefor
• 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 2210/0618 Nose

Abstract

A cushion includes a substantially triangularly shaped frame from which extends a membrane. The frame has a scalloped edge by which the cushion is affixed to a mask body. The membrane has an aperture into which the wearer'"'"'s nose is received. The membrane is spaced away from the rim of the frame. The wearer'"'"'s nose is received through the aperture into the chamber within the mask body. The shape of the seal forming portion 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 nasal mask cushion to sealingly connect a mask to a wearer'"'"'s face, the cushion comprising:

a substantially triangularly-shaped frame of resilient material having a rim to substantially surround wearer s nose;

a membrane also of resilient material, said membrane being thinner than and relatively more flexible than said frame, and being of the same general shape as said rim and fixed to and extending away from said frame so as to have an outer surface spaced from said rim, a portion of said outer surface forming a face contacting seal portion that is pre-shaped to generally match the contours of the wearer'"'"'s face, wherein the face contacting seal portion is structured such that it is not required to turn in on itself to conform with the wearer'"'"'s face, in use; and

a nose-receiving cavity bounded by said frame and/or said membrane;

wherein;

the frame is sufficiently rigid to retain its shape and resist deformation so as to form a support structure for the membrane,

said frame is not in contact with the wearer'"'"'s face in use,

each of the frame and the membrane having an inner edge defining a respective aperture,

each of the frame and the membrane has an outer edge, the outer edges of the frame and the membrane joining one another, and

said seal portion is resiliently deformable towards said rim in use of said cushion.

2. A nasal cushion as claimed in claim 1, wherein said membrane and said rim have a co-located notch to accommodate the bridge of a nose.

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

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

5. A nasal 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 base of the nose and the top lip.

6. A nasal cushion as claimed in claim 1, 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 base of the nose and the top lip.

7. A nasal cushion as claimed in claim 1, wherein the face contacting seal portion is pre-shaped to closely imitate the contours of the wearer'"'"'s face.

8. A nasal cushion as claimed in claim 1, wherein the face contacting seal portion is structured to enable contact with the wearer'"'"'s face without folds or creases.

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

10. A nasal mask for connection to a wearer'"'"'s face comprising:

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

a nasal cushion, the body and cushion defining a nose-receiving cavity, said cushion including;

a substantially triangularly-shaped frame of resilient material having a rim to substantially surround the wearer'"'"'s nose;

a membrane also of resilient material, said membrane being thinner than and relatively more flexible than said frame, and being of the same general shape as said rim and fixed to and extending away from said frame so as to have an outer surface spaced from said frame, a portion of said outer surface forming a face contacting seal portion that is pre-shaped to generally match the contours of the wearer'"'"'s face, wherein the face contacting seal portion is structured such that it is not required to turn in on itself to conform with the wearer'"'"'s face, in use;

wherein;

the frame is sufficiently rigid to retain its shape and resist deformation so as to form a support structure for the membrane,

said frame is not in contact with the wearer'"'"'s face in use,

each of the frame and the membrane has an inner edge defining a respective aperture,

each of the frame and the membrane has a respective outer edge, the outer edges of the frame and the membrane joining one another, and

said seal portion is resiliently deformable towards said rim in use of said mask.

11. A nasal mask as claimed in claim 10, wherein said mask body includes attachment points.

12. A nasal mask as claimed in claim 11, further comprising securing straps fixed to said attachment points.

13. A nasal mask as claimed in claim 12, wherein said membrane and said rim each have a co-located notch to accommodate the bridge of a nose.

14. A nasal mask as claimed in claim 13, wherein said membrane and said rim are substantially saddle-shaped.

15. A nasal mask as claimed in claim 14, wherein said membrane is shaped so that said seal portion, in use, contacts at least wearer'"'"'s nose.

16. A nasal mask as claimed in claim 15, wherein said seal portion, in use, contacts the facial tissue around the sides and over the bridge of the nose, and between the base of the nose and the top lip.

17. A nasal mask as claimed in claim 10, 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 base of the nose and the top lip.

18. A nasal mask cushion to sealingly connect a mask to a wearer'"'"'s face, the cushion comprising:

a substantially triangularly-shaped frame of resilient material having a rim shaped to generally match facial contours in the region of facial tissue around the sides of the nose, and between the base of the nose and the top lip;

a membrane also of resilient material, the membrane being thinner than and relatively more flexible than the frame, and being of the same general shape as said rim and fixed to and extending away from the frame so as to have an outer surface spaced from the rim, a portion of said outer surface forming a face contacting seal portion that is pre-shaped to generally match the contours of the wearer'"'"'s face, wherein the face contacting seal portion is structured such that it is not required to turn in on itself to conform with the wearer'"'"'s face, in use;

a strap structured to secure the cushion to the patient'"'"'s face, wherein, during normal application of strap tension, the seal portion is spaced from the rim of the cushion, and during excess application of strap tension, the seal portion deforms to abut against the rim of the cushion; and

a nose-receiving cavity bounded by said frame and/or said membrane;

wherein;

the frame is sufficiently rigid to retain its shape and resist deformation so as to form a support structure for the membrane,

said frame is not in contact with the wearer'"'"'s face in use,

each of the frame and the membrane has an inner edge defining a respective aperture,

each of the frame and the membrane has an outer edge, the outer edges of the frame and membrane joining one another,

said seal portion is resiliently deformable towards said rim in use of said cushion, and

the spacing between the membrane and the rim is variable depending on strap tension and the contour of the wearer'"'"'s face.

19. A mask cushion for sealingly connecting a mask to a patient'"'"'s face during the administration of positive airway pressure, the cushion including:

a frame of resilient material, said frame having a rim for substantially surrounding a portion of the patient'"'"'s face;

a membrane of resilient material and fixed to and extending away from the frame so as to have an outer surface spaced from the rim, in at least one region of the frame, to define a gas-filled gap between the membrane and the frame before the cushion is in use, said membrane being longer than and/or fully covering or overlying the rim as seen in cross section,

a seal forming portion of said outer surface forming a face contacting seal, said seal forming portion being provided only on said membrane, said seal forming portion presenting a convex sealing surface to the patient'"'"'s face;

the membrane being pre-shaped to

     1) generally match the contours of the patient'"'"'s face; and

     2) have the same general shape as said rim, wherein said seal forming portion is resiliently deformable into the gap towards the rim in use of the cushion, and wherein the face contacting seal portion is structured such that it is not required to turn in on itself to conform with the wearer'"'"'s face, in use.

20. A mask cushion as claimed in claim 19, wherein said frame defines a nose receiving cavity, and the membrane includes a contoured notch to accommodate the bridge of the patient'"'"'s nose.

21. A mask cushion as claimed in claim 20, wherein said rim has a preformed and contoured notch, co-located relative to the notch of the membrane, also to accommodate the bridge of the patient'"'"'s nose.

22. A mask cushion as claimed in claim 19, wherein said membrane is shaped so that said seal forming portion, in use, contacts at least a patient'"'"'s nose.

23. A mask cushion as claimed in claim 19, wherein the seal forming portion, in use, contacts the facial tissue around the sides and over the bridge of the nose, and between the base of the nose and the top lip.

24. A mask cushion as claimed in claim 19, wherein said rim and said seal forming portion are pre-shaped to generally match facial contours of the facial tissue around the sides and over the bridge of the nose, and between the base of the nose and the top lip.

25. A mask cushion as claimed in claim 19, wherein the frame and the membrane are formed as a one piece unit.

26. A mask cushion as claimed in claim 19, wherein the rim has a thickness that is greater than a thickness of the membrane.

27. A mask cushion as claimed in claim 26, wherein the rim is about four times thicker than the membrane.

28. A mask cushion as claimed in claim 26, wherein the rim thickness is about 1.5 mm, and the membrane thickness is about 0.35 mm.

29. A mask cushion as claimed in claim 19, further comprising a strap structured to secure the cushion to the patient'"'"'s face, wherein, during normal application of strap tension, the seal forming portion is spaced from the rim of the cushion, and during excess application of strap tension, the seal forming portion deforms to abut against the rim of the cushion.

30. A mask cushion as claimed in claim 19, wherein the membrane is formed of silicone.

31. A mask cushion as claimed in claim 19, wherein the membrane is molded.

32. A mask cushion as claimed in claim 19, wherein the membrane is molded to generally match the contours of the patient'"'"'s face even when the mask is not in use.

33. A mask cushion as claimed in claim 19, wherein the outer surface of the membrane is substantially the same shape as the rim of the frame in at least the one region.

34. A mask cushion as claimed in claim 19, wherein the gap is formed between the frame and the membrane in the lip region of the wearer, whereby the membrane may resiliently deform into the gap toward the frame in use of the cushion.

35. A mask cushion as claimed in claim 19, wherein the rim of the frame is designed to define a maximum deformation position of the membrane in normal use.

36. A mask cushion as claimed in claim 19, further comprising a strap structured to secure the cushion to the patient'"'"'s face, wherein the outer surface forms a seal upon connection to the patient'"'"'s face and application of minimal force, if any, to the strap.

37. A mask cushion as claimed in claim 19, wherein the rim of the frame is approximately 1.5 mm thick.

38. A mask cushion as claimed in claim 19, wherein the membrane is approximately 0.35 mm thick.

39. A mask cushion as claimed in claim 19, wherein the frame is formed of silicone.

40. A mask cushion as claimed in claim 19, wherein frame is molded.

41. A mask comprising a mask cushion as claimed in claim 19, said mask including a mask body for connection with a supply of breathable gas.

42. A mask as claimed in claim 41, wherein the body and the cushion define the nose-receiving cavity.

43. A mask as claimed in claim 41, wherein said mask body includes attachment points.

44. A mask as claimed in claim 41, further comprising securing straps fixed to said attachment points.

45. CPAP treatment apparatus comprising the mask as claimed in claim 41, the CPAP treatment apparatus including a flow generator for the supply of gas at a pressure elevated above atmospheric pressure;

and a gas delivery conduit coupled to said flow generator.