Nasal assembly

• US 8,312,883 B2
• Filed: 12/31/2007
• Issued: 11/20/2012
• Est. Priority Date: 02/21/2003
• Status: Active Grant

• Current Assignee: ResMed Pty Ltd. (ResMed Incorporated)
• Original Assignee: Resmed Limited (ResMed Incorporated)
• Inventors: Gunaratnam, Michael K., Kwok, Philip R., Hitchcock, Robin G., Veliss, Lee J., Guney, Memduh, Sokolov, Richard, Lithgow, Perry D., Darkin, Donald, Lynch, Susan R.
• Primary Examiner(s): Dixon, Annette
• Application Number:
  US11/967,346
• Publication Number:
  US 20080105264A1
• Time in Patent Office: 1,786 Days
• Field of Search: 128/857, 128/863, 128/200.24, 128/200.26, 128/203.22, 128/205.25, 128/206.21, 128/206.28, 128/207.13, 128/207.18
• US Class Current: 128/207.18
• CPC Class Codes: A61M 16/0611 with a gusset portion
• CPC Class Codes: A61M 16/0622 having an underlying cushion
• CPC Class Codes: A61M 16/0633 with forehead support
• CPC Class Codes: A61M 16/0644 having the means for adjusting its position
• CPC Class Codes: A61M 16/0666 Nasal cannulas or tubing devices for improving normal breathing through the nose A61F5/08; nose filters A62B23/06; outside holding devices A61M25/02
• CPC Class Codes: A61M 16/0683 Holding devices therefor
• CPC Class Codes: A61M 16/08 Bellows; Connecting tubes having means for taking samples G01N1/22; Water traps; Patient circuits
• CPC Class Codes: A61M 16/0816 Joints or connectors
• CPC Class Codes: A61M 16/0825 with ball-sockets
• CPC Class Codes: A61M 16/0833 T- or Y-type connectors, e.g. Y-piece
• CPC Class Codes: A61M 2016/0661 with customised shape

Abstract

A nasal assembly for delivering breathable gas to a patient includes a frame having an integrally formed first connector portion. A nozzle assembly includes a gusset or base portion and a pair of nozzles. At least one inlet conduit is structured to deliver breathable gas into the frame and nozzle assembly for breathing by the patient. A pair of second connector portions are removably and rotatably connected to respective first connector portions of the frame and are in communication with respective inlet conduits, e.g., directly or via angle connectors. A headgear assembly is removably connected to the pair of second connector portions and/or the angle connectors so as to maintain the frame and the nozzle assembly in a desired adjusted position on the patient'"'"'s face.

Claims

1. A nasal pillows mask assembly to provide a supply of air at positive pressure to the entrance of an airway of a patient for treatment of sleep disordered breathing comprising:

i) a patient interface provided by a cushion assembly, the cushion assembly comprising;

a base portion;

a pair of nasal pillows extending from the base portion,

each nasal pillow being structured to direct a sealing force to the underside of the nose of the patient and comprising a first concave portion having one end extending from the base portion, and a second sealing portion extending from the other end of the first concave portion, the second sealing portion having a narrower first end configured to enter the nasal passage of the patient'"'"'s nose in use and a wider second end adjacent the first concave portion, the second sealing portion defining between the narrower first end and the wider second end a tapered surface upon at least part of which sealing is adapted to occur with a patient'"'"'s nose on the underside of the nostrils in an area about the rim of the nostril openings in use, and

a contour portion structured to contact and direct a stability force to the maxilla of the patient in use;

ii) a patient interface retainer assembly configured to maintain in use the patient interface provided by the cushion assembly in position with respect to an underside of a patient'"'"'s nose in a region about the nostrils and to provide in use the stability force to the maxilla of the patient, the retainer assembly comprising;

a left side portion and a right side portion structured to extend in use from positions on either side of the cushion assembly along the left and right cheeks of the patient towards the left and right temples, the left and right side portions including respective left and right semi-rigid stiffeners structured to add rigidity to the nasal pillows retainer assembly in certain planes and directions, and left and right side straps joined to the respective left and right stiffeners,

a coronal strap portion constructed from a soft, flexible fabric material and adapted to extend in use over the crown of the patient'"'"'s head between the left and right side straps;

a rear strap portion constructed from a soft, flexible fabric material and adapted to extend in use over the rear of the patient'"'"'s head between the left and right side straps, and

a tension adjusting arrangement for adjusting the tension in the patient interface retainer assembly,

wherein the tension adjusting arrangement is operatively configured to adjust the stability force delivered by the contour portion against the maxilla of the patient.

2. The nasal pillows mask assembly of claim 1, wherein the tension adjusting arrangement is further operative to adjust the sealing force against the underside of the nose of the patient.

3. The nasal pillows mask assembly of claim 2, wherein the tension adjusting arrangement is operative to adjust tension in the coronal and rear strap portions.

4. The nasal pillows mask assembly of claim 1, wherein the tension adjusting arrangement includes a coronal strap adjuster.

5. The nasal pillows mask assembly of claim 3, wherein the tension adjusting arrangement includes a coronal strap adjuster and a rear strap adjuster which are independently adjustable for selectively adjusting the sealing force against the nose of the patient and the stability force against the maxilla of the patient, respectively.

6. The nasal pillows mask assembly of claim 2, wherein the tension adjusting arrangement includes left and right side strap adjusters.

7. The nasal pillows mask assembly of claim 1, wherein the contour portion is configured to conform with the upper lip of the patient.

8. The nasal pillows mask assembly of claim 7, wherein the contour portion is formed as part of the base portion.

9. The nasal pillows mask assembly of claim 1, wherein the contour portion is elastically deformable.

10. The nasal pillows mask assembly of claim 1, wherein the nasal pillows and the base portion are moulded in one piece.

11. The nasal pillows mask assembly of claim 10, wherein the nasal pillows and the base portion are moulded from silicone.

12. The nasal pillows mask assembly of claim 1, wherein the base portion is structured to align the nasal pillows at an alar angle.

13. The nasal pillows mask assembly of claim 12, wherein the alar angle is in the range of 135 to 155 degrees.

14. The nasal pillows mask assembly of claim 13, wherein the alar angle is 145 degrees.

15. The nasal pillows mask assembly of claim 12, wherein the base portion includes end portions angled relative to one another to define the angle of the nasal pillows.

16. The nasal pillows mask assembly of claim 1, which includes a frame to which the base portion is attached, and an air conduit connected to an opening in the frame.

17. The nasal pillows mask assembly of claim 16, wherein the left and right stiffeners extend from either side of the frame.

18. The nasal pillows mask assembly of claim 17, wherein the left and right stiffeners are formed integrally with the frame.

19. The nasal pillows mask assembly of claim 17, wherein the left and right stiffeners are detachably joined to the left and right side straps.

20. The nasal pillows mask assembly of claim 17, wherein the left and right stiffeners are rotatably connected to the frame via left and right connectors.

21. The nasal pillows mask assembly of claim 1, wherein the left and right stiffeners are provided with left and right cheek contacting layers of soft flexible material.

22. The nasal pillows mask assembly of claim 21, wherein the left and right cheek contacting layers form part of the left and right side straps which are joined to the left and right stiffeners by stitching.

23. The nasal pillows mask assembly of claim 1, wherein the left and right stiffeners are each in the form of unitary yokes have a front relatively short arm portion extending towards the cushion assembly, a rear relatively long arm portion adapted to extend towards the temples, and an intermediate elbow portion.

24. The nasal pillows mask assembly of claim 1, wherein the second sealing portion has a height of about 9 mm.

25. The nasal pillows mask assembly of claim 1, wherein the nasal pillows have an elliptical geometry.

26. The nasal pillows mask assembly of claim 25, wherein the nasal pillows have an ellipse ratio of about 0.7.

27. The nasal pillows mask assembly of claim 1, wherein the second sealing portion comprises a truncated hollows cone, with the wider second end being spaced from and positioned over the base portion.

28. A nasal pillows mask assembly to provide a supply of air at positive pressure to the entrance of an airway of a patient for treatment of sleep disordered breathing comprising:

i) a patient interface provided by a cushion assembly, the cushion assembly comprising;

a base portion;

a pair of nasal pillows extending from the base portion,

each nasal pillow being structured to direct a sealing force to the underside of the nose of the patient in use and comprising a first concave portion having one end extending from the base portion, and a second sealing portion extending from the other end of the first concave portion, the second sealing portion having a narrower first end that is configured to enter the nasal passage of the patient'"'"'s nose in use and a wider second end adjacent the first concave portion, the second sealing portion defining between the narrower first end and the wider second end a tapered surface upon at least part of which sealing is adapted to occur with a patient'"'"'s nose on the underside of the nostrils in an area about the rim of the nostril openings in use, and

a contour portion structured to contact and direct a stability force to the maxilla of the patient in use;

ii) a patient interface retainer assembly configured to maintain in use the patient interface provided by the cushion assembly in position with respect to an underside of a patient'"'"'s nose in a region about the nostrils and to provide in use the stability force to the maxilla of the patient the retainer assembly comprising;

a left side portion and a right side portion configured to extend in use from positions on either side of the cushion assembly along the left and right cheeks of the patient towards the left and right temples, the left and right side portions including respective left and right stiffeners structured to add rigidity to the nasal pillows retainer assembly, and left and right side straps joined to the respective left and right stiffeners,

a coronal strap portion constructed from a soft, flexible fabric material and configured to extend in use over the crown of the patient'"'"'s head between the left and right side straps;

a rear strap portion constructed from a soft, flexible fabric material and configured to extend in use over the rear of the patient'"'"'s head between the left and right side straps, and

a tension adjusting arrangement to adjust the tension in the coronal and rear strap portions of the patient interface retainer assembly,

wherein the tension adjusting arrangement is operatively configured to adjust the stability force delivered by the contour portion against the maxilla of the patient and to adjust the sealing force against the underside of the nose of the patient.

29. A nasal pillows mask assembly to provide a supply of air at positive pressure to the entrance of an airway of a patient for treatment of sleep disordered breathing comprising:

i) a cushion assembly comprising;

a base portion;

a pair of nasal pillows extending from the base portion,

each nasal pillow being structured to direct a sealing force to the underside of the nose of the patient in use and comprising a first gusset portion having one end extending from the base portion, and a second sealing portion extending from the other end of the first gusset portion, the second sealing portion having a narrower first end that is configured to enter the nasal passage of the patient'"'"'s nose in use and a wider second end adjacent the first gusset portion, the second portion defining between the narrower first end and the wider second end a tapered surface upon at least part of which sealing is adapted to occur with a patient'"'"'s nose on the underside of the nostrils in an area about the rim of the nostril openings in use, and

a contour portion structured to contact and direct an adjustable stability force to the maxilla of the patient in use;

ii) a retainer assembly structured to maintain in use the cushion assembly in a sealed position with respect to an underside of a patient'"'"'s nose in a region about the nares and to provide in use the adjustable stability force to the maxilla of the patient, the retainer assembly comprising;

left and right retainers including;

respective left and right relatively flexible Y-shaped straps constructed from a soft flexible fabric material, each of the left and right Y-shaped straps including;

respective left and right rear strap portions configured to extend from above the patient'"'"'s ears around the back of the patient'"'"'s head and being adjustably coupled together;

respective left and right upper strap portions configured to extend in use over the top of the patient'"'"'s head and being adjustably coupled together; and

respective left and right side strap portions extending in use towards the cushion assembly;

left and right stiffening yokes joined to the respective left and right side strap portions and configured to extend from either side of the cushion assembly along the left and right cheeks of the patient,

wherein adjustment of the tension in the top and rear strap portions is operatively configured to adjust the stability force against the maxilla of the patient and the sealing force against the underside of the nostrils of the patient.

30. A nasal pillows mask assembly to provide a supply of air at positive pressure to the entrance of an airway of a patient for treatment of sleep disordered breathing comprising:

i) a patient interface provided by a cushion assembly, the cushion assembly comprising;

a base portion;

a pair of nasal pillows extending from the base portion,

each nasal pillow being structured to direct a sealing force to the underside of the nose of the patient and comprising a first portion having one end extending from the base portion, and a second sealing portion extending from the other end of the first portion, the second sealing portion having a narrower first end configured to enter the nasal passage of the patient'"'"'s nose in use and a wider second end adjacent the first portion, the second sealing portion defining between the narrower first end and the wider second end a tapered surface upon at least part of which sealing is adapted to occur with a patient'"'"'s nose on the underside of the nostrils in an area about the rim of the nostril openings in use, and

a contour portion structured to contact and direct a stability force to the maxilla of the patient in use;

ii) a patient interface retainer assembly configured to maintain in use the patient interface provided by the cushion assembly in position with respect to an underside of a patient'"'"'s nose in a region about the nostrils and to provide in use the stability force to the maxilla of the patient, the retainer assembly comprising;

a left side portion and a right side portion structured to extend in use from positions on either side of the cushion assembly along the left and right cheeks of the patient towards the left and right temples, the left and right side portions including respective left and right semi-rigid stiffeners structured to add rigidity to the nasal pillows retainer assembly in certain planes and directions, and left and right side straps joined to the respective left and right stiffeners,

a coronal strap portion constructed from a soft, flexible fabric material and adapted to extend in use over the crown of the patient'"'"'s head between the left and right side straps;

a rear strap portion constructed from a soft, flexible fabric material and adapted to extend in use over the rear of the patient'"'"'s head between the left and right side straps, and

a tension adjusting arrangement for adjusting the tension in the patient interface retainer assembly,

wherein the tension adjusting arrangement is operatively configured to adjust the stability force delivered by the contour portion against the maxilla of the patient,

wherein the left and right stiffeners are rotatably connected to the frame via left and right connectors,

wherein the left and right stiffeners extend from either side of the frame, and

which includes a frame to which the base portion is attached, and an air conduit connected to an opening in the frame.

31. A nasal pillows mask assembly to provide a supply of air at positive pressure to the entrance of an airway of a patient for treatment of sleep disordered breathing comprising:

i) a patient interface provided by a cushion assembly, the cushion assembly comprising;

a base portion;

a pair of nasal pillows extending from the base portion,

each nasal pillow being structured to direct a sealing force to the underside of the nose of the patient and comprising a stalk portion having a proximal end extending from the base portion, and a head portion extending from a distal end of the stalk portion, the head portion having a narrower first end that is configured to enter the nasal passage of the patient'"'"'s nose and a wider second end extending from the stalk portion, the head portion having between the narrower first end and the wider second end a tapered surface upon at least part of which sealing is adapted to occur with a patient'"'"'s nose on the underside of the nostrils in an area about the rim of the nostril openings, the wider second end of the head portion being wider than the distal end of the stalk portion, the wider second end being spaced from the base portion, and

a contour portion structured to contact and direct a stability force to the maxilla of the patient;

ii) a patient interface retainer assembly configured to maintain the patient interface provided by the cushion assembly in position with respect to an underside of a patient'"'"'s nose in a region about the nostrils and to provide in use the stability force to the maxilla of the patient, the retainer assembly comprising;

a left side portion and a right side portion configured to extend in use from positions on either side of the cushion assembly along the left and right cheeks of the patient towards the left and right temples, the left and right side portions including respective left and right stiffeners structured to add rigidity to the nasal pillows retainer assembly, and left and right side straps joined to the respective left and right stiffeners,

a coronal strap portion constructed from a soft, flexible fabric material and configured to extend in use over the crown of the patient'"'"'s head between the left and right side straps;

a rear strap portion constructed from a soft, flexible fabric material and configured to extend in use over the rear of the patient'"'"'s head between the left and right side straps, and

a tension adjusting arrangement to adjust the tension in the coronal and rear strap portions of the patient interface retainer assembly,

wherein the tension adjusting arrangement is operatively configured to adjust the stability force delivered by the contour portion against the maxilla of the patient and to adjust the sealing force against the underside of the nose of the patient.

32. The nasal pillows mask assembly of claim 31, wherein the tension adjusting arrangement is operative to adjust tension in the coronal and rear strap portions.

33. The nasal pillows mask assembly of claim 31, wherein the tension adjusting arrangement includes a coronal strap adjuster for selectively adjusting the sealing force against the nose of the patient and a rear strap adjuster, substantially independent of the coronal strap adjuster, for selectively adapting the stability force against the maxilla of the patient.

34. The nasal pillows mask assembly of claim 31, wherein the contour portion is configured to conform with the upper lip of the patient.

35. The nasal pillows mask assembly of claim 34, wherein the contour portion is formed as part of the base portion.

36. The nasal pillows mask assembly of claim 31, wherein the contour portion is elastically deformable.

37. The nasal pillows mask assembly of claim 31, wherein the nasal pillows and the base portion comprise one piece of silicone molded material.

38. The nasal pillows mask assembly of claim 31, wherein the base portion is structured to align the nasal pillows at an alar angle,

wherein the base portion includes end portions angled relative to one another to define the angle of the nasal pillows.

39. The nasal pillows mask assembly of claim 38, wherein the base portion includes end portions angled relative to one another to define the angle of the nasal pillows.

40. The nasal pillows mask assembly of claim 31, which includes a frame to which the base portion is attached, and an air conduit connected to an opening in the frame.

41. The nasal pillows mask assembly of claim 40, wherein the left and right stiffeners extend from either side of the frame.

42. The nasal pillows mask assembly of claim 41, wherein the left and right stiffeners are formed integrally with the frame.

43. The nasal pillows mask assembly of claim 41, wherein the left and right stiffeners are detachably joined to the left and right side straps.

44. The nasal pillows mask assembly of claim 41, wherein the left and right stiffeners are rotatably connected to the frame via left and right connectors.

45. The nasal pillows mask assembly of claim 31, wherein the left and right stiffeners are provided with left and right cheek contacting layers of soft flexible material.

46. The nasal pillows mask assembly of claim 45, further comprising stitching that joins the left and right cheek contacting layers to the left and right stiffeners.

47. The nasal pillows mask assembly of claim 31, wherein the left and right stiffeners are each in the form of unitary yokes have a front relatively short arm portion extending towards the cushion assembly, a rear relatively long arm portion adapted to extend towards the temples, and an intermediate elbow portion positioned between the short arm and the long arm portions.

48. The nasal pillows mask assembly of claim 31, wherein the head portion has a height of about 9 mm.

49. The nasal pillows mask assembly of claim 31, wherein the nasal pillows have an elliptical geometry.

50. The nasal pillows mask assembly of claim 49, wherein the nasal pillows have an ellipse ratio of about 0.7.

51. The nasal pillows mask assembly of claim 31, wherein the head portion comprises a truncated hollow cone, with the wider second end being spaced from and positioned over the base portion.

52. The nasal pillows mask assembly of claim 31, wherein the pillows are structured to apply a component of sealing force to patient'"'"'s face, substantially independent of the sealing force provided by the strap tension.

53. The nasal pillows mask assembly of claim 31, wherein the pillows are adapted to act as a spring structure in a direction along an axis of each pillow.

54. The nasal pillows mask assembly of claim 31, wherein the base portion is relatively more rigid compared to the nasal pillows and the head portion is adapted to resiliently move towards and away from the base portion, to accommodate for variations in the patient'"'"'s facial topography.

55. The nasal pillows mask assembly of claim 31, wherein a resultant force, due to the relative positioning of the contour portion, pillows and retainer assembly, is directed along a line extending from the maxilla to a rear of the patient'"'"'s head, the line being adapted to extend between the eye and ear of the patient.

56. The nasal pillows mask assembly of claim 31, wherein primary adjustment of the stability force occurs as a result of adjustment of tension in the rear strap portion, and primary adjustment of the sealing force occurs as a result of adjustment of tension in the coronal strap portion.

57. The nasal pillows mask assembly of claim 31, wherein the rear strap portion is adapted to pull the contour region against the maxilla and the coronal strap portion is adapted to pull the tapered surface of the head portion towards or into contact with the under side of the patient'"'"'s nostrils.

58. The nasal pillows mask assembly of claim 31, wherein the rear strap portion includes a pair of rear strap ends coupled via a buckle.

59. The nasal pillows mask assembly of claim 31, wherein the rear strap ends are adapted to be pulled away from each other to adjust the stability force.

60. The nasal pillows mask assembly of claim 31, wherein the coronal strap includes a pair of coronal strap ends coupled via a buckle.

61. The nasal pillows mask assembly of claim 60, wherein the coronal strap ends are adapted to be pulled away from each other to adjust the sealing force.

62. The nasal pillows mask assembly of claim 31, further comprising a visual indicator to indicate an angle of the nasal pillows relative to the patient'"'"'s nasal openings.

63. The nasal pillows mask assembly of claim 31, further comprising a swivel elbow coupled to an air delivery tube, wherein the tube is structured to be routed in a first configuration in which the elbow is swivelable and a second configuration over the head whereby the tube is connected to one of the straps.

64. The nasal pillows mask assembly of claim 31, wherein the elbow is a quick release elbow that is structured to be easily disconnected.