Disposable mask system

• US 8,136,524 B2
• Filed: 01/03/2005
• Issued: 03/20/2012
• Est. Priority Date: 12/31/2003
• Status: Active Grant

• Current Assignee: Lexmark International Incorporated (Ninestar Corporation), ResMed Pty Ltd. (ResMed Incorporated)
• Original Assignee: Resmed Limited (ResMed Incorporated)
• Inventors: Ging, Anthony Michael, Worboys, David John, Smart, Gregory Scott, Dantanarayana, Muditha, Snow, John Michael, Stallard, Philip Thomas
• Primary Examiner(s): Bianco, Patricia
• Assistant Examiner(s): Patel, Nihir
• Application Number:
  US11/027,689
• Publication Number:
  US 20050172969A1
• Time in Patent Office: 2,633 Days
• Field of Search: 128/205.25, 128/206.12, 128/206.13, 128/206.16, 128/206.18, 128/206.19, 128/206.21, 128/206.24, 128/206.26, 128/206.27, 128/206.28, 128/207.11, 128/207.17
• US Class Current: 128/206.26
• CPC Class Codes: A61M 16/06 Respiratory or anaesthetic masks
• CPC Class Codes: A61M 16/0633 with forehead support
• CPC Class Codes: A61M 16/0683 Holding devices therefor
• CPC Class Codes: A61M 16/0816 Joints or connectors
• CPC Class Codes: A61M 16/0825 with ball-sockets
• CPC Class Codes: A61M 16/0858 Pressure sampling ports
• CPC Class Codes: A61M 16/208 Non-controlled one-way valves, e.g. exhalation, check, pop-off non-rebreathing valves
• CPC Class Codes: A61M 2205/0227 Materials having sensing or indicating function, e.g. indicating a pressure increase
• CPC Class Codes: A61M 2205/43 making noise when used correctly
• CPC Class Codes: A61M 2205/44 making noise when used incorrectly
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 2205/582 by tactile feedback
• CPC Class Codes: A61M 2205/583 by visual feedback

Abstract

A mask system includes a frame, cushion, cushion clip, swivel elbow, headgear and/or headgear clips that are configured for use in a clinical or hospital environment. One or more components of the mask system are configured to promote single patient use, e.g., by providing an age indicator and/or preventing disassembly and/or cleaning, etc.

Claims

1. A mask assembly for a patient, comprising:

a frame;

a cushion provided to the frame;

a pair of flexible members connected to and extending from one lateral side of the frame, the pair of flexible members having distal ends supporting a common receptacle configured to receive a headgear strap portion.

2. A mask assembly according to claim 1, wherein the receptacle is configured to receive a connector clip associated with the headgear strap portion.

3. A mask assembly according to claim 2, wherein the connector clip has at least one flexible arm that may be flexed to squeeze into the receptacle.

4. A mask assembly according to claim 3, wherein the receptacle has a catch that engages the at least one flexible arm to retain the connector clip in the receptacle.

5. A mask assembly according to claim 4, wherein the at least one flexible arm is flexed to disengage the connector clip from the catch and remove the connector clip from the receptacle.

6. A mask assembly according to claim 5, wherein the pair of flexible members and the receptacle are unitarily formed as one piece.

7. A mask assembly according to claim 1, wherein the flexible members are configured to bend, pivot and/or flex about an axis between the frame and the receptacle.

8. A mask assembly according to claim 7, wherein the flexible members move towards and away from the patient for self-tensioning of the respective headgear strap portion upon fitting of the mask assembly by the patient.

9. A mask assembly according to claim 1, wherein the pair of flexible members are connected to and extend from the frame so that the headgear strap portion connected to the receptacle extends below the patient'"'"'s ears.

10. A mask assembly according to claim 1, wherein the cushion is configured to cover the patient'"'"'s nose and mouth.

11. A mask assembly according to claim 10, wherein the cushion comprises a membrane configured to sealingly engage the patient'"'"'s face and an underlying profile configured to support the membrane.

12. A mask assembly according to claim 11, wherein the frame comprises a circular aperture to receive a flow of pressurized breathable gas, and the flexible members are spaced apart a distance greater than a diameter of the aperture.

13. A mask assembly according to claim 12, wherein the distal ends of the flexible members are configured to move generally in a longitudinal direction of the frame.

14. A mask assembly according to claim 12, further comprising a swivel elbow rotatably coupled to the frame to deliver the flow of pressurized breathable gas to the aperture.

15. A mask assembly according to claim 14, wherein the swivel elbow comprises an anti-asphyxia valve.

16. A mask assembly according to claim 14, wherein the swivel elbow comprises a vent.

17. A mask assembly according to claim 15, wherein the anti-asphyxia valve comprises a duck bill valve.

18. A mask assembly according to claim 1, wherein the flexible members are formed of polypropylene or polyethylene.

19. A mask assembly according to claim 1, further comprising a headgear to support the mask assembly on the patient in use, wherein the headgear comprises the headgear strap portion.

20. A mask assembly according to claim 19, wherein the headgear strap portion comprises elastic material.

21. A mask assembly according to claim 1, wherein the cushion is attached to the frame.

22. A mask assembly according to claim 1, wherein the frame and the cushion form a breathing chamber.

23. A full face mask for a patient, comprising:

a shell having a main portion;

a cushion provided to the shell;

a swivel elbow connected to the shell;

headgear having at least first and second lateral straps; and

a pair of flexible legs provided to each lateral side of the main portion of the shell, each said pair of legs being spaced from one another and defining distal ends which together support a headgear strap attachment point to be coupled with a respective one of the first and second lateral straps.

24. A mask according to claim 23, wherein each said pair of legs is positionable to extend beyond a perimeter of the shell.

25. A mask according to claim 23, wherein, in use, the legs bend or flex towards the back of the patient'"'"'s head when fitting the mask over the patient'"'"'s head, and subsequently, when the mask and headgear are in place, the legs spring forward away from the patient'"'"'s face to apply a degree of tension to the first and second lateral straps.

26. A mask according to claim 23, wherein the headgear strap attachment points are below the patient'"'"'s ears when the mask is in place on the patient'"'"' face.

27. A mask according to claim 23, wherein the shell comprises a circular aperture at the connection of the swivel elbow and the legs of each pair are spaced apart a distance greater than a diameter of the aperture.

28. A mask according to claim 23, wherein the cushion comprises a membrane to sealingly engage the patient'"'"'s face and an underlying profile to support the membrane.

29. A mask according to claim 23, wherein at least a portion of the headgear comprises elastic material.

30. A mask according to claim 23, wherein at least one of the strap attachment points comprises a receptacle and a corresponding lateral strap has a clip configured to be received in the receptacle.

31. A mask according to claim 30, wherein the clip has at least one flexible arm that may be flexed to squeeze into the receptacle.

32. A mask according to claim 31, wherein the receptacle has a catch that engages the at least one flexible arm to retain the clip in the receptacle.

33. A mask according to claim 32, wherein the at least one flexible arm is flexed to disengage the clip from the catch and remove the clip from the receptacle.

34. A mask according to claim 33, wherein the pair of flexible legs and the receptacle are unitarily formed as one piece.

35. A mask according to claim 23, wherein the swivel elbow comprises an anti-asphyxia valve.

36. A mask according to claim 35, wherein the anti-asphyxia valve comprises a duck bill valve.

37. A mask according to claim 35, wherein the swivel elbow further comprises a vent.

38. A mask according to claim 23, wherein the legs are formed of polypropylene or polyethylene.

39. A mask according to claim 23, wherein the distal ends of the legs are configured to move generally in a longitudinal direction of the shell.

40. A mask according to claim 23, wherein each pair of legs is configured to bend, pivot and/or flex about an axis between the shell and a corresponding headgear strap attachment point.

41. A mask according to claim 40, wherein the legs move towards and away from the patient for self-tensioning of the respective headgear strap portion upon fitting of the mask by the patient.

42. A mask according to claim 23, wherein the cushion is attached to the shell.

43. A mask according to claim 23, wherein the shell and the cushion form a breathing chamber.

44. A mask assembly for a patient, comprising:

a flexible frame comprising an opening in a rear surface configured to receive a nose of the patient, the opening having a perimeter, the frame further comprising an upstanding wall extending along the perimeter, a lateral perimeter flange extending around the perimeter and comprising a plurality of apertures, and a pair of outrigger assemblies extending laterally from the lateral perimeter flange, each outrigger assembly comprising a pair of flexible legs attached to the lateral perimeter flange and a connector clip receptacle connected to the pair of flexible legs;

a cushion comprising a side wall defining an opening corresponding in shape to the opening of the frame, the side wall being supported by the upstanding wall of the frame, the cushion further comprising a lateral perimeter flange having a shape corresponding to a shape of the lateral perimeter flange of the frame and a plurality of apertures at positions corresponding to the apertures in the lateral perimeter flange of the frame; and

a cushion clip configured to secure the cushion to the frame, the cushion clip comprising a flanged perimeter portion having a shape corresponding to the lateral perimeter flange of the frame and the lateral perimeter flange of the cushion, wherein the lateral perimeter flange of the cushion is sandwiched between the flanged perimeter portion of the cushion clip and the lateral perimeter of the frame in an assembled condition, the cushion clip further comprising a plurality of fasteners corresponding to the plurality of apertures in the lateral perimeter flange of the frame and the lateral perimeter flange of the cushion, the plurality of fasteners being configured to align with an extend through the plurality of apertures in the assembled condition to fasten the cushion clip to the frame so that the cushion is secured to the frame in the assembled condition, wherein the frame and the cushion form a breathing chamber in the assembled condition.

45. A mask assembly according to claim 44, wherein each fastener comprises an enlarged head that permits the fastener to pass through the apertures to secure the cushion clip to frame with the cushion therebetween and prevent removal of the fasteners from the apertures once the fasteners are passed through the apertures.

46. A mask assembly according to claim 44, wherein tips of the fasteners are melted in the assembled condition to prevent disassembly of the cushion and cushion clip from the frame.

47. A mask assembly according to claim 44, wherein the frame comprises an aperture for introduction of a flow of breathable gas, the aperture being formed in a circular support.

48. A mask assembly according to claim 47, further comprising a swivel elbow rotatably coupled to the frame, the swivel elbow comprising an inlet conduit configured to receive the flow of breathable gas and at least one aperture that is configured to continually wash out exhaled CO₂ from the breathing chamber.

49. A mask assembly according to claim 48, further comprising an anti-asphyxia valve positioned between the circular support and the swivel elbow.

50. A mask assembly according to claim 44, wherein the frame comprises a port at a bottom portion of the frame and the cushion comprises a port cap attached thereto that is movable between a first position wherein the port cap covers the port and a second position wherein the port cap does not cover the port.

51. A mask assembly according to claim 44, wherein the frame and the flexible legs are formed of polypropylene, polyethylene, or PETE.

52. A mask assembly according to claim 51, wherein the flexible legs are configured to display stress whitening after flexing of the flexible legs.

53. A mask assembly according to claim 51, wherein the flexible legs are attached to the lateral perimeter flange of the frame by living hinges.

54. A mask assembly according to claim 44, wherein each connector clip receptacle comprises a pair of protrusion catches formed on a pair of flexible arms.

55. A mask assembly for a patient, comprising:

a frame;

a cushion provided to the frame;

a pair of flexible members extending from one lateral side of the frame, the pair of flexible members having distal ends supporting a receptacle;

a swivel elbow rotatably coupled to the frame to deliver a flow of pressurized breathable gas through an aperture in the frame;

an anti-asphyxia valve provided in the swivel elbow;

a vent to continually washout exhalation gas from the patient from a breathing chamber formed by the frame and the cushion;

a port in the frame;

a port cap to cover the port;

a headgear to support the mask assembly on the patient in use, the headgear comprising a headgear strap portion; and

a clip connected to the headgear strap portion, the clip being configured to be selectively inserted into the receptacle and retained and selectively released and removed from the receptacle.

56. A mask assembly according to claim 55, wherein the clip has at least one flexible arm that may be flexed to squeeze into the receptacle.

57. A mask assembly according to claim 56, wherein the receptacle has a catch that engages the at least one flexible arm to retain the connector clip in the receptacle.

58. A mask assembly according to claim 57, wherein the at least one flexible arm is flexed to disengage the connector clip from the catch and remove the connector clip from the receptacle.

59. A mask assembly according to claim 58, wherein the pair of flexible members and the receptacle are unitarily formed as one piece.