Mask and components thereof

• US 10,307,554 B2
• Filed: 08/12/2009
• Issued: 06/04/2019
• Est. Priority Date: 11/06/2002
• Status: Active Grant

• Current Assignee: ResMed Pty Ltd. (ResMed Incorporated)
• Original Assignee: Resmed Limited (ResMed Incorporated)
• Inventors: Berthon-Jones, Michael, Bateman, Peter Edward, Darkin, Donald, Hitchcock, Robin Garth, Jenkinson, Philip James, Lynch, Susan Robyn, Malouf, Gordon Joseph, McAuliffe, Patrick John, Raje, Milind Chandrakant, Robinson, Gary Christopher, Sokolov, Richard, Stallard, Philip Thomas, Gunaratnam, Michael Kassipillai
• Primary Examiner(s): Sippel, Rachel T
• Application Number:
  US12/461,448
• Publication Number:
  US 20100000543A1
• Time in Patent Office: 3,583 Days
• Field of Search: 12820621, 12820623, 12820624, 12820625, 12820526, 12820628, 12820718
• CPC Class Codes: A61M 16/0003 Accessories therefor, e.g. sensors, vibrators, negative pressure
• CPC Class Codes: A61M 16/0051 with alarm devices
• CPC Class Codes: A61M 16/0057 Pumps therefor
• CPC Class Codes: A61M 16/022 Control means therefor
• CPC Class Codes: A61M 16/06 Respiratory or anaesthetic masks
• CPC Class Codes: A61M 16/0605 Means for improving the adaptation of the mask to the patient
• 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 16/0825 with ball-sockets
• CPC Class Codes: A61M 16/0875 Connecting tubes
• CPC Class Codes: A61M 16/20 Valves specially adapted to medical respiratory devices
• CPC Class Codes: A61M 2016/0027 pressure meter
• CPC Class Codes: A61M 2016/0661 with customised shape
• CPC Class Codes: A61M 2205/0266 Shape memory materials
• CPC Class Codes: A61M 2205/10 with powered movement mechanisms
• CPC Class Codes: A61M 2205/15 Detection of leaks
• CPC Class Codes: A61M 2205/3344 Measuring or controlling pressure at the body treatment site

Abstract

A comfortable low-leak mask assembly for use with Non-Invasive Positive Pressure Ventilation (NIPPV) is provided to improve patient compliance and/or treatment. The mask system may include headgear having straps that are substantially inextensible and/or micro-adjustable; and/or a mask and/or cushion that includes various structures to allow enhanced/tailored sealing and/or fit at selected locations on the patient'"'"'s face.

Claims

1. A cushion for non-invasive positive pressure ventilation mask, the cushion comprising:

a flexible element including foam; and

a cushion flange joined to the flexible element, wherein

said cushion flange includes a receptacle adapted to releasably receive a portion of a frame of the mask, the receptacle facing away from the flexible element, and

the entirety of the flexible element is more flexible than the cushion flange,

wherein a surface of the flexible element constitutes a front surface of the cushion and a mask-engaging surface of the cushion flange constitutes a rear surface of the cushion,

wherein the cushion extends from the front surface to the rear surface, and

wherein the flexible element is joined to more than one surface of the cushion flange.

2. The cushion of claim 1, wherein the cushion flange is rigid.

3. A cushion according to claim 1, wherein the flexible element is joined to a front surface of the cushion flange that opposes the mask-engaging surface of the cushion flange.

4. A cushion according to claim 3, wherein a flexibility of the cushion increases from the mask-engaging surface to the front surface.

5. A non-invasive positive pressure ventilation mask comprising:

a frame; and

a cushion according to claim 1.

6. A cushion assembly for a mask used for treatment of sleep disordered breathing, the cushion assembly comprising:

a first layer including a) a front side with a receptacle adapted to receive a portion of a frame of the mask and b) a rear side opposite the front side, the receptacle facing away from the rear side; and

a second layer constructed of a foam material and being fixed to the rear side of the first layer, the second layer defining a cushion shape and including a first surface adapted to engage a wearer'"'"'s face and form a seal between the mask and the wearer'"'"'s face upon engagement and compress upon application of a force to the cushion assembly,

wherein the second layer is molded to the first layer.

7. A cushion assembly according to claim 6, wherein the second layer includes a skin.

8. A cushion assembly according to claim 7, wherein the skin is formed of a silicone.

9. The cushion assembly according to claim 6, wherein the foam material is at least partially made from a viscoelastic foam.

10. The cushion assembly according to claim 9, wherein the foam material includes multiple densities of foam material.

11. The cushion assembly according to claim 6, wherein the foam material is constructed from an open cell foam or a closed cell foam.

12. The cushion assembly according to claim 6, wherein the foam material includes one or more of a neoprene foam, a latex foam or a urethane foam.

13. The cushion assembly according to claim 6, wherein the first layer includes a second surface adapted to engage the frame of the mask.

14. The cushion assembly according to claim 13, wherein the second surface includes a shoulder to engage the frame of the mask.

15. The cushion assembly according to claim 14, wherein the shoulder includes a groove adapted to engage one or more surfaces of the frame of the mask.

16. The cushion assembly according to claim 15 wherein the one or more surfaces of the frame include one or more edges.

17. The cushion assembly according to claim 6, wherein a density of the foam material is in a range of 1 to 4 pounds per cubic foot.

18. The cushion assembly according to claim 6, wherein the first layer is constructed of an elastomer material.

19. The cushion assembly according to claim 6, wherein the second layer includes a region that extends beyond the first layer.

20. A cushion assembly according to claim 6, wherein the second layer includes no skin.

21. A cushion assembly according to claim 6, wherein the first layer is more rigid than the second layer.

22. A cushion assembly according to claim 6, wherein the first layer includes no foam material.

23. A cushion assembly according to claim 6, wherein the first layer provides a support structure for the second layer.

24. A cushion assembly according to claim 6, wherein the first layer is adapted to compress upon application of a force from the second layer.

25. A cushion assembly according to claim 6, wherein the first layer and the second layer form a subassembly adapted to be connected to the frame of the mask.

26. A cushion assembly according to claim 6, wherein the first layer is structured to connect to the frame with a snap-fit.

27. A mask assembly, comprising:

a frame; and

a cushion assembly according to claim 6.

28. A cushion according to claim 6, wherein the second layer is positioned so that when a force is applied to the first surface, the second layer compresses against the first layer.

29. A cushion assembly according to claim 6, wherein the cushion assembly is configured so that at least a portion of the second layer is sandwiched between the first layer and the wearer'"'"'s face when the first layer is connected to the mask frame and the mask is engaged with the wearer'"'"'s face.