Nasal mask system

• US 10,166,355 B2
• Filed: 11/15/2012
• Issued: 01/01/2019
• Est. Priority Date: 11/15/2011
• Status: Active Grant

• Current Assignee: ResMed Pty Ltd. (ResMed Incorporated)
• Original Assignee: Resmed Limited (ResMed Incorporated)
• Inventors: Eves, Matthew, Guney, Memduh, Scheiner, Rupert Christian
• Primary Examiner(s): Anderson, Gregory
• Assistant Examiner(s): Luarca, Margaret
• Application Number:
  US14/358,482
• Publication Number:
  US 20140283843A1
• Time in Patent Office: 2,238 Days
• CPC Class Codes: A61M 11/00 Sprayers or atomisers specially adapted for therapeutic purposes in general B05B; aerosol containers B65D83/14
• 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 16/0825 with ball-sockets
• CPC Class Codes: A61M 16/107 in the inspiratory path
• CPC Class Codes: A61M 2202/0225 Carbon oxides, e.g. Carbon dioxide
• CPC Class Codes: A61M 2202/30 Vaccines
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/6054 Magnetic identification systems
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 2205/84 for treating several patients simultaneously
• CPC Class Codes: A61M 2230/432 partial CO2 pressure (P-CO2)
• CPC Class Codes: A61M 2250/00 Specially adapted for animals

Abstract

A mask system includes a cushion for a mask that seals at its upper extent in a region of the nose that is generally above the tip of the nose or pronasale, and extends across a portion of the cartilaginous framework, alar or flares of the patient'"'"'s nose, e.g., not extending over or across the bone nasal bone of the patient'"'"'s nose.

Claims

1. A nasal mask for delivery of a supply of air to an entrance of a patient'"'"'s airways, the nasal mask comprising:

a superior sealing portion and an inferior sealing portion,

wherein the superior sealing portion and the inferior sealing portion provide a sealing region including a flexible membrane adapted to engage a patient'"'"'s face and form a seal around both nares of a patient'"'"'s nose,

wherein the superior sealing portion is constructed and arranged to be substantially located on and to form a seal with a portion of the cartilaginous framework of a patient'"'"'s nose,

wherein the superior sealing portion comprises the flexible membrane without an undercushion or backup band to provide a first sealing mechanism,

wherein the inferior sealing portion is constructed and arranged to be located in part on a portion of an upper lip of a patient and to direct a sealing force to a portion of a maxilla bone of the patient,

wherein the inferior sealing portion comprises the flexible membrane and an undercushion or backup band to provide a second sealing mechanism that is different than the first sealing mechanism, and

wherein the first and second sealing mechanisms are configured and arranged around a perimeter of the sealing region such that a contact area of the sealing region engaged with the patient'"'"'s face in use varies around the perimeter of the sealing region to form the seal around both nares of the patient'"'"'s nose.

2. The nasal mask according to claim 1, wherein the superior sealing portion includes a nose ridge region adapted to be positioned and seal along a nasal cartilage region which is above the pronasale and below a nasal bone region of the patient'"'"'s nasal bridge.

3. The nasal mask according to claim 1, wherein the superior sealing portion includes a sides of nose region including a portion adapted to be positioned and seal substantially on the cartilaginous framework of the patient'"'"'s nose along a region adjacent the junction between the nasal greater alar cartilage and the lateral nasal cartilage of the patient'"'"'s nose.

4. The nasal mask according to claim 3, wherein the portion includes a wing or sealing flap that protrudes from an edge of the flexible membrane along its inner perimeter.

5. The nasal mask according to claim 4, wherein the wing or sealing flap is at least partially angled or pre-biased outwardly away from a breathing chamber provided by the nasal mask.

6. The nasal mask according to claim 1, wherein the sealing region includes a nose ridge region, sides of nose region, corners of nose region, and an upper lip region adapted to seal around both nares of the patient'"'"'s nose.

7. The nasal mask according to claim 6, wherein the flexible membrane extends around an entire perimeter of the sealing region and the undercushion or backup band is only provided in the upper lip and corners of nose regions.

8. The nasal mask according to claim 7, wherein the flexible membrane and the undercushion or backup band provide a compression seal in the upper lip and corners of nose regions.

9. The nasal mask according to claim 7, wherein the flexible membrane in the nose ridge and sides of the nose regions is constructed and arranged to be in tension in use, and/or the flexible membrane is constructed and arranged such that a pressure within a breathing chamber provided by the nasal mask acts on the flexible membrane to provide a seal.

10. The nasal mask according to claim 6, wherein the contact area in the sides of nose region is relatively larger than the contact area in the nose ridge region.

11. The nasal mask according to claim 6, wherein the contact area includes a width extending from an inner edge along an edge of an orifice defined by the flexible membrane to an outer edge, and the width of the contact area in the nose ridge region is relatively narrower than the width of the contact area in the sides of nose region.

12. The nasal mask according to claim 1, wherein the superior sealing portion includes a nose ridge region including at least a portion that is locally saddle-shaped in curvature.

13. The nasal mask according to claim 1, wherein the inferior sealing portion includes an upper lip region including at least a portion that is locally saddle-shaped in curvature.

14. The nasal mask according to claim 1, wherein the superior sealing portion comprises a wing or sealing flap that protrudes from an edge of the flexible membrane along its inner perimeter, and the wing or sealing flap along with a curvature and a magnitude of the curvature of the flexible membrane around the perimeter of the sealing region form at least a portion of the first and second sealing mechanisms and determinative of the contact area of the sealing region in use.

15. A nasal mask system, comprising:

a cushion assembly including a sealing region having a nose ridge region, sides of nose region, corners of nose region, and a top lip region adapted to seal around both nares of a patient'"'"'s nose, the nose ridge region adapted to be positioned and seal along a nasal cartilage region which is above the pronasale and below a nasal bone region of the patient'"'"'s nasal bridge, and the sides of nose region is adapted to extend across the alar or flares of the patient'"'"'s nose,

the sealing region including a membrane that extends around an entire perimeter of the sealing region and an undercushion that is only provided in the top lip and corners of nose regions such that the sides of nose region includes a single layer or membrane only structure configured and arranged to seal along the alar or flares of the patient'"'"'s nose and prevent excess pressure on the alar or flares of the patient'"'"'s nose.

16. The nasal mask system according to claim 15, wherein the membrane and undercushion provide a compression seal in the top lip and corners of nose regions.

17. The nasal mask system according to claim 15, wherein the nose ridge and sides of the nose regions of the membrane is constructed and arranged to be in tension in use, and/or the membrane is constructed and arranged such that a pressure within a breathing chamber provided by the cushion assembly acts on the membrane to provide a seal.

18. The nasal mask system according to claim 15, wherein the sides of nose region includes a portion adapted to be positioned and seal substantially on the cartilaginous framework of the patient'"'"'s nose along a region adjacent the junction between the nasal greater alar cartilage and the lateral nasal cartilage of the patient'"'"'s nose.

19. The nasal mask system according to claim 18, wherein the portion includes a wing or sealing flap that protrudes from an edge of the membrane along its inner perimeter.

20. The nasal mask system according to claim 19, wherein the wing or sealing flap is at least partially angled or pre-biased outwardly away from a breathing chamber provided by the cushion assembly.

21. The nasal mask system according to claim 15, wherein the membrane has an edge that defines a T-shaped orifice.

22. The nasal mask system according to claim 15, wherein the nose ridge region includes at least a portion that is locally saddle-shaped in curvature.

23. The nasal mask system according to claim 15, wherein the top lip region includes at least a portion that is locally saddle-shaped in curvature.

24. A nasal mask system, comprising:

a cushion assembly including a sealing region adapted to seal around both nares of a patient'"'"'s nose, an attachment region adapted to receive an elbow assembly, and a side wall region extending between the sealing region and the attachment region,

the sealing region having a nose ridge region, sides of nose region, corners of nose region, and a top lip region, and

the sealing region including a membrane that extends around an entire perimeter of the sealing region and an undercushion that is only provided in the top lip and corners of nose regions, the membrane and the undercushion in the top lip and corners of nose regions adapted to provide a compressive force in top lip and corners of nose regions of a patient'"'"'s face in use,

wherein the side wall region includes an area adjacent the top lip region of the sealing region, said area of the side wall region includes a cross-sectional wall thickness that is thinner than corresponding cross-sectional wall thicknesses of respective side wall regions adjacent the nose ridge, sides of nose, and corners of nose regions of the sealing region,

wherein said area of thinner cross-sectional wall thickness is configured and arranged to lessen the compressive force provided by the membrane and the undercushion in the top lip region compared to the corners of nose region in order to avoid excessive pressure on the columella or septum of the patient'"'"'s nose.

25. The nasal mask system according to claim 24, wherein the attachment region includes a decoupling portion having a cross-sectional wall thickness that is thinner than a corresponding cross-sectional wall thickness of an adjacent portion of the side wall region to permit decoupling of tube drag forces.

26. The nasal mask system according to claim 24, wherein the sides of nose region includes a portion adapted to be positioned and seal substantially on the cartilaginous framework of the patient'"'"'s nose along a region adjacent the junction between the nasal greater alar cartilage and the lateral nasal cartilage of the patient'"'"'s nose.

27. The nasal mask system according to claim 26, wherein the portion includes a wing or sealing flap that protrudes from an edge of the sealing region along its inner perimeter.

28. The nasal mask system according to claim 24, wherein, in a cross-sectional view through the nose ridge region and the top lip region, the sealing region includes a single layer or membrane only structure in the nose ridge region and a dual layer or membrane and undercushion structure in the top lip region.

29. A nasal mask system, comprising:

a cushion assembly including a sealing region having a nose ridge region, sides of nose region, corners of nose region, and a top lip region adapted to seal around both nares of a patient'"'"'s nose,

the sides of nose region including a portion adapted to be positioned and seal substantially on the cartilaginous framework of the patient'"'"'s nose along a region adjacent the junction between the nasal greater alar cartilage and the lateral nasal cartilage of the patient'"'"'s nose,

wherein the sealing region includes a membrane that extends around an entire perimeter of the sealing region, and the portion includes a wing or sealing flap that protrudes from an edge of the membrane along its inner perimeter,

wherein the edge of the membrane along its inner perimeter along with an edge of each wing or sealing flap along its inner perimeter cooperate to define an orifice into a breathing chamber provided by the cushion assembly, and

wherein each wing or sealing flap is configured to extend outwardly at an incline from the edge of the membrane so that each wing or sealing flap is at least partially angled outwardly away from the breathing chamber before engagement with the patient'"'"'s nose.

30. The nasal mask system according to claim 29, wherein the nasal mask system is constructed to have a seal-forming region that forms a seal along a nasal ridge without contacting a nasal bridge or the skin on the nasal bone.

31. The nasal mask system according to claim 29, wherein each wing or sealing flap is at least partially pre-biased outwardly away from the breathing chamber provided by the cushion assembly.

32. The nasal mask system according to claim 31, wherein the wing or sealing flap is adapted to deflect towards the breathing chamber when engaged with the patient'"'"'s nose to provide a bias for sealing in the junction.

33. The nasal mask system according to claim 29, wherein the shape, flexibility, and pre-bias of the wing or sealing flap allows the wing or sealing flap to accommodate changes in curvature or contour in the junction so as to maintain seal and prevent leaks in use.

34. The nasal mask system according to claim 29, wherein the orifice is generally T-shaped.

35. The nasal mask system according to claim 34, wherein the generally T-shaped orifice includes an upper orifice portion and a lower orifice portion that extends generally transverse to the upper orifice portion.

36. The nasal mask system according to claim 34, wherein the wing or sealing flap changes a curvature and/or angle of the edge defining the generally T-shaped orifice.

37. The nasal mask system according to claim 36, wherein the edge of the generally T-shaped orifice curves upwardly and outwardly away from the breathing chamber at least along the wing or sealing flap.

38. The nasal mask system according to claim 29, wherein, in a cross-sectional view through the nose ridge region and the top lip region, the sealing region includes a single layer or membrane only structure in the nose ridge region and a dual layer or membrane and undercushion structure in the top lip region.