Mask system

• US 8,528,561 B2
• Filed: 01/18/2013
• Issued: 09/10/2013
• Est. Priority Date: 03/04/2008
• Status: Active Grant

• Current Assignee: ResMed Pty Ltd. (ResMed Incorporated)
• Original Assignee: Resmed Limited (ResMed Incorporated)
• Inventors: Ng, Eva, Lockwood, David James, Wehbeh, Jamie Graeme, Valcic, Zoran, D'Souza, Errol Savio Alex, Eves, Matthew, Sari, Mahsita
• Primary Examiner(s): MATTER, KRISTEN CLARETTE
• Application Number:
  US13/745,077
• Publication Number:
  US 20130133659A1
• Time in Patent Office: 235 Days
• Field of Search: 128/205.25, 128/206.21, 128/206.24, 128/206.28, 128/207.11, 128/202.27
• US Class Current: 128/206.28
• CPC Class Codes: A61M 16/0057 Pumps therefor
• CPC Class Codes: A61M 16/0066 Blowers or centrifugal pumps
• CPC Class Codes: A61M 16/06 Respiratory or anaesthetic masks
• CPC Class Codes: A61M 16/0611 with a gusset portion
• 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 16/0694 Chin straps
• CPC Class Codes: A61M 16/0816 Joints or connectors
• CPC Class Codes: A61M 16/0825 with ball-sockets
• CPC Class Codes: A61M 16/0841 for sampling
• CPC Class Codes: A61M 16/0858 Pressure sampling ports
• 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 16/208 Non-controlled one-way valves, e.g. exhalation, check, pop-off non-rebreathing valves
• CPC Class Codes: A61M 2016/0661 with customised shape
• CPC Class Codes: A61M 2202/0085 product washed out
• CPC Class Codes: A61M 2202/0225 Carbon oxides, e.g. Carbon dioxide

Abstract

A mask includes a shroud; a cushion module that engages the shroud, the cushion module including a frame and a full-face cushion adapted to engage the patient'"'"'s face generally along nasal bridge, cheek, and chin regions of the patient'"'"'s face, the frame at least partly defining a breathing chamber; an elbow connected to the frame in a releasable and rotatable manner, the elbow being adapted to be connected to an air delivery tube to deliver breathable gas to the patient; and headgear removably attachable to the shroud, wherein: the frame includes an opening, the elbow including a distal end releasably inserted into the opening of the frame with a snap-fit, thereby connecting the elbow to the frame, whereby the connection between the elbow and the frame also maintains the shroud in engagement with the frame.

Claims

1. A full-face mask system for delivering a supply of breathable gas at positive pressure to a patient'"'"'s airways to treat a respiratory disorder, the mask system comprising:

a shroud;

a cushion module that engages the shroud, the cushion module including a frame of relatively rigid, polycarbonate material and a full-face cushion of relatively soft, elastomeric material, said full-face cushion being adapted to engage the patient'"'"'s face generally along nasal bridge, cheek, and chin regions of the patient'"'"'s face, the frame including an opening and the frame at least partly defining a breathing chamber, the full-face cushion including a base wall provided to the frame, an undercushion layer extending away from the base wall, and a membrane provided to cover the undercushion layer, the undercushion layer being provided in a nasal bridge region of the full-face cushion, the undercushion layer not being provided in at least a part of the chin region;

an elbow connected to the frame in a releasable and rotatable manner, the elbow including a gas washout vent arrangement, and an anti-asphyxia valve, the elbow including a first end portion and a second end portion, the second end portion having a swivel joint adapted to be connected to an air delivery tube, the vent arrangement comprising a vent insert that is adapted to be supported within an outlet opening in the elbow, the vent insert having a plurality of vent holes, the elbow including a port that is selectively closed by a flap portion of the anti-asphyxia valve depending on the presence of pressurized gas, the port being positioned between the swivel joint and the vent arrangement; and

headgear to maintain the mask system in position on the patient'"'"'s face, wherein;

the first end portion of the elbow including a distal end releasably inserted into the opening of the frame with a snap-fit, thereby creating a retention structure to retain the elbow with the frame, whereby the retention structure between the elbow and the frame also maintains the shroud in engagement with the frame, the shroud and the frame being structured to prevent relative rotation when the elbow is snap-fitted to the frame, and

the shroud includes an interfacing structure configured and shaped to hold the cushion module in an operative position with respect to the patient'"'"'s face, the interfacing structure being positioned along an inner side of the shroud that contacts the frame of the cushion module.

2. The mask system according to claim 1, wherein:

the shroud has a tight conforming fit to the frame,

the shroud includes an opening through which the distal end of the elbow is inserted, the shroud including a sandwich portion extending radially inwards,

the elbow includes an annular protrusion projecting away from an outer surface of the elbow, and

the sandwich portion of the shroud is sandwiched between the annular protrusion of the elbow and the frame.

3. The mask system according to claim 2, wherein the distal end of the elbow has a distal shoulder adapted to extend under an edge of the frame to retain the elbow to the frame, and wherein the frame includes a frame-to-elbow bearing surface for the rotatable elbow.

4. The mask system according to claim 3, wherein the opening of the frame is at least partially surrounded by a collar, and an inner circumferential surface of the collar comprises said frame-to-elbow bearing surface, wherein the collar includes a distal end with a bearing surface, and wherein a surface of the annular protrusion of the elbow rotatably engages with the sandwich portion.

5. The mask system according to claim 4, wherein:

the shroud includes a forehead support,

the mask system includes four headgear connectors, and

the headgear includes a pair of upper and lower straps and a rear strap adapted to pass behind the patient'"'"'s head, the upper straps being removably attached to respective upper headgear connectors and the lower straps being removably attached to respective lower headgear connectors, a free end of each strap including a hook and loop tab structured to adjustably engage the remainder of the strap to secure the strap in place.

6. The mask system according to claim 5, wherein each lower headgear connector includes an arm with a slot at the free end of the arm adapted to receive a respective lower strap, and wherein each arm extends outward of the cushion module and is oriented to retain the respective lower strap in spaced relation under the patient'"'"'s ear.

7. The mask system according to claim 6, further comprising a concertina section provided in the nasal bridge region of the full-face cushion of the cushion module, the concertina section including one or more folds that provide a degree of flexibility or movement relative to the frame, wherein:

the concertina section is provided around the entire perimeter of the full-face cushion of the cushion module,

flexibility of the concertina section is varied in different regions of the full-face cushion of the cushion module,

the concertina section in the nasal bridge region has a different flexibility compared to the concertina section in the chin region, and

wherein the flexibility of the concertina section is varied by varying the wall length and/or the depth of the one or more folds.

8. The mask system according to claim 6, wherein the mask system is provided with a number of differently sized cushion modules, the frame of each cushion module including a common configuration for interfacing with the shroud, thus providing a modular arrangement that allows the shroud to be selectively and removably coupled to each of the number of cushion modules.

9. The mask system according to claim 8, wherein the differently sized cushion modules include small, medium, and large full-face cushions.

10. The mask system according to claim 9, wherein the frame and full-face cushion are co-molded with one another to form an integrated component, the frame being molded of said relatively rigid polycarbonate material adapted to interface with the shroud, and the full-face cushion is co-molded with the frame of said relatively soft, elastomeric material adapted to interface with patient'"'"'s face.

11. The mask system according to claim 10, wherein said co-molding of the frame to the full-face cushion provides a chemical bond.

12. The mask system according to claim 1, wherein the mask system is provided with a number of differently sized cushion modules, the frame of each cushion module including a common configuration for interfacing with the shroud, thus providing a modular arrangement that allows the shroud to be selectively and removably coupled to each of the number of cushion modules.

13. The mask system according to claim 12, wherein the differently sized cushion modules include small, medium, and large full-face cushions.

14. The mask system according to claim 13, wherein the frame and full-face cushion are co-molded with one another to form an integrated component, the frame being molded of said relatively rigid polycarbonate material adapted to interface with the shroud, and the full-face cushion is co-molded with the frame of said relatively soft, elastomeric material adapted to interface with patient'"'"'s face, and

wherein said co-molding of the frame to the full-face cushion provides a chemical bond.

15. A full-face mask system for delivering a supply of breathable gas at positive pressure to a patient'"'"'s airways to treat a respiratory disorder, the mask system comprising:

a shroud;

a cushion module that engages the shroud, the cushion module including a frame and a full-face cushion adapted to engage the patient'"'"'s face generally along nasal bridge, cheek, and chin regions of the patient'"'"'s face, the frame at least partly defining a breathing chamber;

an elbow connected to the frame in a releasable and rotatable manner, the elbow being adapted to be connected to an air delivery tube to deliver breathable gas to the patient; and

headgear directly or indirectly attachable to the shroud in a removable manner, wherein;

the frame includes an opening, the elbow including a distal end releasably inserted into the opening of the frame with a snap-fit connection to retain the elbow with the frame, whereby the snap-fit connection between the elbow and the frame also maintains the shroud in engagement with the frame, the shroud and the frame having shapes that prevent relative rotation when the elbow is snap-fitted to the frame.

16. The mask system according to claim 15, wherein:

the shroud includes an opening through which the distal end of the elbow is inserted, the shroud including a sandwich portion extending radially inwards,

the elbow includes an annular protrusion projecting away from an outer surface of the elbow, and

the sandwich portion of the shroud is sandwiched between the annular protrusion and the frame.

17. The mask system according to claim 16, wherein the distal end of the elbow has a distal shoulder adapted to extend under an edge of the frame to retain the elbow to the frame, said distal shoulder including a plurality of spaced apart tangs.

18. The mask system according to claim 17, wherein the frame includes at least one bearing surface for the rotatable elbow, and

wherein the opening is at least partially surrounded by a collar, and an inner circumferential surface of the collar comprises said at least one bearing surface.

19. The mask system according to claim 15, wherein:

the full-face cushion includes a base wall provided to the frame, an undercushion layer extending away from the base wall, and a membrane provided to cover the undercushion layer,

the undercushion layer is provided in a nasal bridge region of the full-face cushion and is structured to provide improved stability across the patient'"'"'s nasal bridge, and

the undercushion layer is not provided in at least a portion of the chin region.

20. The mask system according to claim 15, wherein:

the elbow includes a vent arrangement for gas washout, and an anti-asphyxia valve,

the elbow includes a swivel joint adapted to be connected to the air delivery tube,

the vent arrangement comprises a vent insert that is adapted to be supported within an outlet opening in the elbow, the vent insert having one or more vent holes, and

the elbow includes a port that is selectively closed by a flap portion of the anti-asphyxia valve depending on the presence of pressurized gas, the port being positioned between a swivel joint and the vent arrangement.

21. The mask system according to claim 15, wherein:

the shroud includes a forehead support and four headgear connectors that are integrally molded or otherwise attached to the shroud to connect with the headgear, two of the headgear connectors including an elongated arm and a slot at a free end of the arm adapted to receive a respective headgear strap of the headgear, each arm being at least semi-rigid to stabilize the mask system on the patient'"'"'s face, and

each arm is removably coupled to the shroud, each said arm including clip structure adapted to removably engage with a corresponding portion provided to the shroud.

22. The mask system according to claim 15, wherein the frame is associable with a plurality of differently sized full-face cushions, to thereby form a plurality of differently sized cushion modules, the frame of each cushion module including a universal configuration for interfacing with the shroud, thus providing a modular arrangement that allows the shroud to be selectively and removably coupled to each of the plurality of cushion modules.

23. The mask system according to claim 15, wherein the frame and full-face cushion together comprise a co-molded, integrated component, the frame comprising a molded polycarbonate material that interfaces with the shroud and the full-face cushion comprises a molded elastomeric material adapted to interface with patient'"'"'s face.

24. The mask system according to claim 23, wherein said co-molded integrated component includes a chemical bond that bonds the frame to the full-face cushion.

25. A full-face mask system for delivering a supply of breathable gas at positive pressure to a patient'"'"'s airways to treat a respiratory disorder, the mask system comprising:

a shroud;

a cushion module that engages the shroud, the cushion module including a frame of relatively rigid, polycarbonate material and a full-face cushion of relatively soft, elastomeric material, said full-face cushion being adapted to engage the patient'"'"'s face generally along nasal bridge, cheek, and chin regions of the patient'"'"'s face, the frame including an opening and the frame at least partly defining a breathing chamber, the full-face cushion including a base wall provided to the frame, an undercushion layer extending away from the base wall, and a membrane provided to cover the undercushion layer, the undercushion layer being provided in a nasal bridge region of the full-face cushion, the undercushion layer not being provided in at least a part of the chin region; and

an elbow engaged with the frame in a releasable and rotatable manner, the elbow including a gas washout vent arrangement, and an anti-asphyxia valve, the elbow including a first end portion and a second end portion, the second end portion having a swivel joint adapted to be connected to an air delivery tube, the vent arrangement comprising a vent insert that is adapted to be supported within an outlet opening in the elbow, the vent insert having a plurality of vent holes, the elbow including a port that is selectively closed by a flap portion of the anti-asphyxia valve depending on the presence of pressurized gas, the port being positioned between the swivel joint and the vent arrangement, wherein;

the shroud and the frame have complimentary shapes that provide for non-rotatable engagement relative to one another, and

the first end portion of the elbow includes a distal end releasably inserted into the opening of the frame with a snap-fit, thereby creating a retention structure to retain the elbow with the frame, whereby the retention structure to retain the elbow with the frame also maintains the shroud in engagement with the frame in a non-rotatable manner due to the complimentary shapes.

26. The mask system according to claim 25, wherein:

the shroud has a tight conforming fit to the frame,

the shroud includes an opening through which the distal end of the elbow is inserted, the shroud including a sandwich portion extending radially inwards,

the elbow includes an annular protrusion projecting away from an outer surface of the elbow,

the sandwich portion of the shroud is sandwiched between the annular protrusion of the elbow and the frame,

the distal end of the elbow has a distal shoulder adapted to extend under an edge of the frame to retain the elbow to the frame,

the frame includes a first bearing surface for the rotatable elbow,

the opening of the frame is at least partially surrounded by a collar, and an inner circumferential surface of the collar comprises said at least one bearing surface,

the collar includes a second bearing surface positioned at a distal end of the collar, and

a surface of the annular protrusion of the elbow rotatably engages with the sandwich portion.

27. The mask system according to claim 25, wherein the mask system is provided with a number of differently sized cushion modules, the frame of each cushion module including a common configuration for interfacing with the shroud, thus providing a modular arrangement that allows the shroud to be selectively and removably coupled to each of the number of cushion modules, and

wherein the differently sized cushion modules include small, medium, and large full-face cushions.

28. A full-face mask system for delivering a supply of breathable gas at positive pressure to a patient'"'"'s airways to treat a respiratory disorder, the mask system comprising:

a shroud;

a cushion module that engages the shroud, the cushion module including a frame and a full-face cushion adapted to engage the patient'"'"'s face generally along nasal bridge, cheek, and chin regions of the patient'"'"'s face, the frame at least partly defining a breathing chamber;

an elbow connected to the frame in a releasable and rotatable manner, the elbow being adapted to be connected to an air delivery tube to deliver breathable gas to the patient; and

headgear removably attachable, directly or indirectly, to the shroud, wherein;

the frame includes an opening, the elbow including a distal end releasably inserted into the opening of the frame with a snap-fit, thereby connecting the elbow to the frame, whereby the connection between the elbow and the frame also maintains the shroud in engagement with the frame, and

the shroud and the frame are prevented from rotation relative to one another when the elbow is snap-fitted to the frame.

29. The mask system according to claim 28, wherein:

the shroud includes an opening through which the distal end of the elbow is inserted, the shroud including a sandwich portion extending radially inwards,

the elbow includes an annular protrusion projecting away from an outer surface of the elbow,

the sandwich portion of the shroud is sandwiched between the annular protrusion and the frame,

the distal end of the elbow has a distal shoulder adapted to extend under an edge of the frame to retain the elbow to the frame, said distal shoulder including a plurality of spaced apart tangs,

the frame includes at least one bearing surface for the rotatable elbow, and

the opening is at least partially surrounded by a collar, and an inner circumferential surface of the collar comprises said at least one bearing surface.

30. The mask system according to claim 28, wherein the frame is associable with a plurality of differently sized full-face cushions, to thereby form a plurality of differently sized cushion modules, the frame of each cushion module including a universal configuration for interfacing with the shroud, thus providing a modular arrangement that allows the shroud to be selectively and removably coupled to each of the plurality of cushion modules.