MASK SYSTEM

• US 20130133660A1
• Filed: 01/23/2013
• Published: 05/30/2013
• Est. Priority Date: 03/04/2008
• Status: Active Grant

• Current Assignee: Resmed Limited (ResMed Incorporated)
• Original Assignee: Resmed Limited (ResMed Incorporated)
• Inventors: Ng, Eva, Lockwood, David James, Wehbeh, Jamie Graeme, Valcic, Zoran, Eves, Matthew, Sari, Mahsita, D'souza, Errol Savio Alex
• Granted Patent: US 9,027,556 B2
• Time in Patent Office: Days
• US Class Current: 128/205.25
• 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 cushion module provided to a frame module for delivery of a supply of gas at positive pressure to be delivered to a patient'"'"'s airways, the cushion module comprising a main body and a cushion, the main body defining a breathing chamber and having an exterior surface adapted to directly engage with a surface of the frame module, wherein the main body and the cushion together comprise a co-molded, integrated component, the main body comprising a molded polycarbonate material adapted to directly contact the frame module and the cushion comprises a molded silicone material adapted to interface with patient'"'"'s face, and wherein the molded polycarbonate material of the main body is a more rigid material than the molded silicone material of the cushion.

Claims

1. A mask system for delivery of a supply of gas at positive pressure to a patient for medical treatment, the mask system comprising:

a frame module;

a cushion module provided to the frame module and adapted to form a seal with the patient'"'"'s face;

an elbow module provided to the frame module and adapted to be connected to an air delivery tube that delivers breathable gas to the patient; and

headgear removably attachable to the frame module to assist in maintaining the mask system in a desired adjusted position on the patient'"'"'s face, wherein;

the cushion module includes a main body and a cushion, the main body defining a breathing chamber and having an exterior surface directly engaged with a surface of the frame module, and

the main body and cushion together comprise a co-molded, integrated component, the main body comprising a molded polycarbonate material that interfaces with the frame module and the cushion comprises a molded silicone material adapted to interface with patient'"'"'s face, and the molded polycarbonate material of the main body is a more rigid material than the molded silicone material of the cushion.

2. The mask system according to claim 1, wherein a co-molded joint between the molded polycarbonate material of the main body and the molded silicone material of the cushion extends around the respective perimeters of the main body and the cushion such that the cushion is oriented to extend from the joint towards the patient'"'"'s face and the main body extends away from the joint and towards the frame module.

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

the cushion provides a sealing portion adapted to form a seal with the patient'"'"'s nose and mouth, and wherein the cushion is adapted to engage the patient'"'"'s face generally along nasal bridge, cheek, and chin regions of the patient'"'"'s face,

wherein the cushion includes a base wall provided to the main body, an undercushion layer extending away from the base wall, and a membrane provided to substantially cover the undercushion layer,

the undercushion layer is provided in a nasal bridge region of the cushion, and

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

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

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

the elbow includes a first end portion and a second end portion, the first end portion being attached to the frame module, the second end portion being provided to 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, and structure to attach the anti-asphyxia valve, the structure being positioned between a swivel joint and the vent arrangement.

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

the frame module is structured to maintain the elbow module in an operative position with respect to the patient'"'"'s face, with the frame module and elbow module being connected with a mechanical interlock,

the elbow module is rotatably attached to the frame module so that the elbow module may be rotated 360 degrees relative to the frame module.

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

the frame module includes a forehead support,

the frame module includes four headgear connectors to connect with the headgear, two of the headgear connectors including an arm and a slot at the 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,

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

the headgear is removably attachable to the headgear connectors of the frame module to maintain the mask system in a desired position on the patient'"'"'s face, and

the headgear includes a pair of upper and lower straps with the upper straps removably attached to respective upper headgear connectors and the lower straps 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.

7. The mask system according to claim 1, further comprising a concertina section provided in a nasal bridge region of the cushion, the concertina section including one or more folds that provide a higher degree of flexibility or increased movement relative to the main body, wherein:

the concertina section is provided around the entire perimeter of the cushion,

flexibility of the concertina section is varied in different regions of the cushion,

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

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

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

wherein the differently sized cushion modules include different size cushions, including small, medium, and large.

9. The mask system according to claim 1, wherein said co-molded integrated component includes a chemical bond that bonds the main body to the cushion.

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

the cushion provides a sealing portion adapted to form a seal with the patient'"'"'s nose and mouth, and wherein the cushion is adapted to engage the patient'"'"'s face generally along nasal bridge, cheek, and chin regions of the patient'"'"'s face,

the cushion includes a base wall provided to the main body, an undercushion layer extending away from the base wall, and a membrane provided to substantially cover the undercushion layer,

the undercushion layer is provided in a nasal bridge region of the cushion,

the undercushion layer is not provided in at least a part of a chin region of the cushion,

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

the elbow includes a first end portion and a second end portion, the first end portion being attached to the frame module, the second end portion being provided to 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,

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, and structure to attach the anti-asphyxia valve, the structure being positioned between a swivel joint and the vent arrangement,

the frame module is structured to maintain the elbow module in an operative position with respect to the patient'"'"'s face, with the frame module and elbow module being connected with a mechanical interlock,

the elbow module is rotatably attached to the frame module so that the elbow module may be rotated 360 degrees relative to the frame module,

the frame module includes a forehead support,

the frame module includes four headgear connectors to connect with the headgear, two of the headgear connectors including an arm and a slot at the 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,

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

the headgear is removably attachable to the headgear connectors of the frame module to maintain the mask system in a desired position on the patient'"'"'s face,

the headgear includes a pair of upper and lower straps with the upper straps removably attached to respective upper headgear connectors and the lower straps removably attached to respective lower headgear connectors, the 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,

a concertina section is provided in a nasal bridge region of the cushion, the concertina section including one or more folds that provide a higher degree of flexibility or increased movement relative to the main body,

the concertina section is provided around the entire perimeter of the cushion,

flexibility of the concertina section is varied in different regions of the cushion,

the concertina section in the nasal bridge region has a different degree of flexibility compared to the concertina section in a chin region of the cushion,

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

the mask system is provided with a number of differently sized cushion modules, the main body of each cushion module including a common configuration for interfacing with the frame module, thus providing a modular arrangement that allows the frame module to be selectively and removably coupled to each of the number of cushion modules, and

the differently sized cushion modules include different size cushions, including small, medium, and large.

11. The mask system according to claim 10, wherein said co-molded integrated component includes a chemical bond that bonds the main body to the cushion.

12. The mask system according to claim 11, wherein a co-molded joint between the molded polycarbonate material of the main body and the molded silicone material of the cushion extends around the respective perimeters of the main body and the cushion such that the cushion is adapted to extend from the joint towards the patient'"'"'s face and the main body extends away from the joint and towards the frame module.

13. A cushion module provided to a frame module for delivery of a supply of gas at positive pressure to be delivered to a patient'"'"'s airways, the cushion module comprising:

a main body and a cushion, the main body defining a breathing chamber and having an exterior surface adapted to directly engage with a surface of the frame module, wherein;

the main body and the cushion together comprise a co-molded, integrated component, the main body comprising a molded polycarbonate material adapted to directly contact the frame module and the cushion comprises a molded silicone material adapted to interface with patient'"'"'s face, and

wherein the molded polycarbonate material of the main body is a more rigid material than the molded silicone material of the cushion.

14. The cushion module according to claim 13, wherein a co-molded joint between the molded polycarbonate material of the main body and the molded silicone material of the cushion extends around the respective perimeters of the main body and the cushion such that when worn the cushion is oriented to extend from the joint towards the patient'"'"'s face and the main body is oriented to extend away from the joint and towards the frame module.

15. The cushion module according to claim 13, wherein the cushion provides a sealing portion adapted to form a seal with the patient'"'"'s nose and mouth, and wherein the cushion is adapted to engage the patient'"'"'s face generally along nasal bridge, cheek, and chin regions of the patient'"'"'s face.

16. The cushion module according to claim 15, wherein the main body includes an opening that is adapted to communicate with an elbow module.

17. The cushion module according to claim 13, wherein the cushion includes a base wall provided to the main body, an undercushion layer extending away from the base wall, and a membrane provided to cover the undercushion layer.

18. The cushion module according to claim 17, wherein the undercushion layer is provided in a nasal bridge region of the cushion and is structured to provide improved stability across the patient'"'"'s nasal bridge.

19. The cushion module according to claim 18, wherein the undercushion layer is not provided in at least a portion of a chin region of the cushion.

20. The cushion module according to claim 13, further comprising a concertina section is provided in a nasal bridge region of the cushion of the cushion module, the concertina section including one or more folds that provide a degree of flexibility or movement relative to the main body.

21. The cushion module according to claim 20, wherein the concertina section is provided around the entire perimeter of the cushion of the cushion module.

22. The cushion module according to claim 21, wherein flexibility of the concertina section is varied in different regions of the cushion of the cushion module.

23. The cushion module according to claim 18, wherein the concertina section in the nasal bridge region has a different degree of flexibility compared to the concertina section in a chin region of the cushion of the cushion module.

24. The cushion module according to claim 23, wherein the flexibility of the concertina section is varied by varying a wall length and/or depth of the one or more folds around the perimeter of the cushion of the cushion module.

25. The cushion module according to claim 13, wherein said co-molded integrated component includes a chemical bond that bonds the main body to the cushion.

26. The cushion module according to claim 13, wherein:

the cushion provides a sealing portion adapted to form a seal with the patient'"'"'s nose and mouth, and wherein the cushion is adapted to engage the patient'"'"'s face generally along nasal bridge, cheek, and chin regions of the patient'"'"'s face,

the main body includes an opening that is adapted to communicate with an elbow module,

the cushion includes a base wall provided to the main body, 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 cushion and is structured to provide improved stability across the patient'"'"'s nasal bridge,

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

a concertina section is provided in the nasal bridge region of the cushion of the cushion module, the concertina section including one or more folds that provide a degree of flexibility or movement relative to the main body,

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

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

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

the flexibility of the concertina section is varied by varying the wall length and/or the depth of the one or more folds around the perimeter of the cushion of the cushion module.

27. The cushion module according to claim 26, wherein said co-molded integrated component includes a chemical bond that bonds the main body to the cushion.

28. The cushion module according to claim 27, wherein a co-molded joint between the molded polycarbonate material of the main body and the molded silicone material of the cushion extends around the respective perimeters of the main body and the cushion such that when worn the cushion is oriented to extend from the joint towards the patient'"'"'s face and the main body is oriented to extend away from the joint and towards the frame module.