Mask system

• US 9,737,678 B2
• Filed: 09/30/2011
• Issued: 08/22/2017
• Est. Priority Date: 09/30/2010
• Status: Active Grant

• Current Assignee: ResMed Pty Ltd. (ResMed Incorporated)
• Original Assignee: Resmed Limited (ResMed Incorporated)
• Inventors: Formica, Justin John, Romagnoli, Jose Ignacio, Kwok, Philip Rodney, Gibson, Joel Edward, Pidcock, David Anthony, Skipper, Christopher Scott, Gray, Stephen
• Primary Examiner(s): Ho, (Jackie) Tan-Uyen T
• Assistant Examiner(s): Boecker, Joseph D
• Application Number:
  US13/876,606
• Publication Number:
  US 20130199537A1
• Time in Patent Office: 2,153 Days
• Field of Search: 12820024, 12820123, 12820227, 12820329, 12820525, 12820612, 12820613, 12820615, 12820618, 12820621, 12820628, 12820711-20713, 12820717, 12820718
• CPC Class Codes: A61M 16/0057 Pumps therefor
• 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 16/0655 in the form of a linear or curvilinear slide
• CPC Class Codes: A61M 16/0666 Nasal cannulas or tubing devices for improving normal breathing through the nose A61F5/08; nose filters A62B23/06; outside holding devices A61M25/02
• 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 16/0875 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 2202/0085 product washed out
• CPC Class Codes: A61M 2202/0225 Carbon oxides, e.g. Carbon dioxide
• CPC Class Codes: A61M 2205/0216 Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking
• CPC Class Codes: A61M 2209/06 Packaging for specific medical equipment
• CPC Class Codes: A61M 2210/0618 Nose
• CPC Class Codes: A61M 2210/0625 Mouth

Abstract

A mask system for delivery of respiratory therapy to a patient includes a nares portion and a mouth portion and an inlet conduit connected to at least one of the nares portion and the mouth portion to deliver the pressurized, breathable gas. The mask system is adapted to selectively utilize the nares portion and/or the mouth portion in a first mode utilizing both the nares portion and the mouth portion, and in a second mode utilizing the nares portion and not utilizing the mouth portion.

Claims

1. A mask system for delivery of respiratory therapy to a patient, comprising:

a nares portion adapted to form a seal with a patient'"'"'s nares;

a mouth portion including a mouth chamber and a mouth sealing portion adapted to form a seal with a patient'"'"'s mouth, the mouth chamber including an opening adapted to selectively receive pressurized, breathable gas; and

an inlet conduit connected to at least one of the nares portion and the mouth portion to deliver the pressurized, breathable gas,

wherein the mouth portion is selectively removable from the mask system to selectively arrange the mask system between;

(1) a first configuration utilizing both the nares portion and the mouth portion to form the seal with both the patient'"'"'s nares and the patient'"'"'s mouth and deliver the pressurized, breathable gas to the patient'"'"'s nares and/or the patient'"'"'s mouth;

(2) a second configuration utilizing only the nares portion to only form the seal with the patient'"'"'s nares and only deliver the pressurized, breathable gas to the patient'"'"'s nares; and

(3) a third configuration utilizing only the mouth portion to only form the seal with the patient'"'"'s mouth and only deliver the pressurized, breathable gas to the patient'"'"'s mouth, and

wherein said opening of the mouth portion is a first opening and the mouth portion further comprises a second opening that is separate and distinct from the first opening, and the first opening is structured and arranged to allow selective attachment to the nares portion and the second opening is structured and arranged to allow selective attachment to the inlet conduit.

2. The mask system according to claim 1, further comprising a plug adapted to plug the first or second opening in the mouth chamber in the first configuration so that the mouth chamber is utilized as a mouth seal that does not deliver any of the pressurized, breathable gas to the patient'"'"'s mouth.

3. The mask system according to claim 1, wherein the inlet conduit is connectable to the nares portion to deliver the pressurized, breathable gas to the nares of the patient.

4. The mask system according to claim 1, wherein when in use in the first configuration, the second opening in the mouth chamber is connectable to the inlet conduit to deliver the pressurized, breathable gas to the patient'"'"'s mouth.

5. The mask system according to claim 4, further comprising a connector adapted to connect the nares portion to the mouth chamber of the mouth portion, wherein the connector is adapted to communicate a portion of the pressurized, breathable gas between the mouth chamber and the nares portion.

6. The mask system according to claim 1, further comprising a double elbow connector adapted to connect the inlet conduit to both the nares portion and the mouth portion for use of the mask system in the first configuration.

7. The mask system according to claim 3, further comprising a swivel ring in the nares portion or in the second opening in the mouth chamber adapted to connect to the inlet conduit.

8. The mask system according to claim 1, wherein the mouth sealing portion includes a silicone cushion.

9. The mask system according to claim 1, wherein at least one of the nares portion and the mouth portion includes headgear connectors adapted to connect to headgear.

10. The mask system according to claim 1, wherein both of the nares portion and the mouth portion include headgear connectors adapted to connect to headgear.

11. The mask system according to claim 9, wherein the headgear includes upper side straps adapted to be routed between the patient'"'"'s eyes and ears and lower side straps routed under the patient'"'"'s ears.

12. The mask system according to claim 11, wherein the headgear includes a crown strap portion adapted to be positioned in use over the crown of the patient'"'"'s head.

13. The mask system according to claim 12, wherein the headgear includes a rear strap portion connected to the upper side straps above the patient'"'"'s ears and adapted to angle downward along the sides of the patient'"'"'s head in use to capture the occiput of the patient'"'"'s head.

14. The mask system according to claim 13, wherein the rear strap portion is connected to the lower side strap below the occiput of the patient'"'"'s head.

15. The mask system according to claim 1, wherein the nares portion includes a nares sealing portion adapted to form the seal with the patient'"'"'s nares in use.

16. The mask system according to claim 15, wherein the nares sealing portion comprises one of pillows, prongs, a membrane seal, or a nasal chamber.

17. The mask system according to claim 16, wherein the nares sealing portion is structured to extend or curve outwardly from a supporting wall defining an air path into the nares sealing portion.

18. The mask system according to claim 17, further comprising a plurality of rigid elements disposed on a lower side of the nares sealing portion, and a dial connected to the rigid elements, the dial when turned adapted to cause the rigid elements to move upwards or downwards to adjust a pinching force of the nares sealing portion.

19. The mask system according to claim 1, wherein the mouth sealing portion includes a foam patient contacting portion.

20. The mask system according to claim 8, wherein the silicone cushion is formed in a substantially u-shape, and the nares portion includes a nares sealing portion adapted to form the seal with the patient'"'"'s nares in use, the nares sealing portion being connected to two side portions of the silicone cushion.

21. The mask system according to claim 20, wherein the nares sealing portion includes a stretching element adapted to allow the patient to selectively stretch the nares sealing portion.

22. The mask system according to claim 1, further comprising a vent formed in at least one of the nares portion and the mouth portion, the vent adapted to vent gas exhaled by the patient.

23. The mask system according to claim 22, wherein the vent comprises a plurality of vent holes.

24. The mask system according to claim 15, wherein the inlet conduit is connected to the nares portion, and the nares portion includes a nares decoupling portion adapted to decouple forces applied to the inlet conduit from the nares sealing portion.

25. The mask system according to claim 1, wherein the inlet conduit is connected to the mouth portion, and the mouth portion includes a mouth decoupling portion adapted to decouple forces applied to the inlet conduit from the mouth sealing portion.

26. A mask system for delivery of respiratory therapy to a patient, comprising:

a nares portion adapted to form a seal with a patient'"'"'s nares;

a mouth portion including a mouth chamber and a mouth sealing portion adapted to form a seal with a patient'"'"'s mouth; and

an inlet conduit connected to at least one of the nares portion and the mouth portion to deliver pressurized, breathable gas to the patient,

wherein the nares portion and the mouth portion are adapted to selectively attach to each other and detach from each other,

wherein the mouth portion is adapted to selectively function in both a first configuration where at least a portion of the pressurized, breathable gas is delivered to the patient'"'"'s mouth and in a second configuration where the mouth portion functions as a mouth seal that prevents any of the pressurized, breathable gas from being delivered to the patient'"'"'s mouth,

wherein the mouth portion is adapted to selectively function in both the first configuration and the second configuration when the mouth portion is either attached to the nares portion or detached from the nares portion, and

wherein the mouth chamber of the mouth portion includes a first opening and a second opening that is separate and distinct from the first opening, and the first opening is structured and arranged to allow selective attachment to the nares portion and the second opening is structured and arranged to allow selective attachment to the inlet conduit.

27. The mask system according to claim 26, further comprising a connector in the nares portion connectable to the first opening in the mouth chamber to deliver a portion of the pressurized, breathable gas between the nares portion and the mouth chamber.

28. The mask system according to claim 27, wherein the inlet conduit is connectable to the nares portion to deliver a portion of the pressurized, breathable gas to the nares of the patient.

29. The mask system according to claim 27, wherein the inlet conduit is connectable to the mouth portion to deliver a portion of the pressurized, breathable gas to the mouth of the patient.

30. The mask system according to claim 27, further comprising a plug adapted to plug the first or second opening in the mouth chamber in the second configuration so that the pressurized, breathable gas is not delivered to the mouth chamber.

31. The mask system according to claim 26, further comprising a mouth portion sealing device allowing a patient to selectively switch the mouth portion between the first and second configurations.

32. The mask system according to claim 31, wherein the mouth portion sealing device comprises a turnable knob on the mouth portion.

33. The mask system according to claim 26, wherein the mouth portion is configured so that gas in the mouth portion does not communicate with atmosphere when the mouth portion is functioning as the mouth seal in the second configuration.

34. A method for delivering respiratory therapy to a patient, the method comprising:

providing a nares portion adapted to form a seal with a patient'"'"'s nares;

providing a mouth portion including a mouth chamber and a mouth sealing portion adapted to form a seal with a patient'"'"'s mouth, the mouth chamber including an opening adapted to selectively receive pressurized, breathable gas;

providing an inlet conduit connectable to at least one of the nares portion and the mouth chamber to deliver the pressurized, breathable gas; and

selectively arranging the nares portion and/or the mouth portion between at least first and second configurations, the first configuration utilizing both the nares portion and the mouth portion to form the seal with both the patient'"'"'s nares and the patient'"'"'s mouth and deliver the pressurized, breathable gas to the patient'"'"'s nares and/or the patient'"'"'s mouth, and the second configuration utilizing only the nares portion to only form the seal with the patient'"'"'s nares and only deliver the pressurized, breathable gas to the patient'"'"'s nares,

wherein the mouth portion is selectively removable from the nares portion to selectively arrange the nares portion and/or the mouth portion between the at least first and second configurations.

35. The method of claim 34, further comprising plugging the opening in the mouth chamber in the first configuration so that the mouth chamber is utilized as a mouth seal that does not deliver any of the pressurized, breathable gas to the patient'"'"'s mouth.

36. The method of claim 34, further comprising connecting the nares portion to the chamber of the mouth portion to communicate a portion of the pressurized, breathable gas between the mouth chamber and the nares portion.

37. The method of claim 34, further comprising connecting the inlet conduit to both the nares portion and the mouth portion for use in the first configuration.

38. The method of claim 34, further comprising connecting the nares portion or the mouth chamber to the inlet conduit by a swivel ring.

39. The method of claim 34, further comprising connecting the nares portion and the mouth portion to headgear.

40. The method of claim 39, further comprising routing upper side straps of the headgear between the patient'"'"'s eyes and ears and routing lower side straps of the headgear under the patient'"'"'s ears.

41. The method of claim 40, wherein the headgear includes a crown strap portion adapted to be positioned in use over the crown of the patient'"'"'s head.

42. The method of claim 41, wherein the headgear includes a rear strap portion connected to the upper side straps above the patient'"'"'s ears and adapted to angle downward along the sides of the patient'"'"'s head in use to capture the occiput of the patient'"'"'s head.

43. The method of claim 42, wherein the rear strap portion is connected to the lower side strap below the occiput of the patient'"'"'s head.

44. The method of claim 34, wherein the nares portion includes a nares sealing portion adapted to form the seal with the patient'"'"'s nares, and the nares sealing portion is structured to extend or curve outwardly from a supporting wall defining an air path into the nares sealing portion.

45. A method of converting a mask system between first and second configurations, the mask system adapted for delivery of respiratory therapy to a patient, the method comprising:

providing a nares portion adapted to form a seal with a patient'"'"'s nares;

providing a mouth portion including a mouth chamber and a mouth sealing portion adapted to form a seal with a patient'"'"'s mouth, the mouth chamber including an opening adapted to selectively receive pressurized, breathable gas; and

assembling the mask system into the first configuration wherein the nares portion and the mouth portion are usable to form the seal with both the patient'"'"'s nares and the patient'"'"'s mouth and deliver the pressurized, breathable gas to the patient'"'"'s nares and/or the patient'"'"'s mouth; and

converting the mask system into the second configuration wherein only the nares portion is usable to only form the seal with the patient'"'"'s nares and only deliver the pressurized, breathable gas to the patient'"'"'s nares.

46. The method of claim 45, wherein assembling the mask system into the first configuration further comprises plugging the opening in the mouth chamber so that the mouth chamber is utilized as a mouth seal that does not deliver any of the pressurized, breathable gas to the patient'"'"'s mouth.

47. The method of claim 45, wherein assembling the mask system into the first configuration further comprises connecting the nares portion to the chamber of the mouth portion so that a portion of the pressurized, breathable gas is transferred between the mouth chamber and the nares portion.

48. The method of claim 45, wherein assembling the mask system into the first configuration further comprises connecting an inlet tube to the nares portion.

49. The method of claim 45, wherein assembling the mask system into the first configuration further comprises connecting an inlet tube to the mouth portion.

50. The method of claim 45, wherein converting the mask system into the second configuration comprises disconnecting the mouth portion from the nares portion.

51. The method of claim 49, wherein converting the mask system into the second configuration further comprises disconnecting the inlet tube from the mouth portion, and connecting the inlet tube to the nares portion.

52. A mask system for delivery of respiratory therapy to a patient, comprising:

a mouth portion including a mouth chamber and a mouth sealing portion adapted to form a seal with a patient'"'"'s mouth, the mouth chamber including an opening adapted to selectively receive pressurized, breathable gas; and

a nares portion docking station formed on the mouth portion, the nares portion docking station adapted to receive a nares portion,

wherein the nares portion is selectively detachable from the nares portion docking station and capable of functioning as a nares only device adapted to only form a seal with a patient'"'"'s nares and only deliver pressurized, breathable gas to the patient'"'"'s nares,

wherein the mask system is selectively arrangeable in a configuration utilizing only the mouth portion to only form the seal with the patient'"'"'s mouth and only deliver the pressurized, breathable gas to the patient'"'"'s mouth, and

wherein the nares portion docking station comprises a docking station aperture that is separate and distinct from the opening of the mouth chamber, and the docking station aperture is structured and arranged to allow selective attachment to the nares portion and the opening of the mouth chamber is structured and arranged to allow selective attachment to an inlet conduit.

53. The mask system of claim 52, wherein the nares portion docking station is shaped to mate with a shape of the nares portion.

54. The mask system of claim 52, wherein the docking station aperture is structured and arranged to mate with a connector on the nares portion.

55. The mask system of claim 54, further comprising a plug adapted to fit into the docking station aperture or the connector of the nares portion.

56. The mask system of claim 54, further comprising a valve in the mouth portion adapted to selectively close the docking station aperture.

57. A medical package including a kit for converting a CPAP device comprising a nares only portion to a CPAP device having a nares and mouth portion, the medical package including the mouth portion of claim 52, a vent plug adapted to plug an aperture in the nares only portion, and headgear adapted to secure at least the mouth portion to a patient'"'"'s head.

58. The medical package of claim 57, further comprising a plug adapted to fit into the docking station aperture of the nares portion docking station.

59. The medical package of claim 57, wherein the headgear is adapted to connect the mouth portion and the nares only portion to the patient'"'"'s head.