Mask and mask cushion therefor

• US 9,463,295 B2
• Filed: 08/28/2013
• Issued: 10/11/2016
• Est. Priority Date: 07/26/1996
• Status: Expired due to Fees

• Current Assignee: Resmed Limited (ResMed Incorporated)
• Original Assignee: Resmed Limited (ResMed Incorporated)
• Inventors: Kwok, Philip Rodney, Styles, Robert Edward
• Primary Examiner(s): Anderson, Lynne
• Assistant Examiner(s): DITMER, KATHRYN ELIZABETH
• Application Number:
  US14/012,483
• Publication Number:
  US 20130340762A1
• Time in Patent Office: 1,140 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 5/097 Devices for facilitating collection of breath or for directing breath into or through measuring devices
• CPC Class Codes: A61B 5/6819 Nose
• CPC Class Codes: A61B 5/682 Mouth, e.g., oral cavity; tongue; Lips; Teeth
• CPC Class Codes: A61M 16/0057 Pumps therefor
• 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 2210/0618 Nose

Abstract

A cushion comprises a substantially triangularly shaped frame from which extends a membrane. The membrane is spaced away from the rim of the frame, and its outer surface is of substantially the same shape as the rim. The seal forming portion thus contacts both the surface of the wearer'"'"'s nose and a portion of the wearer'"'"'s face. The shape of the seal forming portion is particularly suited to effectively seal the difficult region of the facial contour that is the crease between the sides of the nose and the face.

Claims

1. A mask cushion to sealingly connect a mask to a wearer'"'"'s face, the cushion comprising:

a frame of resilient material having a rim to at least partially surround the wearer'"'"'s nose; and

a membrane also of resilient material and defining an aperture sized to receive the wearer'"'"'s nose, said membrane being thinner than and relatively more flexible than said frame, said membrane being fixed to and extending away from said frame so as to be spaced from said rim by a gap, said membrane having an outer surface forming a face contacting seal portion that is pre-shaped to generally match the contours of the wearer'"'"'s face, wherein the face contacting seal portion is structured such that it is not required to turn in on itself to conform with the wearer'"'"'s face, in use;

wherein;

the cushion at least partly forms a breathing chamber to receive pressurized breathable gas, for delivery to at least a nasal passage of the wearer, the breathing chamber being accessible by the wearer via the aperture of the membrane;

the rim and the membrane are commonly curved towards the breathing chamber,

the cushion is structured so that the pressurized gas in the chamber assists in maintaining a seal between the membrane and the wearer in use;

the frame and rim are structured to resist deformation so as to form a support structure for the membrane,

said membrane is resiliently deformable towards said gap to abut said rim in use of said cushion; and

the rim and the membrane have a pre-formed co-located notch to accommodate the bridge of the wearer'"'"'s nose.

2. A cushion as claimed in claim 1, wherein said membrane and said rim are substantially saddle-shaped.

3. A cushion as claimed in claim 2, wherein said membrane is shaped so that said seal portion, in use, contacts at least the wearer'"'"'s nose.

4. A cushion as claimed in claim 3, wherein said seal portion, in use, contacts the facial tissue around the sides and over the bridge of the nose, and between the base of the nose and the top lip.

5. A cushion as claimed in claim 1, wherein said rim and said seal portion are pre-shaped to generally match facial contours in the region of facial tissue around the sides and over the bridge of the nose, and between the base of the nose and the top lip.

6. A cushion as claimed in claim 1, wherein the face contacting seal portion is pre-shaped to closely imitate the contours of the wearer'"'"'s face.

7. A cushion as claimed in claim 1, wherein the face contacting seal portion is structured to enable contact with the wearer'"'"'s face without folds or creases.

8. A cushion as claimed in claim 1, wherein the membrane is less stiff than the frame, to conform with the wearer'"'"'s facial structure with minimum force, without a tendency to fold or crease.

9. A mask for connection to a wearer'"'"'s face comprising:

a mask body for connection with a supply of breathable gas;

a cushion, the body and cushion defining a nose-receiving cavity adapted to receive pressurized gas for breathing by the wearer in use;

at least one securing strap to secure the mask body and cushion to the wearer'"'"'s head, the strap being structured to be tensioned to balance force due to the pressurized gas that tends to lift the mask off of the wearer'"'"'s face; and

at least one vent opening by which gas expired by the wearer is exhausted to atmosphere;

wherein the cushion includes;

a frame of resilient material having a rim to surround at least a portion of the wearer'"'"'s nose;

a membrane also of resilient material, said membrane being thinner than and relatively more flexible than said frame, the membrane being fixed to and extending away from said frame so as to be spaced from said rim by a gap, said membrane having an outer surface forming a face contacting seal portion that is pre-shaped to generally match the contours of the wearer'"'"'s face, wherein the face contacting seal portion is structured such that it is not required to turn in on itself to conform with the wearer'"'"'s face, in use;

wherein;

the rim and frame are curled inwardly towards the nose-receiving cavity and structured to resist deformation so as to form a support structure for the membrane, and

said seal portion is resiliently deformable towards said gap to abut said rim in use of said mask, depending on the facial contours of the wearer and/or strap tension applied the at least one securing strap; and

said membrane and said rim each have a co-located notch to accommodate the bridge of a nose.

10. A mask as claimed in claim 9, wherein said mask body includes at least one attachment point to which the at least one securing strap is coupled.

11. A mask as claimed in claim 9, wherein said membrane is shaped so that said seal portion, in use, contacts at least the wearer'"'"'s nose.

12. A mask as claimed in claim 11, wherein said seal portion, in use, contacts the facial tissue around the sides and over the bridge of the nose, and between the base of the nose and the top lip.

13. A mask as claimed in claim 9, wherein said rim and said seal portion are shaped to generally match facial contours in the region of facial tissue around the sides and over the bridge of the nose, and between the base of the nose and the top lip.

14. A mask cushion to sealingly connect a mask to a wearer'"'"'s face, the cushion comprising:

a frame of resilient material having a rim shaped to generally match facial contours at least in the region of facial tissue around the sides of the nose, and between the base of the nose and the top lip;

a membrane also of resilient material, the membrane being thinner than and relatively more flexible than the frame, said membrane being fixed to and extending away from the frame so as to be spaced from the rim by a gap, said membrane having an outer surface forming a face contacting seal portion that is pre-shaped to generally match the contours of the wearer'"'"'s face, the membrane including a pre-formed notch to accommodate the wearer'"'"'s nose bridge, wherein the face contacting seal portion is structured such that it is not required to turn in on itself to conform with the wearer'"'"'s face, in use; and

wherein the rim and the membrane are inwardly curled in a common orientation towards the wearer'"'"'s nose in use, and

a strap structured to secure the cushion to the wearer'"'"'s face, wherein, before application of strap tension, the seal portion is spaced from the rim of the cushion by the gap, and as a result of application of strap tension and/or to accommodate the wearer'"'"'s facial contours, the seal portion is resiliently deformable into said gap to abut against the rim, said membrane resiliently returning to its original position, spaced from said rim by said gap, when the mask cushion is not in use.

15. A mask cushion for sealingly connecting a mask to a patient'"'"'s face during the administration of positive airway pressure, the cushion including:

a frame of resilient material, said frame having a rim to surround at least a portion of the patient'"'"'s face;

a membrane of resilient material and fixed to and extending away from the frame so as to be spaced from the rim, in at least one region of the frame, so as to include a gas-filled gap between the membrane and the rim before the cushion is in use, said membrane fully covering or overlying the rim as seen in cross section, wherein each of the rim and the membrane includes a distal end that is unsupported, the distal ends curled inwardly and terminating in a substantially common orientation,

a seal forming portion on an outer surface of said membrane, said seal forming portion being provided only on said membrane such that only the membrane forms a seal with the patient'"'"'s face in use;

the membrane being pre-shaped to generally match the contours of the patient'"'"'s face including a preformed contoured notch to accommodate the bridge of the patient'"'"'s nose,

wherein the seal forming portion is structured such that it is not required to turn in on itself to conform with the patient'"'"'s face,

wherein the frame and the membrane at least partly define a breathing cavity to receive pressurized gas for delivery to at least a nasal airway of the patient, the membrane having an aperture comprised to receive the patient'"'"'s nose and allow the pressurized gas to flow from the breathing cavity to the patient'"'"'s nasal airway.

16. A mask cushion as claimed in claim 15, wherein said seal forming portion is resiliently deformable into the gap towards the rim in use of the cushion.

17. A mask cushion as claimed in claim 15, wherein said rim has a preformed and contoured notch, co-located relative to the notch of the membrane, also to accommodate the bridge of the patient'"'"'s nose.

18. A mask cushion as claimed in claim 15, wherein said membrane is shaped so that said seal forming portion, in use, contacts at least a patient'"'"'s nose.

19. A mask cushion as claimed in claim 15, wherein the seal forming portion, in use, contacts the facial tissue around the sides and over the bridge of the nose, and between the base of the nose and the top lip.

20. A mask cushion as claimed in claim 15, wherein said rim and said seal forming portion are pre-shaped to generally match facial contours of the facial tissue around the sides and over the bridge of the nose, and between the base of the nose and the top lip.

21. A mask cushion as claimed in claim 15, wherein the frame, the rim and the membrane are formed as a one piece unit.

22. A mask cushion as claimed in claim 15, wherein the rim has a thickness that is greater than a thickness of the membrane.

23. A mask cushion as claimed in claim 22, wherein the rim is about four times thicker than the membrane.

24. A mask cushion as claimed in claim 22, wherein the rim thickness is about 1.5 mm, and the membrane thickness is about 0.35 mm.

25. A mask cushion as claimed in claim 15, further comprising a strap structured to secure the cushion to the patient'"'"'s face, wherein, before application of strap tension, the seal forming portion is spaced from the rim of the cushion by said gap, and during application of strap tension and/or depending on the patient'"'"'s contours, the seal forming portion deforms to abut against the rim of the cushion.

26. A mask cushion as claimed in claim 15, wherein the membrane is formed of silicone.

27. A mask cushion as claimed in claim 15, wherein the membrane is molded.

28. A mask cushion as claimed in claim 15, wherein the membrane is molded to generally match the contours of the patient'"'"'s face even when the mask is not in use.

29. A mask cushion as claimed in claim 15, wherein the outer surface of the membrane is substantially the same shape as the rim of the frame in the at least one region.

30. A mask cushion as claimed in claim 15, wherein the gap is formed between the frame and the membrane in the lip region of the wearer, whereby the membrane may resiliently deform into the gap toward the frame in use of the cushion.

31. A mask cushion as claimed in claim 15, wherein the rim of the frame is designed to define a maximum deformation position of the membrane in normal use.

32. A mask cushion as claimed in claim 15, further comprising a strap structured to secure the cushion to the patient'"'"'s face, wherein the outer surface forms a seal upon connection to the patient'"'"'s face and application of minimal force, if any, to the strap.

33. A mask cushion as claimed in claim 15, wherein the rim of the frame is approximately 1.5 mm thick.

34. A mask cushion as claimed in claim 15, wherein the membrane is approximately 0.35 mm thick.

35. A mask cushion as claimed in claim 15, wherein the frame is formed of silicone.

36. A mask cushion as claimed in claim 15, wherein frame is molded.

37. A mask cushion as claimed in claim 15, wherein said rim is structured to resist deformation so as to form support structure for the membrane.

38. A mask comprising the mask cushion as claimed in claim 15, said mask including a mask body for connection with a supply of pressurized breathable gas.

39. A mask as claimed in claim 38, wherein the mask further includes at least one vent opening by which gas expired by the patient is exhausted to atmosphere.

40. A mask as claimed in claim 38, wherein said mask body includes attachment points.

41. A mask as claimed in claim 40, further comprising securing straps fixed to said attachment points.

42. A CPAP treatment apparatus comprising the mask as claimed in claim 38, the CPAP treatment apparatus including a flow generator for the supply of gas at a pressure elevated above atmospheric pressure;

and a gas delivery conduit coupled to said flow generator.