Mask and vent assembly therefor

• US 7,207,335 B2
• Filed: 02/12/2003
• Issued: 04/24/2007
• Est. Priority Date: 02/10/1997
• Status: Expired due to Fees

• Current Assignee: Resmed Limited (ResMed Incorporated)
• Original Assignee: Resmed Limited (ResMed Incorporated)
• Inventors: Lithgow, Perry David, Kwok, Philip Rodney
• Primary Examiner(s): Nguyen; Anhtuan T.
• Assistant Examiner(s): Erezo; Darwin P
• Application Number:
  US10/364,358
• Publication Number:
  US 20030116160A1
• Time in Patent Office: 1,532 Days
• Field of Search: 128/207.12, 128/207.16, 128/205.24, 128/204.18, 128/206.12, 128/206.21
• US Class Current: 128/207.12
• CPC Class Codes: A61M 16/06 Respiratory or anaesthetic masks
• CPC Class Codes: A61M 16/0683 Holding devices therefor
• 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 2205/42 Reducing noise
• CPC Class Codes: A62B 18/02 Masks gas-masks for animals A62B18/06; masks for welders A61F9/06
• CPC Class Codes: A62B 18/10 Valves

Abstract

A mask (10) for use with a system for supplying breathable gas pressurised above atmospheric pressure to a human or animal'"'"'s airways. The mask (10) includes a mask shell (12) which is, in use, in fluid communication with a gas supply conduit (30), and a gas washout vent assembly (20). At least the region of the mask shell (12) or conduit (30) surrounding or adjacent the vent assembly is formed from a relatively flexible elastomeric material.

Claims

1. A CPAP mask assembly for use with a system for supplying breathable gas pressurized above atmospheric pressure to a human or animal, the CPAP mask assembly comprising:

a mask adapted to be in fluid communication with a gas supply conduit; and

a vent assembly provided to the mask, the vent assembly including at least one gas washout orifice extending from an inner side of the vent assembly placed, in use, adjacent the human or animal'"'"'s face to an outer side placed, in use, adjacent the atmosphere, the gas washout orifice being open in use, wherein

a cross-sectional area of the orifice at the inner side of the vent assembly is larger than a cross-sectional area of the orifice at the outer side of the vent assembly,

the inner side of the vent assembly extends inside the mask and the outer side of the vent assembly extends outside the mask, and

the orifice does not substantially change shape upon application of pressurized gas at a level suitable for CPAP treatment for obstructive sleep apnea.

2. A CPAP mask assembly as claimed in claim 1, wherein the orifice includes a first substantially cylindrical portion adjacent the inner side of the vent assembly, a second substantially cylindrical portion adjacent the outer side of the vent assembly and a tapering portion between the first substantially cylindrical portion and the second substantially cylindrical portion.

3. A CPAP mask assembly as claimed in claim 2, wherein the second substantially cylindrical portion and the tapering portion are of approximately equal thickness in the axial direction of the orifice and are thicker than the first substantially cylindrical portion.

4. A CPAP mask assembly as claimed in claim 1, wherein the vent assembly is an insert of relatively elastomeric material and is selectively attachable to and detachable from the mask.

5. A CPAP mask assembly as claimed in claim 4, wherein the insert is fonned from one of SILASTIC™

and SANTOPRENE™

.

6. A CPAP mask assembly as claimed in claim 4, wherein the insert includes a groove around its periphery, the groove locating the insert against a correspondingly sized rim of an opening formed in the mask.

7. A CPAP mask assembly as claimed in claim 4, wherein the insert is substantially crescent shaped.

8. A CPAP mask assembly as claimed in claim 1, wherein first and second ends of the orifice are located proximate an opening of the mask at, respectively, the inner side of the vent assembly and the outer side of the vent assembly.

9. A CPAP mask assembly as claimed in claim 1, wherein a thickness of the vent assembly is greater than an inner diameter of the orifice.

10. A CPAP mask assembly as claimed in claim 1, wherein the orifice does not substantially change shape upon application of pressurized gas less than about 18 cmH₂O.

11. A CPAP mask assembly as claimed in claim 1, wherein the orifice does not substantially change shape upon application of pressurized gas in the range of 4–

18 cmH₂O.

12. A CPAP mask assembly as claimed in claim 1, wherein the orifice does not substantially change shape upon application of pressurized gas in the range of 5–

15 cmH₂O.

13. A CPAP assembly as claimed in claim 1, wherein the orifice has a length of about 3.60 mm, an inner diameter at the inner side of about 3.30 mm, and an outer diameter at the outer side of about 1.73 mm.

14. A CPAP mask assembly as claimed in claim 1, wherein the vent assembly includes an insert formed from one of SILASTIC™

and SANTOPRENE™ and

the orifice has a length of about 3.60 mm, an inner diameter at the inner side of about 3.30 mm, and an outer diameter at the outer side of about 1.73 mm, and wherein the orifice does not substantially change shape upon application of pressurized gas less than about 18 cmH₂O.

15. A CPAP mask assembly as claimed in claim 1, wherein a ratio of an inner diameter at the inner side of the orifice to an outer diameter at the outer side of the orifice is about 2.

16. A CPAP mask assembly as claimed in claim 1, wherein the orifice includes a central portion having a curved portion that transitions a larger cross-sectional area of the orifice at the inner side to a smaller cross-sectional area of the orifice at the outer side.

17. A CPAP mask assembly for use with a system for supplying breathable gas pressurized above atmospheric pressure to a human or animal for treatment of obstructive sleep apnea, the CPAP mask assembly comprising:

a mask adapted to be in fluid communication with a gas supply conduit; and

a vent assembly provided to the mask, the vent assembly including at least one gas washout orifice extending from an inner side of the vent assembly placed, in use, adjacent the human or animal'"'"'s face to an outer side placed, in use, adjacent the atmosphere, the gas washout orifice being open in use, and a cross-sectional area of the orifice at the inner side of the vent assembly is larger than a cross-sectional area of the orifice at the outer side of the vent assembly;

wherein

the orifice includes a first substantially cylindrical portion adjacent the inner side of the vent assembly, a second substantially cylindrical portion adjacent the outer side of the vent assembly and a tapering portion between the first substantially cylindrical portion and the second substantially cylindrical portion, and

the orifice does not substantially change shape upon application of pressurized gas at a level suitable for CPAP treatment for obstructive sleep apnea.

18. A CPAP mask assembly as claimed in claim 17, wherein the tapering portion is present independent of whether the mask is in use.

19. A mask assembly for use wit a system for supplying breathable gas pressurized above atmospheric pressure to a human or animal'"'"'s airways, the mask assembly comprising:

a mask including an inlet tube that is, in use, adapted to be in fluid communication with a gas supply conduit pressurized above atmospheric pressure; and

a gas washout vent assembly located on the mask, wherein

the gas washout vent assembly comprises an elastic, deformable insert that can be removably inserted into an opening provided on the mask,

the insert includes a first surface to engage an inner surface of the mask, a second surface to engage an outer surface of the mask and a groove between the first and second surfaces to receive an edge defining the opening of the mask;

the insert includes at least one gas washout orifice with an outlet opening positioned, in use, adjacent atmosphere,

the orifice does not substantially change shape upon application of pressurized gas at a level suitable for CPAP treatment of obstructive sleep apnea,

a cross-sectional area of orifice oriented towards an inner side of the insert is larger than a cross-sectional area of the orifice oriented towards the outlet opening of the insert, and

a thickness of the insert is greater than a diameter of orifice.

20. A mask assembly as claimed in claim 19, wherein at least one orifice includes at least two orifices.

21. A mask assembly as claimed in claim 19, wherein, in use, pressure delivered to the patient is above atmospheric pressure at least during the inhalation and exhalation phases of the patient'"'"'s breathing cycle, during which phases gas washout through the orifice is possible.

22. An assembly for use with a system for supplying breathable gas pressurized above atmospheric pressure to a patient'"'"'s airways, the assembly comprising:

a patient interface including an air inlet tube that is, in use, adapted to be in fluid communication with a gas supply conduit pressurized above atmospheric pressure at least during inhalation and exhalation phases of the patient'"'"'s breathing cycle, the patient interface including a sealing membrane to provide a gas tight seal with the patient in use;

a gas washout vent assembly including at least two gas washout orifices extending towards an outer side of the patient interface positioned, in use, adjacent the atmosphere, each said orifice being open in use and having a cross-sectional area at an inner side that is larger than a cross-sectional area at the outer side, wherein

the outer side of each said orifice is substantially circular,

each said orifice includes a central portion connecting the inner and outer sides, the central portion having a cross-sectional area that varies along a length of the central portion,

the patient interface is defined at least in part by a wall structure wade of a relatively rigid material compared to the vent assembly, and the vent assembly is made of an elastomeric material,

the vent assembly comprises an insert that can be removably inserted into an opening on the mask, the insert including a first surface to engage an inner surface of the mask, a second surface to engage an outer surface of the mask, and a groove provided between the first and second surfaces to receive a rim of the opening,

the orifice does not substantially change shape upon application of pressurized gas, and

the inner side of each said orifice is located proximate the opening of the mask.

23. A mask assembly for use with a system for supplying breathable gas pressurized above atmospheric pressure to a human or animal patient'"'"'s airways, the mask assembly comprising:

a mask including an inlet tube which is adapted for fluid connection with a gas supply conduit,

a region of the mask defining a vent opening adapted for gas washout, and

an insert formed of an elastomeric material positioned within said vent opening, said insert having at least two orifices provided for gas washout, said each orifice having a cross-sectional contour structured and configured to remain substantially constant in size as gas is passed therethrough, wherein

the mask is formed from a material that is relatively rigid compared to the elastomeric material of the insert,

the insert comprises a groove around a periphery of the insert, the groove being adapted to locate the insert against a correspondingly sized rim of the vent opening after being resiliently squeezed through the vent opening during assembly,

the insert groove is substantially circular, and

a portion of the cross-sectional contour of each said orifice near an atmosphere side of the respective orifice is smaller than a portion of the cross-sectional contour of each said orifice near a side of the orifice oriented towards the patient'"'"'s side of the mask.

24. A CPAP mask assembly for use with a system for supplying breathable gas pressurized above atmospheric pressure to a human or animal patient, the CPAP mask assembly comprising:

a mask adapted to be in fluid communication with a gas supply conduit; and

a vent assembly provided to the mask, the vent assembly including an insert formed from an elastomeric material, said insert having at least two orifices therethrough for gas washout, each said orifice having a cross-sectional contour structured and configured to remain substantially constant in size as gas is passed therethrough at a pressure level suitable for CPAP treatment for obstructive sleep apnea, wherein

the insert includes a groove around a periphery of the insert, the groove abutting against a correspondingly sized rim of the mask vent opening,

the insert groove is substantially circular, and

a portion of the cross-sectional contour of each said orifice near an atmosphere side of the orifice is smaller than a portion of the cross-sectional contour of the orifice near a side of the orifice oriented towards the patient'"'"'s side of the mask.

25. A mask assembly for use with a system for supplying breathable gas pressurized above atmospheric pressure to a human patient'"'"'s airways, the mask assembly including:

a mask including an inlet tube which is adapted for fluid communication with a gas supply conduit, said mask including an opening therein; and

an insert fanned of an elastomeric material at least partially positioned within said opening, said insert having at least two orifices provided for gas washout at least when the patient is in the inspiratory phase of the breathing cycle, wherein

said mask adjacent said opening has a first thickness and said insert has a second thickness that is greater than said first thickness,

the mask is formed from a relatively rigid material compared to the elastomeric material of the insert,

the insert is selectively attachable to and detachable from the mask, and

the insert comprises a groove around a periphery of the insert, the groove being adapted to locate the insert against a correspondingly sized rim of the mask opening, the insert being structured to resiliently expand to engage the rim during assembly.

26. The mask assembly as claimed in claim 25, wherein

the insert groove is substantially circular, and

a portion of each said orifice near an atmosphere side of the mask is smaller than a portion of the orifice oriented towards a side of the mask on the patient'"'"'s side.

27. The mask assembly as claimed in claim 25, wherein the mask includes a shell that includes the first thickness, and the second thickness is measured along a similar axis as the first thickness.

28. A mask assembly for use with a system for supplying breathable gas pressurized above atmospheric pressure to a human patient'"'"'s airways, the mask assembly including:

a mask including an inlet tube and an interior chamber which is adapted for fluid communication with a gas supply conduit via the inlet tube, said mask including an opening in communication with atmosphere and having a thickness in a direction substantially normal to a surface of said mask adjacent said opening; and

an insert of an elastomeric material, the insert at least partially positioned within said opening and having at least one orifice provided for gas washout, wherein

the orifice does not substantially change shape upon application of pressurized gas at a level suitable for CPAP treatment for obstructive sleep apnea,

the mask is formed from a material that is relatively rigid compared to the elastomeric material of the insert,

the insert is attachable to the mask via compression and resilient expansion,

the insert comprises a groove around a periphery of the insert, the groove being adapted to locate the insert against a correspondingly sized rim of the mask opening,

the insert groove is substantially circular, and

a portion of the orifice near an atmosphere side of the mask is smaller than a portion of the orifice oriented towards a side of the mask on the patient'"'"'s side.

29. A mask assembly as claimed in claim 28, wherein the at least one orifice includes at least two orifices.

30. A mask assembly for use with a system for supplying breathable gas pressurized above atmospheric pressure to a patient'"'"'s airways, the mask assembly comprising:

a mask having an inlet tube adapted for fluid connection with a gas supply conduit;

a vent opening for gas washout formed in the mask; and

an insert formed of an elastomeric material positioned within the vent opening, said insert having at least two orifices provided for gas washout, each said orifice having a cross-sectional contour structured and configured to remain substantially constant in size as gas is passed therethrough, wherein;

the mask is fonned from a material that is relatively rigid compared to the elastomeric material of the insert,

the insert includes a groove around a periphery of the insert, the groove being adapted to locate the insert against a correspondingly sized rim of the vent opening via resilient expansion of the insert,

a size of a first end of each said orifice oriented towards the patient side in use is larger than a size of a second end of each respective orifice oriented towards an atmospheric side in use, a portion of each orifice between the first and second ends varying in size along a length thereof, and

the mask has a first thickness adjacent the vent opening that is less than a second thickness of the insert.

31. The mask assembly as claimed in claim 30, wherein the mask includes a shell that is formed from a material that is relatively rigid compared to the elastomeric material of the insert.

32. A CPAP mask assembly for use with a system for supplying breathable gas pressurized above atmospheric pressure to a human or animal, the CPAP mask assembly comprising:

a mask adapted to be in fluid communication with a gas supply conduit; and

a vent assembly including at least one gas washout orifice, in use, communicating between atmosphere and a first pressure region, higher than atmospheric pressure, the gas washout orifice being open in use, wherein

a cross-sectional area of the orifice towards the first pressure region is larger than a cross-sectional area of the orifice oriented towards atmosphere,

an inner side of the vent assembly is structured to extend inside the mask or conduit and an outer side of the vent assembly is structured to extend outside the mask or conduit,

the orifice does not substantially change shape upon application of pressurized gas at a level suitable for CPAP treatment for obstructive sleep apnea,

wherein the vent assembly includes a plurality of said orifices, and

wherein the vent assembly is an insert of relatively elastomeric material and is selectively attachable to and detachable from one of the mask and conduit.

33. A CPAP mask assembly including the vent assembly as claimed in claim 32, wherein the mask includes a shell.

34. A CPAP mask assembly as claimed in claim 33, wherein the insert is provided to the shell.

35. A CPAP mask assembly as claimed in claim 33, wherein the insert is provided upstream of the shell, wherein upstream is measured in terms of the flow direction of said breathable gas towards the patient.

36. A CPAP mask assembly as claimed in claim 35, wherein the insert is provided on the conduit.

37. A CPAP mask assembly for use with a system for supplying breathable gas pressurized above atmospheric pressure to a human or animal for treatment of obstructive sleep apnea, the CPAP mask assembly comprising:

a mask adapted to be in fluid communication with a gas supply conduit; and

an insert provided to the mask, the insert including at least one gas washout orifice extending therethrough, the insert being dimensioned and constricted of a silicone material such that the at least one orifice does not substantially change shape upon application of pressurized gas,

wherein the insert is formed from one of SILASTIC™ and

SANTOPRENE™ and

the orifice has a length of about 3.60 mm, an inner diameter at the inner side of about 3.30 mm, and an outer diameter at the outer side of about 1.73 mm, and wherein the orifice does not substantially change shape upon application of pressurized gas less than about 18 cmH₂O.

38. A CPAP mask assembly for use with a system for supplying breathable gas pressurized above atmospheric pressure to a human or animal for treatment of obstructive sleep apnea, the CPAP mask assembly comprising:

a mask adapted to be in fluid communication with a gas supply conduit; and

an insert provided to the mask, the insert including at least one gas washout orifice extending therethrough, the insert being dimensioned and constructed of a silicone material effective for maintaining the shape or cross-sectional contour of the at least one orifice upon application of pressurized gas,

wherein the insert is formed from one of SILASTIC™ and

SANTOPRENE™

the insert has a thickness of about 3.60 mm, an inner diameter at the inner side is larger than an outer diameter at the outer side, and wherein the orifice does not substantially change shape upon application of pressurized gas less than 18 cmH₂O.

39. A mask assembly for use with a system for supplying breathable gas pressurized above atmospheric pressure to a patient'"'"'s airways, the mask assembly comprising:

a mask having an inlet tube adapted for fluid communication with a gas supply conduit;

a substantially circular vent opening formed in the mask and a substantially circular rim surrounding the vent opening; and

a gas washout vent assembly positioned in covering relation with respect to the vent opening, the gas washout vent assembly including an insert formed of an elastomeric material,

the insert including a plurality of gas washout orifices each having a cross-sectional area on a first side of the insert that is larger than a cross-sectional area on a second side of the insert, and each orifice including a central portion connecting the first and second sides having a cross-sectional area that varies along at least a portion of a length of the central portion,

the insert being removably insertable into the vent opening, the insert including a first surface adapted to engage an inner surface of the mask, a second surface adapted to engage an outer surface of the mask, and a substantially circular groove provided between the first and second surfaces to receive the substantially circular rim of the vent opening.

40. The mask assembly as claimed in claim 39, wherein the cross-sectional area of the central portion tapers along substantially an entire length of the central portion.

41. A mask assembly for use with a system for supplying breathable gas pressurized above atmospheric pressure to a patient'"'"'s airways, the mask assembly comprising:

a mask having an inlet tube adapted for fluid connection with a gas supply conduit;

a vent opening for gas washout formed in the mask; and

an insert formed of an elastomeric material positioned within the vent opening, said insert having a gas washout orifice having a cross-sectional area on a first side of the insert that is larger than a cross-sectional area on a second side of the insert, and said orifice including a central portion between the first and second sides having a cross-sectional area that varies along at least a portion of a length of the central portion, wherein;

the orifice is open in use at least during the inhalation and exhalation phases of the patient'"'"'s breathing cycle,

the mask is defined at least in part by a wall structure made of relatively rigid material compared to the elastomeric material of the insert, the wall structure defining a rim surrounding the vent opening, and

the insert is removably insertable into the vent opening, the insert including a first surface adapted to engage an inner surface of the mask, a second surface adapted to engage an outer surface of the mask, and a groove provided between the first and second surfaces to receive the rim via resilient expansion of the insert.

42. A mask assembly as claimed in claim 41, wherein the mask includes a nose mask.

43. A mask assembly as claimed in claim 41, wherein an inner side of the insert extends inside the mask and an outer side of the insert extends outside the mask.

44. A CPAP mask assembly for use with a system for supplying breathable gas pressurized above atmospheric pressure to a user for treatment of obstructive sleep apnea, the CPAP mask assembly comprising:

a mask having an inlet tube that is, in use, adapted to be in fluid communication with a gas supply conduit, said mask including a shell made from polycarbonate or another rigid plastic material, the shell being provided with a sealing membrane to provide a gas tight seal with the user in use; and

a vent provided to the shell, the vent including at least four gas washout orifices, each said orifice having an inner side that, in use, is positioned adjacent the user'"'"'s face, and an outer side that, in use, is positioned adjacent atmosphere, each said orifice being open in use at least during the inhalation and exhalation phases of the user'"'"'s breathing cycle, wherein

each said orifice has a substantially round cross section along its length,

a cross-sectional size or area of each orifice at the inner side is larger than a cross-sectional size or area of the orifice at the outer side, and a transition portion between the inner and outer sides of each said orifice has a cross-sectional size or area that varies along at least a portion of a length thereof,

an inner end of each said orifice extends inside the shell, and

a length of each orifice is greater than a thickness of a portion of said shell surrounding the orifice.

45. A CPAP mask assembly as claimed in claim 44, wherein the vent includes six orifices.

46. A CPAP mask assembly as claimed in claim 45, wherein a ratio of an inner diameter at the inner side of the orifice to an outer diameter at the outer side of the orifice is about 1.9.

47. A CPAP mask assembly as claimed in claim 45, wherein the length of each said orifice is greater than an inner diameter at the inner side of each said orifice.

48. A CPAP mask assembly as claimed in claim 45, wherein said orifices are separated from each other by at least a diameter of the orifice at the outer side.

49. A CPAP mask assembly as claimed in claim 45, wherein an axis defined within the orifice extends substantially linearly from the inner aide to the outer side.

50. A CPAP mask assembly as claimed in claim 45, wherein the shell includes a lug on each side thereof for connecting the mask to a headgear strap to retain the mask in place relative to the user in use.

51. A CPAP mask assembly as claimed in claim 45, wherein the length of each orifice is about 3 times a thickness of the shell.

52. A CPAP mask assembly as claimed in claim 45, wherein the length of each said orifice is about 3.60 mm, and each said orifice has an inner diameter at the inner side of about 3.30 mm, and an outer diameter at the outer side of about 1.73 mm.

53. A CPAP mask assembly as claimed in claim 45, wherein the vent includes an elastomeric insert and the orifices are provided in the insert.