AU2008237535B2

AU2008237535B2 - Facial Mask and Forehead Support

Info

Publication number: AU2008237535B2
Application number: AU2008237535A
Authority: AU
Inventors: Michael Kassipillai Gunaratnam; Johnathan Paul Harrison; Philip Rodney Kwok; Jonathan Lee Liston; Perry David Lithgow; Robert Stephen Matchett; Robert Edward Styles
Original assignee: Resmed Pty Ltd
Current assignee: Resmed Pty Ltd
Priority date: 1999-06-18
Filing date: 2008-10-28
Publication date: 2012-03-29
Anticipated expiration: 2020-02-11
Also published as: AU2008237535A1; AU2006252221B2; AU2006252221A1

Abstract

FACIAL MASK AND FOREHEAD SUPPORT A forehead support (10) is disclosed that is adapted to be secured to, or form part of, a respiratory mask (16). The forehead support (10) includes a cushion frame (12) pivotally mounted to the joining member (14). The cushion frame (12) is adapted to locate one or more forehead cushions (25). The cushion frame (12) is also adapted to pivot relative to the joining member (14). A respiratory mask assembly comprising a respiratory mask (16) and a forehead support (10) adapted to be secured to the mask (16) is also disclosed.

Description

FIEtD OF THE INVENTION The present invention relates to a forehead support for a facial mask used to s supply breathable gas to a wearer's airways. The invention has been developed primarily for use in supporting a nasal mask used in Continuous Positive Airway Pressure (CPAP) treatment of, for example, Obstructive Sleep Apnea (OSA) and other ventilatory assistance treatments such as Non-Invasive Positive Pressure Ventilation (NIPPV) and will be described hereinafter 10 with reference to this application. However, it will be appreciated that the invention is not limited to these particular uses and is also suitable for use with, for example, full face (ie. nose and mouth) masks. BACKGROUND OF THE INVENTION 1s CPAP treatment is a common ameliorative treatment for breathing disorders including OSA. CPAP treatment, as described in US Patent No. 4,944,310, provides pressurised air or other breathable gas to the entrance of a patient's airways at a pressure elevated above atmospheric pressure, typically in the range 4-20cm H20. It is also known for the level of treatment pressure to vary during a period of 20 treatment in accordance with patient need, that form of CPAP being known as automatically adjusting nasal CPAP treatment, as described in US Patent No. 5,245,995. NIPPV is another form of treatment for breathing disorders which can involve a relatively higher pressure of gas being provided in the patient mask during the 25 inspiratory phase of respiration and a relatively lower pressure or atmospheric pressure being provided in the patient mask during the expiratory phase of respiration. In other NIPPV modes the pressure can be made to vary in a complex manner throughout the respiratory cycle. For example, the pressure at the mask during inspiration or expiration can be varied through the period of treatment as disclosed in 30 the applicant's international PCT patent application No. PCT/AU97/0063 1. Typically, the ventilatory assistance for CPAP or NIPPV treatment is delivered to the patient by way of a nasal mask. Alternatively, a mouth mask or full face mask or nasal prongs can be used. In this specification any reference to a mask is to be understood as incorporating a reference to a nasal mask, mouth mask, fall face mask or 3S nasal prongs, unless otherwise specifically indicated. In this specification any reference to CPAP treatment is to be understood as embracing all of the above described forms of ventilatory treatment or assistance.

-2 A CPAP apparatus broadly comprises a flow generator constituted by a continuous source of air or other breathable gas such as a hospital piped supply or a blower. In the latter case, an electric motor drives the blower and is typically controlled by a servo-controller under the control of a microcontroller unit. In either 6 case, the gas supply is connected to a conduit or tube which in turn is connected to a patient nasal or full-face mask which incorporates, or has in close proximity, an exhaust to atmosphere for venting exhaled gases. Examples of prior art nasal masks are shown in U.S. Patent Nos. 4,782,832 and 5,243,971. The supply conduit delivers gas into a chamber formed by walls of the mask. 1o The mask includes a cushion positioned against the wearer's face and is normally secured to the wearer's head by straps. The straps are adjusted to pull the mask against the face to achieve a gas tight seal between the cushion and the wearer's face. A problem that arises with existing masks is that with the use of straps, the mask is compressed against the wearer's face and may push unduly hard on the 15 wearer's nose. Additionally, the mask may move around the wearer's face. Thus, there has been hitherto provided a forehead support, which provides a support mechanism between the mask and the forehead. This forehead support prevents both the mask from pushing too strongly against the wearer's nose and/or facial region as well as minimising movement of the mask with the addition of a contact point between 20 the mask and the wearer's head thereby reducing uncomfortable pressure points. Additionally, the forehead support can be arranged to prevent the gas supply conduit from contacting the wearer's forehead or face. Forehead supports with a single cushion and a single contact point on the forehead are known. 25 The applicant's U.S. Patent Application Serial No. 09/008,708 relates to a substantially rigid one-piece forehead support having a pair of forehead cushions mounted at each outer end of the support. This forehead support is connected to the top of a facial mask and includes an adjustment mechanism to allow the spacing between the top of the facial mask and the forehead support to be altered between 30 predetermined positions to alter the angle of the mask relative to the wearer's head to suit the wearer's facial topography. The applicant's Australian provisional patent application No. PP9499 relates to a forehead support having a pair of pivotable arms that each have a forehead cushion mounted at their distal end. This forehead support is connected to the top of a mask 3s and includes an adjustable mechanism to allow the angle between the arms to be altered between predetermined positions to alter the angle of the mask relative to the wearer's head to suit the wearer's facial topography. It is an object of the present invention to provide an alternate form of forehead support.

3 SUMMARY OF THE INVENTION Accordingly, in a first aspect, the present invention provides a respiratory mask including a joining member forming part of the mask 5 an upwardly extending cushion frame having at its upper end at least one forehead cushion the lower end of said frame being pivotally mounted on the joining member. In a second aspect, the present invention provides a respiratory mask including 10 a joining member forming part of the mask a T-shaped cushion frame having at its upper end a pair of arms each carrying a forehead cushion the lower end of said frame being pivotally mounted on the joining member to enable variation of the relative positions of the cushion frame and the joining member to suit 15 the topography of the wearer's face. In a third aspect, the invention provides a respiratory mask including a forehead support through which gas supplied to the mask flows, the forehead support including 20 a joining member forming part of the mask and an upwardly extending cushion frame having at its upper end at least one forehead cushion the lower end of said frame being pivotally mounted on the joining member.

-4 BRIEF DESCRIPTION OF THE DRAWINGS' 5 Preferred embodiments of the invention will now be described, by way of examples only, with reference to the accompanying drawings in which: Fig. 1 is a front perspective view of a first embodiment of a forehead support according to the invention connected to a nasal mask; Fig. 2 is a cross sectional side view of the forehead support shown in Fig. 1 10 with the tongue of the cushion frame engaged with one of the pairs of grooves of the joining member; Fig. 3 is a cross sectional side view of the forehead support shown in Fig. 1 with the tongue of the cushion frame free of engagement with the pairs of grooves of the joining member; 18 Fig. 4 is a cross sectional side view of the forehead support shown in Fig. 1 adjacent a wearer's head with the tongues and grooves engaged at the first of four positions; Fig. 5 is a cross sectional side view of the forehead support shown in Fig. 1 adjacent a wearer's head with the tongues and grooves engaged in the second of four 20 positions; Fig. 6 is a cross sectional side view of the forehead support shown in Fig. 1 adjacent a wearer's head with the tongues and grooves engaged at the third of four positions; Fig. 7 is a cross sectional side view of the forehead support shown in Fig. 1 25 adjacent a wearer's head with the tongues and grooves engaged at the fourth of four positions; Fig. 8 is a partial exploded perspective view of a second embodiment of a forehead support according to the invention. Fig. 9 is a cross sectional side view of a third embodiment of a forehead 30 support according to the invention that includes an integrally formed cushion frame and joining member; Fig. 10 is a cross sectional view of the forehead support shown in Fig. 9 with the tongue and grooves engaged at the first of four positions. Fig. 11 is a cross sectional.view of the forehead support shown in Fig. 9 with 3s the tongue and grooves engaged at the second of four positions. Fig. 12 is a cross sectional view of the forehead support shown in Fig. 9 with the tongue and grooves engaged at the third of four positions. Fig. 13 is a cross sectional view of the forehead support shown in Fig. 9 with the tongue and grooves engaged at the fourth.of four positions; .5 Fig. 14 is a cross sectional view of the forehead support shown in Fig. 9 with the tongue free of engagement with the grooves; and Fig. 15 is a side view, with enlarged details, of a fourth embodiment of a forehead support according to the invention. 5 DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT Fig. 1 shows a first embodiment of a forehead support 10 according to the present invention. The forehead support 10 includes a generally T-shaped cushion frame 12 pivotally mounted to a joining member 14. The joining member 14 is 10 connected to a nasal respiratory mask 16 used to supply breathable gas to a wearer's airways. The mask 16 includes a mask shell 17 -and a mask cushion 19. The mask shell 17 also includes an angled connector 18 which has a distal end 20 for connection to a gas supply conduit (not shown) and a proximal end 22 for connection to the mask 16. is The connector 18 communicates the supplied gas from the gas supply conduit to the interior of the mask 16. The mask shell 17 also includes a pair of slotted connectors 24 to which are respectively connected ends of a lower head strap (not shown) for securing the nasal mask to the wearer's head. The joining member 14 is connected on top of the mask shell 17 generally 20 adjacent and above the wearer's nose. It will be appreciated that the nasal mask 16 shown is just one example of a respiratory mask that -could be supported by the forehead support 10. For example, the forehead support also finds application in supporting full-face (ie. nose and mouth) masks. Forehead supports according to the invention can also be used with facial 25 masks in which the gas supply connector 18 is incorporated into the mask in the general position of the joining member 14. In this type of mask, the supplied gas flows through or past the forehead support 10. The T-shaped cushion frame 12 includes a pair of forehead cushions 25 mounted at each end of the upper portion of the T on the wearer contacting side. 30 Examples of cushions 25 include open or closed cell foam, silicone, dual durometer foams, single pads or multiple pads joined together. The forehead cushions 25 can be integrally moulded with the frame 12 or attached thereto by clips or adhesives or the like. The frame 12 also includes a slotted connector 26 adjacent each of the forehead cushions 25 to which are respectively connected ends of an upper head strap (not as shown) for securing the cushion frame 12 to the wearer's head. The T-shaped cushion frame 12 also includes a pair of shafts 27 (only one shown) on the lower portion of the T which are each respectively received in part circular openings 28 (only one shown) provided on the joining member 14. The shafts 27 can pivot or rotate in their respective openings 28 to provide for pivotal or rotational movement between the cushion frame 12 and the joining member 14 about axis 30 in the direction of double-headed arrow 31. Put another way, the axis 30 is substantially transverse to the joining member 14 and the cushion frame 12 is able to pivot about the transverse axis 30. 5 The curved shape of the cushions 25 allows them to effectively "roll" over the wearer's forehead during angular adjustment between the cushion frame 12 and the joining member 14. As best shown in Figs. 2 and 3, the cushion frame 12 also includes a flexible member 32 which has two side by side spaced apart tongues 34 and a middle protruding 10 button 36 on its distal end. The joining member 14 also includes two generally arcuate shaped portion 38 that each have a pair of four grooves 40. It will be appreciated that the pair of four grooves is merely preferably and that only two or more grooves are required. It will also be appreciated that the flexible member 32 can be on the joining member 14 and the grooves 40 can be on the cushion frame 12. The tongue 34 and the Is grooves 40 extend in a direction substantially parallel to a line extending radially from the axis 30. The cushion frame 12 is constructed from a plastics material, such as polypropylene or polycarbonate, which allows the member 32 to be flexed relative to the cushion frame 12 upon which is mounted when pressure is applied to the button 36 20 in the direction of arrow 42. The corresponding movement of the tongues 34 releases them from engagement with one of the pairs of grooves 40 (as shown in Fig. 3) to allow angular adjustment between the cushion frame 12 and the joining member 14 about the axis 30. Releasing the button 36 allows the tongue 34 to resiliently flex back towards the grooves 40. When the tongues 34 and one of the pairs of grooves 40 are 25 aligned (as shown in Figs. 2 and 4 to 7) the tongues 34 engage one of the pair of grooves 40. When the tongues 34 are engaged with one of the pair of grooves, the cushion frame 12 and joining member 14 are locked against pivotal movement therebetween at a predetermined angle. Figs. 4 to 7 respectively show forehead support 10 adjacent the heads of 30 different wearers with the tongues 34 engaged in the first, second, third and fourth of the four pairs of grooves 40. As Figs. 4 to 7 show, the angle between the cushion frame 12 and the joining member 14 adjacent the wearer's forehead can be increased to suit wearer's with relatively high nasal regions and relatively low foreheads (Figs. 4 and 5) and decreased 35 to suit wearers with relatively low nasal regions and relatively high foreheads (Figs. 6 and 7). In this way the forehead support 10 advantageously allows the mask 16 to be positioned to comfortably suit the particular topography of the wearer's face to ensure the mask cushion 19 is positioned ideally relative to the wearer's face. As examples, .7. the relative position of the cushion frame 12 and the joining member 14 in Fig. 4 would be more suitable for use with a wearer having a shallow forehead or protruding cheeks or nose whilst the position of the cushion frame and joining member 14 in Fig. 7 would be more suitable for use with a wearers having a protruding or bulbous forehead. s Fig. 8 shows a second embodiment of a forehead support 50 according to the present invention. Like reference numerals to those used in describing the first embodiment will be used to denote like features in relation to the second embodiment. In the second embodiment, there are two buttons 36. Pressing the buttons together in the direction of arrows 52 flexes the tongues 34 towards each other to to disengage them from the grooves 40 and allow angular adjustment between the cushion frame 12 and the joining member 14. Releasing the buttons 36 allows the tongues 34 to resiliently flex towards, and into engagement with, the grooves 40 to lock the cushion frame 12 and the joining member 14 against relative pivotal movement. Figs. 9 to 14 show a third embodiment of a forehead support 60 according to 15 the present invention. Like reference to those used in describing the first embodiment will also be used to denote like features in relation to the third embodiment. In the third embodiment, the cushion frame 12 is integrally moulded with the joining member 14 and joined by an integral hinge 62 (sometimes known as a natural or living hinge). The cushion frame 12 and the joining member 14 can be pivotted 20 relative to each other about the hinge 62. The forehead support 60 is moulded in a substantially 'flat' configuration, as shown in Fig. 9. The cushion frame 12 is then pivotted through approximately 180* relative to the joining member 14 until the tongue 34 engages one of the four grooves 40. As with the earlier embodiments, pressing the button 36 in the direction of arrow 42 frees the tongue 34 from engagement with the 25 grooves to allow adjustment of the angle between the cushion frame 12 and the joining member 14. The button 36 and the tongue 34 are inherently biased to a position engaging one of the grooves 40, again consistent with earlier embodiments. In the preferred form shown, the mask shell 17 is also integrally formed with the joining member 14. This simplifies manufacturing and assembly and reduces 30 production costs. The forehead support 60 is preferably manufactured from polypropylene due to its ability to mould integral hinges. Fig. 15 shows a fourth embodiment of a forehead support 100 according to the invention. Like reference to those used in describing the first embodiment will also be used to denote like features in relation to the fourth embodiment. 35 The fourth embodiment is almost identical to the first embodiment except the tongue 34 and the grooves 40 are angled with respect to a line extending radially from the axis 30 to the tongue 34 or the grooves 40. This angled arrangement reduces the likelihood that the tongue 34 will inadvertently release from engagement with one of the

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grooves 40 if the front of the mask 16 is subjected to a force in the direction of the wearer's face. Although the invention has been described with reference to a specific example, it will be appreciated by those skilled in the art that the invention may be 5 embodied in many other forms. As an example, the forehead support can include means to resiliently bias the cushion frame and the joining member relative to one another such that they increase or decrease their angle relative to one another when the tongues are disengaged from one of the pairs of slots. 10

Claims

1. A CPAP mask for use in positive pressure respiratory therapy, the mask including: a mask shell, wherein said mask shell comprises a joining member including a pair of circular openings and two generally arcuate shaped portions, each arcuate shaped portion having at least two grooves arranged in corresponding positions provided thereon; a mask cushion provided to the mask shell; and a forehead support adapted to be secured to the mask shell, wherein said forehead support includes a frame having a pair of shafts adapted to be received in the circular openings provided on the joining member to allow a pivotal or a rotational movement between the frame and the joining member; wherein the frame further comprises two tongues, each tongue adapted to be received in one of the corresponding at least two grooves provided on each arcuate shaped portion of the joining member to lock the frame and joining member in at least one of two or more predetermined angular positions.

2. A CPAP mask according to claim 1, wherein the joining member further comprises two buttons adapted to allow angular adjustment between the frame and the joining member by: pressing the two buttons together to flex the two tongues on the frame towards each other to disengage the two tongues from one of the grooves provided on each arcuate shaped portions of the joining member; allowing pivotal movement; and subsequently releasing of the two buttons to allow the tongues to resiliently flex towards and engage with another one of the grooves provided on each arcuate shaped portions of the joining member to lock the frame with the joining member against further pivotal movement.

3. A CPAP mask according to claim 1 or 2, wherein the forehead support is produced from polypropylene or polycarbonate.

4. A CPAP mask according to any one of claims 1 to 3, wherein a pair of forehead pads are attached to the forehead support. 10

5. A CPAP mask according to any one of claims 1 to 4, wherein the forehead support includes a generally T-shaped cushion frame

6. A CPAP mask according to claim 4 or 5, wherein a curved shape of the forehead pads is adapted to allow the forehead pads to roll over a forehead of the CPAP mask wearer during the pivotal or the rotational movement.

7. A CPAP mask according to any one of claims 1 to 6, wherein a slotted connector is provided on each end of the forehead support for connection to an upper headgear strap for securing the CPAP mask to the head of a wearer in use.

8. A CPAP mask according to any one of claims I to 6, further comprising a means for connecting a head strap to the mask frame.

9. A CPAP mask according to any one of claims I to 8, wherein the tongues and respective grooves are in an angled relationship with respect to a radial line from an axis as disclosed in figure 15.

10. A CPAP mask according to any one of claims I to 9, wherein the pivotal or the rotational movement includes adjusting the CPAP mask to a topography of a wearer of the CPAP mask

11. A CPAP mask for use in positive pressure respiratory therapy, the mask including: a mask frame, wherein said mask frame comprises a joining member; said joining member including a pair of circular openings and two generally arcuate shaped portions having at least two pairs of lock receiving means provided thereon, wherein one lock receiving means from each pair of lock receiving means is provided on each of the two arcuate shaped portions; a mask cushion provided to the mask frame; and a forehead support adapted to be secured to the mask frame, wherein said forehead support includes a forehead support cushion frame having a pair of shafts adapted to be received in said circular openings on the joining member to allow a pivotal or a rotational movement between the cushion frame and the joining member; I I wherein the forehead support cushion frame further comprises a pair of locking means adapted to engage with a first pair of the lock receiving means on the arcuate shaped portions of the joining member to secure the forehead support cushion frame and joining member at a first position of a plurality of predetermined angular positions; and wherein the pair of locking means are each attached to a release means adapted to allow adjustment of the forehead support to provide the plurality of predetermined angular positions.

12. A CPAP mask according to claim 11, wherein the release means is formed from a semi-rigid material that allows manual manipulation of the release means to allow adjustment of the forehead support.

13. A CPAP mask according to claim 12, wherein the manual manipulation is by: pressing each of the release means towards the other release means to release the pair of locking means from the first pair of the lock receiving means allowing the pivotal or rotational movement between the forehead support cushion frame and the joining member and subsequently releasing the release means to allow the pair of locking means to engage a second pair of the lock receiving means at a second position of the plurality of predetermined angular positions.

14. A CPAP mask according to any one of claims I1 to 13, wherein the mask frame is produced from polypropylene or polycarbonate.

15. A CPAP mask according to any one of claims 1 to 14, wherein the forehead support is produced from polypropylene or polycarbonate.

16. A CPAP mask according to any one of claims 1I to 15, wherein a pair of forehead pads are attached to the forehead support.

17. A CPAP mask according to any one of claims 11 to 16, wherein the forehead support cushion frame is generally T-shaped.

18. A CPAP mask according to claim 16 or 17, wherein a curved shape of the forehead pads is adapted to allow the forehead pads to roll over a forehead of the CPAP mask wearer during the pivotal or the rotational movement. 12

19. A CPAP mask according to any one of claims I1 to 18, wherein a slotted connector is provided on each end of the forehead support for connection to an upper headgear strap for securing the mask to the users' head in use.

20. A CPAP mask according to any one of claims 11 to 18, further comprising a means for connecting a head strap to the mask frame.

21. A CPAP mask according to any one of claims 12 to 20, wherein the lock receiving means comprises: at least one groove.

22. A CPAP mask according to any one of claims 12 to 21, wherein the locking means comprises: at least one tongue.

23. A CPAP mask according to claim 22, wherein the tongues and respective grooves are in an angled relationship with respect to a radial line from an axis as disclosed in figure 15.

24. A CPAP mask according to any one of claims 13 to 23, wherein the release means includes: a button adapted for pressing each of the release means.

25. A CPAP mask according to any one of claims I I to 24, wherein the pivotal or the rotational movement includes adjusting the CPAP mask to a topography of a wearer of the CPAP mask

26. A CPAP mask for use in positive pressure respiratory therapy, the mask including: a mask frame, wherein said mask frame comprises a joining member; said joining member including a pair of circular openings and two generally curved portions having a plurality of corresponding pairs of tongue receiving means provided thereon; a mask cushion provided to the mask frame; and a forehead support adapted to be secured to the mask frame, wherein said forehead support includes a forehead support cushion frame having rotating means adapted to be received in said pair of circular openings on the joining 13 member to allow a pivotal or a rotational movement between the cushion frame and the joining member about an axis; wherein the forehead support cushion frame further comprises a pair of tongues adapted to be received in a respective pair of the tongue receiving means on the curved portions of the joining member to secure the cushion frame and joining member at one of a plurality of predetermined angular positions; and wherein each tongue is provided on a semi-rigid member adapted to permit the tongues to be moved out of engagement with the tongue receiving means by manual manipulation of the semi-rigid members allowing adjustment of the forehead support between the plurality of predetermined angular positions.

27. A CPAP mask according to claim 26, wherein each semi-rigid member includes a button adapted to protrude from the forehead support cushion frame to facilitate the manual manuipulation of the semi-rigid members.

28. A CPAP mask according to claim 27, wherein the buttons are pressed towards each other to facilitate the manual manipulation of the semi-rigid members.

29. A CPAP mask according to any one of claims 26 to 28, wherein the tongue receiving means comprises: at least one groove.

30. A CPAP mask according to any one of claims 26 to 28, wherein the rotating means includes: at least one shaft.

31. A CPAP mask according to any one of claims 26 to 30, wherein the forehead support cushion frame is produced from polypropylene or polycarbonate.

32. A CPAP mask according to any one of claims 26 to 31, wherein a pair of forehead pads are attached to the forehead support.

33. A CPAP mask according to any one of claims 26 to 32, wherein the forehead support cushion frame is generally T-shaped 14

34. A CPAP mask according to claim 32 or 33, wherein a curved shape of the forehead pads is adapted to allow the forehead pads to roll over a forehead of the CPAP mask wearer during the pivotal or the rotational movement.

35. A CPAP mask according to any one of claims 26 to 34, wherein a slotted connector is provided on each end of the forehead support for connection to an upper headgear strap for securing the CPAP mask to the head of a wearer in use.

36. A CPAP mask according to any one of claims 26 to 34, further comprising a means for connecting a head strap to the mask frame.

37. A CPAP mask according to any one of claims 29 to 36, wherein the tongues and respective grooves are in an angled relationship with respect to a radial line from an axis as disclosed in figure 15.

38. A CPAP mask according to any one of claims 26 to 37, wherein the pivotal or the rotational movement includes adjusting the CPAP mask to a topography of a wearer of the CPAP mask

39. A CPAP mask for use in positive pressure respiratory therapy, the mask including: a mask frame comprising a first joining means; a cushion provided to the mask frame; a forehead support comprising a second joining means; and a pair of forehead pads provided to the forehead support; wherein said first joining means and said second joining means are adapted to attach the forehead support to the mask frame and allow pivotal adjustment of the forehead support about an axis; characterised in that the first joining means comprises a plurality of pairs of tongue receiving means and the second joining means comprises a pair of tongues; and wherein in use the forehead support is secured in one of a plurality of predetermined angular positions relative to the mask frame to be adjacent to the forehead of a user by the engagement of the pair of tongues in one of the pairs of tongue receiving means. 15

40. A CPAP mask according to claim 39, wherein the second joining means further comprises: a pair of semi-rigid members each having one of the pair of tongues provided thereon, wherein the semi-rigid members are manually manipulated to allow the pivotal adjustment of the forehead support.

41. A CPAP mask according to claims 39 or 40, wherein the forehead support is removably attached to the mask frame.

42. A CPAP mask according to any one of claims 39 to 41, wherein the tongue receiving means comprises: at least one groove adapted to receive one tongue.

43. A CPAP mask according to any one of claims 39 to 42 wherein the forehead support is produced from polypropylene or polycarbonate.

44. A CPAP mask according to any one of claims 39 to 43, wherein the forehead support is generally T-shaped

45. A CPAP mask according to any one of claims 39 to 44, wherein a curved shape of the forehead pads is adapted to allow the forehead pads to roll over a forehead of the CPAP mask wearer during the pivotal adjustment.

46. A CPAP mask according to any one of claims 39 to 45, wherein a slotted connector is provided on each end of the forehead support for connection to an upper headgear strap for securing the CPAP mask to the head of a wearer in use.

47. A CPAP mask according to any one of claims 39 to 45 further comprising a means for connecting a head strap to the mask frame.

48. A CPAP mask according to any one of claims 42 to 47, wherein the tongues and respective grooves are in an angled relationship with respect to a radial line from an axis as disclosed in figure 15. 16

49. A CPAP mask according to any one of claims 39 to 48, wherein the pivotal adjustment includes adjusting the CPAP mask to a topography of a wearer of the CPAP mask

50. A CPAP mask comprising: a mask shell; a joining member attached to the mask shell and having a plurality of pairs of tongue-receiving means provided thereon; a cushion attached to the mask shell; and a forehead support connected to the joining member of the mask shell via a frame, the frame having a pair of shafts to allow rotation of the forehead support with respect to the joining member and a pair of semi-rigid members, each semi-rigid member having a button at one end and a tongue adjacent the button, the two tongues being engaged with a first pair of the plurality of pairs of tongue-receiving means to position the forehead support in one of a plurality of predetermined angular positions defined by the plurality of pairs of tongue receiving means; wherein the position of the forehead support is adjusted by: pressing and holding the buttons on the semi-rigid members towards each other to cause disengagement of the tongues from the first pair of the plurality of pairs of tongue-receiving means; pivotally moving the forehead support with respect to the mask shell to align the tongues with a second pair of the plurality of pairs of tongue-receiving means; and releasing the buttons to allow engagment of the tongues with the second pair of tongue-receiving means to position the forehead support in another of the plurality of predetermined angular positions.

51. A CPAP mask according to claim 50, wherein the tongue receiving means comprises: at least one groove adapted to receive the respective tongue.

52. A CPAP mask according to claim 50 or 51, wherein the forehead support is produced from polypropylene or polycarbonate.

53. A CPAP mask according to any one of claims 50 to 52, wherein a pair of forehead pads are attached to the forehead support. 17

54. A CPAP mask according to claim 53, wherein the forehead support includes a generally T-shaped cushion frame

55. A CPAP mask according to claim 53 or 54, wherein a curved shape of the forehead pads is adapted to allow the forehead pads to roll over a forehead of the CPAP mask wearer during the pivotal or the rotational movement.

56. A CPAP mask according to any one of claims 50 to 55, wherein a slotted connector is provided on each end of the forehead support for connection to an upper headgear strap for securing the CPAP mask to the head of a wearer in use.

57. A CPAP mask according to any one of claims 50 to 55, further comprising a means for connecting a head strap to the mask frame.

58. A CPAP mask according to any one of claims 51 to 57, wherein the tongues and respective grooves are in an angled relationship with respect to a radial line from an axis as disclosed in figure 15.

59. A CPAP mask according to any one of claims 50 to 58, wherein pivotally moving the forehead support with respect to the mask shell includes adjusting the CPAP mask to a topography of a wearer of the CPAP mask