HK1070847B - Forehead support for facial mask - Google Patents

Description

Forehead support for a mask

CROSS-REFERENCE TO PRIOR APPLICATIONS

This application claims the benefit of U.S. provisional patent application No.60/467,570, filed 5/2003, the entire contents of which are hereby incorporated by reference.

Technical Field

The present invention relates to a forehead support for a mask for providing breathing gas to the airways of a wearer.

The present invention has been developed primarily for supporting a nasal mask for Continuous Positive Airway Pressure (CPAP) therapy, such as Obstructive Sleep Apnea (OSA), and other ventilatory assist therapies, such as non-invasive positive airway pressure (NIPPV). The invention is described below with reference to the present application. It will be appreciated, however, that the invention is not limited to these particular applications and is also applicable to, for example, masks that cover the entire face (e.g., nose and mouth).

Background

Continuous Positive Airway Pressure (CPAP) treatment is a common treatment for respiratory disorders, including the improvement of OSA, and is described in U.S. Pat. No.4,944,310, which is directed to treating CPAP at a pressure above atmospheric pressure, typically 4-20cm H₂O range, delivering pressurized air or other breathing gas to the entrance of the patient's airways.

It is also known that the treatment pressure varies during the treatment according to the needs of the patient. This form of Continuous Positive Airway Pressure (CPAP) treatment is known as an automatically adjustable nasal CPAP treatment as described in U.S. patent No. 5245995.

Non-invasive positive pressure ventilation (NIPPV) is another way of treating respiratory disorders by providing relatively high air pressure in the patient's mask during the inspiratory phase of the breathing process and relatively low or atmospheric pressure in the patient's mask during the expiratory phase of the breathing process.

In other non-invasive positive pressure ventilation (NIPPV) modalities, the air pressure may vary in a complex manner throughout the expiratory cycle. For example, during treatment, the pressure of the mask during inhalation or exhalation is varied, as disclosed in the applicant's PCT International patent application No. PCT/AU 97/00631.

Typically, supplemental ventilation for CPAP or NIPPV therapy is delivered to the patient via a nasal mask. Alternatively, a mask or full face mask or nasal cannula may be used. Unless otherwise specified, reference to a mask in this specification should be understood to include a nasal mask, oral mask, full face mask or nasal cannula.

The CPAP treatment referred to in this specification encompasses all of the above-mentioned modes of respiratory treatment or assistance.

CPAP devices broadly comprise a flow generator comprising a continuous source of air or other breathable gas, such as a hospital tubing source or blower. In the latter case, an electric motor drives the blower and is typically controlled by a servo controller controlled by a microcontroller unit. In either case, the gas source is connected to a conduit or tube and in turn connected to the patient's nasal or full face mask with which it is integrated, or has a vent to air at a close distance to vent exhaled gases. Examples of prior art nasal masks are shown in U.S. patent nos. 4,782,832 and 5,243,971.

The gas flow conduit delivers gas into the cavity formed by the walls of the mask. The mask includes a cushion that sits against the face of the wearer and is typically secured to the head of the wearer with straps. The straps are adjusted to tighten the mask against the face to maintain an airtight seal between the cushion and the wearer's face.

A problem with exposure in prior masks is that due to the use of straps, the mask compresses the wearer's face and excessively compresses the wearer's nose. Additionally, the mask may move on the wearer's face. Accordingly, a forehead support is now provided, providing a support means between the mask and the forehead. The forehead support reduces uncomfortable pressure points by increasing the contact point between the mask and the head to prevent the mask from pressing too hard against the wearer's nose and/or face area and to reduce movement of the mask. In addition, a forehead support is provided to prevent the airflow conduit from touching the forehead or face of the wearer.

Forehead supports having a pad and a contact on the forehead are known.

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 pads mounted to each outer end of the support. The forehead support is connected to the top of the mask and includes adjustment means to allow the top of the mask to be spaced from the forehead support as it is moved between predetermined positions to vary the angle of the mask relative to the wearer's head to suit the wearer's facial configuration.

The applicant filed australian provisional patent application No. pp9499, relating to a forehead support having a pair of pivoting arms, each arm having a forehead pad mounted at its distal end. The forehead support is connected to the top of the mask and includes adjustment means to allow the angle between the arms to be changed between predetermined positions to change the angle of the mask relative to the wearer's head to suit the wearer's facial configuration.

It is an object of the present invention to provide another form of forehead support.

Disclosure of Invention

In view of this, a first aspect of the present invention provides a forehead support adapted to be secured to a respiratory mask, the forehead support comprising a connection part for securing to the mask and a cushion frame rotatably mounted on the connection part. Wherein: the cushion frame is adapted to position one or more forehead cushions; the cushion frame is adapted to pivot relative to the connecting member; and the cushion frame is selectively lockable in two or more predetermined angular positions relative to the connecting member.

A second aspect of the invention provides a respiratory mask assembly comprising a respiratory mask and a forehead support adapted to be secured to the mask, the forehead support comprising a connection part for securing to the mask and a cushion frame rotatably mounted on the connection part. Wherein: the cushion frame is adapted to position one or more forehead cushions; the cushion frame is adapted to pivot relative to the connecting member; and the cushion frame is selectively lockable in two or more predetermined angular positions relative to the connecting member.

The cushion frame is preferably T-shaped and includes a forehead cushion at each end of the upper portion of the T-shape.

Suitably, one of the cushion frame or the connecting member comprises a tongue adapted to be received in one of at least two grooves formed in the other cushion frame or the connecting member to lock the cushion frame and the connecting member in a certain predetermined angular position of the two or more predetermined angular positions.

Preferably, one pair of tongues is provided on the spacer frame and at least two pairs of grooves are provided on the attachment members.

The tongue is preferably provided on the semi-rigid member so that it is adapted to be manually manipulated to move it out of engagement with the groove. The tongue is preferably connected to a button projecting from the gasket frame to facilitate manual manipulation of the unit.

The gasket frame preferably includes means for attaching a tape.

The mask preferably further comprises means for attaching a head strap.

The connecting member may be made of, for example, polypropylene or polycarbonate.

The mask may include a mask shell and a mask cushion, and the mask shell may be made of, for example, polypropylene or polycarbonate.

The cushion frame may be made of, for example, polypropylene or polycarbonate.

Drawings

Preferred embodiments of the present invention will now be described, by way of example only, with reference to the accompanying drawings, in which:

fig. 1 is a front perspective view of a first embodiment of a forehead support connected to a nasal mask according to the present invention;

fig. 2 is a cross-sectional view of the forehead support shown in fig. 1 having a cushion frame tongue engaging one of a pair of grooves of the connection member;

fig. 3 is a cross-sectional view of the forehead support shown in fig. 1 having a gasket frame tongue that does not engage with a pair of grooves of the attachment member;

fig. 4 is a cross-sectional view of the forehead support approaching the head of a wearer with the groove and tongue shown in fig. 1 engaged in a first of four positions;

fig. 5 is a cross-sectional view of the forehead support approaching the head of a wearer with the groove and tongue shown in fig. 1 engaged in a second of the four positions;

fig. 6 is a cross-sectional view of the forehead support approaching the wearer's head with the groove and tongue shown in fig. 1 engaged in a third of the four positions;

fig. 7 is a cross-sectional view of the forehead support approaching the head of a wearer with the groove and tongue shown in fig. 1 engaged in a fourth of the four positions;

fig. 8 is a partially exploded perspective view of a second embodiment of a forehead support according to the present invention;

fig. 9 is a cross-sectional view of a third embodiment of a forehead support including an integrated cushion frame and connection member according to the present invention;

fig. 10 is a cross-sectional view of the forehead support shown in fig. 9 with the groove engaging the tongue in a first of four positions;

fig. 11 is a cross-sectional view of the forehead support shown in fig. 9 with the groove engaging the tongue in a second of the four positions;

fig. 12 is a cross-sectional view of the forehead support shown in fig. 9 with the groove engaging the tongue in a third of the four positions;

fig. 13 is a cross-sectional view of the forehead support shown in fig. 9 with the groove engaging the tongue in a fourth of the four positions;

fig. 14 is a cross-sectional view of the unengaged forehead support shown in fig. 9 with the tongues engaged with the grooves;

fig. 15 is a side view of a fourth embodiment of a forehead support according to the present invention;

fig. 16 is a detail view enlarged from fig. 15.

FIG. 17 is a side perspective view of a full face mask assembly having a forehead support worn by a patient;

FIG. 18 is an enlarged front elevational view of the full-face mask assembly illustrated in FIG. 17;

FIG. 19 is an enlarged side perspective view of the full-face mask assembly shown in FIG. 17;

FIG. 20 is a perspective view of the frame and forehead support of the full-face mask assembly shown in FIG. 17;

FIG. 20B is a perspective view of the full-face mask assembly of FIG. 17;

fig. 21 is a side view of the forehead support and frame shown in fig. 20 with the forehead support in one of four positions;

fig. 22 is a side view of the forehead support and frame shown in fig. 20 with the forehead support in a second of the four positions;

fig. 23 is a side view of the forehead support and frame shown in fig. 20 with the forehead support in a third of four positions;

fig. 24 is a side view of the forehead support and frame shown in fig. 20 with the forehead support in a fourth of the four positions;

fig. 25 is a perspective view of a locking clip for the forehead support and frame shown in fig. 20;

fig. 26 is a top view of the forehead support shown in fig. 20;

fig. 27 is a rear perspective view of the forehead support shown in fig. 26;

fig. 28 is a front perspective view of the forehead support shown in fig. 26;

fig. 29 is a front view of the forehead support shown in fig. 26;

fig. 30 is a side view of the forehead support shown in fig. 26;

fig. 31 is a top view of the forehead support shown in fig. 26;

fig. 32 is a rear perspective view of an embodiment of a forehead pad for the forehead support shown in fig. 20;

fig. 33 is a front perspective view of the forehead pad shown in fig. 32;

fig. 34 is a cross-sectional view of the forehead pad shown in fig. 32 secured to the forehead support shown in fig. 20;

fig. 35 is a front view of an embodiment of a forehead support;

fig. 36 is a side view of the forehead support shown in fig. 35;

FIG. 37 is an enlarged view of FIG. 36;

FIG. 38 is a cross-sectional view taken along line 38-38 of FIG. 35;

FIG. 39 is a cross-sectional view taken along line 39-39 of FIG. 35;

FIG. 40 is a cross-sectional view taken along line 40-40 of FIG. 38;

FIG. 41 is an enlarged view of FIG. 35;

fig. 42 is a partial rear view of the forehead support shown in fig. 35;

FIG. 43 is a front perspective view of the frame shown in FIG. 20;

FIG. 44 is a front perspective view of the frame of FIG. 43, similar to FIG. 43 but at a different angle;

FIG. 45 is a rear perspective view of the frame shown in FIG. 43;

FIG. 46 is a front view of the frame shown in FIG. 43;

FIG. 47 is a side view of the frame shown in FIG. 43;

FIG. 48 is a top view of the frame shown in FIG. 43;

FIG. 49 illustrates a front view of an embodiment of a small size frame of a full-face mask assembly;

FIG. 50 is a cross-sectional view taken along line 50-50 of FIG. 49;

FIG. 51 is a cross-sectional view taken along line 51-51 of FIG. 49;

FIG. 52 is a cross-sectional view taken along line 52-52 of FIG. 49;

FIG. 53 is a cross-sectional view taken along line 53-53 of FIG. 51;

FIG. 54 is an enlarged view of FIG. 52;

FIG. 55 is an enlarged view of FIG. 52;

FIG. 56 is an enlarged view of FIG. 52;

FIG. 57 illustrates a front view of an embodiment of a mid-sized frame of a full-face mask assembly;

FIG. 58 is a cross-sectional view taken along line 58-58 of FIG. 57;

FIG. 59 is a cross-sectional view taken along line 59-59 of FIG. 57;

FIG. 60 is a cross-sectional view taken along line 60-60 of FIG. 57;

FIG. 61 is a cross-sectional view taken along line 61-61 of FIG. 59;

FIG. 62 is an enlarged view of FIG. 60;

FIG. 63 is an enlarged view of FIG. 60;

FIG. 64 is an enlarged view of FIG. 60;

FIG. 65 illustrates a front view of an embodiment of a large frame of a full-face mask assembly;

FIG. 66 is a cross-sectional view taken along line 66-66 of FIG. 65;

FIG. 67 is a cross-sectional view taken along line 67-67 of FIG. 65;

FIG. 68 is a cross-sectional view taken along line 68-68 of FIG. 65;

FIG. 69 is a cross-sectional view taken along line 69-69 of FIG. 67;

FIG. 70 is an enlarged view of FIG. 68;

FIG. 71 is an enlarged view of FIG. 68;

FIG. 72 is an enlarged view of FIG. 68;

FIG. 73 is a top view of the full-face mask assembly shown in FIG. 17 being worn by the patient;

FIG. 74 is a front view of a full-face mask assembly worn by the patient shown in FIG. 17;

FIG. 75 is a side view of the full face mask assembly shown in FIG. 17 with the forehead support worn by the patient in a first of four positions;

FIG. 76 is a side view of the full face mask assembly shown in FIG. 17 with the forehead support worn by the patient in a second of the four positions;

FIG. 77 is a side view of the full face mask assembly shown in FIG. 17 with the forehead support in a third of the four positions worn by the patient;

fig. 78 is a side view of the full face mask assembly shown in fig. 17 with the forehead support worn by the patient in a fourth of the four positions.

Detailed Description

Fig. 1 illustrates 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 connecting member 14. The coupling component 14 is coupled to a nasal respiratory mask 16 for providing breathing gas to the airway of a wearer, as described in U.S. patent application Ser. No.10/264,326, currently in examination, and U.S. patent application Ser. No.09/502,745, now U.S. Pat. No.6,532,961, the entire contents of which are incorporated herein by reference.

Mask 16 includes a mask shell 17 and a mask cushion 19. Mask shell 17 also includes an angled connector 18 having a distal end 20 for connection to a gas conduit (not shown) and a proximal end 22 for connection to mask 16. Connector 18 delivers the supplied gas from the gas conduit to the interior of mask 16. Mask shell 17 also includes a pair of slotted connectors 24 that are respectively connected to the ends of a lower headgear (not shown) to secure the nasal mask to the head of the wearer.

The connecting member 14 is typically connected to the top of a mask shell 17 proximate to and above the nose of the wearer, it being understood that the illustrated nasal mask 16 is only one example of a respiratory mask that may be supported by the forehead support 10. For example, the forehead support may also be applied to a mask that supports the entire face (i.e., nose and mouth).

The forehead support according to the present invention may also be used with a mask in which the gas supply connector 18 is integrated with the mask at the general location of the connection part 14. In this type of mask, the gas is provided to flow through or past the forehead support 10.

The T-shaped cushion frame 12 includes a pair of forehead cushions 25 mounted to each end of the upper portion of the T-shaped frame on the wearer contacting side. Examples of the pad 25 include open and closed cell foam, silicone, dual durometer foam, single piece or multiple pieces joined together. The forehead pad 25 may be integrally molded with the frame 12 or joined together by clips or adhesives or the like. Frame 12 also includes a notched connector 26 adjacent each forehead pad 25 that connects with the respective ends of an upper headband (not shown) to secure the cushion frame 12 to the head of a wearer.

The T-shaped cushion frame 12 further includes a pair of shafts 27 (only one shown) at the lower end of the T, each of which is received in a respective circular opening 28 (only one shown) in the connecting member 14. The shafts 27 are pivotable or rotatable in the respective openings 28 to enable pivoting or rotation between the cushion frame 12 and the connecting member 14 about the shaft 30 in the direction of double arrow 31.

The curved shape of the cushion 25 allows it to effectively rotate on the forehead of the wearer as the angle between the cushion frame 12 and the connecting member 14 is adjusted.

As shown in fig. 2 and 3, the cushion frame 12 further includes a flexible member 32 having two side-by-side spaced tongues 34 and a centrally projecting button 36 at a distal end thereof. The connecting member 14 also includes two generally arcuate portions 38, each having a pair of four grooves 40. It will be appreciated that the pair of four grooves is only a preferred choice, as only two or more grooves are required. It is also understood that the flexible member 32 may be located on the connecting member 14 and the groove 40 may be located on the cushion frame 12. The tongue 34 and groove 40 extend in a direction substantially parallel to the radial extension of the shaft 30.

The cushion frame 12 is made of plastic, such as polypropylene or polycarbonate, which allows the member 32 to flex relative to the cushion frame 12 to which it is mounted when pressure in the direction of arrow 42 is applied to the button 36. The corresponding movement of the tongue 34 releases its engagement with the pair of grooves 40 (as shown in fig. 3) to allow angular adjustment between the cushion frame 12 and the attachment member 14 about the axis 30. Release button 36 allows tongue 34 to spring back into groove 40. When the tongue 34 is aligned with one of the pair of grooves 40 (as shown in fig. 2 and 4-7), the tongue 34 engages one of the pair of grooves 40. When the tongue 34 engages one of the pair of grooves 40, the cushion frame 12 and the connecting member 14 are locked at a predetermined angular position therebetween without being pivotable.

Fig. 4-7 show the forehead support 10 having tongues 34 engaging the first, second, third and fourth pairs of grooves 40, respectively, proximate the head of different wearers.

As shown in fig. 4-7, the angle between the cushion frame 12 and the connecting member 14 near the forehead of the wearer may be increased to accommodate a relatively high nose area and a relatively low forehead of the wearer (e.g., fig. 4 and 5), and decreased to accommodate a relatively low nose area and a relatively high forehead of the wearer (e.g., fig. 6 and 7).

The forehead support 10 advantageously allows the mask 16 to be positioned in a position appropriate to the particular configuration of the wearer's face, ensuring perfect positioning of the mask cushion 19 on the wearer's face. For example, the relative positions of the cushion frame 12 and the attachment member 14 in fig. 4 are more suitable for wearers having a shallow forehead or a convex cheek or nose, while the positions of the cushion frame 12 and the attachment member 14 in fig. 7 are more suitable for wearers having a convex or rounded forehead.

Fig. 8 shows a second embodiment of a forehead support 50 according to the present invention, and like reference numerals will be used to refer to corresponding like features in the second embodiment when describing the first embodiment.

In the second embodiment, there are two buttons 36 that are pressed together in the direction of arrows 52 to bend the tongues 34 towards each other to disengage the grooves 40 and allow adjustment of the angle between the cushion frame 12 and the attachment member 14. Releasing the button 36 causes the tongue 34 to spring back and engage the groove 40 to lock the cushion frame 12 and the attachment member 14 against relative pivoting.

Fig. 9-14 illustrate a third embodiment of a forehead support 60 according to the present invention. Like reference numerals will be used to refer to corresponding like features in the third embodiment when describing the first embodiment.

In a third embodiment, the cushion frame 12 is integrally molded with the connecting member 14 and joined by an integral hinge 62 (sometimes as a natural or existing hinge). The cushion frame 12 and the connecting member 14 are rotatable relative to each other about the hinge 62. The forehead support 60 is made sufficiently 'thick' that the cushion frame 12 is twisted about 180 deg. from the connection member 14 until the tongue 34 engages one of the four grooves 40, as shown in fig. 9. As with the previous embodiment, pressing the button 36 in the direction of arrow 42 disengages the tongue 34 from the groove to adjust the angle between the cushion frame 12 and the attachment member 14. The button 36 and tongue 34 are naturally offset from engagement with one of the grooves 40, again in accordance with the previous embodiment.

In the preferred form shown, the mask shell 17 is integrally formed with the attachment member 14. This simplifies manufacturing and assembly and reduces product costs. The forehead support 60 is preferably made of polypropylene, since polypropylene can cast an integral hinge.

Fig. 15 and 16 are fourth embodiments of forehead supports 100 according to the present invention. Like reference numerals will be used to refer to corresponding like features in the fourth embodiment when describing the first embodiment.

The fourth embodiment is almost identical to the first embodiment except that the tongue 34 and groove 40 are rotated relative to the radial extension of the shaft 30. This angled arrangement reduces the likelihood that tongue 34 will inadvertently disengage from one of grooves 40 if the front of mask 16 is acted upon by a force directed along the wearer's face.

Although the invention has been described with reference to specific examples, it will be appreciated by those skilled in the art that the invention may be embodied in many other forms.

As an example, the forehead support may include means for resiliently biasing the cushion frame and the connecting member away from each other to increase or decrease the angle between each other when the tongue disengages from one of the grooves.

Fig. 17-78 show another embodiment of a forehead support, indicated at 210, and a connection member, indicated at 214. As shown, a forehead support 210 and attachment members 214 are used to form the full-face mask 200. However, for example, the forehead support 210 and the connection member 214 may also be used to form a nasal mask.

As shown in Figs. 17-19, the full-face mask assembly 200 includes a shell or frame 217 and a cushion 219 that may be permanently or removably attached to the frame 217 in any suitable manner. In the illustrated embodiment, the connecting member 214 is integrally formed with an upper portion of the frame 217. The forehead support 210 is rotatably mounted to the connection member 214. A swivel elbow assembly 218 is movably connected to the front of the frame 217. Elbow assembly 218 is connected to a conduit in communication with a pressurized gas source.

A headgear assembly (not shown) is movably attached to the frame 217 and forehead support 210 to maintain the mask assembly 200 in a desired position on the patient's face.

As shown in fig. 20, the rear side of each frame 217 includes a locking clip receiving assembly 270 that interlocks with a locking clip 272 (see fig. 25). As shown in fig. 20, the rear side of each forehead support 210 includes a locking clip receiving assembly 270 that interlocks with the locking clip 272. Thus, four locking clips 272 are employed, two locking clips 272 for the frame 217 and two locking clips 272 for the forehead support 210. As shown in fig. 20B, the locking clip 272 engages with a locking clip receiving assembly 270 provided on the frame 217 and forehead support 210. In use, the upper strap of the headgear assembly is removably attached to the locking clip 272 of the forehead support 210 and the lower strap of the headgear assembly is removably attached to the locking clip 272 of the frame 217.

Further details of the structure and use of the locking clip receiving assembly 270 and the locking clip 272 are disclosed in U.S. patent application No.10/655,603 filed on rithgow et al, 9/5/2003, the contents of which are incorporated herein by reference in their entirety.

As shown in fig. 16-30, the forehead support 210 includes a generally T-shaped cushion frame 212. Each end of the T-shaped upper portion includes an opening 215 (see fig. 32 and 33) adapted to secure a forehead pad 225. As shown in fig. 34, the opening 215 is rotated downward to properly orient the forehead pad 225 with respect to the patient's face. For example, the forehead pad 225 shown in fig. 73 and 74 engages the forehead of the patient. Also, the forehead pad 225 is shown engaged with the patient's forehead at various locations on the forehead support 210 in fig. 75-78. As shown, the forehead pad 225 is angled to engage the patient's forehead in the proper position. Furthermore, the forehead pad 225 is constructed to allow the forehead pad 225 to move relative to the forehead support 210 to improve the comfort of the patient wearing the mask.

Further details of the structure and operation of the forehead pad 225 are disclosed in U.S. patent application No.10/655,595, filed 9/5/lang et al 2003, the contents of which are incorporated herein by reference in their entirety.

As shown in fig. 26 to 31, the T-shaped cushion frame 212 includes a pair of shafts 227 at a lower portion of the T-shape, each of which is received in an opening 228 provided on the connecting member 214, respectively, the shafts 227 of the T-shaped cushion frame 212 having a smaller shape and a different angle than the shafts 27 of the T-shaped cushion frame 12 in fig. 16.

Specifically, the shafts 27 and 227 may have a generally non-circular shape, such as a rectangular shape, defining a major longitudinal axis. The diameter and width of shaft 227 is less than the diameter and width of shaft 27.

Also, as shown in fig. 16, the cushion frame 12 has a vertical axis 90 and a horizontal axis 92. The longitudinal edges of shaft 27 define a longitudinal axis 94 of shaft 27 therebetween. If the portion of the cushion frame 12 facing the patient is considered the rear of the cushion frame 12 and the portion of the cushion frame 12 facing outward from the patient is considered the front of the cushion frame 12, the shaft 27 rotates rearward of the vertical axis 90 of the cushion frame 12, i.e., toward the rear of the cushion frame 12. As shown in fig. 30, the cushion frame 212 has a vertical axis 290 and a horizontal axis 292. The longitudinal sides of the shaft 227 define therebetween a longitudinal axis 294 of the shaft 227. In contrast to axis 27, if the portion of cushion frame 212 facing the patient is considered the rear of cushion frame 212 and the portion of cushion frame 212 facing outward from the patient is considered the front of cushion frame 212, axis 227 rotates forward of the vertical axis 290 of cushion frame 212, i.e., toward the front of cushion frame 212.

This change in shape and geometry of the shaft 227 facilitates assembly of the forehead support 210 assembly with the connection member 214 and provides more spacing between the forehead support 210 and the patient's forehead, as will be further described below.

The cushion frame 212 also includes a flexible member 232 having two side-by-side spaced tongues 234 and a centrally projecting button 236 at the end thereof.

Fig. 35-42 illustrate a more detailed structure and various dimensions of one embodiment of the forehead support 210, such as the shaft 227 of the forehead support 210 having a diameter of about 5mm and a width of about 3 mm. The shaft 227 is also rotated approximately 15 degrees forward of the vertical axis 290 of the cushion frame 212 (as shown in fig. 36). In one embodiment of the forehead pad 210, the dimensions shown in fig. 35-42 may float up and down by 10%.

Fig. 43-48 illustrate one embodiment of a frame 217, including a connecting member 214. As shown, the coupling member 214 includes two generally arcuate portions 238 each having a pair of four recesses 240. It will be appreciated that a pair of four grooves is preferred and only two or more grooves are required. As described above, the tongue 234 engages one of the pair of grooves 240 to lock the gasket frame 212 and the frame 217 at a predetermined angle to prevent rotation therebetween. It will be appreciated that the tongue/groove positioning may be reversed, for example, the tongue may be on the connecting member 214 and the groove 240 may be on the cushion frame 212. Also, the connecting members 214 and the cushion frame 212 may be made to allow the cushion frame 212 to slide relative to the connecting members 214.

Fig. 21-24 show different positions of the forehead support 210 and the frame 217, namely the tongue 234 engaging with the first, second, third and fourth grooves of the four pairs of grooves 240. In addition, fig. 75-78 illustrate the forehead support 210 adjacent the patient's face and the frame 217 having a tongue 234 that engages a first, second, third and fourth pair of grooves 240 of the four pairs. In use, the angle between the forehead support 210 and the frame 217 may be decreased to accommodate a relatively low nose area and a relatively high forehead of the wearer (e.g., fig. 75 and 76), and may be increased to accommodate a relatively high nose area and a relatively low forehead of the wearer (e.g., 77 and 78).

As shown in fig. 47, the opening 228 in the connecting member 214 is smaller than the opening 28 in the connecting member 14 of fig. 15 and 16 to match the smaller shaft 227 on the cushion frame 212, for example, as shown in fig. 56, 64 and 72, the opening 228 in the connecting member 214 is approximately 5mm in diameter. In contrast, the diameter of the opening in the connecting part 14 is approximately 6.5 mm. As a result, the attachment member 214 of the frame 217 has a reduced thickness, reducing the profile of the mask. As a result, there is a wider space and space between the connection member 14 and the forehead of the patient (see fig. 75 to 78). This will ensure that the connecting part 14 does not interfere with the forehead or bridge of the nose of the patient.

In addition, the groove 229 leading to the opening 228 provided in the connecting member 14 has a central axis 295 (shown in fig. 47) substantially parallel to the horizontal axis 296 of the frame 217. In the embodiment of the forehead support 10, the recess 29 has a central axis 95 that is rotated, i.e., downward, relative to a horizontal axis 96 of the frame 17 (as shown in fig. 15). As described above, this geometric change of the forehead support 210 facilitates the assembly of the forehead support 210 with the connection part 214 and also helps to increase the spacing.

Specifically, due to the geometry of the shaft of the T-shaped cushion frame 212 and the slots 229 in the openings 228 of the attachment member 14, the vertical shaft 290 (FIG. 30) of the cushion frame 212 may be oriented 90 from the attachment member 14 such that the shafts 227 are inserted through the respective slots 229 into the respective openings 228. As a result, the forehead support 210 may be easily assembled and disassembled with the frame 217 to which the forehead pad 225 is connected. In the foregoing embodiment, the shaft 27 of the cushion frame 12 and the recess of the opening 28 are rotated so that the forehead cushion 25 can interfere with the cushion 19 on the mask shell 17 when the forehead support 10 is assembled and disassembled from the attachment member 14.

In addition, as shown in fig. 43, 44, and 46, the connecting member 214 includes an additional supporting member 274. The support member 274 increases the support of the side of the connecting member 214.

The support member 274 also has a function of spacing the connection member 214 from the vent hole 276 provided in the upper portion of the frame 217 so that the connection member 214 does not block the vent hole 276. The noise of the air output from the vent 276 is also reduced. In use, a vent cover 278 (see fig. 18 and 19) is attached to the vent 276 to vent air output from the connection 214 completely (e.g., australian patent No.712236 and U.S. patent application No.09/021,541, the entire contents of which are incorporated herein by reference).

The frame 217 of the mask assembly 200 for a full face may be of different sizes, such as small, medium and large, to accommodate a variety of patients. The same forehead support 210 may employ frames 217 of different specifications. For example, fig. 49-56 illustrate more detailed structures and various dimensions in one embodiment of a small frame for a full-face mask assembly. Fig. 57-64 illustrate more detailed structures and various dimensions in one embodiment of a medium frame for a full-face mask assembly. Fig. 65-72 illustrate more detailed structure and various dimensions in one embodiment of a large frame for a full-face mask assembly. As shown, the small size frame has a width of about 91mm and a height of about 108mm (minus connecting members), the medium size frame has a width of about 100mm and a height of about 119mm (minus connecting members), and the large size frame has a width of about 105mm and a height of about 126mm (minus connecting members), in the embodiment of the frame 217, the dimensions shown in FIGS. 49-72 may be varied up and down by 10%, or more.

While the described embodiment rotates about an axis in the cushion frame, a number of different means may be used to adjust the angle of rotation of the forehead support, e.g., the axis may be positioned on the connecting member rather than on the cushion frame. Alternatively, the rotation angle of the forehead support may be performed by sliding the frame relative to the shaft. The frame may rotate about a point that is not physically located within the mask assembly. In addition, the locking angle of the frame with respect to the connecting member may be achieved by a mechanical device instead of a button. In one case, the forehead support may be selectively locked in one position and freely rotated to the other position. Also, the forehead pad, rather than the pad frame, may have a corresponding opening.

It will be appreciated that these aspects of the invention can be implemented sufficiently effectively. The foregoing description of the specific embodiments is provided to illustrate the structural and functional principles of the present invention, but is not intended to limit the invention thereto. Rather, the invention is intended to embrace all such alterations, modifications and variations that fall within the spirit and scope of the detailed description.

Claims (12)

1. A respiratory mask assembly for delivering breathable gas to a patient, comprising:

a frame; and

a forehead support secured to the frame, the forehead support comprising

A connecting member fixed to an upper portion of the frame; and

a cushion frame movably fitted to the connection member;

one of the connecting member and the cushion frame includes a pair of shafts and the other of the connecting member and the cushion frame includes a pair of openings, the pair of shafts being respectively received in the pair of openings to couple the connecting member and the cushion frame together and to allow the cushion frame to be movable relative to the connecting member;

wherein each shaft has a non-circular cross-section and defines a major longitudinal axis that is angled forwardly relative to a vertical axis of one of the attachment member and the cushion frame to rotate an angle toward the front of the attachment member and the cushion frame.

2. The respiratory mask assembly according to claim 1, wherein the respiratory mask assembly is a full-face mask.

3. The respiratory mask assembly according to claim 1, wherein the cushion frame is lockable in two or more predetermined angular positions relative to the connection member by use of a resilient button associated with the cushion frame.

4. The respiratory mask assembly according to claim 1, wherein the frame and the cushion frame each include a locking clip receiving assembly configured to interlock with a locking clip coupled to the headgear.

5. The respiratory mask assembly according to claim 1, wherein each of the shafts has a diameter of about 5mm and a width of about 3 mm.

6. The respiratory mask assembly according to claim 1, wherein each of the axes is rotated forward at an angle of about 15 ° from the vertical axis.

7. The respiratory mask assembly according to claim 1, wherein each of the openings has a diameter of about 5 mm.

8. The respiratory mask assembly according to claim 1, wherein one of the attachment member and the cushion frame includes a pair of notches leading to the pair of openings, the pair of notches being substantially parallel to a horizontal axis of the one of the attachment member and the cushion frame.

9. The respiratory mask assembly according to claim 1, wherein the attachment member includes a pair of support members that space the attachment member from vent holes provided in an upper portion of the frame.

10. The respiratory mask assembly according to claim 1, wherein the cushion frame includes one or more openings to receive one or more forehead cushions, the one or more openings being rotated downward when viewed from the side so that the one or more forehead cushions are properly oriented relative to the forehead of the patient in use.

11. The respiratory mask assembly according to claim 1, wherein the cushion frame includes a pair of openings in a pair of shafts at a lower portion of the cushion frame and the attachment member.

12. A method for assembling a respiratory mask assembly including a frame and a forehead support, comprising the steps of:

preparing a pair of grooves in one of the frame and forehead support to open to a pair of openings;

providing a pair of shafts on the other of the frame and the forehead support;

rotating the vertical axis of one of the frame and the forehead support by about 90 ° relative to the other of the frame and the forehead support; and is

The pair of shafts are inserted into the pair of openings through the pair of grooves to assemble the forehead support to the frame.