Full-face mask and mask cushion therefor

Abstract

A full-face cushion comprises a substantially triangularly shaped frame from which extends a membrane. The frame has a scalloped edge by which the cushion is affixed to a mask body to form a full-face mask. The membrane has an aperture into which the wearer's nose is received. The member is spaced away from the rim of the frame, and its outer surface is of substantially the same shape as the rim. Respective notches receive the bridge of the wearer's nose. The wearer's nose and lips are received through the aperture into the chamber within the mask body. The seal forming portion thus contacts both the surface of the wearer's nose and a portion of the wearer's face in the region between the bottom lip and the chin, and around the sides and over the bridge of the nose. The shape of the seal forming portion is particularly suited to effectively seal the difficult region of the facial contour that is the crease between the sides of the nose and the face.

1 - 25 . (canceled) 
     
     
         26 . A mask assembly for delivery of a supply of gas to an entrance to the airways of a patient, said patient having a nasal bridge region, a cheek region and a chin region, said mask assembly comprising:
 a headstrap system to secure the mask assembly relative to the patient's head; and   a cushion adapted to confront a face of a patient, said cushion comprising first and second membranes of integrally formed elastomeric material, said first and second membranes having respective first and second distal ends delimiting respective first and second apertures adapted to receive the patient's nose and mouth, said first distal end terminating adjacent the second aperture,
 said second membrane defines a seal-forming portion on an outer surface thereof, said seal-forming portion being constructed and arranged to be positioned adjacent a nasal bridge region, along sides of the nose, and below lips or on a chin to effect a seal, 
   the seal forming portion is structured such that it is not required to turn in on itself to conform with the patient's face,   said first membrane provides a supporting structure for the second membrane, and   said second membrane covering said first membrane.   
     
     
         27 . The mask assembly of  claim 26 , wherein the second membrane is substantially unsupported by the first membrane where the cushion is adapted to seal with the nasal bridge region. 
     
     
         28 . The mask assembly of  claim 26 , wherein, in a portion of the cushion adapted to contact the chin region, the first and second membranes extend a chin region distance towards the aperture, the chin region distances of the rims being generally equal. 
     
     
         29 . The mask assembly of  claim 26 , wherein, in a portion of the cushion adapted to contact the cheek region, the second membrane extends a cheek region distance towards the aperture that is greater than the chin region distance of the second membrane. 
     
     
         30 . The mask assembly of  claim 28 , wherein, in the nasal bridge region, the second membrane extends a nasal bridge region distance that is greater than the chin region distance of the second membrane. 
     
     
         31 . The mask assembly of  claim 30 , wherein in the nasal bridge region, the second membrane extends towards the aperture to a degree relative to the first membrane that is greater than that of the second membrane relative to the first membrane in the cheek region. 
     
     
         32 . The mask assembly of  claim 26 , wherein, in the nasal bridge region, the shape between the first and second membranes is different from one another such that the nasal bridge is able to be inserted into a space where there is substantially no first membrane, with the second membrane stretching across a gap in the first membrane. 
     
     
         33 . The mask assembly of  claim 26 , further comprising a notch in both the first and second membranes to receive the bridge of the wearer's nose. 
     
     
         34 . The mask assembly of  claim 26 , wherein the first membrane has a thickness of about 1.5 mm and the second membrane has a thickness of about 0.35 mm. 
     
     
         35 . The mask assembly of  claim 26 , wherein the first membrane extends a first distance towards the aperture in the nasal bridge region, and a second distance towards the aperture in the chin region, wherein said first distance is less than said second distance. 
     
     
         36 . A mask assembly for delivery of a supply of gas to an entrance to the airways of a patient, said patient having a nasal bridge region, a cheek region and a chin region, said mask assembly comprising:
 a headstrap system to secure the mask assembly relative to the patient's head; and   a cushion adapted to confront a face of a patient, said cushion comprising:
 first and second membranes of integrally formed elastomeric material, each of said first and second membranes having a proximal portion and a distal end, the distal ends defining respective first and second apertures adapted to receive the patient's nose and mouth, proximal portions intersecting one another, and the first and second membranes extending in spaced relation to one another toward the respective distal ends; and 
 a support portion from which the first and second membranes extend, the support portion including an edge configured to connect the cushion to a mask body, 
 said second membrane defines a seal-forming portion on an outer surface thereof, said seal-forming portion being constructed and arranged to be positioned adjacent a nasal bridge region, along sides of the nose, and below lips or on a chin to effect a seal, 
   the seal forming portion is structured such that it is not required to turn in on itself to conform with the patient's face,
 said first membrane provides a supporting structure for the second membrane, and 
 said second membrane covering said first membrane. 
   
     
     
         37 . The mask assembly of  claim 36 , wherein the second membrane is substantially unsupported by the first membrane wherein the cushion is adapted to seal with the nasal bridge region. 
     
     
         38 . The mask assembly of  claim 36 , wherein, a portion of the cushion adapted to contact in the chin region, the first and second membranes extend a chin region distance towards the aperture, the chin region distance of the second membrane being greater than the chin region distance of the first membrane. 
     
     
         39 . The mask assembly of  claim 38 , wherein, in a portion of the cushion adapted to contact the cheek region, the second membrane extends a cheek region distance towards the aperture that is greater than the chin region distance of the second membrane. 
     
     
         40 . The mask assembly of  claim 38 , wherein, in the nasal bridge region, the second membrane extends a nasal bridge region distance that is greater than the chin or cheek region distances of the second membrane. 
     
     
         41 . The mask assembly of  claim 40 , wherein in the nasal bridge region, the second membrane extends towards the aperture to a degree relative to the first membrane that is greater than that of the second membrane relative to the first membrane in the cheek and chin regions. 
     
     
         42 . The mask assembly of  claim 36 , wherein, in the nasal bridge region, the shape between the first and second membranes is different from one another such that the nasal bridge is able to be inserted into a space where there is substantially no first membrane, with the second membrane stretching across a gap in the first membrane. 
     
     
         43 . The mask assembly of  claim 36 , further comprising a notch in both the first and second membranes to receive the bridge of the wearer's nose. 
     
     
         44 . The mask assembly of  claim 36 , wherein the first membrane has a thickness of about 1.5 mm and the second membrane has a thickness of about 0.35 mm. 
     
     
         45 . A mask assembly for delivery of a supply of gas to an entrance to the airways of a patient, said patient having a nasal bridge region, a cheek region and a chin region, said mask assembly comprising:
 a headstrap system to secure the mask assembly relative to the patient's head; and   a cushion adapted to confront a face of a patient, said cushion comprising:
 first and second membranes of integrally formed elastomeric material, each of said first and second membranes having an aperture adapted to receive the patient's nose and mouth, each of the first and second membranes having a distal end and a proximal end, the proximal ends intersecting one another and the first and second membranes extending in spaced relation to one another toward the respective distal ends, 
 said second membrane defines a seal-forming portion on an outer surface thereof, said seal-forming portion being constructed and arranged to be positioned adjacent a nasal bridge region, along sides of the nose, and below lips or on a chin to effect a seal, 
 said first membrane provides a supporting structure for the second membrane, and 
 said second membrane covering said first membrane, 
   wherein the second membrane has a variable dimension suited to the nasal bridge region, the cheek region and the chin region,   wherein the first membrane has a variable dimension suited to the nasal bridge region, the cheek region and the chin region, and/or   the first and second membranes have variable widths relative to one another suited to the nasal bridge region, the cheek region and the chin region.   
     
     
         46 . The mask assembly of  claim 45 , wherein the second membrane is substantially unsupported by the first membrane where the cushion is adapted to seal with the nasal bridge region. 
     
     
         47 . A mask assembly for delivery of a supply of gas to an entrance to the airways of a patient, said patient having a nasal bridge region, a cheek region and a chin region, said mask assembly comprising:
 a headstrap system to secure the mask assembly relative to the patient's head; and   a cushion adapted to confront a face of a patient, said cushion comprising:
 first and second membranes of integrally formed elastomeric material, each of said first and second membranes having an end forming a respective rim defining an aperture through which the patient's nose and mouth, 
 said second membrane defines a seal-forming portion on an outer surface thereof, said seal-forming portion being constructed and arranged to be positioned adjacent a nasal bridge region, along sides of the nose, and below lips or on a chin to effect a seal, 
   the seal forming portion is structured such that it is not required to turn in on itself to conform with the patient's face,
 said first membrane provides a supporting structure for the second membrane, 
 said second membrane covering said first membrane, and 
 wherein the second membrane is substantially unsupported by the first membrane 
   where the cushion is adapted to seal with the nasal bridge region in use.   
     
     
         48 . The mask assembly of  claim 47 , wherein, a portion of the cushion adapted to contact in the chin region, the first and second membranes extend a chin region distance towards the aperture, the chin region distance of the second membrane being greater than the chin region distance of the first membrane. 
     
     
         49 . The mask assembly of  claim 48 , wherein, in a portion of the cushion adapted to contact the cheek region, the second membrane extends a cheek region distance towards the aperture that is greater than the chin region distance of the second membrane. 
     
     
         50 . The mask assembly of  claim 48 , wherein, in the nasal bridge region, the second membrane extends a nasal bridge region distance that is greater than the chin or cheek region distances of the second membrane. 
     
     
         51 . The mask assembly of  claim 50 , wherein in the nasal bridge region, the second membrane extends towards the aperture to a degree relative to the first membrane that is greater than that of the second membrane relative to the first membrane in the cheek and chin regions. 
     
     
         52 . The mask assembly of  claim 47 , wherein, in the nasal bridge region, the shape between the first and second membranes is different from one another such that the nasal bridge is able to be inserted into a space where there is substantially no first membrane, with the second membrane stretching across a gap in the first membrane. 
     
     
         53 . The mask assembly of  claim 47 , further comprising a notch in both the first and second membranes to receive the bridge of the wearer's nose. 
     
     
         54 . The mask assembly of  claim 47 , wherein the first membrane has a thickness at its rim of about 1.5 mm and the second membrane has a thickness at its rim of about 0.35 mm. 
     
     
         55 . A mask assembly for delivery of a supply of gas to an entrance to the airways of a patient, said patient having a nasal bridge region, a cheek region and a chin region, said mask assembly comprising:
 a headstrap system to secure the mask assembly relative to the patient's head; and   a cushion adapted to confront a face of a patient, said cushion comprising:
 first and second membranes of integrally formed elastomeric material, each of said first and second membranes having an aperture through which the patient's nose and mouth are received, 
 said second membrane defines a seal-forming portion on an outer surface thereof, said seal-forming portion being constructed and arranged to be positioned adjacent a nasal bridge region, along sides of the nose, and below lips or on a chin to effect a seal, 
 said first membrane provides a supporting structure for the second membrane, and 
 said second membrane covering said first membrane, 
   wherein the second membrane has a variable dimension suited to the nasal bridge region, the cheek region and the chin region, the first membrane has a variable dimension suited to the nasal bridge region, the cheek region and the chin region, and/or the first and second membranes have variable widths relative to one another suited to the nasal bridge region, the cheek region and the chin region, and   wherein the second membrane is substantially unsupported by the first membrane where the cushion is adapted to seal with the nasal bridge region in use.   
     
     
         56 . The mask assembly of  claim 26 , wherein first and second membranes extend in spaced relation to one another. 
     
     
         57 . The mask assembly of  claim 26 , wherein the cushion comprises a support portion from which the first and second membranes extend, the support portion including an edge configured to connect the cushion to a mask body.