Adjustable mask system and related methods

Abstract

An adjustable mask system ( 100 ) includes a cushion with a seal ( 130 ) having the ability to change size and/or shape. The seal is preferably a one-piece, continuous member without interruptions. To effect adjustment of the size and/or shape of the seal, an actuator may be provided, which may take the form of a dial ( 190 ).

What is claimed is: 
     
         1 . A mask system for a wearer, comprising:
 a frame;   a cushion provided to the frame, the cushion having a one-piece seal to contact the wearer's skin, the seal being adjustable in size and/or shape relative to one or more dimensions of the wearer's face.   
     
     
         2 . The mask system according to  claim 1 , wherein the seal comprises foam. 
     
     
         3 . The mask system according to  claim 1 , wherein the seal has a shape that is variable to match the dimensions of the wearer's face, while a perimeter of the seal remains generally constant even as the shape varies. 
     
     
         4 . The mask system according to  claim 1 , wherein the frame includes upper and lower frame portions that are connected by one or more intermediate members. 
     
     
         5 . The mask system according to  claim 4 , wherein the one or more intermediate members takes the form of an adjustable region or gusset having one or more folds to allow expansion or contraction as the size and/or shape of the seal varies. 
     
     
         6 . The mask system according to  claim 4 , wherein the seal includes structure to commonly mate with both the intermediate member and the upper and lower frame portions. 
     
     
         7 . The mask system according to  claim 4 , wherein the seal includes a groove and the upper and lower frame portions form a common tongue with the intermediate member inserted within the groove. 
     
     
         8 . The mask system according to  claim 4 , wherein the seal includes a tongue and the upper and lower frame portions form a common and continuous groove with the intermediate member to receive the tongue. 
     
     
         9 . The mask system according to  claim 4 , wherein the height of the intermediate member is variable during adjustment, while the length and shape of the nasal bridge region and the lower chin or upper lip region remain generally constant. 
     
     
         10 . The mask system according to  claim 1 , wherein the seal comprises stretchable and compressible material. 
     
     
         11 . The mask system according to  claim 10 , wherein an area defined within a perimeter of the seal is variable. 
     
     
         12 . The mask system according to  claim 1 , wherein a height of the seal is variable over a range of between about 5 to about 75 mm. 
     
     
         13 . The mask system according to  claim 12 , wherein the range is between about 25 to about 35 mm. 
     
     
         14 . The mask system according to  claim 12 , wherein the range is between about 30 to about 40 mm. 
     
     
         15 . The mask system according to  claim 1 , wherein a height of the seal is variable over a range of at least 10 mm. 
     
     
         16 . The mask system according to  claim 1 , wherein the seal is designed and dimensioned, for a relatively taller face, to seal near a minimum nasal bridge sealing position, and, for a relatively smaller face, to seal at a maximum nasal bridge sealing position. 
     
     
         17 . A method of making a mask system for a wearer, comprising:
 providing a frame;   providing a cushion to the frame, the cushion including a one-piece seal; and   structuring the seal such that it may be adjusted between an initial size and a plurality of different sizes for customization to the wearer.   
     
     
         18 . The method of making a mask system for a wearer according to  claim 17 , arranging the adjustability of the seal to fit up to 95% of population. 
     
     
         19 . A method of fitting a CPAP mask system adapted to deliver pressurized air in the range of 2-30 cmH 2 O to a patient, comprising:
 fitting a one-piece seal of the mask system to the wearer; and   adjusting one or more dimensions of the seal tailored to the wearer's face.   
     
     
         20 . A method of fitting a mask system to a wearer according to  claim 19 , wherein said adjusting includes changing the shape of a perimeter of the seal to increase or decrease a height of the seal height to match the height of the wearer's face, while the length of the perimeter remains generally constant.