Nasal mask system

Abstract

A mask system includes a frame ( 20 ) adapted to attach headgear, a sealing arrangement ( 40 ) releasably connectable to the frame, and an elbow ( 70 ) provided to the sealing arrangement and adapted to be connected to an air delivery tube that delivers breathable gas to the patient. The sealing arrangement defines a breathing chamber and is adapted to form a seal with the patient's face. The sealing arrangement includes structure ( 50 ) to establish a positive connection with the frame and with the elbow.

1 - 20 . (canceled) 
     
     
         21 . A mask system for use in treatment of Sleep Disordered Breathing with Continuous Positive Airway Pressure or Non-Invasive Positive Pressure Ventilation, the mask system comprising:
 an elbow having a first end portion including an interfacing structure and a second end portion configured to be connected to an air delivery tube to receive a supply of air at positive pressure from a blower or flow generator in a range of 2 to 30 cm H 2 O, the elbow including a vent arrangement for gas washout, the vent arrangement including 20 to 50 holes;   a sealing arrangement defining a breathing chamber for delivery of the supply of air at positive pressure to the airways of a patient, the sealing arrangement being adapted to seal with the patient's face in use, the sealing arrangement including a cushion;   headgear to hold the sealing arrangement in a sealing position on the patient's head to enable the supply of air at positive pressure to be delivered to the patient's airways, the headgear being constructed of a flexible material, the headgear comprising a pair of upper headgear straps configured to be routed over the ears in use, and a pair of lower headgear straps configured to be routed under the ears in use; and   a frame to maintain, stabilize, and/or support the sealing arrangement in an operative position with respect to the patient's face, the frame being structured such that the sealing arrangement is releasably connectable to the frame, each lateral side of the frame including a lower headgear connector, the frame including a central opening to allow the sealing arrangement to communicate with the elbow,   wherein the cushion is constructed of silicone,   wherein the cushion is adapted to seal around the patient's nose,   wherein the cushion includes a membrane,   wherein the membrane is inwardly curving and extends around the perimeter of the cushion to define a rearward sealing surface of the cushion,   wherein the cushion includes an orifice through which a portion of the patient's nose of passes in use, the membrane having an inner edge that forms a boundary of the orifice,   wherein a seal forming surface of the cushion has a non-tacky, frosted surface finish,   wherein the membrane has a membrane nasal bridge region that is structured to seal at the patient's nasal bridge region lower than the sellion in use,   wherein the membrane has a scallop having a depth when viewed from the top,   wherein the membrane includes a membrane top lip region that is adapted to seal on the patient's top lip of in use,   wherein the membrane top lip region has a length or extension,   wherein the membrane top lip region is formed to have a concave curvature,   wherein the rearward sealing surface of the membrane is adapted to extend along the top lip of the patient from the left side of the nose to the right side of the nose in use,   wherein each lateral side of the membrane includes a membrane side of nose region that is adapted to seal with a side of the patient's nose proximal to the patient's eyes in use,   wherein the membrane side of nose region is configured to engage and compress on the sides of the patient's nose in use,   wherein each membrane side of nose region includes a first flexible side flap extending into the orifice and a second flexible side flap extending into the orifice.   
     
     
         22 . The mask system according to  claim 21 , wherein the inner edge of the membrane at the first flexible side flap and the second flexible side flap each extends further into the breathing chamber than the inner edge of the membrane top lip region. 
     
     
         23 . The mask system according to  claim 21 , wherein the orifice has a first lateral width defined between the inner edge of the membrane at the first flexible side flap and the inner edge of the membrane at the second flexible side flap and a second lateral width defined below the first flexible side flap and the second flexible side flap and above the membrane top lip region, the first lateral width being less than the second lateral width. 
     
     
         24 . The mask system according to  claim 21 , wherein an upper portion of the orifice between the first flexible side flap and the second flexible side flap is narrower than a lower portion of the orifice that is above the membrane top lip region. 
     
     
         25 . The mask system of  claim 21 , wherein the membrane extends from a connecting portion of the cushion to a patient contacting portion of the cushion. 
     
     
         26 . The mask system of  claim 25 , wherein the membrane has a depth in a side view in the range of about 10 to 30 mm from the connecting portion to a tangent of the patient contacting portion. 
     
     
         27 . The mask system of  claim 25 , wherein the membrane nasal bridge region is configured to flex or hinge at the connecting portion. 
     
     
         28 . The mask system of  claim 21 , wherein the membrane nasal bridge region has a scallop having a scallop depth when viewed from the top. 
     
     
         29 . The mask system of  claim 21 , wherein in a rear view the membrane nasal bridge region extends a first distance, wherein the membrane has a depth in the membrane nasal bridge region in the range of about 10 to 30 mm. 
     
     
         30 . The mask system of  claim 29 , wherein in a rear view the membrane in the membrane top lip region extends a second distance. 
     
     
         31 . The mask system of  claim 30 , wherein the first flexible side flap and the second flexible side flap extend a third distance in a rear view, said third distance being longer than said first and second distances. 
     
     
         32 . The mask system of  claim 21 , wherein the sealing arrangement further comprises an undercushion. 
     
     
         33 . The mask system of  claim 32 , wherein the undercushion is provided along the cheek regions. 
     
     
         34 . The mask system of  claim 32 , wherein the undercushion is provided in a region of the sealing arrangement adapted to engage the patient's top lip. 
     
     
         35 . The mask system of  claim 21 , wherein the cushion further includes a concertina or a bellows-type arrangement in the membrane nasal bridge region. 
     
     
         36 . The mask system of  claim 21 , wherein the sealing arrangement further comprises a foam cushion. 
     
     
         37 . The mask system of  claim 21 , wherein the membrane is molded from a material having a type A durometer of about 35 to about 45. 
     
     
         38 . The mask system of  claim 21 , wherein the membrane further includes a sickle shape in one or more of the membrane top lip region, the membrane side of nose region, and a region of the cushion adapted to engage the corners of the patient's nose. 
     
     
         39 . The mask system of  claim 21 , wherein the frame comprises a rear connector or an engagement portion positioned on the patient side of the frame. 
     
     
         40 . The mask system of  claim 39 , wherein the rear connector or the engagement portion is a cut-out or an aperture. 
     
     
         41 . The mask system of  claim 21 , wherein the first end portion of the elbow is angled about  135  degrees with respect to the second end portion. 
     
     
         42 . The mask system of  claim 21 , wherein the frame includes a main body and a forehead support, the forehead support extending from a top end of the main body, the forehead support including an elongated arm and an upper headgear connector providing slots to receive corresponding ones of the pair of upper headgear straps in use. 
     
     
         43 . The mask system of  claim 42 , wherein the forehead support further comprises a forehead support pad. 
     
     
         44 . The mask system according to  claim 21 , wherein the orifice defined by the inner edge of the membrane has a height in the range of approximately 25 mm to 35 mm. 
     
     
         45 . The mask system according to  claim 21 , wherein the orifice defined by the inner edge of the membrane has a height in the range of approximately 28 mm to 32 mm. 
     
     
         46 . The mask system according to  claim 21 , wherein the orifice defined by the inner edge of the membrane has a width in a corner region in the range of approximately 30 mm to approximately 40 mm. 
     
     
         47 . The mask system according to  claim 21 , wherein the orifice defined by the inner edge of the membrane has a width in a corner region in the range of approximately 30 mm to approximately 35 mm. 
     
     
         48 . The mask system according to  claim 21 , wherein the membrane nasal bridge region extends from a connecting portion to a patient contacting portion of the rearward sealing surface of the membrane, and the membrane nasal bridge region of the membrane is configured to flex or hinge at the connecting portion. 
     
     
         49 . The mask system according to  claim 21 , wherein the frame is structured to maintain, stabilize and/or support the elbow in an operative position with respect to the patient's face. 
     
     
         50 . The mask system according to  claim 21 , wherein said holes have an exit diameter in the range of about 0.1 to 2 mm. 
     
     
         51 . The mask system according to  claim 21 , wherein the second end portion of the elbow comprises a swivel configured to be connected to the air delivery tube. 
     
     
         52 . The mask system according to  claim 21 , wherein each of the holes of the vent arrangement includes a contour or a taper along its length. 
     
     
         53 . The mask system according to  claim 21 , wherein the headgear further comprises hook and loop material to facilitate attachment to the frame and adjustment of the headgear. 
     
     
         54 . The mask system according to  claim 21 , wherein the headgear further comprises a two-tone color combination to indicate orientation of the headgear to the patient when fitting the mask system. 
     
     
         55 . The mask system according to  claim 21 , wherein the inner edge of the membrane further comprises a bead adjacent to the orifice. 
     
     
         56 . The mask system according to  claim 55 , wherein the bead extends into the breathing chamber from an interior surface of the membrane.