referring now to the drawings wherein the showings are for purposes of illustrating various embodiments of the present invention only , and not for purposes of limiting the same , fig1 - 4 depict a ventilation mask 10 constructed in accordance with a first embodiment of the present invention . the mask is depicted as a nasal prongs mask , however those skilled in the art will recognize that other ventilation masks are contemplated herein such as nasal pillows masks , nasal masks and oronasal masks and for purposes of this application the term mask and / or ventilation mask will include all such mask structures . additionally , for purposes of this application , the term “ direct nasal interface mask ” will be deemed to encompass those masks which are configured to facilitate the direct introduction of therapeutic fluid pressure into the nostrils of a patent , such masks including , but not being limited to , nasal pillows masks , nasal prongs masks , and nasal cradle masks . the mask 10 includes an integrated , diaphragm - implemented , piloted exhalation valve 12 , the structural and functional attributes of which will be described in more detail below . as seen in fig1 - 4 , the mask 10 comprises a housing 14 which defines first and second fluid flow passages 16 , 18 . as best seen in fig3 and 4 , the flow passages 16 , 18 are formed within the housing 14 to have substantially identical shapes or contours . although illustrated with a pair of flow passages , 16 , 18 , those skilled in the art will recognize that a single flow passage is additionally contemplated herein . in the mask 10 , one end of each of the flow passages 16 , 18 is defined by a respective one of an identically configured pair of generally cylindrical , tubular protrusions 20 a , 20 b of the housing 14 . the opposite end of each of the flow passages 16 , 18 is defined by a respective one of an identically configured pair of connector ports 22 a , 22 b of the housing 14 . as seen in fig3 and 4 , the connector ports 22 a , 22 b are each sized and configured to accommodate the advancement of a distal end portion of a tubular fluid line 24 therein . as is apparent from fig3 , the operative engagement of a fluid line 24 to each of the connector ports 22 a , 22 b effectively places such fluid lines 24 into fluid communication with respective ones of the flow passages 16 , 18 . in the housing 14 , the spacing between the protrusions 20 a , 20 b is selected to facilitate the general alignment thereof with the nostrils of an adult patient when the mask 10 is worn by such patient . in the mask 10 , the flow passages 16 , 18 are preferably not fluidly isolated from each other . rather , as also seen in fig3 and 4 , the housing 14 may define an optional cross passage 26 which extends between the protrusions 20 a , 20 b thereof , and effectively places the flow passages 16 , 18 into fluid communication with each other . the cross passage 26 is further placed into fluid communication with ambient air by an optional vent port 28 which is fluidly coupled thereto . the vent port 28 is defined by and extends axially through a generally cylindrical boss 30 of the housing 14 which protrudes upwardly between the protrusions 20 a , 20 b thereof . the housing 14 of the mask 10 further defines an internal valve chamber 32 which fluidly communicates with the cross passage 26 . as further seen in fig3 and 4 , disposed at the junction between the cross passage 26 and valve chamber 32 is a tubular projection 34 of the housing 14 . the projection 34 defines an annular distal rim or seating surface 36 which is used in the operation of the valve 12 in manner which will be described in more detail below . the projection 34 protrudes into the valve chamber 32 , and defines the conduit which places the valve chamber 32 into fluid communication with the cross passage 26 . as best seen in fig3 and 4 , the valve chamber 32 is defined in large measure by a valve wall 38 of the housing 14 which is generally oriented between the flow passages 16 , 18 thereof and , when viewed from the perspective shown in fig1 - 4 , is disposed below the cross passage 26 . as is also apparent from fig1 and 2 , the valve wall 38 has a perforated construction , thus facilitating the fluid communication between the valve chamber 32 partially defined thereby and ambient air . in the mask 10 , the end of the valve chamber 32 disposed furthest from the cross passage 26 is enclosed by a valve cap 40 which may be removably attached or permanently attached to the distal portion or rim of the valve wall 38 in the manner best seen in fig3 . the valve cap 40 includes a pilot port 42 which , when the valve cap 40 is coupled to the valve wall 38 , is placed into fluid communication with the valve chamber 32 . the pilot port 42 is partially defined by and extends axially through a generally cylindrical connector 44 of the valve cap 40 . as best seen in fig3 and 4 , one end of the pilot port 42 is disposed within a generally planar base surface 46 defined by the valve cap 40 . in addition to the base surface 46 , the valve cap 40 defines a continuous shoulder 48 which , from the perspective shown in fig4 , is elevated above the base surface 46 . this embodiment shows a pneumatically piloted diaphragm ; it is additionally contemplated that the valve 12 can be driven in an electromechanical manner ( e . g ., with an electromagnet instead of using the above mentioned pilot port 42 ). the mask 10 of the present invention further comprises a diaphragm 50 which resides within the valve chamber 32 . although various configurations of diaphragms 50 are contemplated herein , as is also best seen in fig3 and 4 , the diaphragm 50 has an enlarged , central main body portion 52 , and a peripheral flange portion 54 which is integrally connected to and circumvents the main body portion 52 . the flange portion 54 includes an arcuately contoured central region which is oriented between the distal region thereof and the main body portion 52 , and defines a continuous , generally concave channel 56 . the diaphragm 50 is preferably fabricated from a suitable resilient material . in the mask 10 , the distal region of the flange portion 54 of the diaphragm 50 which is disposed outward of the arcuate central region thereof is normally captured between the valve cap 40 and the valve wall 38 when the valve cap 40 is operatively engaged to the valve wall 38 . more particularly , as seen in fig3 , the distal region of the flange portion 54 is compressed and thus captured between the shoulder 48 of the valve cap 40 and a lip portion 58 of the valve wall 38 which protrudes inwardly from the inner surface thereof . the diaphragm 50 is preferably sized such that when the distal region of the flange portion 54 thereof is captured between the shoulder 48 and lip portion 58 in the aforementioned manner , the arcuate central region of the flange portion 54 is disposed directly adjacent the inner peripheral surface of the lip portion 58 . additionally , the channel 56 defined by the flange portion 54 is directed toward and thus faces the base surface 46 of the valve cap 40 . in the mask 10 , the diaphragm 50 effectively segregates the valve chamber 32 into a patient side or region 32 a , and a pilot side or region 32 b . more particularly , due to the aforementioned manner in which the diaphragm 50 is captured between the valve cap 40 and the valve wall 38 , the patient and pilot regions 32 a , 32 b of the valve chamber 32 are separated from each other by the diaphragm 50 , and are of differing volumes . along these lines , the fluid conduit defined by the projection 34 communicates directly with the patient region 32 a of the valve chamber 32 , while the pilot port 42 defined by the connector 44 communicates directly with the pilot region 32 b of the valve chamber 32 . the diaphragm 50 ( and hence the valve 12 ) is selectively moveable between an open position ( shown in fig3 ) and a closed position . importantly , in either of its open or closed positions , the diaphragm 50 is not seated directly against the base surface 46 of the valve cap 40 . rather , a gap is normally maintained therebetween . as seen in fig3 , the width of such gap when the diaphragm 50 is in its open position is generally equal to the fixed distance separating the base surface 46 of the valve cap 40 from the shoulder 48 thereof . when the diaphragm 50 is in its open position , it is also disposed in spaced relation to the projection 34 of the housing 14 , and in particular the seating surface 36 defined thereby . as such , when the diaphragm 50 is in its open position , fluid is able to freely pass between the flow passages 16 , 18 and ambient air via the cross passage 26 , the flow conduit defined by the projection 34 , and the perforated openings within the valve wall 38 partially defining the valve chamber 32 . the diaphragm 50 may be resiliently deformable from its open position ( to which it may be normally biased ) to its closed position . it is an important feature of the present invention that the diaphragm 50 is normally biased in its open position which provides a fail safe to allow a patient to inhale ambient air through the valve and exhale ambient air through the valve even during any ventilator malfunction . when moved or actuated to the closed position , the main body portion 52 of the diaphragm 50 is firmly seated against the seating surface 36 defined by the projection 34 , thus effectively blocking fluid communication between the cross passage 26 ( and hence the flow passages 16 , 18 ) and the valve chamber 32 . more particularly , when viewed from the perspective shown in fig3 , the peripheral region of the top surface of the main body portion 52 is seated against the seating surface 36 , with a central region of the top surface of the main body portion 52 protruding slightly into the interior of the projection 34 , i . e ., the fluid conduit defined by the projection 34 . as is apparent from the foregoing description , in the mask 10 , the valve 12 thereof is collectively defined by the projection 34 , valve wall 38 , valve cap 40 and diaphragm 50 . additionally , in the mask 10 , it is contemplated that the valve 12 will be piloted , with the movement of the diaphragm 50 to the closed position as described above being facilitated by the introduction of positive fluid pressure into the gap normally defined between the diaphragm 50 and the base surface 46 via the pilot port 42 , i . e ., into the pilot region 32 b of the valve chamber 32 . in this regard , it is contemplated that during the use of the mask 10 by a patient , a pilot fluid line ( not shown ) from a ventilator will be coupled to the connector 44 . it is also contemplated that during the inspiratory phase of the breathing cycle of the patient wearing the mask 10 , the fluid pressure level introduced into the pilot region 32 b of the valve chamber 32 via the pilot port 42 will be sufficient to facilitate the movement of the diaphragm 50 to its closed position . conversely , during the expiratory phase of the breathing cycle of the patient wearing the mask 10 , it is contemplated that the discontinuation of the fluid flow through the pilot port 42 , coupled with the resiliency of the diaphragm 50 , a biasing spring ( not shown ) operatively coupled to the main body portion 52 of the diaphragm 50 , and / or positive pressure applied to the main body portion 52 of the diaphragm 50 , will facilitate the movement of the diaphragm 50 back to the open position . as will be recognized , the movement of the diaphragm 50 to the open position allows the air exhaled from the patient to be vented to ambient air after entering the patient region 32 a of the valve chamber 32 via the perforated openings of the valve wall 38 communicating with the valve chamber 32 . as will be recognized , based upon the application of pilot pressure , the diaphragm 50 travels from a fully open position through a partially open position to a fully closed position . in this regard , the diaphragm 50 will be partially open or partially closed during exhalation to maintain desired ventilation therapy . additionally , a positive airway pressure can be controlled with any expiratory flow value by modulating the pilot pressure within the pilot region 32 b of the valve chamber 32 and hence the position of the diaphragm 50 . further , when pilot pressure is discontinued to the diaphragm , the diaphragm 50 moves to an open position wherein the patient can inhale and exhale through the mask with minimal restriction and with minimal carbon dioxide retention within the mask 10 . this is an important feature of the present invention which allows a patient to wear the mask 10 without ventilation therapy being applied to the mask such that the mask 10 is comfortable to wear and can be worn without carbon dioxide buildup . this feature is highly advantageous for the treatment of obstructive sleep apnea where patients complain of discomfort with ventilation therapy due to mask and pressure discomfort . when it is detected that a patient requires sleep apnea therapy , the ventilation therapy can be started ( i . e ., in an obstructive sleep apnea situation ). in this regard , the present invention contemplates a method of ventilation utilizing a mask wherein patient inhalation and patient exhalation is facilitated through the mask to ambient air when the ventilator is not delivering a therapeutic level of pressure . for instance , additional valving in the mask may be implemented for this purpose . since the mask does not facilitate co2 buildup , the ventilator can remain off while the mask is worn by the patient and ventilation therapy can be initiated upon sensing or detecting a patient requirement , such as sleep apnea therapy , by conventional sensors incorporated into the mask and ventilator . in this regard , conventional ventilators can be readily modified via conventional software changes to allow the mask to be worn without supplying pressure to the mask unless and until a patient requirement is sensed and subsequently communicated to the ventilator to provide necessary ventilation to the patient . such modification may additionally require the use of a conventional check valve to ensure that patient exhalation is facilitated through the exhalation valve on the mask and not back into the ventilator delivery circuit . as indicated above , in the embodiment shown in fig1 - 4 , the diaphragm 50 is pneumatically piloted , with the position thereof being regulated by selectively modulating the pilot pressure within the pilot region 32 b of the valve chamber 32 . however , it is contemplated that alternative modalities , such as an electromagnetic actuator , can be used to drive the valve 12 . for example , as also indicated above , in an alternative embodiment , the valve 12 may be driven in an electromechanical manner through the use of an electromagnet instead of using the above - described pilot port 42 . as indicated above , in the mask 10 , the valve cap 40 is releasably attached to the valve wall 38 of the housing 14 . as a result , the selective detachment of the valve cap 40 from the housing 14 allows for the removal of the diaphragm 50 from within the valve chamber 32 as permits the periodic cleaning or disinfection thereof . in addition , the detachment of the valve cap 40 from the valve wall 38 of the housing 14 also permits access to and the cleaning or disinfection of the interior surfaces of the valve chamber 32 . port 28 provides a means for pressure measurement inside the mask . referring now to fig5 - 9 , there is shown a nasal pillows mask 100 constructed in accordance with a second embodiment of the present invention . the mask 100 includes an integrated , flapper - implemented exhalation valve 112 , the structural and functional attributes of which will be described in more detail below . as seen in fig5 - 9 , the mask 100 comprises a housing 114 which defines first and second fluid flow passages 116 , 118 . as seen in fig8 and 9 , the flow passages 116 , 118 are formed within the housing 114 to have substantially identical shapes or contours . as with the first embodiment of this invention , a single flow passage is additionally expressly contemplated herein . in the mask 100 , one end of each of the flow passages 116 , 118 is defined by a respective one of an identically configured pair of generally cylindrical , tubular protrusions 120 a , 120 b of the housing 114 . the opposite end of each of the flow passages 116 , 118 is defined by a respective one of an identically configured pair of connector ports 122 a , 122 b of the housing 114 . the connector ports 122 a , 122 b are each sized and configured to accommodate the advancement and frictional retention of a distal end portion of a tubular fluid line 124 therein . as most apparent from fig8 and 9 , the operative engagement of a fluid line 124 to each of the connector portions 122 a , 122 b effectively places such fluid lines 124 into fluid communication with respective ones of the flow passages 116 , 118 . in the housing 114 , the spacing between the protrusions 120 a , 120 b is selected to facilitate the general alignment thereof with the nostrils of an adult patient when the mask 100 is worn by such patient . in the mask 100 , the flow passages 116 , 118 are not fluidly isolated from each other . rather , as seen in fig8 and 9 , the housing 114 further defines an optional cross passage 126 which extends between the protrusions 120 a , 120 b thereof , and effectively places the flow passages 116 , 118 into fluid communication with each other . the cross passage 126 is further placed into communication with ambient air by an identically configured pair of vent ports 128 which are fluidly coupled thereto . the vent ports 128 , which are disposed in side - by - side , spaced relation to each other , are formed within the housing 14 between the protrusions 120 a , 120 b thereof and , when viewed from the perspective shown in fig9 , face downwardly in a direction opposite that of the open distal ends of the protrusions 120 a , 120 b . as is best seen in fig8 and 9 , the protrusions 120 a , 120 b are preferably formed as separate and distinct components or sections of the housing 114 which , when mated to the remainder thereof , facilitate the formation of an identically configured pair of arcuate , semi - circular shoulders 130 a , 130 b . the shoulders 130 a , 130 b defined by the housing 114 are located within the interiors of respective ones of the protrusions 120 a , 120 b thereof . more particularly , each shoulder 130 a , 130 b is formed in close proximity to that end of the corresponding protrusion 120 a , 120 b disposed furthest from the open distal end thereof . the use of the shoulders 130 a , 130 b will be described in more detail below . in the mask 100 , the cross passage 126 is partially defined by one or more valve projections 132 a , 132 b of the housing 114 which are integrally connected to respective ones of the protrusions 120 a , 120 b , and protrude generally perpendicularly from the inner surfaces thereof in opposed relation to each other . as seen in fig6 , 8 , and 9 , the valve projections 132 a , 132 b are not sized to completely span or cover those portions of the flow passages 116 , 118 defined by the protrusions 120 a , 120 b . rather , each of the valve projections 132 a , 132 b is formed to define an arcuate peripheral edge segment , and sized such that the arcuate peripheral edge segment thereof is separated or spaced from the inner surface of the corresponding protrusion 120 a , 120 b by a gap which is of a prescribed width . further , as seen in fig6 and 8 , each of the valve projections 132 a , 132 b preferably includes a plurality of flow openings 134 disposed therein in a generally circular pattern . the flow openings 134 of the valve projections 132 a , 132 b each fluidly communicate with the cross passage 126 , and are used for purposed which will also be described in more detail below . the mask 100 of the present invention further comprises a flapper , which is preferably segregated into an identically configured pair of flapper segments 136 a , 136 b . the flapper segments 136 a , 136 b are each preferably fabricated from a suitable , resilient material . as seen in fig8 and 9 , the flapper segments 136 a , 136 b reside within the interiors of respective ones of the protrusions 120 a , 120 b . additionally , when viewed from the perspective shown in fig8 and 9 , an inner end portion of each of the flapper segments 136 a , 136 b is firmly secured to the housing 114 as a result of being captured between prescribed components or sections thereof . however , those portions of the flapper segments 136 a , 136 b not rigidly secured to the housing 114 are free to resiliently move relative thereto , in a manner which will be described in more detail below . the flapper segments 136 a , 136 b ( and hence the valve 112 ) are selectively moveable between a closed position ( shown in fig8 and 9 ) and an open position . when the flapper segments 136 a , 136 b are each in the open position , that portion of the peripheral edge thereof not secured to the housing 114 ( i . e ., not captured between separate sections of the housing 114 ) is normally seated against a corresponding one of the shoulders 130 a , 130 b . as a result , any fluid ( e . g ., air exhaled from the nose of a patient wearing the mask ) flowing into the flow passages 116 , 118 via the open distal ends of the protrusions 120 a , 120 b is vented to ambient air via the cross passage 126 and vent ports 128 . in this regard , such fluid is able to enter the cross passage 126 through the gaps defined between the valve projections 132 a , 132 b and inner surfaces of the corresponding protrusions 120 a , 120 b . the flapper segments 136 a , 136 b may be resiliently deformable from the open position described above ( to which they are normally biased ) to the closed position shown in fig8 and 9 . more particularly , when moved or actuated to the closed position , those portions of the flapper segments 136 a , 136 b not secured to the housing 114 are effectively placed into sealed contact with peripheral portions of respective ones of the valve projections 132 a , 132 b in a manner substantially covering or obstructing the opposed ends of the cross passage 126 fluidly communicating the flow passages 116 , 118 . however , even when the flapper segments 136 a , 136 b are in the closed position , some measure of fluid may still be vented from the flow passages 116 , 118 to ambient air by entering the cross passage 126 via the flow openings 134 included in each of the valve projections 132 a , 132 b . as is apparent from the foregoing description , in the mask 100 , the valve 112 thereof is collectively defined by the shoulders 130 a , 130 b , valve projections 132 a , 132 b , and flapper segments 136 a , 136 b of the flapper . additionally , in the mask 100 , it is contemplated that the flapper segments 136 a , 136 b will normally be biased to the open position . in this regard , it is contemplated that during the inspiratory phase of the breathing cycle of a patient using the mask 100 , positive fluid pressure introduced into the flow passages 116 , 118 by a ventilator fluidly coupled thereto via the fluid lines 124 will act against the flapper segments 136 a , 136 b in a manner facilitating the movement of such flapper segments 136 a , 136 b from their normally open position , to the closed position shown in fig8 and 9 . as a result , fluid is able to flow freely through the flow passages 116 , 118 into the patient &# 39 ; s nostrils , and is substantially prevented from being vented to ambient air via the cross passage 126 , except for a small portion of flow that passes through flow openings 134 . this small flow through flow openings 134 provides for a means to bleed off pressure and therefore more easily control the valve . conversely , during the expiratory phase of the breathing cycle of the patient wearing the mask 100 , it is contemplated that a reduction in the fluid pressure level introduced into the flow passages 116 , 118 from the fluid lines 124 to below a prescribed level will allow the flapper segments 136 a , 136 b to resiliently return to their normal , open positions engaging respective ones of the shoulders 130 a , 130 b . when the flapper segments 136 a , 136 b return to their open positions , air exhaled from the patient &# 39 ; s nostrils during the expiratory phase of the patient &# 39 ; s breathing circuit is vented to ambient air via the cross passage 126 and vent ports 128 . in this regard , though the movement of the flapper segments 136 a , 136 b to the open positions effectively blocks those portions of the flow passages 116 , 118 , air exhaled from the patient is able to flow through the gaps defined between the valve projections 132 a , 132 b and the inner surfaces of the protrusions 120 a , 120 b , and hence into the opposed open ends of the cross passage 126 . advantageously , the mask 100 constructed in accordance with the present invention has a total flow requirement which is much lower in comparison to that of a traditional vented pap mask . this provides the mask 100 with several advantages , including : reduced flow from the ventilator , and thus the ability to use smaller tubes ; a reduction in the conducted noise from the ventilator to ambient air through the open vent ports 128 in the mask 100 ; a reduction in oxygen consumption when required with the pap therapy due to lower flow requirements ; and a reduction in water consumption of a humidifier due to lower flow requirements . this disclosure provides exemplary embodiments of the present invention . the scope of the present invention is not limited by these exemplary embodiments . numerous variations , whether explicitly provided for by the specification or implied by the specification , such as variations in structure , dimension , type of material and manufacturing process may be implemented by one of skill in the art in view of this disclosure .
in accordance with the present invention , there is provided a mask for achieving positive pressure mechanical ventilation , and a method for a operating a ventilation system including such mask . the mask of the present invention includes a piloted exhalation valve that is used to achieve the target pressures / flows to the patient . the pilot for the valve may be pneumatic and driven from the gas supply tubing from the ventilator . the pilot may also be a preset pressure derived in the mask , a separate pneumatic line from the ventilator , or an electro - mechanical control . additionally , the valve can be implemented with a diaphragm or with a flapper .