Patent Publication Number: US-2015075530-A1

Title: Ventilation interface

Description:
FIELD OF THE INVENTION 
     This invention relates generally to the field of respiration or breathing assist masks. In particular, the invention relates to respiration or breathing assist masks utilizing both the nose and mouth. 
     BACKGROUND 
     Obstructive sleep apnea syndrome (commonly referred to as obstructive sleep apnea, sleep apnea syndrome, and/or sleep apnea) is a medical condition that includes repeated, prolonged episodes of cessation of breathing during sleep. During a period of wakefulness, the muscles of the upper part of the throat passage of an individual keep the passage open, thereby permitting an adequate amount of oxygen to flow into the lungs. During sleep, the throat passage tends to narrow due to the relaxation of the muscles. In those individuals having a relatively normal-sized throat passage, the narrowed throat passage remains open enough to permit the adequate amount of oxygen to flow into the lungs. However, in those individuals having a relatively smaller-sized throat passage, the narrowed throat passage prohibits the adequate amount of oxygen from flowing into the lungs. Additionally, a nasal obstruction, such as a relatively large tongue, and/or certain shapes of the palate and/or the jaw of the individual, further prohibit the adequate amount of oxygen from flowing into the lungs. 
     An individual having the above-discussed conditions can stop breathing for one or more prolonged periods of time (e.g. ten seconds or more). The prolonged periods of time during which breathing is stopped, or apneas, are generally followed by sudden reflexive attempts to breathe. The reflexive attempts to breathe are generally accompanied by a change from a relatively deeper stage of sleep to a relatively lighter stage of sleep. As a result, the individual suffering from obstructive sleep apnea syndrome generally experiences fragmented sleep that is not restful. The fragmented sleep results in one or more of excessive and/or inappropriate daytime drowsiness, headache, weight gain or loss, limited attention span, memory loss, poor judgment, personality changes, lethargy, inability to maintain concentration, and/or depression. 
     Other medical conditions can also prevent individuals, including adults and infants, from receiving the adequate amount of oxygen into the lungs. For example, an infant who is born prematurely can have lungs that are not developed to an extent necessary to receive the adequate amount of oxygen. Further, prior to, during and/or subsequent to certain medical procedures and/or medical treatments, an individual can be unable to receive the adequate amount of oxygen. Under these circumstances, it is known to use a ventilation interface to apply a positive pressure to the throat of the individual, thereby permitting the adequate amount of oxygen to flow into the lungs. In the known ventilation interface, oxygen and/or room air containing oxygen is delivered through the mouth and/or nose of the individual. Existing types of positive pressure applied by the known ventilation interface include continuous positive airway pressure (CPAP), in which a positive pressure is maintained in the throat passage throughout a respiratory cycle, bi-level positive airway pressure (BiPAP), in which a relatively high positive pressure is maintained during inspiration and a relatively low positive pressure is maintained during expiration, and intermittent mechanical positive pressure ventilation (IPPV) in which a positive pressure is applied when apnea is sensed (I.e., the positive airway pressure is applied intermittently or non-continuously). 
     One conventional ventilation interface for the application of positive pressure includes a face mask that covers both the nose and the mouth. See, for example, U.S. Pat. Nos. 4,263,212 to Mizerak and 6,123,071 to Berthon-Jones et al. Other face masks include configurations that cover only the nose or only the mouth. Standard masks have air supplied under pressure and use headgear or harnesses configured at least with what is referred to as a lip strap, thereby preventing air from escaping from the user&#39;s mouth. Such a strap is positioned level the patient&#39;s lips and wasp circumferentially around the patient&#39;s head from one side of the mask to the other. To keep the supply of positive gas pressure and to maintain the required seal that prevents the gas supply from leaking, a force must be applied to the head of the individual. As a result, the harness is generally uncomfortable to wear, particularly when sleeping. The applied pressure often results in undesirable irritation and sores caused by movement of the mask and harness during periods of both wakefulness and sleep. Further, the required seal is generally difficult to maintain when the mask and harness is moved. 
     The force that the harness applied to the mask against the face also applies an undesirable pressure to the sinus area adjacent to the nose, causing the nasal sinus airways to narrow. This narrowing causes an increase in the velocity of flow through the upper anatomical airways and a decrease in the lateral pressure against the nasal mucosal wall. Additionally, if the tubing between the mask and the gas supply unit folds undesirably, this problem will be exacerbated. The above-discussed combination of increased flow velocity and decreased pressure results in the removal of moisture form the mucosal walls during inspiration and may cause an undesirable drying and a burning sensation within the nares. As a result, the individual may remove the mask to alleviate these discomforts, consequently discontinuing the beneficial application of the positive pressure. Such increased air flow velocity and decreased pressure deteriorate the laminar flow between the air input and output portions of the conventional mask. 
     A common complaint of a patient regarding ventilation masks is that they cause claustrophobia. Such masks have large headgear that wrap around the entirety of the user&#39;s head and cover a significant area of the face including the periphery of both the nose and the mouth. Additionally such masks have a large amount of dead space within the mask where gas can be re-breathed by a patient, and a large area against the face of a user that must be sealed against the mask. 
     SUMMARY 
     In one exemplary embodiment, a respiration assist mask is disclosed. The respiration assist mask may include a ventilation interface. A cushion may be connected to the ventilation interface and the cushion may have one or more openings designed to receive one or more inputs. Additionally, the respiration assist mask may have at least one nasal pillow that may be adjustably coupled to the cushion. 
     In another exemplary embodiment, a method of providing respiration assistance is disclosed. The method may include coupling at least one nasal pillow with at least one flange with a cushion having at least one flange. Additionally, the cushion may be coupled to a ventilation interface. Further, breathable gas may be provided to the ventilation interface. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  shows an exploded view of an exemplary embodiment of the invention. 
         FIG. 2  shows a side perspective view of an exemplary embodiment of the invention. 
         FIG. 3  shows a front view of an exemplary embodiment of the invention. 
         FIG. 4  shows a back view of an exemplary embodiment of the invention. 
         FIG. 5  shows a top view of an exemplary embodiment of the invention. 
         FIG. 6  shows a bottom view of an exemplary embodiment of the invention. 
         FIG. 7  shows a right side view of an exemplary embodiment of the invention. 
         FIG. 8  shows a left side view of an exemplary embodiment of the invention. 
         FIG. 9  shows a top-down view of an exemplary embodiment of the invention. 
         FIG. 10  shows a rotated top-down view of an exemplary embodiment of the invention. 
         FIG. 11  shows a bottom-up view of an exemplary embodiment of the invention. 
         FIG. 12  shows a side view of an exemplary embodiment of the invention. 
         FIG. 13  shows a front view of an exemplary embodiment of the invention. 
         FIG. 14  shows cut out views of membranes in another exemplary embodiment of the invention. 
         FIG. 15  shows cut out view of membranes in another exemplary embodiment of the invention. 
         FIG. 16  shows a top-down view of an exemplary embodiment of the invention. 
         FIG. 17  shows a rotated top-down view of an exemplary embodiment of the invention. 
         FIG. 18  shows a bottom-up view of an exemplary embodiment of the invention. 
         FIG. 19  shows a side view of an exemplary embodiment of the invention. 
         FIG. 20  shows a front view of an exemplary embodiment of the invention. 
         FIG. 21  shows cut out views of membranes in another exemplary embodiment of the invention. 
         FIG. 22  shows cut out view of membranes in another exemplary embodiment of the invention. 
         FIG. 23  shows an exemplary view of a pair of nasal pillows 
         FIG. 24  shows an exemplary rotated view of a pair of nasal pillows. 
         FIG. 25  shows an exemplary rotated view of a pair of nasal pillows. 
         FIG. 26  shows an exemplary perspective view of a nasal pillow. 
         FIG. 27  shows an exemplary cross sectional view of a nasal pillow. 
         FIG. 28  shows an exemplary rotated view of a pair of nasal pillows. 
         FIG. 29  shows an exemplary top-down view of a nasal pillow. 
         FIG. 30  shows an exemplary side view of a nasal pillow. 
         FIG. 31  shows an exemplary bottom-up view of a nasal pillow. 
         FIG. 32  shows an exemplary side view of a nasal pillow. 
         FIG. 33  shows an exemplary rotated view of a nasal pillow. 
         FIG. 34A  shows an exemplary cross-sectional view of a pair of nasal cushions. 
         FIG. 34B  shows an exemplary cross-sectional view of a pair of nasal cushions. 
         FIG. 35A  shows an exemplary view of a cushioned interface having adjustable nasal pillows. 
         FIG. 35B  shows an exemplary cross-sectional view of a cushioned interface having adjustable nasal pillows 
         FIG. 35C  shows an exemplary cross-sectional view of a cushioned interface having adjustable nasal pillows. 
         FIG. 36A  shows an exemplary cross-sectional view of an adjustable nasal pillow for a ventilation interface. 
         FIG. 36B  shows an exemplary cross-sectional view of an adjustable nasal pillow for a ventilation interface. 
         FIG. 37A  shows an exemplary view of a cushion for a ventilation interface having adjustable nasal pillows. 
         FIG. 37B  shows an exemplary cross-sectional view of a cushion for a ventilation interface having adjustable nasal pillows. 
         FIG. 37C  shows an exemplary cross-sectional view of a cushion for a ventilation interface having adjustable nasal pillows. 
         FIG. 38  shows an exemplary view of a cushion for a ventilation interface having adjustable nasal pillows. 
         FIG. 39  shows an exemplary view of a cushion for a ventilation interface having adjustable nasal pillows. 
         FIG. 40  shows an exemplary view of a cushion for a ventilation interface having adjustable nasal pillows. 
         FIG. 41A  shows an exemplary view of a ventilation interface having adjustable nasal pillows. 
         FIG. 41B  shows an exemplary perspective view of a ventilation interface having adjustable nasal pillows. 
         FIG. 41C  shows an exemplary cross-sectional view of a ventilation interface having adjustable nasal pillows. 
         FIG. 42  shows an exemplary view of a ventilation interface having adjustable nasal pillows. 
         FIG. 43A  shows an exemplary view of a ventilation interface having adjustable nasal pillows. 
         FIG. 43B  shows an exemplary cross-sectional view of a ventilation interface having adjustable nasal pillows. 
         FIG. 44A  shows an exemplary view of a ventilation interface having adjustable nasal pillows. 
         FIG. 44B  shows an exemplary cross-sectional view of a ventilation interface having adjustable nasal pillows. 
         FIG. 44C  shows an exemplary cross-sectional view of a ventilation interface having adjustable nasal pillows. 
         FIG. 45A  shows an exemplary view of a ventilation interface having adjustable nasal pillows. 
         FIG. 45B  shows an exemplary cross-sectional view of a ventilation interface having adjustable nasal pillows. 
     
    
    
     DETAILED DESCRIPTION 
     Aspects of the invention are disclosed in the following description and related drawings directed to specific embodiments of the invention. Alternate embodiments may be devised without departing from the spirit or the scope of the invention. Additionally, well-known elements of exemplary embodiments of the invention will not be described in detail or will be omitted so as not to obscure the relevant details of the invention. Further, to facilitate an understanding of the description discussion of several terms used herein follows. 
     The word “exemplary” is used herein to mean “serving as an example, instance, or illustration.” Any embodiment described herein as “exemplary” is not necessarily to be construed as preferred or advantageous over other embodiments. Likewise, the term “embodiments of the invention” does not require that all embodiments of the invention include the discussed feature, advantage or mode of operation. 
     Generally referring to  FIGS. 1-8 , a ventilation interface mask is disclosed. The interface may be used for a variety of purposes, for example providing continuous positive airway pressure to a user. The ventilation interface may alleviate concerns some users have by being small than other types of ventilation masks and by eliminating portions of the mask that fit over the nose of a user. Additionally, by eliminating the portions of a mask that fit over the nose of a user, less sealing is required against the face of a user. Also, the small size of the ventilation interface reduces the amount of space on the interior of the mask, thus resulting in less gas to exhaust and a decreased amount of gas that is breathed more than once. 
       FIG. 1  shows an exploded view of an exemplary embodiment of a respiration assist mask. Respiration assist mask  2  may have several separable components, such as ventilation interface  4 , cushioned facial interface  6 , nasal inserts  8  and  9 , and gas supply tube  10 . In one embodiment of the invention, supply tube  10  may be connected to ventilation interface  4  in order for input gas may be supplied to the device. In a further embodiment, facial interface  6  may be joined with ventilation interface  4 . Ventilation interface  4  may also accept nasal inserts  8  through receiving holes  12  and  14 . The respiration assist mask  2  may then be positioned over the mouth of a user such that facial interface  6  forms an airtight seal over the mouth of the user. Additionally, in a further embodiment, facial interface  6  may form a seal against the upper and lower lips of the user. When respiration assist mask  2  is positioned over the mouth of a user, the user may insert nasal inserts  8  and  9  into the nares of a user. When nasal inserts  8  and  9  are inserted into the nares of a user, an airtight seal may be formed. 
     In another exemplary embodiment, nasal inserts  8  and  9  may be formed in a variety of shapes, for example the volcano style shown in  FIG. 1 . Additionally, any size or shape nasal insert that fits into the nares of a user and optionally provides an airtight seal may be used with respiration assist mask  2 . Nasal inserts may be formed from any suitable material, for example silicone. In a further embodiment, nasal inserts  8  and  9  may be connected by connector  16 . Connector  16  may be formed out of any material and is, optionally, formed out of the same material as the nasal inserts. Connector  16  can also be separable from nasal inserts  8  and  9 , or, in a different embodiment, nasal inserts  8  and  9  can be formed without a connector. If connector  16  is fitted to nasal inserts  8  and  9 , it may function to prevent the rotation of nasal inserts  8  and  9  when they are engaged on facial interface  6  in receiving holes  12  and  14 , respectively. Additionally, connector  16  may act to retain nasal inserts  8  and  9  in a desired position. Alternatively, connector  16  may be removed to allow for rotation of nasal inserts  8  and  9  in receiving holes  12  and  14 , respectively. Further, if connector  16  is removed, two different size nasal inserts may used and attached to respiration assist mask  2  if it is needed or desired by a user. 
     In another embodiment shown in  FIG. 1 , nasal inserts  8  and  9  may be formed with elliptical distal ends  18  and  20 , respectively. Elliptical ends  18  and  20  may be formed so as to provide comfortable and airtight seals within the nares of a user. Connector  16  may be positioned on nasal inserts  8  and  9  so as to hold nasal inserts  8  and  9  in a position which provides a comfortable and airtight seal in the nares of the user. 
     In yet another embodiment shown in  FIG. 1 , facial interface  6  may provide an airtight seal against the face of a user. Additionally, facial interface  6  may act as a cushion against the face of a user. Similar to the removable cushion disclosed in U.S. Pat. No. 6,595,214 (the &#39;214 patent), which was incorporated by reference into Provisional U.S. Patent Application No. 60/634,188 to which priority is claimed, facial interface  6  may act as a removable cushion that attaches to a ventilation interface. Facial interface  6  may also act to form a seal against an upper and/or lower lip of a user. 
     Additionally, facial interface  6  may include chin flap  22 . When respiration assist mask  2  is placed on the face of a user, chin flap  22  may be positioned under the chin of the user. In one embodiment, chin flap  22  may provide additional sealing against the face of a user. Additionally, in another embodiment, chin flap  22  may act to provide additional comfort for a user. In a further embodiment, chin flap  22  can act to limit the movement of the lower jaw of a user. 
     In yet a further embodiment shown in  FIG. 1 , facial interface  6  may have multiple membranes  24   a ,  24   b  and  24   c  (collectively membranes  24 ). Membranes  24  may serve to provide additional seals against the face of a user. For example, membranes  24 , and specifically membrane  24   a , may seal against an upper and/or lower lip of a user who is wearing respiration assist mask  2 . In this exemplary embodiment, membrane  24   a  may be formed to be thinner than membrane  24   b . Thus, membrane  24   a  can adhere to facial contours and fill small facial gaps as it can be a thin, flexible material. Additionally, membrane  24   b  may be thicker than membrane  24   a  to provide auxiliary sealing against the face of a user and provide structural support for the device. For example, membrane  24   a  may be made of any suitable material, for example silicone, and may be approximately 0.020″ thick. Membrane  24   b  may also be made of any suitable material, for example silicone, and have a thickness of approximately 0.050″. Still other parts of facial interface  6 , for example  24   c , may have a thickness of approximately 0.100″. This thickness may extend around the periphery of that portion of the device. 
     Also, membranes  24  may work in conjunction with chin flap  22  to provide additional sealing capabilities. As stated previously, in one embodiment, chin flap  22  may act to limit the movement of the lower jaw of a user. In a further embodiment, chin flap  22  may have some elasticity which allows a user wearing respiration assist mask  2  to move their jaw and, for example, open their mouth. In the event of this happening, membrane  24   a , which also may be elastic, may stretch upper portion of the lower jaw of the user, thus maintaining the seal between the interface and a wearer&#39;s face. Membrane  24   b , which may also be elastic, may then stretch against the bottom portion of the mouth of the user, thus maintaining an airtight seal between facial interface  6  and the face of a user. 
     Moreover, in a further exemplary embodiment of the invention, movement of the lower jaw of a user will not break the airtight seal of respiration assist mask  2  against the face of a user or dislodge the nasal inserts which may be positioned against the nares of a user. In this embodiment, when the mouth of a user wearing the mask opens, chin flap  22  allows facial interface  6  to stretch. For example, if a user were to open their mouth, the lower jaw of the user would move against chin flap  22 , but remain in contact with chin flap  22  as it stretches. Thus, when facial interface  6  stretches, membranes  24  remain sealed against the moving face of the user. 
     In another embodiment shown in  FIG. 1 , facial interface  6  may have contoured surfaces around receiving holes  12  and  14 . These contoured surfaces may work in conjunction with flange  26  of nasal insert  8  and flange  28  of nasal insert  9 . Contoured surface  30  and contoured surface  32  may act to hold nasal insert  8  and nasal insert  9 , respectively, in a position that allows for an airtight seal to be formed between the nasal inserts and the nares of a user wearing respiration assist mask  2 . Also, contoured surfaces  30  and  32  may act to provide an airtight seal between nasal inserts  8  and  9 , respectively and facial interface  6 . In a further embodiment, contoured surfaces  30  and  32  can act to angle nasal inserts  8  and  9 , respectively, towards each other and thus orientate them to be better received into the nares of a user. 
     In another exemplary embodiment shown in  FIG. 1 , auxiliary ports  34  and  36  may be positioned on ventilation interface  4 . Auxiliary ports  34  and  36  may be positioned on an upper portion of interface  4  and may project outwardly. Additionally, when they are not being otherwise utilized, auxiliary ports  34  and  36  may be capped with coverings  38  and  40 , respectively. Auxiliary ports may be used, for example, to connect to outside devices for the purposes of measuring oxygen or carbon dioxide levels, pressure, or to connect to any other outside device to provide measurements, readings or additional inputs. Alternatively, auxiliary ports  34  and  36  may be utilized as exhaust ports to release gas from the interior portion of ventilation interface  4 . Removable coverings  38  and  40  may act to prevent the release of gas from respiration assist mask  2  and maintain the airtight seal within the device when. 
     Ventilation interface  4  may also have a design such that it can accept and seal with cushioned facial interfaces of various sizes. In one exemplary embodiment, cushioned facial interface  6  may be made to have different size or shape cushions or have a different sealing area. Different size facial interfaces may maintain a similar size or shape membrane to connect with ventilation interface  4 , however. In other embodiments, different size facial interfaces may be made out of a material that stretches, so as to allow for an airtight seal to be formed between varying sizes of facial interface and ventilation interface  4 . 
       FIG. 1  also shows input gas tube  10 , which may be formed in an elbow shape or any other shape which may attach to ventilation interface  4 . Input gas tube may be used to deliver any type of gas or aerosol and may be used in any type of respiration application, such as CPAP or BiPAP applications. Input gas tube  10  may have connection portion  42  which can be used to connect input gas tube  10  to ventilation interface  4  through the use of receiving hole  48 . Connection portion  42  may be threading, allowing input gas tube  10  to be screwed into receiving hole  48  or any other connection and sealing mechanism, such as a clip or a clasp. Input gas tube  10  may also have valve  44  disposed on its surface. Valve  44  may be coupled with a flap, held in place by connector  46 , which is closed in an airtight seal when ventilation gas is being passed through input gas tube  10 . However, if there is no gas being inputted through tube  10 , the flap will open, allowing outside air to enter respiration assist mask  2 . 
     In another embodiment of the invention, the device may be worn on the face of a user with any of a variety of types of headgear. The headgear may attach to respiration assist mask  2  through the use of headgear attachment posts  50 . Attachment posts  50  may be positioned at various portions of ventilation interface  4 , for example at the top and bottom of either side face  4 . In a further embodiment, the headgear may have female connectors that allow for the headgear to be securely fastened to male attachment posts  50 . In a different embodiment, the headgear may have looped ends that securely fit around attachment posts  50 . Additionally, any other known type of attachments or posts may be used to securely attach headgear to respiration assist mask  2  in such as manner as to provide for the comfort of a user and allow for an airtight seal to be formed between the face of a user and respiration assist mask  2 . 
       FIG. 2  shows another exemplary embodiment where the components of the device are joined together. In this embodiment, gas input tube  10  may be securely connected to ventilation interface  4  through any of the methods mentioned previously. Additionally, tube  10  may be secured to face  4  to provide an airtight seal between the tube and the face, but it may be rotatably engaged to the face. Thus input gas tube  10  may be rotated so that a feed tube that may, optionally, be connected to input gas tube  10  can be mounted in any location or position and continue to supply input gas to respiration assist mask  2 . 
       FIG. 2  also shows how ventilation interface  4  can be connected to facial interface  6 . The mating of these two devices can create an airtight seal between face  4  and connector  6 . Additionally, any known method of connecting the two components may be utilized, such as tongue in groove, clasps, clips or the like. Connector  6  may also serve to enhance the structural rigidity of respiration assist mask  2 . For example, the top portion and side portions of connector  6  may be thicker than other portions of connector  6 . This can allow for stabilization of nasal inserts  8  and  9  when they are joined with connector  6 . Further, this may prevent fore and aft movement as well as lateral movement of nasal inserts  8  and  9  when they are joined with connector  6 , and may also act to enhance the seal between the nasal inserts  8  and  9  and connector  6 . 
     In a further embodiment shown in  FIG. 2 , nasal inserts  8  and  9  are shown connected to facial interface  6  through the use of receiving holes  12  and  14 . This connection may also form an airtight seal between nasal inserts  8  and  9  and facial interface  6 . 
     The assembled respiration assist mask  2  shown in  FIG. 2  may be joined to provide airtight seals between each of the components. Additionally, when the device is positioned on the face of a user, an airtight seal may exist between the interior portion of respiration assist mask  2  and the face of the user. 
     In a further embodiment of the invention, exhaust ports  52  may be disposed on the face of respiration assist mask  2 . In one exemplary embodiment, a series of exhaust ports  52  may be formed on the surface of ventilation interface  4 . These ports  52  may be utilized to release or output carbon dioxide that is exhaled by a user wearing the mask. In an alternative embodiment, the exhaust ports may protrude from ventilation interface  4 . In another embodiment, a different number of exhaust ports that may be larger or smaller may be utilized on ventilation interface  4 . In yet another embodiment, one or more exhaust ports have adjustable apertures or adjustable flow rates may be disposed on ventilation interface  4 . In still another embodiment, exhaust ports  52  may be capable of being capped or sealed from the interior or exterior of ventilation interface  4  so as to vary the flow rate of exhaust gases. In another exemplary embodiment, exhaust ports  52  may be disposed on any location of ventilation interface  4 . 
     In a further embodiment shown in  FIGS. 3 and 4 , facial interface  6  may have an upper portion that is positioned against the upper lip of a user. For example, upper portion  6   a  of facial interface  6  may rest snugly against the upper lip of a user when respiration assist mask  2  is being worn. Upper portion  6   a  may act to create an airtight seal between the upper lip of a user wearing the device and connector  6 . Additionally, upper portion  6   a  may act as an anchor portion for respiration assist mask  2  when it is being worn by a user. Thus if a user, for example, opens their mouth and moves their lower jaw while wearing the device, upper portion  6   a  of connector  6  will anchor respiration assist mask  2  on the face of the user to prevent it from being dislodged, which could potentially cause a break in the airtight seal between respiration assist mask  2  and the face of a user. Further, when upper portion  6   a  acts as an anchor, it may prevent forces on chin flap  22  caused by jaw or mouth movement of a user wearing the device from affecting the positioning and sealing of nasal inserts  8  and  9 , which may be inserted into the nares of a user wearing the device. In this embodiment, stress exerted elsewhere on respiration assist mask  2  will not be translated into movement of nasal inserts  8  and  9  within the nares of a user and can prevent the dislodging of the nasal inserts from the nares. 
     In another embodiment of the invention shown in  FIG. 4 , upper portion  6   a  may also prevent movement of nasal inserts  8  and  9  when respiration assist mask  2  is worn or adjusted by a user. For example, if respiration assist mask  2  is worn on the face of a user through the use of headgear attached to posts  50 , the user will likely need or desire to adjust the headgear so as to have comfort while ensuring the device is positioned properly. In previous devices having nasal inserts, the tightening of headgear on the head of a user would likely cause articulation and movement apart of the nasal inserts as the device onto which the nasal inserts was mounted stretched as the headgear was tightened. This articulation and movement can cause discomfort for a user and may dislodge the nasal inserts from the nares of a user. In this embodiment, however, upper portion  6   a  of connector  6  acts as an anchor for respiration assist mask  2  because it is positioned against the upper lip of a wearer to create a seal. Therefore any forces acting upon respiration assist mask  2  by the use or tightening of headgear will be absorbed by upper portion  6   a  of connector  6 , rather than by nasal inserts  8  and  9 . Thus, the comfort of a user wearing the device can be enhanced and there is a reduced possibility of nasal inserts  8  and  9  being moved within the nares of a user or dislodged, causing a break in the seal. 
       FIG. 5  shows a top down view of another embodiment of the invention. In this embodiment, nasal inserts  8  and  9  are shown as being angled towards each other. In other embodiments, nasal inserts  8  and  9  may be angled or orientated differently depending on the fitting required or desired by a user. Additionally, hole  54  on nasal insert  8  and hole  56  on nasal insert  9  may be elliptical. Other sizes and shapes of the holes may be utilized depending on the application and wearer of ventilation interface  2 . 
       FIG. 6  shows a bottom up view of a different embodiment of the invention. This embodiment provides a bottom perspective facial interface  6  and chin flap  22 . Additionally, one example of the placement of attachment posts  50  is shown.  FIG. 6  also demonstrates the seal and one possible way of joining facial interface  6  and ventilation interface  4  where facial interface  6  fits into ventilation interface  4  in a tongue-in-groove fashion. 
       FIGS. 7 and 8  show exemplary side views of the invention. In this embodiment, chin flap  22  on facial interface  6  extends beyond other portions of facial interface  6 . Additionally, interface connector may have shaped edges which can contour to the face of a user to better provide a seal against the face of the user.  FIGS. 7 and 8  also show auxiliary ports  34  and  36  as being disposed inside recessed or cut out portions of ventilation interface  4 . In other embodiments of the invention, auxiliary ports  34  and  36  may be disposed in an area on ventilation interface  4  that is not cut out or recessed. 
       FIGS. 9-22  show an exemplary embodiment of cushioned facial interface  6 . In this embodiment various membranes are shown as well as the difference between membranes. For example, the facial interface shown in  FIGS. 9-15  may be smaller than the facial interface shown in  FIGS. 16-22 . Despite any size differences in the facial interfaces, both may be used interchangeably with ventilation interface  2  and nasal inserts  8  and  9  without any alterations to those devices. Additionally, as shown in  FIGS. 14-15  and  21 - 22 , membrane  24   a  is shown as an outer membrane that is thinner than inner membrane  24   b . As discussed previously, membrane  24   a  can be made of any suitable material, such as silicone. As discussed above, membrane  24   a  is thin so as to be able to follow the contours of a user&#39;s face and provide a seal between facial interface  6  and the face of the user. Moreover, the thin membrane may be able to stretch in order to maintain a seal when the user&#39;s face moves, for example, such as when the user opens their mouth. Membrane  24   b  is shown as being thicker than membrane  24   a  and is also positioned inside membrane  24   a . Membrane  24   b  may also be made out of any suitable material, such as silicone, and, as discussed above, may be thicker to provide support on the inside of mask  2 . Membrane  24   b  may also serve to act as a “stop.” In other words, membrane  24   b  may limit the amount of movement a user may have while wearing the mask, for example, preventing the user from opening their mouth beyond a certain point. 
     Additionally, as shown in  FIG. 11 , the differences in the areas separating various membranes can be seen. As shown in  FIGS. 11 and 18 , the distance between membranes  24   a ,  24   b  and  24   c  is larger on axis A-A than it is on the E-E axis. The distance between membranes  24   a - c  on axis A-A can allow for increased user comfort and utility, as a seal can be made around the entire mouth of the user. Additionally, by having a seal around the entire mouth area, the structural rigidity of mask  2  can be increased. Further, because of the increased structural rigidity, a user may be able to tighten mask  2  on their face without causing flex in the central or peripheral portions of the mask which could lead to the seal between the user&#39;s face and the facial interface being broken. This membrane structure can also allow downward pressure to be exerted on nasal inserts  8  and  9  without dislodging nasal inserts  8  and/or  9  and without significantly deforming facial interface  6  so as to cause a break in the seal between the face of the user and facial interface  6 . 
     Referring generally to  FIGS. 23-44 , components of a ventilation interface that may be adjustable in various manners are disclosed. 
     An exemplary view of a pair of nasal pillows is shown in  FIG. 23 . The nasal pillows may be a connected pair or, in another exemplary embodiment, may be disposed separately. In this exemplary embodiment, a pair of nasal pillows is shown as having opening  62  at a distal end of a nasal pillow, as well as nasal insert portion  60 . Nasal insert portion  60  may flare out from opening  62  so as to provide a comfortable fit against the nares of a user. Additionally, connector  64  is shown as coupling a pair of nasal pillows. Connector  64  may be formed out of any soft or rigid material and may be attachable and detachable from one or both nasal pillows. 
       FIG. 24  is another exemplary view of a pair of nasal pillows. This exemplary embodiment shows flanges  68 ,  70 , and  72 , which may be disposed around a perimeter of a nasal pillow. Flanges  68 ,  70  and  72  may be inserted into a cushion associated with a ventilation interface, for example openings  12  and  14  of cushion  6 . The nasal pillows may be inserted into cushion  6  and provide a gas-tight seal between the cushion and the nasal pillows. Additionally, the nasal pillows may be inserted into cushion  6  and form a seal between flange  72  and cushion  6 , flange  70  and cushion  6  or flange  68  and cushion  6 . Thus, the height of the nasal pillows may be varied by a user to obtain a more beneficial height. In another exemplary embodiment, any number of additional flanges may be disposed on a nasal pillow, in additional to flanges  68 ,  70  and  72 , which can allow for a larger degree of adjustment to be obtained. Additionally, the size of the flanges and distance between the flanges may be varied, changed or adjusted, so as to provide additional adjustability. 
     In another exemplary embodiment shown in  FIG. 25 , a pair of nasal pillows is again shown. In this exemplary view, indented portion  74  of a nasal pillow is shown. Indented portion may act to compress when a nasal insert is inserted into the nares of a user. This compression may allow for better fitment and comfort of the nasal pillow as well as provide for an additional adjustment of height, depending on how the user inserts nasal insert portion  60 . Additionally, indented portion  74  can allow for lateral and fore and aft movement of the nasal pillow. Thus, comfort may be increased and additional adjustments may be made to the fitment of the nasal pillows. 
       FIG. 26  shows an exemplary view of a single nasal pillow. This nasal pillow may be separated from another nasal pillow through the removal of connector  64 . Additionally, a single nasal pillow of a first size may be pair with a second nasal pillow having a second size, thus allowing for additional levels of adjustment to be performed by a user.  FIG. 27  shows an exemplary cross sectional view of a single nasal pillow. From this view, an exemplary orientation of various flanges and grooves may be seen. For example, flanges  68 ,  70  and  72  appear in a rotated view as compared to  FIG. 24 . Additionally, grooves  66  and  67  may be seen in this cross-sectional view. Grooves  66  and  67  may act to slot into openings  12  and  14  of cushion  6 , for example. After grooves  66  and  67  are fitted into either opening  12  or  14 , flanges  68 ,  70  and  72  may act to provide a gas tight seal between the nasal pillow and cushion  6  and may use friction, or any manner of preventing movement, to hold a nasal pillow in a location or orientation that is desired by a user. 
       FIG. 28  shows an exemplary rotated view of a pair of nasal inserts. In this view is can be seen that indented portion  74  may again be compressed or expanded, depending on the fitment desired by a user. 
       FIG. 29  is an exemplary top-down view of a nasal pillow. This view allows for a view of opening  62 , which may be circular, oval, substantially circular, substantially oval, or any other shape. Additionally, nasal insert portion  60  may flare out of the perimeter of opening  62 , allowing for a user to insert the nasal pillow to a desired, function and comfortable depth. Nasal insert portion  60  may also act to provide a gas tight seal between a nasal pillow and the nares of a user.  FIG. 31  provides an exemplary bottom-up view of a nasal pillow. From this view it is shown that the bottom portion of a nasal pillow may be of a greater area than opening  62 . 
       FIGS. 30 ,  32  and  33  show additional exemplary embodiments of a nasal pillow. As shown in  FIG. 30 , indented portion  74  may be of a different diameter than in previous embodiments. This can allow for different degrees of adjustability, as a thinner indented portion  74  may allow for more fore and aft movement and more lateral movement. Additionally, a thinner indented portion  74  may allow for indented portion  74  to have a higher level of compression.  FIGS. 32 and 33  show another embodiment of a nasal pillow with different sized features. In one exemplary embodiment, opening  82  can be larger or smaller than that in previous embodiments. Additionally, nasal insert portion  84  can have a lesser slope or a greater slope from opening  82 , as well as different surface areas than previous embodiments. These different orientations of a nasal pillow may allow for the device to fit in the nares of various-sized nares. Additionally, it can allow for flexibility in using a first nasal pillow with a second nasal pillow, if a user has different sized nares. Additionally, indented portion  80  may also have a larger or smaller diameter than in previous embodiments. This, coupled with other larger or smaller features, may allow for a greater or lesser amount of gas flow through a ventilation interface and into the nares of a user. The gas flow provided to a user may be varied through the use of different sized nasal inserts and nasal pillows depending on the needs of that user. 
     In another embodiment of the invention shown in  FIG. 34 , different cushions may utilize different amount of flanges. For example, in  FIG. 34   a , opening  88  is shown with a singular flange  90 . Flange  90  may act to receive and seal with a nasal pillow having one or more flanges and which may or may not be adjustable in height. In  FIG. 34   b , multiple flanges  94  may act with opening  92  to receive a nasal pillow having one or more flanges. Flanges  94  can be used to adjust the height of a nasal pillow having a single flange or may be used with a nasal pillow having multiple flanges to provide a greater degree of vertical adjustability. Each portion of flanges  94  may individually act to couple and seal with a nasal pillow. In a further embodiment, any number of flanges may be disposed on cushion  86  and may provide for a varying amount of adjustability of a cushion, nasal pillow or spacer. 
       FIGS. 35   a - c  show yet another exemplary embodiment of a ventilation interface utilizing nasal pillows that may be adjusted. Here, as shown in  FIG. 35   a , nasal pillows  96  and  98  may have multiple flanges  100  and  102 , respectively. Flanges  100  and  102  may be used to couple nasal pillows  96  and  98 , respectively, to cushion  104 . Flanges  100  and  102  may couple with receiving flanges  106  and  108 , respectively, of cushion  104 . Receiving flanges  106  and  108  may be disposed on cushion  104  and may include any number of flanges. Additionally, receiving flanges  106  and  108  may be disposed on cushion  104  in any manner, for example molding, adhesion or any other manner known to one having ordinary skill in the art. 
     In one example shown in the cutaway view of  FIG. 35   b , nasal pillow  98  is shown as being coupled with cushion  104  through opening  112 . Here nasal pillow  98  may be in a raised position from cushion  104 , as the upper flange of flange  108  is used to couple pillow  98  with cushion  104 . In another exemplary embodiment shown in  FIG. 35   c , nasal pillow  98  is in a lower position relative to that shown in  FIG. 35   b . Here the lower flange of flange  108  may be used to couple pillow  98  with cushion  104 . In further exemplary embodiments, any number of flanges may be disposed on nasal pillows  96  or  98  and any number of receiving flanges  106  and  108  may be disposed on cushion  104 . Therefore, nasal pillows  96  and  98  may be vertically adjusted in a variety of manners and to any height desired by a user of the ventilation interface. 
     In one exemplary embodiment, shown in  FIG. 36 , one or more adjustable nasal pillows  114  and  116  may be configured to be disposed on a cushion. Each nasal pillow  114  and  116  may have a single assembly groove  118 , as shown in  FIG. 36A , or multiple assembly grooves  120 , as shown in  FIG. 36B . Each nasal pillow may fit into a cushion, which may have one or more flanges for receiving assembly groove  118  or assembly grooves  120 . Nasal pillows  114  and  116  may also have nasal insert portions  122  and  124 , as well as indented portions  126  and  128 . Finally, nasal pillows  114  and  116  may have openings  130  and  132 , which may be used to deliver breathable gas to the nares of a user. 
     In a further exemplary embodiment shown in  FIG. 37   a - c , one manner in which nasal pillows may be attached to a cushion is shown. In the exemplary embodiment of  FIG. 37   a , nasal pillows  134  and  136  may be configured to be attached to cushion  138 . Nasal pillows  134  and  136  may be inserted into openings  140  and  142 , respectively, on cushion  138 . Nasal pillows  134  and  136  may include flanges  144  and  146 , respectively, which act to join and seal the nasal pillows with cushion  138 . 
       FIGS. 37   b  and  37   c  show cross-sectional, views of the exemplary embodiment of  FIG. 37   a . In  FIG. 37   b , nasal pillow  134  is shown as separated from cushion  138 . Additionally, interior flanges  148  are shown inside flange  144 . Interior flanges  148  may interlock and seal with flanges and grooves  152  that are associated with opening  140 . Nasal pillow  136  is shown as being joined with cushion  138 . Nasal pillow  136  may use interior flanges  150  inside flange  146  to interlock and seal with flanges and grooves  154  of opening  142 . Nasal pillow  136  can be fitted in the lowest fitting position for this combination of flanges and grooves. However, any of a variety of different combinations of flanges and grooves may be utilized to provide varying degrees of adjustment.  FIG. 35   c  shows a further exemplary embodiment having nasal pillow  134  fitted in a low position and nasal pillow  136  fitted in a raised position. Here, nasal pillow  134  may be coupled with cushion  138 . In other exemplary embodiments, nasal pillow  134  may be either permanently or removably coupled with cushion  138 . Nasal pillow  134  can use interior flanges  148  inside flange  144  to interlock and seal with flanges and grooves  152  of opening  140 . Nasal pillow  136  can join with cushion  138  in a raised position. Nasal pillow  136  may use interior flanges  150  inside flange  146  to interlock and seal with upper flanges and grooves  154  of opening  142 . Other exemplary embodiments may use nasal pillows of varying sizes and may provide additional flanges to allow for different adjustments to be made to the height or orientation of the nasal pillows. 
     In another embodiment shown in  FIG. 38 , a spacer may also then be utilized in conjunction with both a nasal pillow and a cushion. In  FIG. 38 , a pair of nasal pillows, a pair of spacers and a cushion are shown. Nasal pillows  156  and  158  may be similar to those described in other embodiments and may have one or more flanges, for example  160  and  162 , respectively, disposed on a lower portion of each nasal pillow and allowing for varying degrees of adjustability with respect to cushion  164 . Each spacer  166  and  168  may have one or more flanges  170  and  172 , respectively. Flanges  170  and  172  may be disposed at varying locations on spacers  166  and  168 , respectively. Additionally, spacers  166  and  168  may be able to join with a nasal pillow and a cushion using flanges  170  and  172 , respectively. In the exemplary embodiment, spacer  166  may be separated from nasal pillow  156  and cushion  164 . Spacer  168 , however, can be either permanently or removably joined with both nasal pillow  158  and cushion  164 . In this example, nasal pillow  158  uses flanges  162  to couple with the upper flanges  172  of spacer  168 . A gas tight seal may be formed between nasal pillow  158  and spacer  168 . Additionally, spacer  168  may couple with cushion  164  in opening  176 . Lower flanges  172  of spacer  168  may be used to couple with the flange disposed at the edges of opening  176 , and a gas tight seal may be provided between the two. Also, the multiple flanges may allow the spacer to fit into the pillow and the cushion at different levels. For example, if a user of a cushion desires to move a pillow away from the cushion, they may utilize a top flange or flanges of a spacer. If a user of a cushion desires to move a pillow away from the cushion, for example, they may utilize a lower flange or flanges of a spacer. In the exemplary embodiment shown in  FIG. 38 , the lower portion of flange  172  is not shown as being utilized; thus a user could adjust nasal pillow  158  and spacer  168  vertically using flange  172  of spacer  168 . 
       FIG. 39  shows another exemplary embodiment of a pair of nasal pillows that are joined to a cushion using spacers. Similar to the embodiment shown in  FIG. 38 , nasal pillow  170  is shown in an exploded view and not connected to spacer  166  or cushion  164 . Nasal pillow  172  may again be connected to spacer  168  and cushion  164 . However, in this exemplary embodiment, nasal pillow  172  has been adjusted vertically. Here, the lower portion of flange  176  of nasal pillow  172  can be coupled with the upper portion of flange  172  of spacer  168 , as opposed to the exemplary embodiment shown in  FIG. 38 , where both flanges  176  of nasal pillow  172  were coupled to the two upper flanges  172  of spacer  168 . Thus, in the exemplary embodiment shown in  FIG. 39  nasal pillow  172  has been adjusted vertically when compared to nasal pillow  172  in  FIG. 38 . Additionally, pillow  172  in  FIG. 39  may be adjusted in any of a variety of different matters vertically. 
     Another exemplary embodiment of an adjustable nasal pillow is shown in  FIG. 40 . Similar to  FIGS. 37 and 38 , nasal pillow  170  is shown in an exploded view and not connected to spacer  166  or cushion  164 . Nasal pillow  172  may be connected to spacer  168  and cushion  164 . However, in this exemplary embodiment, nasal pillow  172  has again been adjusted vertically. Here, the lower portion of flange  176  of nasal pillow  172  may be coupled with the upper portion of flange  172  of spacer  168 , similar to the exemplary embodiment shown in  FIG. 39 . However, in  FIG. 40 , the bottom-most portion of flange  172  on spacer  168  can be used to couple spacer  168  to cushion  164 , using opening  176 . Thus, in the exemplary embodiment shown in  FIG. 40  nasal pillow  172  has again been adjusted vertically when compared to nasal pillow  172  in  FIG. 39 . Additionally, pillow  172  in  FIG. 40  may also be adjusted in any of a variety of different matters vertically. 
     In further exemplary embodiments of FIGS.  34  and  38 - 40 , a spacer (e.g.  166  or  168 ) used with a nasal pillow, such as  170  or  172 , may have one or more flanges located at varying distances from each other. The flanges may be formed at different distances for different spacers, allowing for variable adjustments to be made to the pillow and cushion. In another embodiment, the spacer may be formed with one or more flanges or one or more grooves. Additionally, the cushion and pillow may also be formed with either flanges or grooves, thus allowing for the spacer to be joined in a male-female or female-male fashion with the cushion and pillow. Flanges or grooves used with any of the spacer, cushion or pillow may be formed in any shape, such as square, fully round, partially rounded or any combination thereof. 
     In yet another exemplary embodiment, the spacer, such as spacer  166  or  168 , may be formed of any soft material, such as silicone, or any rigid material, such as plastic. Additionally, the spacer may be formed in a variety of shapes and having a variety of flanges or grooves regardless of whether the spacer is formed of any soft or hard material. Also, one or more spacers may be joined or connected to provide further adjustability of a pillow or cushion location. For example, an additional spacer could be coupled to nasal pillow  172  and then coupled with spacer  168 . Additionally, any of the embodiments disclosed in this document may be used with a single pillow or one or more connected pillows, and a single spacer, one or more connected spacers, or one or more axially connected spacers. 
     In another exemplary embodiment shown in  FIG. 41 , a pair of nasal pillows may be joined with spacers and then coupled with a cushion for a ventilation interface. In a first view, shown in  FIG. 41   a , nasal pillows  178  and  180  may use flanges  196  and  198 , respectively (and shown as shrouded in  FIG. 41   a ) to couple with spacers. Spacer  188  may couple with flange  196  of nasal pillow  178  using flanges  192 . A similar coupling may occur between nasal pillow  180  and spacer  190 , although they are shown as already coupled in this view, thus flanges  194  are not shown in  FIG. 41   a.    
       FIG. 41   b  shows a side perspective view of the exemplary embodiment of  FIG. 41   a . In this view, it is shown that spacer  188  is substantially round. In another exemplary embodiment, spacer  188  may be any shape that may be coupled with nasal pillow  178  and also may be coupled with opening  196  on cushion  186 . Additionally, in the view shown in  FIG. 41   b , flanges  192  are shown as extending around the entire perimeter of spacer  188 . In other embodiments of the invention, flanges  192  may be disposed on only parts of spacer  188 , may be arranged in different locations, may be located at different distances from the other flanges, may be angled or may not extend around the entire perimeter of a spacer. Additionally, as shown in 
       FIGS. 41   a  and  41   b , cushion  186  may be configured to adhere to the contours of the face of a user. Cushion  186  may also be configured on one side to receive a ventilation interface, such as a plastic interface having a means for accepting input gas, such as CPAP or BiPAP. 
     Additionally, a cross-sectional view of the embodiments shown in  FIGS. 41   a  and  41   b  is shown in  FIG. 41   c . In this view, it can be seen that nasal pillow  180  can use multiple grooves  198  to receive the upper portion of spacer  190  flange  194 . Additionally, only a lower portion of spacer  190  flange  194  may be used in opening  198  to couple spacer  190  to cushion  186 . Further, from this exemplary embodiment, spacers  188  and  190  may be adjusted vertically on cushion  186  without disturbing the coupling of spacers  188  and  190  to nasal pillows  178  and  180 , respectively. Additionally, nasal pillows  178  and  180  may be adjusted vertically on spacers  188  and  190 , respectively, without disturbing the coupling of spacers  188  and  190  with cushion  186 . Also, in another exemplary embodiment, nasal pillows  178  and  180  may be adjusted vertically on spacers  188  and  190 , respectively, while spacers  188  and  190  are being adjusted on cushion  186 . 
       FIG. 42  shows another exemplary embodiment of a ventilation interface where nasal pillows may be adjusted through the use of flanges on the nasal pillows, flanges on the cushion and through the use of spacers. Here, nasal pillows  204  and  206  may be coupled with spacers  214  and  216 , respectively. Spacers  214  and  216  may also be coupled with cushion  212 . Nasal pillows  204  and  206  in  FIG. 42  may also be adjusted to different positions. Nasal pillow  204  may use flanges  208  on two upper flanges  218  of spacer  214 . Spacer  214  may then be coupled to opening  226  of cushion  212  through the use of the upper portion of flange  222 . Nasal pillow  206  can use the bottom portion of flanges  210  on the uppermost flange of flanges  220  of spacer  216 . Spacer  216  can then be coupled to opening  228  of cushion  212  through the use of the upper portion of flange  224 . In each of these embodiments, each of the nasal pillows, spacers and cushion may be adjusted independently or in conjunction with one another. For example, nasal pillow  204  could be adjusted vertically on spacer  214  without affecting the positioning of spacer  214  on flange  222  of cushion  212 . Alternatively, spacer  214  could be adjusted on flanges  218  of cushion  212  without affecting the position of nasal pillow  204  on spacer  214 . In yet another alternative embodiment, the position of nasal pillow  204  on spacer  214  could be adjusted simultaneously or in conjunction with the position of spacer  214  on cushion  212 . 
     In another exemplary embodiment of a ventilation interface shown in  FIG. 43 , nasal pillows may be adjusted through the use of a threaded spacer. Here, as shown in  FIG. 43   a , nasal pillows  230  and  232  may have flanges  234  and  236 , respectively. Flanges  234  and  236  may couple with spacers  240  and  242 , respectively. Spacers  240  and  242  may have threaded portions  244  and  246 . This threading may either be male or female and may mate with threaded portions  252  and  254 , respectively, of cushion  238 . Threaded portions  252  and  254  may be either male or female, so that they may mate with spacers  240  and  242 . 
     In  FIG. 43   b , nasal pillow  230  is shown in a cutaway view as being separated from spacer  240  and cushion  238 . Nasal pillow  232 , however, may be coupled with spacer  242  using flange  236  on pillow  232  and receiving flange  245  on spacer  242 . Spacer  242  may then utilize threads  246  to be threaded into opening  258  of cushion  238 . Flanges  250  on cushion  238  may have internal threading  254  that may receive the threading of  246  of spacer  242 . In one exemplary embodiment, flanges  250  may have male threading that receives female threading of spacer  242 . Alternatively, flanges  250  may have female threading that receives male threading of spacer  242 . In yet another exemplary embodiment, cushion  238  and spacer  242  may snap together, for example with either cushion  238  or spacer  242  having a post that fits into a receiving hole or slot on the other member. In yet another exemplary embodiment, cushion  238  and spacer  242  may be joined by friction. After spacer  242  and cushion  238  are coupled, a user may twist either nasal pillow  232  or spacer  242 . The twisting may result in a raising or lowering of the height of nasal pillow  232 , as well as a changing of the orientation of nasal pillow  232 . In a further embodiment, both the spacers and flanges on a cushion may have threading of any length, allowing a user to adjust one or both nasal pillows to any desired height or orientation. In yet another embodiment, spacers may be coupled to a cushion through the use of friction between the spacer material and the cushion, allowing for an infinite amount of adjustment to be made to the height and orientation of one or both nasal pillows. Alternatively, any other method known to one having ordinary skill in the art may be used to couple a spacer with a cushion. 
       FIG. 44  shows yet another exemplary embodiment of a ventilation interface having adjustable nasal pillows. Similar to other embodiments, as shown in  FIG. 44   a , nasal pillows  260  and  262  may have flanges  264  and  266 , respectively. Flanges  264  and  266  may couple with spacers  270  and  272 , respectively. Spacers  270  and  272  may also have hinged portions  274  and  276 , respectively. Hinged portions  274  and  276  may have a mold-in, living hinge-like detail that has over-center memory or biasing, for example, which may be hinged similar to the gas input tubes found on beach balls. Thus, spacers  270  and  272  may be extended, as shown in  FIG. 44   b , or may be partially collapsed on itself, as shown by spacer  270  in  FIG. 44   c . Alternatively, spacers  270  and  272  may be hinged in any other manner known to a person having ordinary skill in that art. Spacers  270  and  272  may also have flanges  278  and  280 , respectively, which may be coupled with flanges  282  and  284 . Flanges  282  and  284  are associated with openings  286  and  288 , respectively, of cushion  268 . 
     In a further embodiment shown in  FIG. 44   b , nasal pillow  260 , spacer  270  and cushion  268  are shown as separate, in a cutaway view. Nasal pillow  262 , however, may use flange  266  to couple with upper flange  275  of spacer  272 . Lower flange  280  of spacer  272  may then be coupled with flange  284  of cushion  268 , so as to allow gas to flow from a ventilation interface, through spacer  272  and through nasal pillow  262 . In the exemplary embodiment shown in  FIG. 44   b , hinge  276  of spacer  272  is shown in an upright, elongated fashion. 
     In exemplary  FIG. 44   c , the orientation of nasal pillow  262 , spacer  272  and cushion  268  remains similar to that shown in  FIG. 44   b . Nasal pillow  260 , however, may use flange  264  to couple with upper flange  273  of spacer  270 . Lower flange  278  of spacer  270  may then be coupled with flange  282  of cushion  268 , so as to allow gas to flow from a ventilation interface, through spacer  270  and through nasal pillow  260 . Additionally, in the exemplary embodiment shown in  FIG. 44   c , hinge  274  of spacer  270  is shown in a collapsed fashion. Thus, the height of nasal pillow  260  may be varied through the collapsing or elongating of hinge  274 . Additionally, the height of nasal pillow  262  may be varied through the collapsing or elongating of hinge  276 . Each of these hinges may be collapsed or elongated in any of a variety of fashions known to a person having ordinary skill in the art and each hinge may have an infinite range of motion. 
     In another exemplary embodiment, the one or more nasal pillows, for example nasal pillows  260  and  262 , may be joined with a cushion in any of a variety of manners. The nasal pillows  260  and  262  may be joined directly to a cushion, for example cushion  268 . Alternatively, nasal pillows  260  and  262  may be joined with a spacer or spacers, for example spacers  270  and  272 , respectively that may then be joined with a cushion. The spacers may be in the shape of a shroud that can then be joined with a cushion, may be joined with a secondary piece that may then be joined with a cushion, or may be joined in any other manner. In one embodiment, the nasal pillows  260  and  262  may have threads, thus allowing the nasal pillow to be threaded into a cushion, spacer or other secondary piece. For example, by turning the pillow on the threads, a user can adjust the pillow up or down within the range of the threads. Additionally, a pillow may have female threads that thread into male threads on a cushion, spacer or secondary piece or a pillow may have male threads that thread into female threads on a cushion, spacer or secondary piece. Additionally, if a spacer or secondary piece is used to join the one or more nasal pillows to a cushion, the spacer or secondary piece may have threading that is designed to accept the one or more nasal pillows and may have threading that may be used to adjustably connect the spacer or secondary piece to the cushion. 
     In another exemplary embodiment, the spacer or spacers used in any embodiment may be any shape. For example, the spacer may be circular or oval. Additionally, the spacer may be constructed so as to be either soft or rigid. Further, the spacer may be hollow so as to allow for gas to travel through the spacer. Alternatively, the spacer may be solid and have holes or slots disposed internally so as to allow for the flow of gas from a cushion to a nasal pillow. 
     Additionally, different spacers, such as spacers  270  and  272 , may be utilized and interchanged. Spacers may be formed that have a variety of different thicknesses. Also, spacers may be formed with different elasticity, different stretching capabilities or different flexibility. For example, different spacers may be formed of different materials, thus giving the different spacers different material properties and allowing for a wide range of adjustments to be made for size, comfort and style, for example. 
     In another exemplary embodiment, any of the spacers or secondary pieces described herein, for example spacers  270  and  272  of  FIG. 44 , may be assembled and formed in any of a variety of manners. For example, a spacer may be mechanically attached to a nasal pillow or cushion, a spacer may be bonded to a nasal pillow or a cushion or a spacer may be molded into a nasal pillow or cushion. Additionally, any manner of attaching a spacer to a nasal pillow or a cushion that is known to one of ordinary skill in the art may be utilized. 
     In yet another embodiment, a nasal pillow in any of the above exemplary embodiments, for example nasal pillow  260  or  262 , may be fitted or joined into a cushion or spacer in any of a variety of manners. For example, a nasal pillow may press fit into a cushion or spacer. Thus, a pillow may have straight or angled walls and, when the pillow is being inserted into a cushion or spacer, the friction between the walls of the pillow and the walls of the cushion or spacer will act to provide a seal and maintain the height of the nasal pillow. Additionally, a user may adjust the height of the nasal pillow by pushing the nasal pillow down further, and thereby lowering the height of the nasal pillow, or by pulling the nasal pillow up, thus raising the height of the nasal pillow. 
     In another exemplary embodiment shown in  FIGS. 45   a - b , one or more nasal inserts may be oriented in additional positions on a cushion. In  FIG. 45   a , a first nasal pillow  280  is shown as separated from cushion  284 , leaving opening  286  open and flange  288  unengaged. Nasal pillow  282  is shown as engaged to cushion  284  through the use of flange  290 . Additionally, cushion  284  may have edges that seal against the face, for example the upper lip, of a user wearing the ventilation interface. In  FIG. 45   b  a cutaway of nasal pillow  282  engaged with cushion  284  is shown. Nasal pillow  282  may use flanges  292  to engage with flange  290  on cushion  284 . In the exemplary embodiment shown in  FIG. 45   b , the lower portion of flanges  292  are used to engage nasal pillow  282  in cushion  284 . In alternative exemplary embodiments, any of the central or upper flanges  292  may be utilized on nasal pillow  282 . Further, in the exemplary embodiment shown in  FIG. 45   b , cushion  284  has a membrane  300  that may seal against the upper lip of the user, and nasal pillow  282  has a nasal insert portion  298  that may contact the bottom of a nostril. The distance between a top edge  294  of membrane  300  and a bottom edge  296  of nasal insert portion  298  may be in the range of approximately 0.030″ to 2″. 
     Additionally, in further embodiments of the invention, one nasal pillow may be connected to another nasal pillow using a connecting member. The connecting member may be formed as part of a nasal pillow and may be made out of any material and may join the nasal pillows in any manner known to one having ordinary skill in the art. The connecting member may also be removably attached to at least one of the nasal pillows. A connecting member may be utilized with any of the embodiments described herein and may maintain its connection with each nasal pillows regardless of adjustment of the height or angle of the nasal pillows. Additionally, the nasal pillows may have thin portions that are designed to provide a place for a connecting member to securely attach. 
     Any of the above embodiments may be utilized in any of a variety of respiration or respiration assist devices and are not limited to respiration assist masks. The various adjustable nasal pillows, spacers and cushions, for example, may be utilized in any of a variety of devices, including but not limited to respiration assist masks, nasal cannulas, ventilation masks, underwater breathing apparatuses, and other type of device capable of delivering breathable gas or aerosol. 
     The foregoing description and accompanying drawings illustrate the principles, preferred embodiments and modes of operation of the invention. However, the invention should not be construed as being limited to the particular embodiments discussed above. Additional variations of the embodiments discussed above will be appreciated by those skilled in the art. 
     Therefore, the above-described embodiments should be regarded as illustrative rather than restrictive. Accordingly, it should be appreciated that variations to those embodiments can be made by those skilled in the art without departing from the scope of the invention as defined by the following claims.