Patent Publication Number: US-2017361049-A1

Title: Rigid contoured ribbon and variable spring sealing

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This patent application claims the priority benefit under 35 U.S.C. §119(e) of U.S. Provisional Application No. 62/097,829, filed on Dec. 30, 2014, the contents of which are herein incorporated by reference. 
    
    
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     The present invention pertains to patient interface devices for delivering a flow of breathing gas to a patient during, for example, respiratory therapy, and, in particular, to a patient interface device including a support assembly with a ribbon-like body. 
     2. Description of the Related Art 
     There are numerous situations where it is necessary or desirable to deliver a flow of breathing gas non-invasively to the airway of a patient, i.e., without intubating the patient or surgically inserting a tracheal tube in their esophagus. For example, it is known to ventilate a patient using a technique known as non-invasive ventilation. It is also known to deliver continuous positive airway pressure (CPAP) or variable airway pressure, which varies with the patient&#39;s respiratory cycle, to treat a medical disorder, such as sleep apnea syndrome, in particular, obstructive sleep apnea (OSA), or congestive heart failure. 
     Non-invasive ventilation and pressure support therapies involve the placement of a patient interface device including a mask component on the face of a patient. The mask component may be, without limitation, a nasal mask that covers the patient&#39;s nose, a nasal cushion having nasal prongs that are received within the patient&#39;s nares, a nasal/oral mask that covers the nose and mouth, or a full face mask that covers the patient&#39;s face. The patient interface device interfaces the ventilator or pressure support device with the airway of the patient so that a flow of breathing gas can be delivered from a pressure/flow generating device to the airway of the patient. It is known to maintain such devices on the face of a wearer by a headgear having one or more straps adapted to fit over/around the patient&#39;s head. Because such patient interface devices are typically worn for an extended period of time, it is important for the headgear to maintain the mask component of the device in a tight enough seal against the patient&#39;s face without discomfort. 
     A typical cushion includes a thin sealing membrane backed by a thicker support structure, both mounted to a rigid faceplate. The face-contacting portions of the sealing membrane and support have arcuate cross-sections which are swept along the perimeter of the cushion such that the apex of the swept cross-section is contoured to the face in a longitudinal aspect. The radial contour of the face-contacting portion is not contoured to the user&#39;s face; that is, the radial contour of the face-contacting portion maintains the arcuate shape of the respective cross-section. As used herein, the type of seal provided by a cushion with such an arcuate cross-section is a “generally continuous seal.” That is, even when a sealing membrane and a support having an arcuate cross-section is biased against a user&#39;s face and deformed, the type of seal against the user&#39;s face is a “generally continuous seal.” 
     SUMMARY OF THE INVENTION 
     One embodiment of the presently disclosed concept provides a cushion support assembly for a respiratory interface device cushion including a cushion support assembly ribbon-like body. Cushion support assembly ribbon-like body includes an inner side, an outer side and a wide facial side. Cushion support assembly body facial side includes a support surface, the support surface is structured to support the respiratory interface device cushion engagement portion in a generally planar configuration. Cushion support assembly body facial side support surface is generally planar relative to the user&#39;s respiratory interface device contour radial aspect. 
     These and other objects, features, and characteristics of the present invention, as well as the methods of operation and functions of the related elements of structure and the combination of parts and economies of manufacture, will become more apparent upon consideration of the following description and the appended claims with reference to the accompanying drawings, all of which form a part of this specification, wherein like reference numerals designate corresponding parts in the various figures. It is to be expressly understood, however, that the drawings are for the purpose of illustration and description only and are not intended as a definition of the limits of the invention. 
     It is a further object of this invention to provide a method of using a respiratory interface device structured to engage a user&#39;s face, the user&#39;s face including a respiratory interface device contour, wherein the user&#39;s respiratory interface device contour is a shaped loop including an axial aspect and a radial aspect, the method including coupling the respiratory interface device cushion body to the cushion support assembly, positioning the respiratory interface device cushion body engagement portion to extend generally parallel to the adjacent cushion support assembly body facial side support surface, positioning the respiratory interface device over a user&#39;s respiratory orifice with the respiratory interface device cushion body engagement portion engaging the user&#39;s respiratory interface device contour. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a schematic view of a respiratory interface device contour for a nasal and oral respiratory interface device.  FIG. 1B  is a schematic view of a respiratory interface device contour for a cup-like nasal respiratory interface device.  FIG. 1C  is a schematic view of a respiratory interface device contour for a nasal respiratory interface device in a cradle configuration.  FIG. 1D  is a schematic view of a respiratory interface device contour for a nasal respiratory interface device in a sub-nasal surface sealing pillow configuration; 
         FIG. 2  is a schematic view of a ribbon-like body; 
         FIG. 3  is an isometric view of a nasal and oral respiratory interface device; 
         FIG. 4  is an exploded isometric view of a nasal and oral respiratory interface device; 
         FIG. 5  is a partial cross-sectional view of a respiratory interface device; 
         FIG. 5  is a back side view of a faceplate with a cushion support assembly body; 
         FIG. 6  is a cross-sectional view of a portion of a nasal and oral respiratory interface device.  FIG. 6A  is a cross-sectional view of another embodiment of a portion of a nasal and oral respiratory interface device.  FIG. 6B  is a cross-sectional view of another embodiment of a portion of a nasal and oral respiratory interface device.  FIG. 6C  is a cross-sectional view of another embodiment of a portion of a nasal and oral respiratory interface device.  FIG. 6D  is a cross-sectional view of another embodiment of a portion of a nasal and oral respiratory interface device; 
         FIG. 7  is a cross-sectional side view of another embodiment of a nasal and oral respiratory interface device; 
         FIG. 8  is a back side view of a faceplate with a spring element; 
         FIG. 9  is a detail cross-sectional view of a faceplate with a cushion support assembly body; 
         FIG. 10  is a detail cross-sectional view of another embodiment of a faceplate with a cushion support assembly body; 
         FIG. 11  is a detail cross-sectional view of another embodiment of a faceplate with a cushion support assembly body; 
         FIG. 12  is a detail cross-sectional view of another embodiment of a faceplate with a cushion support assembly body; 
         FIG. 13  is a detail cross-sectional view of another embodiment of a faceplate with a cushion support assembly body; 
         FIG. 14  is a detail cross-sectional view of a faceplate with a cushion support assembly body and spring element; 
         FIG. 15  is a detail cross-sectional view of another embodiment of a faceplate with a cushion support assembly body and spring element; 
         FIG. 16  is a detail cross-sectional view of another embodiment of a faceplate with a cushion support assembly body and spring element; 
         FIG. 17  is an isometric view of another embodiment; a nasal embodiment; 
         FIG. 18  is a side cross-sectional view of the embodiment shown in  FIG. 17 ; 
         FIG. 19  is an top view of another embodiment; a nasal embodiment; 
         FIG. 20  is a side cross-sectional view of the embodiment shown in  FIG. 19 ; 
         FIG. 21  is an top view of another embodiment; a nasal embodiment; 
         FIG. 22  is a side cross-sectional view of the embodiment shown in  FIG. 21 ; 
         FIG. 23  is a flow chart of the disclosed method. 
     
    
    
     DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS 
     As used herein, the statement that two or more parts or components are “coupled” shall mean that the parts are joined or operate together either directly or indirectly, i.e., through one or more intermediate parts or components, so long as a link occurs. As used herein, “directly coupled” means that two elements are directly in contact with each other. As used herein, “fixedly coupled” or “fixed” means that two components are coupled so as to move as one while maintaining a constant orientation relative to each other. 
     As used herein, the statement that two or more parts or components “engage” one another shall means that the parts exert a force against one another either directly or through one or more intermediate parts or components. As used herein, the word “unitary” means a component is created as a single piece or unit. That is, a component that includes pieces that are created separately and then coupled together as a unit is not a “unitary” component or body. As used herein, the term “number” shall mean one or an integer greater than one (i.e., a plurality). 
     As used herein, a “coupling” is one element of a coupling assembly. That is, a coupling assembly includes at least two components, or coupling components, that are structured to be coupled together. It is understood that the elements of a coupling assembly are compatible with each other. For example, in a coupling assembly, if one coupling element is a snap socket, the other coupling element is a snap plug. 
     As used herein, “correspond” indicates that two structural components are sized and shaped to be similar to each other and may be coupled with a minimum amount of friction. Thus, an opening which “corresponds” to a member is sized slightly larger than the member so that the member may pass through the opening with a minimum amount of friction. This definition is modified if the two components are said to fit “snugly” together. In that situation, the difference between the size of the components is even smaller whereby the amount of friction increases. If the element defining the opening and/or the component inserted into the opening are made from a deformable or compressible material, the opening may even be slightly smaller than the component being inserted into the opening. With regard to surfaces, shapes, and lines, two, or more, “corresponding” surfaces, shapes, or lines have generally the same size, shape, and contours. 
     As used herein, “a generally continuous seal” may have a gap or may gap when the user moves. As used herein, “a more complete seal” has a gap that is shorter in length than a gap of a generally continuous seal, or, is resistant to gapping when the user moves. 
     As used herein, a “respiratory interface device contour” is the perimeter of the area on a user&#39;s face that a respiratory interface device. For a nasal and oral respiratory interface device, the “respiratory interface device contour” is a loop  1 A that extends around the user&#39;s nose and mouth, as shown in  FIG. 1A . For a cup-like nasal respiratory interface device, the “respiratory interface device contour” is a loop  1 B that extends around the user&#39;s nose and mouth, as shown in  FIG. 1B . For a nasal respiratory interface device in a “cradle” configuration, the “respiratory interface device contour” is a loop  1 C that extends around the lower portion of the user&#39;s nose, as shown in  FIG. 1C . For a nasal respiratory interface device in a sub-nasal surface sealing pillow configuration, the “respiratory interface device contour” is a pair of loops  1 D that extend around a portion of the user&#39;s upper lip and the user&#39;s nostrils, as shown in  FIG. 1D . 
     As used herein, a “longitudinal axis” is not required to be a generally straight line. That is, a “longitudinal axis” as used herein is generally a centerline of a body which can includes curves. 
     As used herein, the “axial aspect” of the “respiratory interface device contour” means in the direction along the line defining the “respiratory interface device contour,” as shown by arrows  2 ′,  2 ″,  2 ′″ in  FIG. 1A . As used herein, the “radial aspect” of the “respiratory interface device contour” means in the direction generally perpendicular to the line defining the “respiratory interface device contour” and parallel to the surface of the user&#39;s face, as shown by arrows  3 ′,  3 ″,  3 ′″ in  FIG. 1A . Thus, a plane defined by the “axial aspect” and the “radial aspect” of the “respiratory interface device contour” means a plane at the surface of the user&#39;s face and parallel to the surface of the user&#39;s face. 
     As used herein, a “ribbon-like” body, shown in  FIG. 2 , includes a thin, elongated body  4  having at least one surface  6  that is offset and generally parallel to the body longitudinal axis  5 . The body longitudinal axis  5  may curve in three dimensions. Thus, for example, a common fabric ribbon has a generally rectangular cross-sectional shape with four surfaces that are offset and generally parallel to the longitudinal axis of the body. As shown in  FIG. 2 , a “ribbon-like” body with a generally rectangular cross-sectional area includes a first wide side  6 , a second wide side  7 , a first thin side  8 , and a second thin side  9 . The first and second thin sides may also be identified as “lateral sides.” 
     As used herein, a “ribbon seal” is a sealing surface extending in the radial aspect direction relative to a longitudinal axis. That is, a “ribbon seal” is a broad sealing surface that extends parallel to a “ribbon-like” body. Further, as used herein, a respiratory interface device that does not have a support construct with a “ribbon-like” body cannot create a “ribbon seal.” As used herein, a “ribbon seal” provides “a more complete seal” compared to a cushion with an arcuate cross-section. 
     Directional phrases used herein, such as, for example and without limitation, top, bottom, left, right, upper, lower, front, back, and derivatives thereof, relate to the orientation of the elements shown in the drawings and are not limiting upon the claims unless expressly recited therein. 
       FIG. 3  shows a respiratory interface assembly  8  according to an embodiment of the invention. Respiratory interface assembly  8  includes a respiratory interface device  10  and a support assembly such as, but not limited to straps (not shown). Respiratory interface device  10  is coupled to a pressure generating system  15  (shown schematically) via a patient circuit, as is conventionally known in the art. For purposes of the present invention, the pressure generating system is any device capable of generating a flow of breathing gas or providing gas at an elevated pressure. Examples of such pressure generating systems include a ventilator, CPAP device, or variable pressure device, e.g. an auto-titrating device, proportional assist ventilation (PAV®) device, proportional positive airway pressure (PPAP) device, C-Flex™ device, Bi-Flex® device, or a BiPAP® device manufactured and distributed by Philips Respironics of Murrysville, Pa., in which the pressure provided to the patient varies with the patient&#39;s respiratory cycle so that a higher pressure is delivered during inspiration than during expiration, or other pressure support device. 
     In an exemplary embodiment, shown in  FIGS. 3-16 , the respiratory interface device  10  is a nasal and oral respiratory interface device  10 A that is structured to be disposed over a user&#39;s nose and mouth. In another exemplary embodiment, shown in  FIGS. 17-18 , respiratory interface device  10  is a nasal respiratory interface device  10 B that is structured to be disposed over a user&#39;s nose. It is understood, however, that respiratory interface device  10  can include, without limitation, a nasal mask, nasal pillows, or any other device that provides a suitable gas flow communicating function. Thus, as used herein, the term “respiratory interface device” shall refer to any of such devices. 
     A nasal and oral respiratory interface device  10 A includes a body  11  with a faceplate  12 , a cushion  30 , a cushion support assembly  80 . As is known, respiratory interface device  10 A is structured to be coupled to a support assembly (not shown) such as, but not limited to a number of straps. Further, and as is known, respiratory interface device  10 A is structured to be coupled to, and in fluid communication with, pressure generating system  15  via a patient circuit such as, but not limited to, a number of hoses. In an exemplary embodiment, respiratory interface device body faceplate  12  (hereinafter “faceplate”  12 ) is a substantially rigid body. In an exemplary embodiment, shown in  FIG. 3 , faceplate  12  is a single piece structured to cover the user&#39;s nose and mouth. That is, respiratory interface device  10 A has a peripheral contour that is, in this embodiment, structured to extend over a user&#39;s nose and mouth. In this embodiment, respiratory interface device body  11  is coextensive with faceplate  12 . Faceplate  12  defines lower opening  14 . Lower opening  14  can function as a gas inlet. 
     Gas inlet (lower opening  14 ) can be coupled to a coupling device  17 , such as, but not limited to, a swivel conduit, for carrying gas such as air between respiratory interface device  10 A and an external gas source (not shown), such as a blower, or any other suitable device. It is contemplated that the external gas source can encompass, without limitation, any gas delivery or gas generation system capable of supplying gas for consumption by a user. Non-limiting examples of various gas delivery therapies can include but are not limited to continuous positive airway pressure (CPAP) therapy, auto-titration positive airway pressure therapy, and bi-level positive airway pressure (BiPAP) therapy, as noted above. The coupling device may be any of a variety of different coupling devices that could be attached, either permanently or selectively, to lower opening  14  to carry gas to or from respiratory interface device  10 . Thus, a variety of coupling devices (e.g., with or without swivels on one or both ends, and with or without an exhalation system formed integral to the device) may be used. 
     In an exemplary embodiment, shown in  FIGS. 3-5 , faceplate  12  is generally convex or bowl-shaped. This shape defines an interior space that accommodates a user&#39;s nose and other features when respiratory interface device  10 A is in use. Faceplate  12  includes a peripheral end  18  that extends about faceplate  12 . In this exemplary embodiment, faceplate peripheral end  18  extends generally towards the user&#39;s face when respiratory interface device  10  is in use. Faceplate peripheral end  18  includes an outer side  20 , an inner side  22  (relative to the interior space), and a face side  24 . That is, as used herein and with reference to faceplate  12 , “outer” or “outwardly” means away from the interior space defined by bowl-shaped faceplate  12 , and, “inner” or “inwardly” means toward the interior space defined by bowl-shaped faceplate  12 . As is known, the faceplate  12  can be custom made to generally correspond to the user&#39;s respiratory interface device contour,  1 A (in this embodiment). That is, the user&#39;s face is measured, e.g. scanned, and relevant dimensions are recorded. The general shape of faceplate  12 , faceplate peripheral end  18 , and faceplate peripheral end face side  24  generally correspond to the user&#39;s respiratory interface device contour  1 A (in this embodiment). 
     In an exemplary embodiment, faceplate peripheral end  18  is unitary with respiratory interface device cushion support assembly  80 . That is, in an exemplary embodiment, faceplate  12  and respiratory interface device cushion support assembly  80  are made as a unitary body. In an alternative embodiment, cushion support assembly body  82  is coupled to faceplate peripheral end  18  and extends toward one of, or both, faceplate peripheral end outer side  20  or faceplate peripheral end inner side  22 . Thus, faceplate peripheral end  18  includes a coupling component  28  ( FIG. 6D ) structured to be coupled, directly coupled, or fixed to respiratory interface device cushion support assembly  80 . 
     Respiratory interface device cushion  30  (hereinafter “cushion”  30 ) includes a body  32 . Cushion body  32  can be constructed of a wide variety of resilient materials known in the art and can include, but is not limited to, a thermoplastic or thermoelastic material, including but not limited to an elastomer such as plastic, rubber, silicone, vinyl, foam, or any combination thereof. Cushion body  32  includes a coupling component  34  and an engagement portion  36 . In the exemplary embodiment shown in  FIG. 6 , cushion body coupling component  34  is a groove  40  within cushion body  32  that is structured to be coupled to a tongue  130 , described below. In an alternate embodiment, cushion body  32  has a generally C-shaped cross-section wherein cushion body  32  cross-sectional shape defines groove  40 . In another alternate embodiment, shown in  FIG. 7 , cushion body coupling component  34  is a tongue  42  structured to be disposed in a groove  40 , described below. 
     Cushion engagement portion  36  is structured to engage a user&#39;s face. Cushion engagement portion  36  is shaped to generally follow user&#39;s respiratory interface device contour,  1 A (as well as  1 B,  1 C,  1 D for other embodiments). That is, cushion engagement portion  36  includes a longitudinal axis  50  that generally conforms to the axial aspect of user&#39;s respiratory interface device contour,  1 A (as well as  1 B,  1 C,  1 D for other embodiments). That is, cushion body engagement portion longitudinal axis  50  generally matches the user&#39;s respiratory interface device contour,  1 A (as well as  1 B,  1 C,  1 D for other embodiments). Cushion engagement portion  36  is, in an unbiased state and when viewed along cushion body engagement portion longitudinal axis  50  generally planar. 
     Cushion support assembly  80  includes a body  82 . Cushion support assembly body  82  is, in an exemplary embodiment, custom made for each user. That is, as noted above, a user&#39;s face may be measured, e.g. scanned, and relevant dimensions recorded. Cushion support assembly body  82  is then made so as to generally correspond to the size, shape, and contour of the user&#39;s face. In an exemplary embodiment, cushion support assembly body  82  is then made so as to generally correspond to the user&#39;s face at the user&#39;s respiratory interface device contour,  1 A (in this embodiment). 
     In an exemplary embodiment, as shown in  FIGS. 5-7 , cushion support assembly body  82  is a ribbon-like body  82 A including an inner side  84 , an outer side  86 , a wide facial side  88 , a wide exposed side  89  opposite facial side  88 , and a longitudinal axis  90 . Cushion support assembly ribbon-like body  82 A is shaped to generally correspond to user&#39;s respiratory interface device contour axial aspect  2 . That is, in this embodiment, cushion support assembly ribbon-like body  82 A is shaped to extend about the user&#39;s nose and mouth. Stated alternately, cushion support assembly ribbon-like body longitudinal axis  90  generally corresponds to the user&#39;s respiratory interface device contour  1 A (in this embodiment). In an exemplary embodiment, cushion support assembly ribbon-like body  82 A is generally rectangular, and planar, when viewed along cushion support assembly ribbon-like body longitudinal axis  90  ( FIG. 5 ). That is, in an exemplary embodiment, a cross-section of cushion support assembly ribbon-like body  82 A is generally rectangular, and planar, when viewed along cushion support assembly ribbon-like body longitudinal axis  90 . 
     Further, cushion support assembly ribbon-like body wide facial side  88  defines a support surface  100 . Cushion support assembly ribbon-like body wide facial side support surface  100  (hereinafter “support surface”  100 ) is structured to support cushion engagement portion  36 . In an exemplary embodiment, support surface  100  is structured to support cushion engagement portion  36  in a generally planar configuration. That is, as used herein, “to support cushion engagement portion  36  in a generally planar configuration” means that cushion engagement portion  36 , when viewed along the longitudinal axis  50 , is maintained in a generally planar configuration. It is understood that support surface  100  and cushion engagement portion  36  are not planar over their entire surface. That is, as set forth below, support surface  100  and cushion engagement portion  36  generally correspond to the user&#39;s respiratory interface device contour, and, support surface  100  and cushion engagement portion  36  each extend generally parallel to the user&#39;s face at any given location. 
     That is, support surface  100  extends in a direction that is generally planar relative to the user&#39;s respiratory interface device contour radial aspect. That is, as used herein, to be “generally planar relative to the user&#39;s respiratory interface device contour radial aspect” means that the surface of cushion body engagement portion  36  at any specific location extends generally parallel to the surface of the user&#39;s face at that specific location. In an exemplary embodiment, a segment of support surface  100  defines a plane. That is, a segment of support surface  100 , such as but not limited to a segment having a length of about 0.1 mm along cushion support assembly ribbon-like body longitudinal axis  90 , is generally a planar surface in the plane defined by the axial aspect and the radial aspect of the respiratory interface device contour  1 A (in this embodiment). In this configuration, support surface  100  provides a planar support for support cushion engagement portion  36 . That is, in an exemplary embodiment, support cushion engagement portion  36  has a width corresponding to the width of support surface  100  so that, when support cushion engagement portion  36  is disposed over support surface  100 , support surface  100  maintains support cushion body engagement portion  36  in a generally planar configuration. A cushion body engagement portion  36  in a generally planar configuration provides a more complete seal compared to a cushion having a generally arcuate cross-sectional shape. 
     In an exemplary embodiment, cushion support assembly ribbon-like body  82 A is structured to be coupled, directly coupled, or fixed to faceplate peripheral end  18 . That is, cushion support assembly ribbon-like body  82 A includes a coupling component  110  structured to be coupled, directly coupled, or fixed to faceplate peripheral end  18 . In an exemplary embodiment, cushion support assembly ribbon-like body  82 A coupling component  110  (hereinafter “cushion support assembly faceplate coupling component”  110 ) is structured to be coupled, directly coupled, or fixed to faceplate peripheral end coupling component  28 . In an exemplary embodiment, cushion support assembly ribbon-like body  82 A extends generally inward from faceplate peripheral end  18 , that is, into the cavity defined by convex or bowl-shaped faceplate  12 . In another exemplary embodiment, cushion support assembly ribbon-like body  82 A extends generally outward from faceplate peripheral end  18 , that is, away the cavity defined by convex or bowl-shaped faceplate  12 . In another exemplary embodiment, faceplate peripheral end  18  is coupled to the medial portion of cushion support assembly body exposed side  89 . Faceplate peripheral end coupling component  28  and cushion support assembly faceplate coupling component  110  can be any type of coupling components. 
     In another alternate embodiment, cushion support assembly ribbon-like body  82 A is unitary with faceplate  12 . As with the embodiments above, a cushion support assembly ribbon-like body  82 A unitary with faceplate  12  can be configured to extend generally outward from faceplate peripheral end  18 , as shown in  FIG. 6A , extend generally inward from faceplate peripheral end  18 , as shown in  FIG. 6B , or extend both generally inward and outward from faceplate peripheral end  18 , as shown in  FIG. 6C . 
     In an exemplary embodiment, as shown in  FIGS. 7 and 8 , cushion support assembly  80  includes a spring element  120 . Cushion support assembly spring element  120  (hereinafter “spring element”  120 ) includes a resilient body  122 . Spring element body  122 , or alternately spring element  120 , is structured to be, and is, disposed between support cushion body engagement portion  36  and support surface  100 . Spring element body  122  is structured to conform to support surface  100 ; that is, in an exemplary embodiment, spring element body  122  that corresponds to support surface  100 . Thus, spring element body  122  is shaped to generally correspond to user&#39;s respiratory interface device contour axial aspect  2 . That is, in this embodiment, spring element body  122  is shaped to extend about the user&#39;s nose and mouth. Spring element body  122  is structured to be coupled, directly coupled, or fixed to support surface  100 . In an exemplary embodiment, spring element body  122  can be constructed of a wide variety of resilient materials known in the art and can include, but is not limited to, a thermoplastic or thermoelastic material, including but not limited to an elastomer such as plastic, rubber, silicone, vinyl, foam, or any combination thereof. 
     In an exemplary embodiment, spring element body  122  is unitary with cushion body engagement portion  36 . That is, in an exemplary embodiment, shown in  FIG. 9 , a lateral edge of cushion engagement portion  36 , i.e. an edge extending generally parallel to cushion body engagement portion longitudinal axis  50 , is unitary with spring element body  122 . Thus, stated alternately, spring element body  122  is unitary with cushion body  32 . Spring element body  122 , in an exemplary embodiment, defines cushion body coupling component  34 , as described above. For example, as shown in  FIG. 10 , spring element body  122  defines a groove  40 . In this embodiment, support surface  100  which is generally planar acts as a tongue  130  sized to correspond to spring element body groove  40 . Further, as shown in  FIG. 11 , support surface  100 , in an exemplary embodiment, includes a number of longitudinal ridges  140  and channels  142 . In this embodiment, spring element body groove  40 , or stated more broadly cushion body  32 , includes longitudinal ridges  144  and channels  146  that correspond to support surface longitudinal ridges  140  and channels  142 . 
     When cushion body  32  is coupled to support surface  100 , support surface longitudinal ridges  140  and channels  142  are disposed in cushion body longitudinal channels  146  and ridges  144 , respectively. It is noted that support surface longitudinal ridges  140  and channels  142  are shallow relative to the thickness of cushion support assembly ribbon-like body  82 A and, as used herein, support surface longitudinal ridges  140  and channels  142  do not change the nature of support surface  100  as “generally planar” as described above. As used herein, “shallow relative to the thickness of cushion support assembly ribbon-like body” means that support surface longitudinal ridges  140  and channels  142  have a depth/height less than 60% of the thickness of cushion support assembly ribbon-like body  82 A. 
     As shown in  FIGS. 9-13 , there are several embodiments of spring element body  122  each with a different cross-sectional shape. In a first exemplary embodiment, shown in  FIG. 9 , spring element body  122  has a ribbon-like body  122 A with a substantially rectangular cross-sectional shape. In this embodiment, spring element body  122 A includes a first, wide cushion support assembly coupling surface  150  and an opposing wide cushion coupling surface  155 . In this embodiment, spring element body cushion support assembly coupling surface  150  is coupled, directly coupled, or fixed to support surface  100 . Further, spring element body cushion coupling surface  155  is coupled, directly coupled, or fixed to cushion body engagement portion  36 . 
     In another exemplary embodiment, as shown in  FIG. 14 , spring element body  122 ″ has a substantially U-shaped cross-section. As used herein, a “U-shape” includes two elongated, generally parallel tines and a curved bight therebetween. Thus, the spring element body  122 ″ includes a first, wide cushion support assembly coupling tine  160  and an opposing wide cushion coupling tine  162 . In this embodiment, spring element body cushion support assembly coupling tine  160  is coupled, directly coupled, or fixed to support surface  100 . Further, spring element body cushion coupling tine  162  is coupled, directly coupled, or fixed to cushion body engagement portion  36 . 
     In another exemplary embodiment, shown in  FIG. 15 , spring element body  122 ′″ has a substantially C-shaped cross-section. As used herein, a “U-shape” includes two generally parallel tines and a curved bight therebetween. That is, unlike the “U-shape” described above, the tines are not elongated relative to the bight. Thus, the spring element body  122 ′″ includes a first, wide cushion support assembly coupling tine  170  and an opposing wide cushion coupling tine  172 . In this embodiment, spring element body cushion support assembly coupling tine  170  is coupled, directly coupled, or fixed to support surface  100 . Further, spring element body cushion coupling tine  172  is coupled, directly coupled, or fixed to cushion body engagement portion  36 . 
     In another exemplary embodiment, shown in  FIG. 16 , spring element body  122 ″″ has a substantially circular cross-section when unbiased. In this embodiment, spring element body  122 ″″ is made from a highly deformable material, such as, but not limited to foam, TPE, gel, or silicone. Such materials have a durometer hardness of less than 10 A. As such, substantially circular cross-section spring element body  122 ″″ is structured to deform under sight bias so as to have a “pill-shaped” cross-sectional shape. As used herein, a “pill-shape” has two generally parallel surfaces maintained in spaced relationship with opposing semi-circular surfaces. In this exemplary embodiment, the pill-shaped cross-section spring element body  122 ″″ includes a first, wide cushion support assembly coupling surface  190  and an opposing wide cushion coupling surface  192 . In this embodiment, spring element body cushion support assembly coupling surface  190  is coupled, directly coupled, or fixed to support surface  100 . Further, spring element body cushion coupling surface  192  is coupled, directly coupled, or fixed to cushion body engagement portion  36 . 
     In another embodiment, shown in  FIGS. 17-18 , respiratory interface device  10  is a cup-like nasal respiratory interface device  10 B that is structured to be disposed over a user&#39;s nose. It is understood that reference numbers identify similar elements as discussed above and that for the embodiment shown in  FIGS. 17-18  the reference numbers are followed by the letter “B.” Thus, for example, a “cushion support assembly ribbon-like body wide facial side” for this embodiment is identified by reference number  88 B. In this embodiment, nasal respiratory interface device  10 B is similar to the embodiment described above with the exception being that general shape of faceplate  12 , faceplate peripheral end  18 , and faceplate peripheral end face side  24  generally correspond to the user&#39;s respiratory interface device contour  1 B (in this embodiment). Thus, cushion support assembly  80 B also generally corresponds to the user&#39;s face at the user&#39;s respiratory interface device contour,  1 B (in this embodiment). 
     In another embodiment, shown in  FIGS. 19-20 , respiratory interface device  10  is a nasal respiratory interface device  10 C in a “cradle” configuration. In this configuration, nasal respiratory interface device  10 C is structured to be generally disposed below the patient&#39;s nose. Nasal respiratory interface device  10 C includes an elongate hollow body  200  defining a cavity  202 . Nasal respiratory interface device body  200  includes an upper side  204 . Nasal respiratory interface device body upper side  204  defines an opening  206  into the nasal respiratory interface device cavity  202 . In this embodiment, cushion  230  is disposed about, i.e. extending around, nasal respiratory interface device body opening  206 . As before, cushion  230  includes a body  232  and an engagement portion  236 . 
     In this embodiment, cushion body engagement portion  236  is structured to engage a user&#39;s face. Cushion engagement portion  236  is shaped to generally follow user&#39;s respiratory interface device contour  1 C in this embodiment. That is, cushion engagement portion  236  includes a longitudinal axis  250  that generally conforms to user&#39;s respiratory interface device contour,  1 C. Cushion engagement portion  236  is, in an unbiased state and when viewed along cushion engagement portion longitudinal axis  250  generally planar. 
     In this embodiment, cushion support assembly  280  includes a body  282 . Cushion support assembly body  282  is, in an exemplary embodiment, custom made for each user. That is, as noted above, a user&#39;s face may be measured, e.g. scanned, and relevant dimensions recorded. Cushion support assembly body  282  is then made so as to generally correspond to the size, shape, and contour of the user&#39;s face. In an exemplary embodiment, cushion support assembly body  282  is then made so as to generally correspond to the user&#39;s face at the user&#39;s respiratory interface device contour,  1 C (in this embodiment). 
     In an exemplary embodiment, cushion support assembly body  282  is a ribbon-like body  282  including a wide facial side  288 , a wide interior side  289  opposite facial side  288 , and a longitudinal axis. Cushion support assembly ribbon-like body  282 C is shaped to generally correspond to user&#39;s respiratory interface device contour axial aspect  2 . That is, in this embodiment, cushion support assembly ribbon-like body  282 C is shaped to extend about the lower side of user&#39;s nose and about (around) the nostrils. Stated alternately, cushion support assembly ribbon-like body longitudinal axis  290  generally corresponds to the user&#39;s respiratory interface device contour  1 C (in this embodiment). In an exemplary embodiment, cushion support assembly ribbon-like body  282  is generally rectangular, and planar, when viewed along cushion support assembly ribbon-like body longitudinal axis  290 . That is, in an exemplary embodiment, a cross-section of cushion support assembly ribbon-like body  282  is generally rectangular, and planar, when viewed along cushion support assembly ribbon-like body longitudinal axis  90 . 
     Further, cushion support assembly ribbon-like body wide facial side  288  defines a support surface  300 . Cushion support assembly ribbon-like body wide facial side support surface  300  (hereinafter “support surface”  300 ) is structured to support cushion engagement portion  236 . In an exemplary embodiment, support surface  300  is structured to support cushion engagement portion  236  in a generally planar configuration. That is, as used herein, “to support cushion engagement portion  236  in a generally planar configuration” means that cushion engagement portion  236 , when viewed along the longitudinal axis  250 , is maintained in a generally planar configuration. It is understood that support surface  300  and cushion engagement portion  236  are not planar over their entire surface. That is, support surface  300  and cushion engagement portion  236  generally correspond to the user&#39;s respiratory interface device contour  1 C, and, support surface  300  and cushion engagement portion  236  each extend generally parallel to the user&#39;s face at any given location. That is, support surface  300  extends in a direction that is generally planar relative to the user&#39;s respiratory interface device contour radial aspect. 
     In an exemplary embodiment, cushion support assembly ribbon-like body  282 C is structured to be coupled, directly coupled, or fixed to nasal respiratory interface device body  200 . 
     As before, this exemplary embodiment may include a spring element  320 . Cushion support assembly spring element  320  (hereinafter “spring element”  320 ) includes a resilient body  322 . Spring element body  322 , or alternately spring element  320 , is structured to be, and is, disposed between support cushion engagement portion  236  and support surface  300 . Spring element body  322  is structured to conform to support surface  300 . That is, in an exemplary embodiment, spring element body  322  corresponds to support surface  300 . Thus, spring element body  322  is shaped to generally correspond to user&#39;s respiratory interface device contour axial aspect  2 . That is, in this embodiment, spring element body  322  is shaped to extend about the user&#39;s nostrils. Spring element body  322  is structured to be coupled, directly coupled, or fixed to support surface  300 . In an exemplary embodiment, spring element body  322  can be constructed of a wide variety of resilient materials known in the art and can include, but is not limited to, a thermoplastic or thermoelastic material, including but not limited to an elastomer such as plastic, rubber, silicone, vinyl, foam, or any combination thereof. 
     In another embodiment, shown in  FIGS. 21-22 , respiratory interface device  10  is a nasal respiratory interface device  10 D in a sub-nasal surface sealing pillow configuration. As used herein, “sub-nasal surface sealing pillow” includes two pillows shaped to conform to the outer nasal surface. That is, unlike respiratory interface device pillows that extend into the nose, the “sub-nasal surface sealing pillows” are generally flat, but rise slightly above a generally planar surface. 
     In this configuration, nasal respiratory interface device  10 D is structured to be generally disposed below the patient&#39;s nose. Nasal respiratory interface device  10 D includes an elongate hollow body  400  defining a cavity  402 . Nasal respiratory interface device body  400  includes an upper side  404 . Nasal respiratory interface device body upper side  404  includes a surface defining two nostril openings  406 ′,  406 ″. In this embodiment, cushion  430  is disposed about, i.e. extending around, each nasal respiratory interface device body nostril opening  406 ′,  406 ″. As before, cushion  430  includes a body  432  and an engagement portion  436 . 
     In this embodiment, cushion body engagement portion  436  is structured to engage a user&#39;s face. Cushion engagement portion  436  is shaped to generally follow user&#39;s respiratory interface device contour  1 D in this embodiment. That is, cushion engagement portion  436  includes a longitudinal axis  450  that generally conforms to user&#39;s respiratory interface device contour,  1 D. That is, for this embodiment, and for the purpose of using consistent terminology, as used herein, the “longitudinal axis” is a line forming two loops disposed about, i.e. extending around, a user&#39;s nostril openings; that is, the surface located on the outer portion and on the lower side of a user&#39;s nose. Cushion engagement portion  436  is, in an unbiased state and when viewed along cushion engagement portion longitudinal axis  450  generally planar. 
     In this embodiment, cushion support assembly  480  includes a body  482 . Cushion support assembly body  482  is, in an exemplary embodiment, custom made for each user. That is, as noted above, a user&#39;s face may be measured, e.g. scanned, and a relevant dimensions recorded. Cushion support assembly body  482  is then made so as to generally correspond to the size, shape, and contour of the user&#39;s face. In an exemplary embodiment, cushion support assembly body  482  is then made so as to generally correspond to the user&#39;s face at the user&#39;s respiratory interface device contour,  1 D (in this embodiment). 
     In an exemplary embodiment, cushion support assembly body  482  is a ribbon-like body  482  including a wide facial side  488 , a wide interior side  489  opposite facial side  488 , and a longitudinal axis. Again, as used herein, the “longitudinal axis” is a line corresponding to two loops disposed about, i.e. extending around, a user&#39;s nostril openings. Cushion support assembly ribbon-like body  482  is shaped to generally correspond to user&#39;s respiratory interface device contour axial aspect  2 . That is, in this embodiment, cushion support assembly ribbon-like body  482  is shaped to extend about the lower side of user&#39;s nose and about (around) the nostrils. Stated alternately, cushion support assembly ribbon-like body longitudinal axis  290  generally corresponds to the user&#39;s respiratory interface device contour  1 C (in this embodiment). In an exemplary embodiment, cushion support assembly ribbon-like body  482  is generally rectangular, and planar, when viewed along cushion support assembly ribbon-like body longitudinal axis. That is, in an exemplary embodiment, a cross-section of cushion support assembly ribbon-like body  482  is generally rectangular, and planar, when viewed along cushion support assembly ribbon-like body longitudinal axis  490 . 
     Further, cushion support assembly ribbon-like body wide facial side  488  defines a support surface  500 . Cushion support assembly ribbon-like body wide facial side support surface  500  (hereinafter “support surface”  500 ) is structured to support cushion engagement portion  436 . In an exemplary embodiment, support surface  300  is structured to support cushion engagement portion  436  in a generally planar configuration. That is, as used herein, “to support cushion engagement portion  436  in a generally planar configuration” means that cushion body engagement portion  436 , when viewed along the longitudinal axis  450 , is maintained in a generally planar configuration. It is understood that support surface  500  and cushion engagement portion  436  are not planar over their entire surface. That is, support surface  300  and cushion body engagement portion  436  generally correspond to the user&#39;s respiratory interface device contour  1 D, and, support surface  500  and cushion engagement portion  436  each extend generally parallel to the user&#39;s face at any given location. That is, support surface  500  extends in a direction that is generally planar relative to the user&#39;s respiratory interface device contour radial aspect. 
     In an exemplary embodiment, cushion support assembly ribbon-like body  482 D is structured to be coupled, directly coupled, or fixed to nasal respiratory interface device body  500 . 
     As before, this exemplary embodiment may include a spring element  520 . Cushion support assembly spring element  520  (hereinafter “spring element”  520 ) includes a resilient body  522 . Spring element body  522 , or alternately spring element  520 , is structured to be, and is, disposed between support cushion engagement portion  436  and support surface  500 . Spring element body  522  is structured to conform to support surface  500 . That is, in an exemplary embodiment, spring element body  522  corresponds to support surface  500 . Thus, spring element body  522  is shaped to generally correspond to user&#39;s respiratory interface device contour axial aspect  2 . That is, in this embodiment, spring element body  522  is shaped to extend about the user&#39;s nostrils. Spring element body  522  is structured to be coupled, directly coupled, or fixed to support surface  500 . In an exemplary embodiment, spring element body  522  can be constructed of a wide variety of resilient materials known in the art and can include, but is not limited to, a thermoplastic or thermoelastic material, including but not limited to an elastomer such as plastic, rubber, silicone, vinyl, foam, or any combination thereof. 
     Accordingly, a method of using respiratory interface device  10 , i.e. any of the embodiments described above, includes the following: coupling  800  respiratory interface device cushion body  32 ,  232 ,  432  to cushion support assembly  80 ,  280 ,  480 , positioning  802  respiratory interface device cushion body engagement portion  36 ,  236 ,  426  to extend generally parallel to adjacent cushion support assembly body facial side support surface  100 ,  300 ,  500 , positioning  804  respiratory interface device  10 ,  10 A,  10 B,  10 C,  10 D over a user&#39;s respiratory orifice with the respiratory interface device cushion body engagement portion  36 ,  236 ,  426  engaging the user&#39;s respiratory interface device contour  1 A,  1 B,  1 C,  1 D. 
     Further, when positioning  804  respiratory interface device  10 ,  10 A,  10 B,  10 C,  10 D over a user&#39;s respiratory orifice with the respiratory interface device cushion body engagement portion  36 ,  236 ,  426  engaging the user&#39;s respiratory interface device contour  1 A,  1 B,  1 C,  1 D, the method includes, creating  810  a ribbon seal over the user&#39;s respiratory interface device contour. Further, when positioning  802  respiratory interface device cushion body engagement portion  36 ,  236 ,  426  to extend generally parallel to adjacent cushion support assembly body facial side support surface  100 ,  300 ,  500 , the method includes positioning  812  a respiratory interface device cushion body engagement portion  36 ,  236 ,  426  over a spring element body  122 ,  322 ,  522 . 
     In the claims, any reference signs placed between parentheses shall not be construed as limiting the claim. The word “comprising” or “including” does not exclude the presence of elements or steps other than those listed in a claim. In a device claim enumerating several means, several of these means may be embodied by one and the same item of hardware. The word “a” or “an” preceding an element does not exclude the presence of a plurality of such elements. In any device claim enumerating several means, several of these means may be embodied by one and the same item of hardware. The mere fact that certain elements are recited in mutually different dependent claims does not indicate that these elements cannot be used in combination. 
     Although the invention has been described in detail for the purpose of illustration based on what is currently considered to be the most practical and preferred embodiments, it is to be understood that such detail is solely for that purpose and that the invention is not limited to the disclosed embodiments, but, on the contrary, is intended to cover modifications and equivalent arrangements that are within the spirit and scope of the appended claims. For example, it is to be understood that the present invention contemplates that, to the extent possible, one or more features of any embodiment can be combined with one or more features of any other embodiment.