Patent Publication Number: US-11642482-B2

Title: Liner and retaining member for use with respiratory mask

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application claims the benefit of U.S. provisional application Ser. No. 62/648,895 filed Mar. 27, 2018, the disclosure of which is hereby incorporated in its entirety by reference herein. 
    
    
     TECHNICAL FIELD 
     Embodiments relate to a respiratory mask, a retaining member and liner for use with a respiratory mask, and combinations thereof. 
     BACKGROUND 
     A respirator is used to protect a user from inhaling dangerous substances, such as chemicals and particulate matter. A respirator typically includes a mask body for covering the user&#39;s nose and mouth, and one or more cartridges or canisters which include filters for removing the dangerous substances from the air inhaled by the user. Most respirator masks currently available are made from silicone, rubber, vinyl, or a nylon-based fabric. These materials are typically water and gas impermeable which can block off pores, cause sweating, and create pressure marks on the face, causing discomfort for the user. Since many users wear respirators for a significant part of each day, they need masks that are ergonomic and do not impose a physical burden even during periods of extended wear or environmental extremes such as high temperature and humidity. 
     Obstructive sleep apnea is a serious and potentially fatal medical condition in which a person&#39;s airway becomes physically blocked multiple times during sleep, restricting oxygen intake and causing the person to awake gasping for breath. Possible effects of the condition include extreme fatigue, high blood pressure, strokes, heart attacks, and sometimes even death. One of the most common treatments of obstructive sleep apnea is the use of a continuous positive airway pressure (CPAP) machine. These machines deliver a continuous flow of pressurized air to the airway through a hose and mask fitted to the face. Patient compliance is a major problem with CPAP users, however, due to discomfort, air leaks, and general ineffectiveness. It is estimated that up to 50% of users discontinue use. 
     As with respirators, most CPAP masks currently available are made from silicone, rubber, vinyl, or a nylon-based fabric. These materials are typically water and gas impermeable, which can block off pores, cause sweating, and create pressure marks on the face, increasing the discomfort of the mask. Furthermore, most mask manufacturers recommend against the use of skin or face cream with CPAP masks such the mask material directly contacts the skin. This is a problem for many users, especially those that have dry skin and depend on night cream for skin care. 
     SUMMARY 
     In one or more embodiments, a respiratory mask includes a mask body having a face-engaging portion. At least one retaining member is connected to the mask body, the at least one retaining member including at least one engaging member for receiving a liner and tethering the liner to the respiratory mask to generally overlie the face-engaging portion. 
     In one or more embodiments, a retaining member for use with a respiratory mask includes a flexible elongated body having a central portion and opposing ends on either side of the central portion, the body having a bottom surface arranged to be attached to the respiratory mask. At least one engaging member extends from the body for receiving a liner and tethering the liner to the respiratory mask. 
     In one or more embodiments, a liner for use with a respiratory mask having a face-engaging portion and a retaining member includes a liner body constructed from an absorbent material, the liner body having an outer edge, an inner edge, and an opening bounded by the inner edge. When the liner is positioned between the face-engaging portion and a face of a user, an extending portion of the liner body is defined which extends outwardly beyond the face-engaging portion, the extending portion including at least one aperture for engaging the retaining member to tether the liner to the respiratory mask. 
     In one or more embodiments, a kit for use with a respiratory mask includes at least one liner including a liner body constructed from an absorbent material, the liner body having an outer edge, an inner edge, and an opening bounded by the inner edge. The kit further includes at least one retaining member arranged to be connected to the respiratory mask, the at least one retaining member including at least one engaging member for receiving the liner and tethering the liner to the respiratory mask. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG.  1    is a top plan view of a liner according to an embodiment, such as for use with a respiratory mask; 
         FIG.  2    is a top plan view of a liner according to another embodiment; 
         FIG.  3    is a top plan view of a liner according to yet another embodiment; 
         FIG.  4    is a perspective view of a retaining member according to an embodiment; 
         FIG.  5    is a top plan view of the retaining member; 
         FIG.  6    is a top perspective view of the retaining member connected to a top side of a respirator; 
         FIG.  7    is a rear view of the retaining member connected to the top side of a respirator; 
         FIG.  8    is front perspective view of the retaining member connected to the top side of a respirator; 
         FIG.  9    is a side view of the retaining member connected to a respirator; 
         FIG.  10    illustrates a liner retained on a respirator; 
         FIG.  11    is a top view of the liner engaged by the hooks of a retaining member on the top side of a respirator; 
         FIG.  12    is a bottom view of the liner engaged by the hooks of a retaining member on a bottom side of a respirator; 
         FIG.  13    is a top perspective view of a retaining member on a CPAP mask; 
         FIG.  14    is perspective view of a retaining member on an oxygen mask; and 
         FIG.  15    is a perspective view of a retaining member according to another embodiment. 
     
    
    
     DETAILED DESCRIPTION 
     As required, detailed embodiments of the present invention are disclosed herein; however, it is to be understood that the disclosed embodiments are merely exemplary of the invention that may be embodied in various and alternative forms. The figures are not necessarily to scale; some features may be exaggerated or minimized to show details of particular components. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a representative basis for teaching one skilled in the art to variously employ the present invention. 
     Embodiments disclosed herein provide a respiratory mask and accessories for use with a respiratory mask which are capable of improving the comfort, effectiveness, and/or user compliance of respiratory masks. 
     With reference to  FIGS.  1 - 3   , a liner for use with a respiratory mask, such as a respirator  100  (see  FIGS.  6 - 12   ), is illustrated and designated generally by reference numeral  10 . In use, the liner  10  may be positioned between the respiratory mask and the face of a user, such as to absorb moisture, maintain proper positioning of the respiratory mask, and to greatly reduce or eliminate air from leaking between the respiratory mask and the user&#39;s face. Although the liner  10  is described herein primarily in relation to use with a respirator  100 , it is understood that the liner  10  is not limited to use with respirators, and that the description provided herein is equally applicable to use of the liner  10  with other types of respiratory masks such as, but not limited to, CPAP masks  200  (see  FIG.  13   ) or oxygen masks  300  (see  FIG.  14   ). 
     In one embodiment, the liner  10  includes a liner body  12  having an outer edge  14 , an inner edge  16 , and an opening  18  bounded by the inner edge  16 . The liner body  12  may be generally oval-shaped, elliptical, round, or triangular, or have any other shape appropriate for use with a respiratory mask and is not limited to the shapes depicted herein. The opening  18  is designed to at least partially receive the nose, mouth, or both nose and mouth, depending upon the type of respiratory mask. The opening  18  may be generally elliptical or oval-shaped as shown, but is not intended to be limited to these shapes. 
     With reference now to  FIGS.  4  and  5   , a retaining member  50  can be connected to the respiratory mask and provided to receive and engage the liner  10 , allowing the liner  10  to be tethered to the respiratory mask and to be retained in a desired position with respect to the respiratory mask. The retaining member  50  includes a body, which in one embodiment may be an elongated body  52  having a central portion  54  and opposing ends  56  on either side of the central portion  54 . The retaining member  50  further includes at least one engaging member, which in one embodiment may include a post or hook  60  having a proximal end  62  and a distal end  64 , where one hook  60  may be provided at or near each end  56  of the body  52 . The retaining member  50  and included hooks  60  may be constructed from any suitably flexible and durable material, such as a plastic or rubber material. Resilience of the retaining member  50  and hooks  60  may be advantageous in conforming the elongated body  52  to the respiratory mask, engaging and retaining the liner  10 , and preventing damage of the retaining member  50  in the event that an external force is applied to the retaining member  50  during use of the respiratory mask. As shown, the central portion  54  of the body  52  may be narrower than the ends  56 , which may also facilitate flexibility of the retaining member  50 . The central portion  54  may also include a marker  66  identifying a center of the body  52  for facilitating alignment and symmetrical placement on the respiratory mask. Although an elongated body  52  is shown herein, the body  52  is not limited to this configuration, and it is contemplated that the body  52  could alternatively have other shapes with one or more engaging members extending therefrom. 
     In one embodiment, each hook  60  extends upwardly from the body  52  at its proximal end  62 , and then extends outwardly or laterally with respect to the body  52  to terminate in the distal end  64 , where the distal end  64  may extend beyond the body  52 . The hooks  60  may have rounded distal ends  64  and may have narrower distal ends  64  compared with the proximal ends  62 , both of which may facilitate receiving and retaining the liner  10  on the retaining member  50 . Of course, the retaining member  50  and the hooks  60  are not limited to the configuration shown and described herein. For example, instead of two spaced hooks  60 , it is contemplated that only one hook or more than two hooks could be provided. In addition, the post or hook  60  may have a different configuration, such as extending upwardly from the body  52  and having a narrower proximal end  62  compared with the distal end  64 . The retaining member  50  may alternatively include another type of engaging member altogether, such as a clip  68  (e.g., hinged, spring-loaded, alligator, etc.) or the like as illustrated in  FIG.  15   . 
     As shown in  FIGS.  1  and  2   , the liner  10  may have one or more apertures sized to be received by the hooks  60  for tethering the liner  10  to the respiratory mask and retaining a desired position of the liner  10 . In the illustrated embodiment, a first or top pair of spaced apertures  70  may be adjacent a first end  72  of the liner  10 , and a second or bottom pair of spaced apertures  74  may be adjacent a second end  76  of the liner  10 . The first and second pairs of apertures  70 ,  74  may be generally circular or oval-shaped as shown, but are not intended to be limited to these shapes. The configuration of the apertures  70 ,  74  can be designed to correspond to the configuration of the hooks  60  and the retaining member  50 . As such, although a pair of apertures  70 ,  74  is shown at each end  72 ,  76  of the liner  10 , the liner  10  is not limited to this embodiment. Alternatively, for example, apertures may be provided on only one end  72 ,  76  of the liner  10 , or a single aperture or more than two apertures may be provided at one or both ends  72 ,  76  or on other portions of the liner  10 . 
     Turning to  FIGS.  6 - 9   , the retaining member  50  may be connected to a respiratory mask, such as a respirator  100 , having a mask body  102  with a front side  104 , a rear side  106 , a top side  108 , and a bottom side  110 . As shown, in one embodiment the hooks  60  may be oriented toward the rear side  106  of the respiratory mask, away from a face-engaging portion  112  on the front side  104 . The retaining member  50  can be affixed to the respiratory mask by any method, such as with an adhesive or with a hook and loop material to join a bottom surface  69  of the retaining member  50  to the mask body  102 . The retaining member  50  can be removably attached to the mask body  102  so that it can be repositioned or removed if necessary. Alternatively, the retaining member  50  could be integrally formed with the mask body  102  during manufacturing, such as via injection molding. In another embodiment, a kit including one or more liners  10  and retaining members  50  could be provided for use in retrofitting a respirator  100 , CPAP mask  200 , oxygen mask  300 , or other respiratory mask. 
       FIGS.  10 - 12    depict a liner  10  tethered to a respirator  100  via one or more retaining members  50 .  FIG.  10    illustrates alignment of the opening  18  with the face-engaging portion  112 , wherein retaining members  50  can be positioned on the mask body  102  with placements that engage and properly align the liner  10  to generally overlie the face-engaging portion  112 .  FIG.  11    illustrates engagement of the first pair of apertures  70  with a retaining member  50  on the top side  108  of the respirator  100 , and  FIG.  12    illustrates engagement of the second pair of apertures  74  with a retaining member  50  on the bottom side  110  of the respirator  100 , such that the liner  10  is retained in a desired position with respect to the respirator  100 . While retaining members  50  are shown positioned on the top and bottom sides  108 ,  110  of the mask body  102 , it is understood that retaining members  50  could additionally or alternatively be positioned on the side or other regions of the respiratory mask and corresponding apertures formed in different portions of the liner  10 . 
     The features of respirator  100  described above with reference to  FIGS.  6 - 12    may also be applicable to the CPAP mask  200  shown in  FIG.  13    and the oxygen mask  300  shown in  FIG.  14   , wherein the respiratory mask features described for respirator  100  are given like reference numerals with the substitution of a “2” prefix for the CPAP mask  200  and with the substitution of a “3” prefix for the oxygen mask  300 . 
     The outer edge  14  of liner  10  may have a shape scaled to a general shape of the face-engaging portion  112 ,  212 ,  312  (see, for example,  FIGS.  8  and  13 - 14   ) of the respiratory mask  100 ,  200 ,  300 . As best shown in  FIG.  10   , a perimeter of the liner outer edge  14 , which may be continuous or discontinuous, is larger than a perimeter of the face-engaging portion  112 , wherein the outer edge  14  extends outwardly beyond the face-engaging portion  112  around at least part of the perimeter of the face-engaging portion  112 . As such, as illustrated in an exemplary manner in  FIGS.  1  and  3    by the broken line, the liner body  12  has a first portion  20  which will be disposed inward of the perimeter of the face-engaging portion  112  when the liner  10  is tethered to the respiratory mask, and a second, extending portion  22  which will be disposed outward of the perimeter of the face-engaging portion  112  in a freely extendible manner when the liner  10  is tethered to the respiratory mask. In general, the area of the extending portion  22  may comprise at least about 5%, 10%, or 15% of the area of the liner body  12 , but larger proportions of area represented by the extending portion  22  are also contemplated. 
     Once the liner  10  is engaged by the retaining member  50  on the respiratory mask  100 ,  200 ,  300 , the user may fit his/her nose and/or mouth (as applicable) into the opening  18  and secure the respiratory mask to his/her head, such as with straps. Securing the respiratory mask releasably holds the liner  10  between the face-engaging portion  112 ,  212 ,  312  and a user&#39;s face, such that the liner  10  may regulate air flow and reduce air leaks between the face-engaging portion and the user&#39;s face. The liner  10  may be adjusted if necessary, such as around the nose and mouth, by pulling outward on the protruding extending portion  22  while the respiratory mask is secured, thereby providing a customized fit for a particular user. The liner  10  is held in place by the retaining member  50  as well as the pressure of the respiratory mask upon the user&#39;s face, and the liner  10  is easily removable and replaceable when the respiratory mask is removed. The outer edge  14  and extending portion  22  will extend outwardly from the face-engaging portion  112 ,  212 ,  312  and may generally follow the contours of the user&#39;s face. The outer edge  14  of the liner  10  loosely protrudes beyond the face-engaging portion such that the extending portion  22  may be in non-adhering, non-sealing communication with a user&#39;s face. In this manner, the liner  10  and its extending portion  22  may serve to reduce air leaks from the perimeter of the face-engaging portion by acting as a baffle to regulate, limit, or diffuse air flow between the respiratory mask and the skin. 
     During use, it may be necessary for the user to remove the respiratory mask temporarily. For example, a user may wish to remove a respirator  100  in certain instances, such as to have a conversation with a coworker, to drink or eat, or to take a break during a job. A CPAP user may wish to remove his/her CPAP mask  200  while in use, such as during the night to use the restroom or to get a drink of water. In a hospital or home setting, a user may need to have an oxygen mask  300  removed for a temporary period, such as to eat, drink, or take medication. According to the embodiments disclosed herein, when the user removes the respiratory mask, the liner  10  is retained in position on the respiratory mask by the retaining member  50 . Accordingly, if a user needs to remove the respiratory mask for any reason, the user will not have to reposition or replace the liner  10  when he/she puts the respiratory mask on again. When the user does wish to replace the liner  10 , the liner  10  is disposable and may be easily removed from the retaining member  50 , discarded, and then replaced with another liner  10 . Advantageously, use of the liner  10  prevents direct skin contact with the mask material, decreasing the need to clean the respiratory mask as frequently. 
     Since the apertures  70 ,  74  may be provided in the extending portion  22  of the liner  10 , the apertures  70 ,  74  do not alter the function of the liner  10  or its interface with the face-engaging portion  112 ,  212 ,  312 . As such, the liner  10  described herein can be used with a respiratory mask whether or not a retaining member  50  is associated with the respiratory mask or whether or not engagement of the liner  10  with a retaining member  50  is utilized. The apertures  70 ,  74  do not increase the overall footprint of the liner  10 , and do not require the liner  10  to be manufactured with auxiliary attachment members. However, alternative embodiments are also contemplated where instead of or in addition to having apertures  70 ,  74  in the extending portion  22  set inwardly from the liner outer edge  14 , the extending portion  22  may include loops or tabs  80  which extend outwardly from the liner outer edge  14  and include apertures  70 ,  74  as illustrated in  FIG.  3   . Still further, such tabs/loops  80  or other portions of the liner  10  could include adhesive for removably affixing the liner  10  to part of the respiratory mask. In an embodiment where the engaging member includes a clip-type structure instead of a hook  60 , a liner  10  without apertures  70 ,  72  could be utilized. 
     According to an embodiment, the liner body  12  may be constructed from a single layer of absorbent material, wherein the thickness of the liner body  12  may be between about 0.005 to 0.05 inches, although these dimensions are not intended to be limiting. In one embodiment, the material may include cotton. In another embodiment, the material may include another material, such as silicone, with cotton embedded therein. However, it is understood that any material with suitable absorption and comfort properties may be used. In further accordance with an embodiment, the material used for the construction of the liner body  12  may be stretchable to aid in adjusting and customizing the fit of the liner  10  to a particular user as described above. The liner  10  may also include a notch  78  or indented section at one end  72  thereof to correspond with the nose region of a user, which may provide a more unobstructed line of sight for the user when the liner  10  is retained in position on the respiratory mask. 
     Copper is a natural mineral having human nutritional benefit. Copper is also known to provide antimicrobial and potential wound healing properties. In one embodiment, the liner described herein may be manufactured with a copper or copper oxide material, such as CUPRON®. 
     Due to the moisture content of the air, facial perspiration (such as due to contact with the mask material), and oil from the skin, the respiratory mask  100 ,  200 ,  300  may slip on the user&#39;s face, thus leaking air. The absorbent material of the liner  10  may function to absorb moisture and/or oils from the user&#39;s skin and wick it away from the face and the face-engaging portion  112 ,  212 ,  312 , enabling the respiratory mask to maintain a consistent and comfortable position with respect to the user&#39;s face when in use. As a result, proper positioning of the face-engaging portion with respect to the user&#39;s skin may be maintained, thus eliminating or greatly reducing air leaks and facilitating the ability for a user to wear their respiratory mask more comfortably. 
     The single layer construction of the liner  10  may act as a sort of “second skin” upon the user&#39;s face. As such, the liner  10  is able to provide its functions without detracting from the prescribed fit of the respiratory mask  100 ,  200 ,  300  since the liner  10  does not appreciably alter the distance of the face-engaging portion  112 ,  212 ,  312  from the user&#39;s face. Pressure markings from the face-engaging portion on a user&#39;s face may also be reduced or eliminated by use of the liner  10 . Furthermore, the absorbent liner material may make use of facial creams possible while wearing a respiratory mask, since direct contact of the skin with the mask material is avoided. 
     Respiratory masks are offered in various shapes and sizes, including full-face, nasal, child-sized, and partial-face (hybrid) configurations. Full-face masks typically include a wider bottom region for covering the mouth area and a narrower upper region for covering the nasal area. Nasal masks generally cover the nasal area and not the mouth area. Child-sized masks may have a proportionally smaller size. Partial-face (hybrid) masks generally cover the mouth and may include a nasal interface. It is therefore contemplated that the outer edge  14  of liner  10  may have a shape similar to a general shape of the face-engaging portion for a selected respiratory mask, wherein the shape of the outer edge  14  may represent a scaled version of the general shape of the face-engaging portion. 
     The liner  10  and the retaining member  50  disclosed herein may facilitate a more comfortable and effective mask-wearing experience for the user by contributing to a good fit of a respiratory mask, providing comfort to the user, eliminating moisture, and reducing or eliminating air leaks. Furthermore, tethering the liner  10  to the respiratory mask via the retaining member  50  makes it easy to remove the respiratory mask temporarily and then secure the mask at a later time without having to reposition or replace the liner  10 . 
     While exemplary embodiments are described above, it is not intended that these embodiments describe all possible forms of the invention. Rather, the words used in the specification are words of description rather than limitation, and it is understood that various changes may be made without departing from the spirit and scope of the invention. Additionally, the features of various implementing embodiments may be combined to form further embodiments of the invention.