Patent Publication Number: US-2013230674-A1

Title: Mask strap head, facial or ear cushion

Description:
FIELD OF THE INVENTION 
     The present invention relates to head, facial or ear cushions for medical respiratory or traditional devices and, more specifically, to head, facial or ear cushions for preventing irritation to a patient&#39;s ears caused by straps securing the respiratory or traditional device to the face of the patient adjacent the region of the patient&#39;s mouth and/or nose. 
     BACKGROUND OF THE INVENTION 
     A number of medical respiratory procedures require the prolonged positioning of a respiratory or other device, such as a mask or cannula, in the region adjacent to or covering either a patient&#39;s nose and/or mouth. Typical applications for such devices include, for example, detecting a patient&#39;s respiratory cycles and exhaled CO 2  levels, such as in detecting and monitoring sleep apnea, or the provision of supplemental or therapeutic gas, such as air or oxygen, to a patient during treatment of a patient with sleep apnea. 
     The respiratory or traditional devices commonly used in such medical procedures, e.g., for treating a patient with sleep apnea, are typically secured onto a patient by at least one strap(s), which is typically an elastic strap, and that strap extends from the respiratory or traditional device and around the patient&#39;s head in the region of the top portion of the patient&#39;s ears, with the strap generally passing just over the upper curvature of the patient&#39;s ears, generally between an ear flap of the outer ear or auricle and the side of the patient&#39;s head. When treating a patient with sleep apnea, this typically requires that the patient wear the respiratory mask or some other device continuously for an extended period of time—typically about 6-11 hours each night so that the patient may sleep. Such extended and repeated wearing of a respiratory mask, or some other device, often results in discomfort to the patient and irritation to the patient&#39;s ears and skin due to rubbing of the strap(s), particularly in the region where the strap passes over and contacts the upper curvature of the patient&#39;s ears generally between the ear flap and the side of the patient&#39;s head. 
     While prior pads have been employed in the art, such pads are generally round or circular and, in order to provide the desired cushioning, tend to be fairly bulky and, in turn, leads to discomfort to the patient. Furthermore, none of the known pads, due to their bulkiness, can be comfortably accommodated about the curvature of the ear, between the ear flap and the side of the patient&#39;s head. 
     The present invention provides a solution to these and related problems of the prior art. 
     SUMMARY OF THE INVENTION 
     The present invention is directed to a head, facial or ear cushion for mounting to a strap of a respiratory or traditional device, either before of after the strap is attached to the mask, and generally includes an elongate, generally flattened, oval body which provides a cushioning effect for the patient in the region where the strap passes over and contacts the upper curvature of the patient&#39;s outer ears to improve comfort to the patient and reduce irritation to the patient&#39;s ears and skin due to pressure and/or rubbing of the strap(s). 
     According to the present invention, the head, facial or ear cushion may be positioned either adjacent an upper portion of the outer ear, adjacent a cheek or behind the back of the head in order to provide comfort to a patient utilizing a mask, or some other breathing apparatus, in a comfortable and streamlined manner. 
     Another object of the invention is to provide a head, facial or ear cushion which is generally much thinner than it is length and its width, e.g., the head, facial or ear cushion generally has a “flattened” oval shape which results in two elongate opposed exterior surfaces of the head, facial or ear cushion that are generally planar and extend parallel to one another so that the width of the head, facial or ear cushion is at least twice, and preferably about three to four times greater than the thickness of the head, facial or ear cushion. Due to such flattened arrangement, the two elongate opposed exterior surfaces can be readily accommodated, during use, between the upper portion of the outer ear lobe of the patient and the side of the patient&#39;s head, adjacent a cheek, or behind the back of the head without causing discomfort. 
     Still another object of the invention is to provide the head, facial or ear cushion with a thickness which is designed so that the head, facial or ear cushion can be lightly, but comfortably, sandwiched between the upper portion of the lobe of the outer ear of the patient and the side of the patient&#39;s head while still assisting with avoiding axial movement of the head, facial or ear cushion along the strap, during use. 
     Yet another object of the invention is to secure the head, facial or ear cushion in a region of the strap bearing against an upper curvature of the outer ear, generally between an ear flap of the outer ear and the side of the patient&#39;s head, by an adhesive strip, which generally includes a removable layer, covering the adhesive strip, which is to be removed prior to securing the head, facial or ear cushion about the strap. 
     The invention also relates to an head, facial or ear cushion for mounting to a strap of a respiratory or traditional device, the head, facial or ear cushion comprising an elongate flattened body defining an internal cavity for accommodating a strap of a respiratory or traditional device, the elongate body being configured so as to restrict axial movement of the elongate body along the strap, during use, and maintain the head, facial or ear cushion substantially centered with respect to an upper curvature of an outer ear, generally between the ear flap and the side of the patient&#39;s head. 
     According to one embodiment, the body is initially folded into a folded configuration, about a longitudinal centerline of the body, to define the internal cavity and at least partially enclose the strap of the respiratory or traditional device. The head, facial or ear cushion is then retained in its folded configuration by an adhesive engaging with opposed inwardly facing surfaces of the folded body adjacent the strap. 
     According to another embodiment, the flattened body is generally a flattened oval shape which has a continuous exterior surface which extends continuously and completely around the strap so as to encase the strap, and the internal cavity extends completely through the body and is defined by the exterior surface for accommodating the strap. 
     In a further embodiment, the continuous exterior surface of the body of the head, facial or ear cushion forms opposing facing first and second exterior sidewall surfaces and at least one of the exterior sidewall surfaces includes a plurality of longitudinally extending ridges separated by corresponding longitudinally extending valleys. 
     In a further embodiment, the continuous exterior surface of the body of the head, facial or ear cushion forms opposing first and second exterior sidewall surfaces of the body and the internal cavity of the head, facial or ear cushion is formed by an interior surface which extends around the internal cavity to form first and second interior sidewall surfaces, with the first and second exterior and interior sidewall surfaces defining corresponding first and second sidewalls of the body of the head, facial or ear cushion. One of the sidewalls of the body includes an access opening that extends longitudinally through the body from the exterior sidewall surface to the interior sidewall surface of the body to form overlapping sidewall flaps which define an access path through one of the first and second sidewalls of the body for inserting the strap of a respiratory or traditional device into the internal cavity of the head, facial or ear cushion and securing the head, facial or ear cushion to the strap. 
     The present invention further includes a head, facial or ear cushion for mounting to a strap of a respiratory or traditional device wherein the head, facial or ear cushion includes a rectangular body, and an adhesive strip located on an inner surface of the body and extending longitudinally parallel to and offset laterally from a longitudinal centerline of the body. The body of the head, facial or ear cushion is foldable into a folded configuration, along the longitudinal centerline of the body, to enclose the strap of the respiratory or traditional device and secure the strap in the folded configuration, by contact of the adhesive strip with opposing regions of the inner surface of the folded body. 
     In further embodiments, at least one corner of the head, facial or ear cushion may be rounded, and the body may further include an inwardly curved recess, centered approximately with respect to the separation line, to facilitate forming a curvature in body when the body is separated along the separation line, in order to provide a design which avoids the formation of strap/head, facial or ear cushion marks in the face of the patient, after wearing a medical respiratory or a traditional device or mask for a prolonged period of time. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The invention will now be described, by way of example, with reference to the accompanying drawings in which: 
         FIG. 1  is a diagrammatic side view illustration of a patient&#39;s head with a respiratory or traditional mask secured thereto by a strap; 
         FIG. 2A  is a diagrammatic front elevational illustration of a head, facial or ear cushion in its flat, unfolded flat configuration; 
         FIG. 2B  is a diagrammatic front elevational illustration of the head, facial or ear cushion in the folded, but not yet secured configuration; 
         FIG. 2C  is an enlarged diagrammatic end view illustration of the head, facial or ear cushion in the folded, but not yet secured configuration of  FIG. 2B ; 
         FIG. 2D  is an enlarged diagrammatic end view illustration of the head, facial or ear cushion shown in the final folded configuration and secured to a strap; 
         FIG. 2E  is a diagrammatic front elevational illustration of the head, facial or ear cushion with an adhesive shown in the folded configuration and attached to a strap; 
         FIG. 2F  is a diagrammatic illustration of the folded head, facial or ear cushion, separated along the separation or perforation line and curved so as to more closely conform with the upper curvature of the ear of the patient; 
         FIG. 3A  is a diagrammatic side elevational view of a second embodiment of the head, facial or ear cushion according to the present invention; 
         FIG. 3B  is a diagrammatic front elevational view of the second embodiment of the head, facial or ear cushion of  FIG. 3A ; 
         FIG. 4A  is a diagrammatic side elevational view of a third embodiment of the head, facial or ear cushion according to the present invention; 
         FIG. 4B  is a diagrammatic front elevational view of the third embodiment of the head, facial or ear cushion of  FIG. 4A ; 
         FIG. 5A  is a diagrammatic side elevational view of a fourth embodiment of the head, facial or ear cushion according to the present invention; 
         FIG. 5B  is a diagrammatic front elevational view of the fourth embodiment of the head, facial or ear cushion of  FIG. 5A ; 
         FIGS. 6A and 6B  are respectively diagrammatic side elevational views of a fifth and sixth embodiment of the head, facial or ear cushion according to the present invention; 
         FIG. 7A  is a diagrammatic side elevational view of a seventh embodiment of the head, facial or ear cushion according to the present invention; 
         FIG. 7B  is a diagrammatic front elevational view of the seventh embodiment of the head, facial or ear cushion of  FIG. 7A ; and 
         FIG. 8  is a front elevational view showing modifications to the head, facial or ear cushion according to the present invention. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     Referring to  FIG. 1 , therein is shown a diagrammatic illustration of a patient&#39;s head  10  with a respiratory or traditional mask  12  positioned over the patient mouth and nose region a strap  14  extending from one side of the mask  12  and around the back of the patient&#39;s head  10  to the other side of the mask  12 . When passing around the back of the patient&#39;s head  10 , the strap  14  passes over a vertically top most portion of the patient&#39;s outer ear, namely, an upper curvature  16  of the left outer ear  20 , generally between the ear flap  18  and the side of the patient&#39;s head  10 , and then extends around the back of the patient&#39;s head  10  and also passes over the upper curvature  16  of the patient&#39;s right outer ear  20 , generally between the ear flap  18  and the side of the patient&#39;s head  10 , which is not shown in the Figure. 
     As discussed herein above, in the prior art a region  24  of the strap  14  typically bears, presses, abrades and/or rubs against the upper curvature  16  of the ear  20 , generally between the ear flap  18  and the side of the patient&#39;s head  10 . Such pressure, scrapping, abrading and/or rubbing action generally results in, overtime, discomfort and/or irritation of the patient&#39;s skin, particularly in the area of upper curvature  16  of the patient&#39;s ear  20 . This is compounded when such pressure, scrapping and/or rubbing is repeated multiple times each night, night after night. Such pressure, scrapping and/or rubbing can easily result in unbearable discomfort which may eventually lead to compliance issues or possibly complete discontinuance of the sleep apnea treatment procedure. 
     According to the present invention, the first and the second head, facial or ear cushions  22  are initially secured to the strap  14  and each of the first and the second head, facial or ear cushions  22  are adjusted along the length of the strap  14  so as to be positioned on a side of the patient&#39;s head  10  in the region  24  of the strap  14  which normally contacts or bears against the upper curvature  16  of the outer ear  20 , generally between the ear flap  18  and the side of the patient&#39;s head  10 . Thereafter, the opposed ends of the strap  14  are then attached to the mask  12  in a conventional manner. The first and the second head, facial or ear cushions  22  are thereby located so as to provide a cushioning engagement between the strap  14  and the patient&#39;s ears  20  and/or skin, in this area, and thereby minimize discomfort and/or irritation that the patient may experience when the mask  12  is worn for a prolonged period of time, e.g, each night for many, many years. 
     As illustrated in a first embodiment illustrated in  FIGS. 2A ,  2 B,  2 C,  2 D and  2 E, the head, facial or ear cushion  22 , according to the present invention, generally comprises a body  26  having a generally rectangular profile or shape that is folded over a longitudinal line or axis to form an internal cavity  27  with an adhesive strip  28  located within the internal cavity  27  of the cushion  22  and along an inwardly facing surface  32  of the body  26 . Generally, the adhesive strip  28  extends longitudinally parallel to and offset laterally from the longitudinal centerline  30  of the body  26 . The adhesive strip  28  comprises, for example, an adhesive tape, having an adhesive  34  on both sides thereof, with one side of the adhesive tape being secured directly to the inwardly facing surface  32  of the body  26  of the head, facial or ear cushion  22 , by the first adhesive  34  on that side of the tape, and the second adhesive  34  on the second opposite side of the tape, that is, on the exposed side of the adhesive tape, being covered by a peel away, removable layer  36 . Alternately, the adhesive strip  28  may be an adhesive  34  which is applied directly to the inwardly facing surface  32  of the body  26 , with the outer surface of the adhesive strip  28  again being covered with a peel away, removable layer  36 . 
     According to a first embodiment, the body  26  of the head, facial or ear cushion  22  is approximately 3 inches long and 1.90 inches wide, in its flat, unfolded state as shown in  FIG. 2A  thereby having a width of approximately 0.90 inches and a thickness of about 0.25 of an inch when folded about a strap  14  so as to define the internal cavity  27  as described below and shown in  FIGS. 2B ,  2 C,  2 D and  2 E, for example. The thickness of the head, facial or ear cushion  22  is designed so that the head, facial or ear cushion  22  can be lightly, but comfortably, sandwiched between the upper most portion of the ear lobe  20  of the patient and the side of the patient&#39;s head  10 , without causing discomfort, and such sandwiching further assists with avoiding axial movement of the head, facial or ear cushion  22  along the strap  14 . An exterior surface, located along the folded longitudinal edge of the head, facial or ear cushion  22 , has a radius of curvature of about 0.125 of an inch. 
     Prior to use of the head, facial or ear cushion  22 , and as illustrated in  FIGS. 2C and 2D , the peel away removable layer  36  is removed from the adhesive strip  28  and then the body  26  is folded, along its longitudinal centerline  30 , generally symmetrically around the strap  14  in the region  24  in which the strap  14  would normally abut or bear against the upper curvature  16  of the ear  20 , generally between the ear flap  18  and the side of the patient&#39;s head  10 , so that the adhesive strip  28  is brought into contact with the opposing region of inner surface  32  of the body  26 , thereby forming the internal cavity  27  accommodating the strap  14  and securing the head, facial or ear cushion  22  to the strap  14  in the region  24  of the strap  14 , as generally shown in  FIG. 2E . 
     If desired, the body  26  of the head, facial or ear cushion  22  may be divided along a separation or perforation line  38  that extends from approximately a mid-point along an outer longitudinal edge  42  of the body  26 , that is, the edge  42  of body  26  located away from the upper curvature  16  of the ear  20 , and partially across the body  26  to an inner ending point  44  which is short of the longitudinal centerline  30  of the body  26 . This separation or perforation line  38  promotes cutting, ripping or separation of the material of the body  26 , along the separation or perforation line  38  prior to use. Alternatively, the head, facial or ear cushion  22  may be cut along the separation or perforation line  38  prior to packaging the head, facial or ear cushion  22 . 
     According to one present embodiment of the head, facial or ear cushion  22 , the separation or perforation lines  38  extends to an inner termination point  44  that may be short of the outer edge of the strap  14 , that is, the edge of the strap  14  away from the upper curvature  16  of the outer ear  20 , but the separation or perforation lines  38  may extend further, if so desired. As indicated, the cutting, ripping or otherwise separating the body  26 , along the separation or perforation line  38 , allows the body  26  of the head, facial or ear cushion  22  to assume a slightly curved shape or configuration which more closely conforms with to the upper curvature  16  of the outer ear  20 , between the ear flap  18  and the side of the patient&#39;s head  10 , as shown in  FIG. 2F . Such curvature of the head, facial or ear cushion  22  thereby further ensures that the head, facial or ear cushion  22  will remain in its installed and desired position along the strap  14 , i.e., the head, facial or ear cushion  22  will avoid sliding or axial movement along the strap  14  during use, thereby reducing the possibility that the head, facial or ear cushion  22  will not provide its intended cushioning effect for the upper curvature  16  of the outer ear  20 , between the ear flap  18  and the side of the patient&#39;s head  10  during use, and minimize discomfort and irritation of the patient. 
     With reference now to  FIGS. 3A and 3B , a description concerning an alternative embodiment of the head, facial or ear cushion  22  will now be discussed. According to this first embodiment, and as shown in  FIG. 3A , the body  26  of the head, facial or ear cushion  22  comprises a unitary body having a generally oval cross section that encloses and defines an internal cavity  48  which extends longitudinally completely through body  26  and this internal cavity  48  is sized to closely receive and accommodate the strap  14  of the mask  12 , during use, with a small clearance. As shown, an external surface  52  of the body  26  forms opposed first and second exterior sidewall surfaces  52 A and  52 B and internal cavity  48  is defined by an interior surface  54  which extends around internal cavity  48  and forms interior sidewall surfaces  54 A and  54 B. The cavity  48  is sized so as to closely receive and accommodate the strap  14 , and minimize axial movement of the head, facial or ear cushion  22  along the strap  14  during use of the head, facial or ear cushion  22 . That is, the opposed inwardly facing surfaces  54 A and  54 B of the internal cavity  48  engage with the strap  14  and generally restrict axial movement of the elongate body along the strap  14 . If desired, one or more bumps, protrusions, nubs, nodes, a piece of adhesive or some other frictional inducing feature, generally depicted as element  54 P, may be applied to or otherwise carried by or formed in one or more of the inwardly facing surfaces  54 A and  54 B of the internal cavity  48  and configured so as to protrude into a surface of the strap  14  and further resist sliding movement of the head, facial or ear cushion  22  with respect to the strap  14 . It is to be appreciated that the frictional inducing feature  54 P can have a variety of shapes, sizes and/or length which helps resist sliding movement of the head, facial or ear cushion  22  with respect to the strap  14 . 
     As diagrammatically shown in  FIG. 3B , the body  26  of the head, facial or ear cushion  22  is approximately 3 inches long, about 0.75 of an inch wide and about 0.25 of an inch thick. As noted above, the thickness of the head, facial or ear cushion  22  is designed so that the head, facial or ear cushion  22  can be lightly, but comfortably, sandwiched between the upper ear lobe of the patient and the side of the patient&#39;s head  10 , without causing discomfort, and such sandwiching further assists with avoiding axial movement of the head, facial or ear cushion  22  along the strap  14 . The thickness of the internal cavity  48  is approximately 0.08 of an inch and a width of the internal cavity  48  is approximately 0.58 of an inch. The exterior surface  52  at each opposed longitudinal edge of the head, facial or ear cushion  22  has a radius of curvature of about 0.125 of an inch. The head, facial or ear cushion  22  typically has a thickness of between about 3/32 of an inch to about ½ of an inch, typically about ¼ of an inch. 
     Further embodiments of the invention will now be described with reference to  FIGS. 4A and 4B ,  5 A and  5 B and  6 A and  6 B. As these embodiments are all quite similar to the above discussed embodiment illustrated in  FIGS. 3A and 3B , for example, only the differences between these embodiments and the previous embodiment of  FIGS. 3A and 3B  will be discussed in detail. 
     With respect to the embodiments of the head, facial or ear cushion  22  illustrated in  FIGS. 4A-6B  in general, in order to provide the desired cushioning effect to the patent and to space a main portion of the body  26  of the head, facial or ear cushion away from the skin of the patient, a plurality of longitudinally extended ribs are provided in at least one of the exterior sidewalls  52 A and/or  52 B of the head, facial or ear cushion  22 . As can be seen in  FIGS. 4A and 4B  and  FIGS. 5A and 5B , at least one of exterior sidewall surfaces  52 A and  52 B has a plurality of longitudinally extending elongate nubs or ridges  56 A which are each separated from one another by a parallel longitudinally extending valley  56 B. The ridges  56 A are designed to minimize the surface contact, between the head, facial or ear cushion  22  and the patient&#39;s skin, while promoting circulation in the head/facial area of the patient wearing the head, facial or ear cushion  22 . That is, the ridges  56 A assist with adequately spacing the main portion of the body  26  of the head, facial or ear cushion  22  a small distance away from the skin of the patient, during use, which improves the overall comfort of the head, facial or ear cushion  22  to a patient wearing the same. According to the embodiment of  FIGS. 4A and 4B , at least one of the exterior sidewall surfaces  52 A or  52 B of the head, facial or ear cushion  22  is provided with four ridges  56 A, while according to the embodiment of  FIGS. 5A and 5B , at least one of the exterior sidewall surfaces  52 A or  52 B of the head, facial or ear cushion  22  is provided with five longitudinally extending ridges  56 A. It is to be appreciated that the number of ridges  56 A provided on each or both of the exterior sidewall surfaces  52 A or  52 B of the head, facial or ear cushion  22  as well as the spacing between each adjacent pair of ridges  56 A can vary depending upon the particular application. In addition, the height or each of the ridges  56 A as well as the depth of each of the longitudinally extending valley  56 B can vary depending upon the particular application. 
       FIGS. 6A and 6B , in turn, illustrate an embodiment of the head, facial or ear cushion  22  in which both opposed exterior sidewall surfaces  52 A and  52 B of the head, facial or ear cushion  22  are each provided with corresponding longitudinal ridges  56 A and valleys  56 B— FIG. 6A  illustrates an embodiment having three longitudinal ridges  56 A—with the valleys  56 B located therebetween—on each of the opposed exterior sidewall surfaces  52 A and  52 B of the head, facial or ear cushion.  FIG. 6B  illustrates an embodiment having six longitudinal ridges  56 A—with the valleys  56 B located therebetween—on each of the opposed exterior sidewall surfaces  52 A and  52 B. 
     It is to be appreciated that the number of ridges  56 A provided on each or both of the exterior sidewall surfaces  52 A or  52 B of the head, facial or ear cushion  22  as well as the spacing between each adjacent pair of ridges  56 A can vary depending upon the particular application. In addition, the height of each of the ridges  56 A as well as the depth of each of the longitudinally extending valley  56 B can also vary depending upon the particular application. It is to be appreciated that the embodiments of  FIGS. 6A and 6B  eliminate the need to orient the head, facial or ear cushion  22  in any particular orientation with respect to the strap  14  when affixing the pair of head, facial or ear cushions  22  to the strap  14 , e.g., one set of ridges  56 A and valleys  56 B is always properly oriented and positioned so as to engage with the head, facial or ears of the patient during use. As noted above, the ridges  56 A and valleys  56 B create a space between the main portion of the body  26  of the head, facial or ear cushion  22  and the patient&#39;s head  10  which generally promote&#39;s the circulation of air between the head, facial or ear cushion  22  and the skin of both the patient&#39;s head and the patient&#39;s ear, thereby increasing circulation in that region and improving the patient&#39;s comfort as well as the wear characteristics of the head, facial or ear cushion  22  while avoiding the formation of “wear marks” in the skin of the patient from prolonged use of the same. In addition, it will also be appreciated that the presence of the ridges  54 A and the valleys  54 B, on both opposes exterior sidewall surfaces  52 A and  52 B of the head, facial or ear cushion  22 , allows the head, facial or ear cushion  22  to be rotated 180 degrees about and relative to the strap  14 , when one set of the ridges  54 A becomes sufficiently worn, thereby prolonging the use of the head, facial or ear cushion  22  before having to replace the same. The location and spacing of the ridges  56 A with respect to the valleys  56 B are designed to avoid the formation of strap/head, facial or ear cushion marks in the face of the patient after wearing a medical respiratory or traditional device for a prolonged period of time, e.g., overnight. 
     With reference now to  FIGS. 7A and 7B , a seventh embodiment of the present invention will now be discussed. According to this embodiment, it is not necessary to attach the head, facial or ear cushions to the strap  14  prior to the strap  14  being connected to the mask  12 . That is, according to the second through the sixth embodiments discussed above, at least one end of the strap  14  must be unconnected to the mask  12  so that at least that free unconnected end of the strap  14  can pass through the internal cavity  27 ,  48  of the first and the second head, facial or ear cushions  22  in order to secure the head, facial or ear cushions  22  to the strap  14 . Thereafter, the unconnected end of the strap  14  can be then connected/reconnected with the mask  12 , in a conventional manner, and each of the first and the second head, facial or ear cushions  22  slid along the strap  14  into their desired axial locations along the strap  14  so each of the first and the second head, facial or ear cushions  22  are correctly positioned to engage with the upper curvature  16  of the outer ear  20 , between the ear flap  18  and the side of the patient&#39;s head  10 , during use, and provide the desired cushioning effect. As noted above, the embodiment of  FIGS. 7A and 7B  allows the head, facial or ear cushions  22  to be affixed to a strap  14  without requiring at least one end of the strap  14  to be unconnected with the mask  12 , thereby facilitating both the subsequent affixing of the head, facial or ear cushions  22  to the strap  14  as well as replacement of a worn or damaged head, facial or ear cushion  22  without requiring disconnection of the strap  14  from the mask  12 . 
     According to the embodiment of  FIGS. 7A and 7B , the body  26  of the head, facial or ear cushion  22  comprises a generally oval transverse cross sectional shape that encloses and defines an internal cavity  48  which extends longitudinally completely through the body  26  from one end to the other opposite end, as with the previous embodiments. The internal cavity  48  is also sized to closely receive and accommodate the strap  14  of the mask  12  therein during use with a small amount of clearance, as with the previous embodiments. As shown, the head, facial or ear cushion  22  has an exterior surface  52  which extends around and thus generally surrounds and/or encloses the body  26  and forms opposed exterior sidewall surfaces  52 A and  52 B. The internal cavity  48  is defined by an interior surface  54  which extends generally around internal cavity  48  to form interior opposed sidewall surfaces  54 A and  54 B. The internal cavity  48  has a small clearance with the strap  14  so as to minimize axial movement of the head, facial or ear cushion  22  along the strap  14  during use of the head, facial or ear cushion  22 . That is, the opposed inwardly facing surfaces  54 A and  54 B of the internal cavity  48  typically engage with the strap  14  and generally restrict axial movement of the elongate body along the strap  14 . If desired, one or more bumps, protrusions, nubs, nodes, a piece of adhesive or some other frictional inducing element, generally depicted as element  54 P, may be applied to or otherwise carried by or formed in one or more of the inwardly facing surfaces  54 A and  54 B of the internal cavity  48  and configured so as to protrude into a surface of the strap  14  and further resist sliding movement of the head, facial or ear cushion  22  with respect to the strap  14 . It is to be appreciated that the frictional inducing element  54 P can have a variety of shapes, sizes and/or length which helps resist sliding movement of the head, facial or ear cushion  22  with respect to the strap  14 . 
     As shown in  FIG. 7B , a first one of the sidewalls  58 A of the body  26  is generally thicker than a second opposed sidewall  58 B of the body  26 . That is, the spacing between the first external sidewall surface  52 A and the corresponding first internal sidewall surface  54 A of the first sidewall  58 A is greater than the spacing between the second external sidewall surface  52 B and the corresponding second internal sidewall surface  54 B of the second sidewall  58 B. The additional thickness of the first sidewall  58 A permits an access opening  60  to be easily and conveniently formed in the first sidewall  58 A during subsequent manufacture of the head, facial or ear cushion  22 . Typically the access opening  60  is cut or otherwise formed by a “water jet” process in which the jetted water removes a portion of the first sidewall  58 A of the body  26  so as to form the access opening  60  therein. It is to be appreciated that the access opening  60  must extend along the entire longitudinal length of the body  26  of the head, facial or ear cushion  22 , from the first end to the second opposed end thereof and also from the first external sidewall surface  52 A completely through to the corresponding first internal sidewall surface  54 A of the first sidewall  58 A. As shown in  FIGS. 7A and 7B , the access opening  60  is generally formed or cut into the first sidewall  58 A at a shallow angle, e.g., about 5 degrees to about 20 degrees, with respect to the external sidewall surface  52 A and extends toward a base of the body  26 . Thereafter, the access opening  60  extends laterally across the base, generally normal to the first internal sidewall surface  54 A of the first sidewall  58 A, until reaching a base of the internal cavity  48 . That is, the access opening  60  is generally L-shaped prior to merging with the internal cavity  48 . 
     As shown in  FIG. 7A , the access opening  60  and the internal cavity  48  together form a generally U-shaped passageway which is configured and sized so as to allow the strap  14  of the mask  12  to pass through the access opening  60  and be received by and within the interior cavity  48  of the body  26 , thereby eliminating the need to detach the strap  14  from the mask  12  in order to install the head, facial or ear cushion  22  on the strap  14  or replace a worn head, facial or ear cushion. Due to the formation of the access opening  60  in the first sidewall  58 A of the body  26 , the first sidewall  58 A is divided into inner and outer sidewall sections  61 ,  62  which overlap one another and assist with retaining the strap  14 , once accommodated within the internal cavity  48 , and prevent inadvertent removal of the head, facial or ear cushion  22  from the strap  14 . As shown in  FIGS. 7A and 7B , the inner sidewall section  61  extends generally the entire height of the cavity  48  and is overlapped by the outer sidewall section  62  which typically extends over a distance of about one half of the entire height of the cavity  48  such that the access opening  60  is formed in a central region of the sidewall. Generally the shape of one or both of the inner and outer sidewall sections  61 ,  62  is altered somewhat during insertion of a strap  14  into the cavity  48 . In addition, and as a result of such arrangement, the head, facial or ear cushion  22  can be releasably secured to the strap  14 , typically without any adhesive, or other fastener, and can also be easily removed from the mask  12  and the strap  14  when desired or when replacement of the head, facial or ear cushion  22  is warranted. 
     According to this embodiment, the head, facial or ear cushion  22  has a width W of about 27/32 to 30/32 inch or so, a length L of about 3 inches and a thickness T of about 10/32 of an inch or so. It will also be appreciated that at least the sidewall  58 A or  58 B which does not include the access opening  60  may include corresponding ridges  56 A and valleys  56 B as described above, for the purposes and benefits described herein above. 
     According to still further modifications of the head, facial or ear cushion  22  as illustrated in  FIG. 8 , a bottom longitudinal edge  63  of the body  26  may include an inwardly curved recess  64 , which is centered with respect to the length L of the head, facial or ear cushion  22  and this inwardly curved recess  64  promotes retention of the head, facial or ear cushion  22  at a desired axial location along the strap  14 . The inwardly curved recess  64  forms a small curvature for engagement with the top most portion of the ear  20  of the patient and such engagement facilitates maintaining the head, facial or ear cushion  22  substantially centered with respect to the upper curvature  16  of the outer ear  20 , between the ear flap  18  and the side of the patient&#39;s head  10 , during use. It is to be appreciated that all of the exposed edges, of the inwardly curved recess  64 , are generally sufficiently rounded or otherwise contoured so as to avoid forming any cutting or scrapping edge(s) or surface(s) which may create discomfort to the patient during use. If the inwardly curved recess  64  is also used in combination with the separation or perforation lines  38 , the inwardly curved recess  64  also facilitates bending or curving of the body  26  when the body  26  is cut, ripped or otherwise separated, along the separation or perforation lines  38 , so that the head, facial or ear cushion  22  more closely conforms with the upper curvature  16  of the outer ear  20 , between the ear flap  18  and the side of the patient&#39;s head  10 . 
     According to a further implementation of the head, facial or ear cushion  22 , and as also illustrated in  FIG. 8 , at least one corner  66  of the body  26  of the head, facial or ear cushion  22  may be curved or otherwise rounded to further decrease the possibility of such corner(s) potentially causing patient discomfort and/or irritation, during use of the head, facial or ear cushion  22 . Preferably at least two or all four of the corners  66  of the head, facial or ear cushion  22  are curved, rounded or otherwise contoured so as to decrease the likelihood of an exposed edge of the head, facial or ear cushion  22  possibly poking or jabbing into the skin of the patient during use and causing discomfort. 
     It will be noted that each head, facial or ear cushion  22  is designed to be worn for a number of nights before any head, facial or ear cushion  22  becomes sufficiently worn, frayed, torn or otherwise requires replacement. That is, each head, facial or ear cushion  22  generally will be worn for a plurality of days, or possibly a few weeks or so before requiring replacement. Moreover, it is to be appreciated that each head, facial or ear cushion  22  has a sufficient axial length L so that the inwardly facing surfaces  54 A,  54 B of the head, facial or ear cushion  22  sufficiently frictionally engage with the exterior surfaces of the strap  14  so as to inhibit generally axial movement of the head, facial or ear cushion  22  along the strap  14 . 
     Also according to the present invention, the head, facial or ear cushion  22  is generally thinner than its length L and its width W, e.g., the head, facial or ear cushion  22  generally has a “flattened” oval shape which results in two elongate opposed exterior sidewall surfaces  52 A and  52 B of the head, facial or ear cushion  22  being generally planar and extending substantially parallel to one another and located fairly close to one another. That is, the two elongate opposed exterior surfaces  52 A and  52 B of the head, facial or ear cushion  22  are generally planar and extend parallel to one another so that the width W of the head, facial or ear cushion  22  is at least twice, and preferably about three to four times greater than, the thickness T of the head, facial or ear cushion  22 . Due to such flattened arrangement, the two elongate opposed exterior surfaces  52 A and  52 B of the head, facial or ear cushion  22  can be conveniently located, during use, between the upper portion of the ear lobe  20  of the patient and the adjacent side of the patient&#39;s head  10  without causing discomfort to the patient. As a result of such arrangement, the two elongate opposed exterior surfaces  52 A and  52 B of the head, facial or ear cushion  22  are located so that one exterior surface  52 A or  52 B of the head, facial or ear cushion  22  abuts against the adjacent surface of the ear lobe  20  of the patient while the other exterior surface  52 B or  52 A of the head, facial or ear cushion  22  abuts against the adjacent skin on the side of the patient&#39;s head  10 . The head, facial or ear cushion  22  has a thickness T which is designed so that the head, facial or ear cushion  22  can be lightly, but comfortably, sandwiched between the upper ear lobe of the patient and the side of the patient&#39;s head  10  so as to assist with avoiding axial movement of the head, facial or ear cushion  22  along the strap  14 . 
     According to the present invention, the head, facial or ear cushion  22  is, for example, typically manufactured from either a soft foam material, a soft cloth, a closed cell chemically crossed linked polyethylene bun foam or other similar material, which is suitable for providing a cushioned, flexible, relatively smooth and relatively non-abrasive surface which bears against the ear  20  and/or skin of the patient so as to avoid discomfort and irritation to the patient. A few possibly closed cell chemically crossed linked polyethylene bun foams are supplied by Sekisui Voltek of Lawrence, Mass. as product identifications numbers Minicel L200, L300 and L380 which have densities of 2.0 pcf, 3.0 pcf and 3.8, respectively, and Minicel L200 is the preferred foam due to its lower density. In the embodiments illustrated in  FIGS. 2A-E  and  3 A and  3 B, for example, the adhesive strip  28  typically extends the full length of the body  26  and has a width of typically between about 0.15 of an inch and 0.35 of an inch and is typically about 0.25 of an inch. 
     It is to be appreciated, that although the above description discusses the use of a pair of head, facial or ear cushions  22 , the use of more of less head, facial or ear cushions  22  is possible. For example, the use of a third and possibly a fourth head, facial or ear cushion(s), located between the pair of head, facial or ear cushions  22 , may be secured to the strap  14  and located for engaging with the back of the patient&#39;s head  10  so as to avoid irritation to the scalp and/or possibly also avoid unwanted tugging or pulling of the patient&#39;s hair by the strap  14  during use of the mask  12 . Alternatively, a single longer elongate head, facial or ear cushion may be utilized which is substantially long enough to extend generally along the strap  14  from adjacent a first connection of the strap  14  with the mask  12  to adjacent a second opposite connection of the strap  14  with the mask  12 . This single elongate head, facial or ear cushion generally avoids or minimizes irritation to the patient&#39;s cheeks, ears  20  as well as the hair and the back of the patient&#39;s head  10 . It is to be appreciated when a pair of head, facial or ear cushions  22  are utilized, if desired, each one of the pair of head, facial or ear cushions  22  can extend a longer distance along the strap  14 , either in the direction toward of the mask  12  or away from the mask  12 , so as to cover a greater surface area of the strap  14  and thereby generally avoid or minimize irritation to the patient&#39;s cheeks, ears  20 , hair and/or back of the patient&#39;s head  10 . 
     Since certain changes may be made in the above described head, facial or ear cushion for a strap of a respiratory or traditional device, without departing from the spirit and scope of the invention herein involved, it is intended that all of the subject matter of the above description or shown in the accompanying drawings shall be interpreted merely as examples illustrating the inventive concept herein and shall not be construed as limiting the invention.