Abstract:
A holder for nasal pillow as used for respiration in the treatment of sleep apnea, is arranged to enclose the mask substantially continuously along its longitudinal axis or axial length, stabilizing the mask against the nose breathing passage openings. The holder is held in position by a soft, deformable, or flexible strap. The flexible strap, which conforms to the contour or shape of the wearer&#39;s face, directs the force holding the nasal pillow in place along the facial contour, without causing any deformation of the face tissue and sleep interfering discomfort.

Description:
BACKGROUND  
       [0001]    Masks are used for various reasons. Typically masks are interconnected with a source of breathable fluid to be inhaled by a patient. These masks are used for anesthesia and also for providing positive air pressure to a patient in the treatment of obstructive sleep apnea. In the treatment of obstructive sleep apnea, positive air pressure is provided to a patient while the patient is sleeping. Accordingly, in the treatment of obstructive sleep apnea, mask comfort is important to ensure that the patient may sleep and also to ensure that the patient complies with the treatment. For the treatment of obstructive sleep apnea, the mask must provide a sufficient seal to enable pressure to be maintained within the airway of the patient. Typical masks are bulbous and enclose a large portion of the nose and engage the face of the patient. These masks tend to produce a claustrophobic effect on the patient. Furthermore, these masks generally irritate the bridge of the nose and parts of the patient&#39;s face hindering patient comfort. Also, generally these masks are secured to a patient&#39;s head by straps to ensure that a tight seal is had, thus further presenting pressure onto the patient&#39;s nose. Additionally, the positioning and securing of the mask with the straps is cumbersome and time consuming. 
         [0002]    Some masks have been developed which are neither bulbous nor fit on a patient&#39;s nose, but consist of a pair of elongated flange members which are inserted directly into the patient&#39;s nares. While this type of mask is suitable for its intended purpose, the presentation of air directly into the patient&#39;s nares is awkward and generally uncomfortable to the patient. 
         [0003]    U.S. Pat. No. 7,178,528 Lau, discloses an adjustable, semi-rigid headgear for maintaining the proper positioning of a headgear for a noninvasive ventilation interface about a wearer&#39;s head and on the wearer&#39;s face, intended to prevent the kinking of medical gas tubing and to hold a nasal cannula in proper position as the wearer sleeps and/or changes their head&#39;s position. 
         [0004]    U.S. Pat. No. 6,119,694 Correa, discloses a nasal mask assembly having a nares or nostril seal for enclosing the nares of a patient and a pair of lateral support members for engaging the cheekbones of a patient and supporting the nasal mask assembly for sleeping. An associated headgear assembly constructed of semi-rigid members is selectively interconnected for defining a headgear. The nasal mask assembly is interconnected with depending arms of the headgear assembly by contact connectors enabling the nasal mask to be adjusted linearly and angularly with respect to the headgear assembly. The headgear assembly, in combination with the contact connectors, enables the nares seal to be quickly and easily attached and detached should the patient need to remove the mask upon waking during the sleep period as well as reattached for subsequent sleeping. The lateral arms of the mask support removes any supporting force from the patient&#39;s nose and positions the force onto a bone structure which is more suitable for supporting the nare seal. 
         [0005]    U.S. Pat. No. 6,938,620 Payne, Jr. discloses head wear adapted for use by a sleep apnea patient to position airway tubes of a nasal interface operatively connected to a positive airway pressure device. The head wear includes an elongated head strap for being worn around a head of the patient. Airway tubes are attached to the head strap, and held by the head strap in a desired position during use, when sleeping. 
         [0006]    U.S. Pat. Nos. 6,857,428 and 6,629,532, disclose a retention system for a respiratory mask adapted to engage a patient in a nasal area with flexible, elastic straps coupled to opposing sides of the respiratory mask. As would be known by those skilled in the art, a nasal pillow is used in Continuous positive airway pressure (CPAP) therapy. CPAP is a popularly used treatment for sleep apnea. An example of a nasal pillow is Miragre™ II Nasal Air Pillow System. 
         [0007]    A CPAP nasal pillow is an alternative to CPAP face masks. Unlike the mask, which covers the entire nose and mouth and part of the face, a CPAP nasal pillow is attached only to the nostrils, designed to fit in there snugly, through a pair of flared openings. CPAP nasal pillows come with a headgear that is intended to secure the pillow as well as possible, consistent with user comfort and with reducing the likelihood of dislodgement during sleep. 
         [0008]    However, conventional headgear for a nasal pillow is constructed to hold the nasal air pillow from its ends, requiring a structure which resists any shifting or twisting movement of the air pillow relative to the user&#39;s nostrils and which is displaced from the user&#39;s facial contour. When a sleeper is in a sleeping position, lying on a side, the face is no longer upright and is positioned with a side of the face, placed against surface such as a pillow. It is in this side position that the nasal pillow head gear, intended to stabilize the position of the nasal pillow, are forced against the facial contour and the facial soft tissue, causing discomfort and disrupting sleep. 
       SUMMARY  
       [0009]    This invention is an improved holder for a nasal air pillow. As is known to those skilled in the art, this invention, according to the disclosed inventive principles, is a holder used to enclose the nasal pillow surface along its axial length, on a circumferential locus describing its surface. The holder includes openings for the nasal pillow flared air openings to protrude from the nasal air pillow holder, fitting into the user&#39;s nostrils. The holder includes, connecting devices adjacent to the flared openings, shown in a preferred embodiment as connecting rings, fixed to an elastic soft strap, which is configured, for fitting in a curvilinear locus or path from proximate the flared openings, around the user&#39;s face and head, thereby providing a stabilizing force directly to the entire surface of the nasal pillow. The tension in the elastic strap is directed along the strap, as would be known to those skilled in the art, to the connecting rings displaced from the flared openings, when inserted into, the user&#39;s nostril openings. The curvilinear path of the soft elastic strap, fitted into place around the user&#39;s head and stretched producing a tension force, creates a compressive force toward the face and head, placing the length of the soft strap against the user&#39;s face and head. That compressive force holds the strap in a substantially contiguous relationship with the surface of the user&#39;s face and head, substantially along the length of the soft strap. 
         [0010]    The tension in the strap, holds the nasal air pillow holder and nasal air pillow against the users face and nostrils, when in use and the nasal air funnel openings are fitted into the user&#39;s nostrils. 
         [0011]    As would be known and understood by those skilled in the art, the use of a soft strap, in tension, which is flexible, deformable, would not create any more discomfort that would be felt by the pressure of an ordinary bed pillow, when used to hold the nasal air pillow in place 
         [0012]    The soft flexible strap is adapted to conform substantially to the contours of the user&#39;s face and direct its force along the user&#39;s facial contour. The tension force in the strap is applied from the soft strap at its points of connection to the nasal pillow holder, and from the nasal pillow holder, over the surface of the nasal air pillow. 
         [0013]    The force applied by the soft flexible head strap, applied proximate the flared air openings, to the nasal pillow holder is applied over the surface of the nasal pillow, and as, as would be understood by those skilled in the art, provides a level of control over the nasal pillow position when in use, to prevent twisting of the nasal pillow, and pulling the flared openings from the user&#39;s nostril, or shifting of the flared air openings relative to the user&#39;s nostrils, and displacing the flared openings from the user&#39;s nostrils. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS  
         [0014]      FIG. 1   a  shows a preferred embodiment of the nasal air pillow holder in the form of a single sheet, and shown separate and apart from its intended use with a nasal air pillow, as shown in  FIGS. 2 ,  3  and  4 . 
           [0015]      FIG. 1   b  shows a two part embodiment of the nasal air pillow holder of  FIG. 1   a.    
           [0016]      FIG. 2   a  shows the nasal pillow holder of  FIG. 1   a  or  1   b,  without the holder strap, as shown in  FIG. 3  and  FIG. 4 , as it would appear in an end view when wrapped around itself and held in place by a fastener, for example, VELCRO® strips and holding enclosed within it, a nasal air pillow. 
           [0017]      FIG. 2   b  shows the nasal air pillow holder of  FIG. 1   a  or  1   b,  with sheet  11 , shown instead not as a single sheet, but as a continuous substantially cylindrical sheet, substantially in the form of a cylinder, and without the holder strap, as shown in  FIG. 3  and  FIG. 4 , as it would appear in an end view holding enclosed within it, a nasal air pillow. 
           [0018]      FIG. 3  shows the nasal air pillow holder, as shown in  FIG. 1   a,  wrapped around a commercially available nasal air pillow, shown partially in phantom, and with a flexible soft strap, partially shown, attached to the nasal pillow holder connector rings. 
           [0019]      FIG. 4  shows in a schematic front view, the nasal air pillow holder, as shown in  FIG. 1   a,  and as used in place, on a user, with the soft head strap substantially in contact with the user&#39;s facial and head contour. 
       
    
    
     DESCRIPTION OF THE INVENTION  
       [0020]    The nasal air pillow holder invention, as shown and described by its inventive principles and in a preferred embodiment, generally designated by numeral  10 , is a flexible enclosure sheet shown in a preferred embodiment as a Neoprene® sheet,  11 . The sheet  11  is shown in perspective with a thickness dimension  13 , a width dimension shown along edge  15 , and a length dimension shown along edge  17 . The Neoprene® sheet may be replaced by any other suitable flexible material, as would be known to those skilled in the art. 
         [0021]    The nasal air pillow holder  10 , enclosure sheet  11 , is shown with a fastening device for fastening itself, from one side  19  of sheet  11 , to the opposite side  21  of sheet  11  in an enclosed relationship, when wrapped around the nasal air pillow  39 , as shown in  FIGS. 2   a,    2   b,    3 , and  4 . The nasal air pillow  39  is a commercially available product and is not part of this disclosed invention. In the preferred embodiment, as shown, and as would be apparent to one skilled in the art, matching Velcro® surfaces  25 , shown in phantom on side  21 , and surface  27 , on side  19 , are used to as fastening devices to fasten side  19  on side  21  at overlap area  29  at junction  27 , as shown in  FIG. 2   a.    
         [0022]    The nasal air pillow holder sheet  11   a,  is shown with a length dimension  18 , between the fastening devices  27  and  25 . 
         [0023]    The sheet  11  may be bifurcated as shown in a preferred embodiment in  FIG. 1   b.  As shown in  FIG. 1   b,  the sheet  11  is in two parts  11   a  and  11   b,  separated along the line  33 , as shown in  FIG. 1   a,  and which is shown passing through the apertures  43   a,    43   b.    
         [0024]    As explained herein, the apertures  43   a  and  43   b,  allow the nasal air pillow funnel air openings  41 , to protrude through the nasal air pillow holder sheet  11 , as shown in  FIGS. 2   a,    2   b,    3 , and  4 . 
         [0025]    Connecting rings  35   a  and  35   b,  are shown attached to sheet  11   a,  by respective clamps  45  for each ring. The clamps may be any suitable clamps, as would be known to those skilled in the art. 
         [0026]    In  FIG. 1   b,  the bifurcated sheets  11   a  and  11   b  shown in two separated parts, for purpose of explanation, as sheet  11   a  and  11   b.  In use, sheet  11   a  and sheet  11   b,  would be moved into an abutting relationship, in the direction of arrow  82 , in the form of sheet  11  as shown in  FIG. 1   a.    
         [0027]    A set of matching fasteners, shown in a preferred embodiment as fastening tab  36  attached in the area  84  of sheet  11   b,  and  86 , shown on sheet  11   a,  and opposed to tab  36 . Any suitable fastening means could be used for matching fasteners  36 ,  86 , as would be known to those skilled in the art. The fastening means  36  and  86 , may be enlarged in its width or length dimension or two or more matching fasteners  36 ,  86 , may be used displaced between the connector rings, shown for explanation on sheet  11   b,  as  35   a ′ and  35   b′.    
         [0028]    Fastening tab  36  may be used to fasten sheet  11   b  to sheet  11   a,  as in an abutting relationship, in the form of the single sheet  11 , as shown in  FIG. 1   a,  by attachment of tab  34  to area  86  on sheet  11   a,  using for example by matching fasteners  36 ,  86 , shown in a preferred embodiment as matching VELCRO® surfaces at area  86  and on the opposed underside of tab  36 , or by using any other suitable fastening means as would be known to those skilled in the art. As would be apparent to those skilled in the art, any suitable fastener may be used and the invention is not limited to the fastening devices shown or to an overlap area  29 , as shown and disclosed in a preferred embodiment. 
         [0029]    The connecting rings  35   a ′ and  35   b ′, are shown on sheet  11   b,  for explanation and in a preferred embodiment, are the same rings  35   a  and  35   b,  shown as attached to sheet  11   a.    
         [0030]    In a preferred embodiment, shown for explanation as separate connector ring pairs  35   a  and  35   b  and  35   a ′ and  35   b ′, the clamps  45 ′, holding the rings  35   a ′ and  35   b ′, are the same clamps as shown by numeral  45  attaching rings  35   a  and  35   b  to sheet  11   a.  In a preferred embodiment, as would be apparent to one skilled in the art, when the bifurcated sheet  11   b  is moved toward sheet  11   a,  in the direction of arrows  84 , and into an abutting relationship, in the same form or shape as the single continuous sheet, as shown in  FIG. 1   a,  the clamps  45  are attached to the respective opposed corners,  72 ,  74 , of sheet  11   b  as shown in a preferred embodiment, hidden under the clamps  45 ′. 
         [0031]    In this way, as would be understood by those skilled in the art, and as shown in a preferred embodiment, each connecting ring  35   a  and  35   b  is held by respective clamps  45  to sheet  11   a  and to sheet  11   b  when in an abutting relationship, as described above. 
         [0032]    As would be apparent to those skilled in the art, any suitable fastener device may be used in this invention and the invention is not limited to the fastening device shown or to an overlap area as shown and disclosed in a preferred embodiment. As would be known to those skilled in the art, two or more connector rings may be used for each of the opposed connecting rings  35   a  and  35   b.  As would be apparent to those skilled in the art, any suitable fastening device may be used in place of the connecting ring, as would be known to those skilled in the art. 
         [0033]    As shown in  FIG. 1 , there are two spaced apertures  43   a  and  43   b,  in the sheet  11 , proximate the middle of the length dimension along edge  17  and extending in a line  33 , between strap connectors  35   a  and  35   b.  Strap connecting rings  35   a  and  35   b,  referred to in the following as strap connecting rings or connectors, or connecting rings,  35   a  and  35   b,  connecting the strap  37  as shown in  FIGS. 3 and 4 , may be rings, as shown for a preferred embodiment or may be buckles, or any other suitable strap connector as would be known by those skilled in the art. 
         [0034]      FIG. 2   a,  shows the nasal pillow and holder of  FIG. 1 , in an end view, without the strap  37 , as shown in  FIGS. 3 and 4 . Sheet  11  is shown from a view toward its thickness dimension  13 , wrapped around the nasal pillow  39  and with fastener parts  27  and  25 , shown in a preferred embodiment as Velcro® surfaces, joined in overlap area  29 . 
         [0035]    As shown in a preferred embodiment, as shown in  FIGS. 2   a  and  2   b,  the curvilinear exterior  42  of the nasal pillow  39  is partially shown in phantom, where hidden by nasal air pillow end cap  53 . 
         [0036]    In a preferred embodiment, as shown in  FIGS. 1   a,    2   a  and  2   b,    3  and  4 , connector rings  35   a  and  35   b,  are shown approximately aligned in  FIG. 1   a,  with line  33 , with a mid point  34 , and the flared nasal pillow flared air openings  41   a  and  41   b,  are shown extending through the nasal air pillow holder apertures  43  to the interior  50  of the nasal air pillow  39 . 
         [0037]    In a preferred embodiment, the clamps  45 , as shown in  FIG. 1   a,  may be placed at any location along the length of the nasal air pillow holder sheet  11 , along the length dimension shown along edge  17 , or within the shorter length dimension  18  extending substantially between the connecting VELCRO® strips  25 ,  27 . As would be understood by those skilled in the art, the end parts of the length dimension shown along edge  17 , are shown included in the overlap area  29 , as shown in a preferred embodiment, in  FIG. 2   a.    
         [0038]    As would be known and understood by those skilled in the art, as the connecting rings,  35   a  and  35   b,  may be located anywhere along the length dimension shown along edge  17  of sheet  11 , the angular displacement position of the connecting rings  35   a  and  35   b,  relative to a center or central position opposed to the apertures  43   a  and  43   b,  and line  33 , as shown in  FIG. 1   a  and  FIG. 3 , may in a range from 0 degrees to an angular position within the overlap area  29 , of plus or minus 180 degrees, as shown with reference to arrow  57 , aligned at 180 degrees with the flared nasal air pillow air openings  41 . As would be understood by those skilled in the art, where the connectors  35   a,    35   b,  are within the length dimension  18 , the angular displacement from the center position or central position aligned with line  33  and apertures  43   a  and  43   b,  would be substantially plus or minus 180 degrees, as shown with reference to arrow  57 , aligned at 180 degrees with the flared nasal air pillow air openings  41   
         [0039]    As would be understood, by those skilled in the art, in a preferred embodiment, where the overlap area  29  is made sufficiently secure, the connector rings  35   a  and  35   b,  may be attached to the ends of the sheet  11  length dimension, shown along edge  17 , and, within the overlap area  29   
         [0040]    In a preferred embodiment, as shown and disclosed in  FIG. 2   b,  the nasal air pillow holder  10 , sheet  11 , is shown as a continuous substantially cylindrical sheet enclosing nasal air pillow  39  and without any fastening device  25 ,  27 , as shown in  FIG. 1   a,  to fasten the sheet  11 , in the disclosed enclosing relationship with the nasal air pillow  39 . 
         [0041]      FIG. 3  shows the strap  37  for the nasal pillow holder. The strap  37  is shown with a flat or major side dimension  61  and edge or minor side dimension  63 . As would be understood to those skilled in the art and as explained below, the tension force produced by the strap  37 , when stretched around the user&#39;s head  60 , as shown in  FIG. 4 , produce a compressive force in a direction toward the interior of strap  37  and toward the contour of the head of the user  60 , as shown by arrow  65 , in  FIG. 4 , directed against the flat or major dimension  61  and against the head and face of the user  60 . 
         [0042]    Where the strap  37  is in a curvilinear path, as for example when stretched around the user&#39;s head  60 , as shown in  FIG. 4 , the force of tension produced in the stretched strap  37 , and in the major side direction  61 , produces a second compressive force in the direction  65 , toward the surface of the user&#39;s face and head as shown in  FIG. 4 . The compressive force inward force is produced as in or with the same effect as an elastic band would produce when stretched around any object, forcing the strap into a substantially contiguous relationship with the contour of the user&#39;s face and head  60 , substantially along the length of the flat surface  61  of strap  37 , as shown in  FIG. 4 . 
         [0043]    The strap  37  may be any suitable elastomeric material enclosed in a soft resilient material, as would be known to those skilled in the art. In a preferred embodiment, the strap  37  is made from Neoprene® stretchable material. 
         [0044]      FIG. 4  shows in schematic form, and in a front view, the nasal pillow holder, shown generally by numeral  10 , with the nasal air pillow holder sheet  11 , as shown in  FIG. 1   a,  wrapped around the nasal air pillow,  39 , as shown in  FIG. 2   a,  with flared air openings  41 , held in place in the user&#39;s nostrils by the soft resilient strap  37 . The nasal pillow  39 , partially shown in phantom in  FIG. 3 , is shown in  FIG. 4 , with the nasal flared air openings  41   a  and  41   b,  partially shown placed in the user&#39;s nose for breathing communication from an air supply tube, not shown but as would be understood by one skilled in the art. 
         [0045]    The strap  37  is made from a resilient elastic material, so any tension force along the flat or major side dimension  61 , produces a compressive force in the direction of arrow  65  as when the strap  37  is stretched around the head of the user to hold the nasal pillow  10  in place. As would be known to those skilled in the art, the tension force along the flat or major side dimension  61 , would be a spring force proportional to the strap displacement, as it is stretched to fit around the user&#39;s head  60 . The tension force applied to the connectors  35   a  and  35   b,  holds the nasal air pillow, when in use, as shown in  FIG. 4 , in place against the user&#39;s  60 , face and nostrils. 
         [0046]    As may be seen in  FIG. 4 , the tension force along the flat surface  61  of the soft strap  37 , is extended to the nasal air pillow holder  11  at the point of attachment of strap connector rings  35 , shown in a preferred embodiment, proximate the nostrils of nose  75 . The tension force of the strap  37 , when stretched to fit over or around the user&#39;s head  60 , is then distributed through the connectors  35 , substantially at the location of the connectors  35 , and over the surface area of the nasal air pillow holder  10  and the sheet  11 , as shown by arrows  52 , forcing the nasal air pillow holder  11  and the nasal air pillow  39 , into its correct position, where the flared air openings  41   a  and  41   b,  are held in the users nose  75  for breathing. 
         [0047]    As shown in  FIG. 4 , a nasal air pillow holder is shown, using a strap  37 , held substantially contiguous to the user&#39;s  60 , face contour, connected to a nasal air pillow enclosure  10  Sheet  11 , for holding the nasal air pillow flared air openings  41 , and for preventing twisting or shifting of the nasal air pillow relative to a stable breathing position opposed to the user&#39;s nostrils. 
         [0048]    As shown in  FIG. 1   a,    FIG. 2   a,    FIG. 3 , and  FIG. 4 , the nasal pillow holder enclosure sheet  11  has a length dimension shown along edge  17  of sheet  11 , spaced apertures  43   a  and  43   b,  strap connectors  35   a  and  35   b,  displaced on sheet  11 , proximate the respective spaced apertures, and the sheet  11  encloses the nasal air pillow  39 , in a wrapped position. 
         [0049]    The curvilinear surface  42 , of nasal air pillow  39 , is shown in  FIGS. 2 ,  3 , and  4 . 
         [0050]    As disclosed in a preferred embodiment, in  FIG. 1   a,  sheet  11 , includes a reference central location  34 , on an alignment of the apertures  43   a  and  43   b,  as shown by alignment reference line  33 . 
         [0051]    As shown in  FIG. 4 , the tension force as shown by arrows  52 , from the elastomeric strap  37  when in place on the head  60 , of the user, is distributed over and through, the connectors  35  and the surface  19 , of said sheet  11  enclosing the nasal air pillow  39 . 
         [0052]    As shown in a preferred embodiment, in  FIG. 3  and  FIG. 4 , the strap  37  is shown looped through the connecting rings  35   a  and  35   b  and back on the surface  61 , shown interior of strap  37 , relative to its placement around the head  60  of the user. However, as would be known and understood by those skilled in the art, the strap  37  may be looped through connecting rings  35   a  and  35   b,  on the outside of strap  37  so the continuous surface of strap  37 , in the flat or major side dimension  61 , is adjacent to or contiguous, with the head and face of the user  60 . 
         [0053]    As shown and described, the enclosure means for enclosing a nasal air pillow is shown as the nasal air pillow holder  10  including sheet  11 . The aperture means is shown as apertures  43   a  and  43   b.    
         [0054]    The connector means for connecting said strap means to said enclosure means substantially adjacent said aperture means is shown as connectors or connecting rings  35   a  and  35   b.    
         [0055]    The nasal air pillow enclosure sheet  11  includes fasteners  27  and  25 , opposed to each other in the width dimension  15 , and positioned on sheet  11  to fasten the sheet in the wrapped position, as shown in  FIGS. 2   a,    3  and  4 . 
         [0056]    As shown in  FIG. 2   a,  for example, the nasal air pillow sheet  11 , the connectors can be displaced in an angular range from a position in alignment with a center or central location to a position + or −180 degrees, relative to the alignment and said central location. 
         [0057]    As shown, in  FIG. 4 , the nasal air pillow holder  11 , holds the air openings  41   a  and  441   b,  of the nasal air pillow  39 , opposed to the nasal air pillow user&#39;s  60  nostrils, as shown in  FIG. 4 , and prevents twisting or shifting of the nasal air pillow relative to it position opposed to the user&#39;s nostrils. 
         [0058]    As shown in  FIG. 3 , are enclosure means  11 , for enclosing a nasal air pillow  39 ,includes aperture means for extending the nasal air pillow air openings through the enclosure means  11 , strap means  37 , and connector means,  35   a  and  35   b,  for connecting the strap means  37 , to the enclosure means  11 . 
         [0059]    The strap means  37  is stretchable for developing a tension force produced in direction along the flat surface  61 , of the soft strap  37 , for forcing the strap means into a substantially contiguous relationship with the face of the nasal air pillow user  60 , from each of the connector means  35   a  and  35   b.    
         [0060]    The connector means  35   a  and  35   b,  includes means shown as clips  45 , for connecting the strap means and its tension force, to the enclosure means  11  and to the the nasal air pillow  39 . 
         [0061]    The nasal air pillow holder, as shown with the enclosure sheet  11 , bifurcated in sheets  11   a  and  11   b,  and includes matching fasteners on each said bifurcated sheet, for holding said bifurcated sheets in an abutting relation. As shown, the apertures  43   a  and  43   b,  are formed when sheet  11   b  abuts sheet  11   a,  where the sheet  11  is bifurcated along a line  33 , in alignment with the apertures 
         [0062]    As would be apparent to those skilled in the art, modifications may be made to the disclosed preferred embodiment, without departing from the disclosed inventive principles or the equivalent way of operation, or functions, or results achieved.