Abstract:
A ventilation mask is provided. The ventilation mask comprises a body having a seal on a peripheral edge. The ventilation mask includes an access aperture having a valve associated therewith. The valve is selectively moveable between an open position, allowing objects to be place through the body and a closed position. In the closed position, the valve minimizes or prevents air leakage through the access aperture. The access aperture allows procedures to be performed on a wearer of the mask, without interrupting air flow to the wearer.

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
       [0001]    This application claims the benefit of U.S. Provisional Application No. 61/112,422, filed Nov. 7, 2008, the disclosure of which is incorporated herein. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The present invention relates generally relates to a ventilation mask. More specifically, the present invention relates to a non-invasive ventilation mask having access openings. 
       BACKGROUND OF THE INVENTION 
       [0003]    Patients who suffer from respiratory failure require positive pressure mechanical ventilation. Positive pressure mechanical ventilation can be provided with either an invasive endobronchial tube or a non-invasive tight fit mask. Accordingly, tight fit masks, such as oronasal masks eliminate the need for intubation or tracheostomy. 
         [0004]    Oronasal masks while having certain advantages over endobronchial tubes have certain deficiencies. For example, in some instances nasogastric tubes or Bronchoscopies may also be required by a user (or patient). However, the use of such a tube requires it to be placed adjacent the plastic rim of the oronasal mask that can result in breaking the seal between the mask and the user&#39;s face and cause a detrimental air leak. Other deficiencies may arise resulting in conditions such as mouth and pharynx dryness causing infections or occasionally mucous plugs in the user. Other upper airways conditions associated with the use of an oronasal mask may include nasal stuffiness, runny nose, bloody nose, or other difficulty managing oral secretions. These conditions often require treatment from a caregiver to be rectified. Some user&#39;s medical conditions do not allow the mask to be removed to deliver necessary oral or nasal care. Further, caring for patients requiring such oronasal masks often requires considerable time. Access to the patient&#39;s mouth or nose is restricted due to the undesirability of or inability to remove the mask. The lack of sufficient time for a caregiver to devote to some patients may exacerbate the conditions needed to be treated. 
         [0005]    Accordingly, it may be desirable to provide a tight-fit mask, such as an oronasal mask that can be used to provide positive pressure ventilation and provides accessibility to the patient&#39;s mouth or nose without adversely affecting the use of the mask for ventilation. 
       SUMMARY OF THE INVENTION 
       [0006]    According to an embodiment, there is provided a ventilation mask comprising a body defining an access aperture therethrough. The mask further comprises a valve associated with said access aperture and moveable between an open position to allow objects to pass through said access aperture and a closed position to close said access aperture. 
         [0007]    According to an embodiment, there is provided method of using a ventilation mask. The method comprises positioning a mask over a user&#39;s mouth and nose. The mask has a valve that is moveable between an open position to allow objects to pass through an access aperture and a closed position to close said access aperture. Air is introduced to the mask through an air delivery aperture to achieve positive pressure ventilation. A valve is opened to allow objects to be inserted through the valve and the access aperture to perform care. The valve is then closed to close the access aperture and prevent air leakage through the access aperture. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0008]    The present invention will become more fully understood from the detailed description and the accompanying drawings, wherein: 
           [0009]      FIG. 1  is a front view of an embodiment of a mask; 
           [0010]      FIG. 2  is a side view of an embodiment of a mask; and 
           [0011]      FIG. 3  is a perspective view of an embodiment of a mask. 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0012]      FIG. 1  is a front view of an oronasal mask, generally shown at  10 .  FIG. 1  shows a valve  28  in an open or accessible position.  FIG. 2  is a side view of an oronasal mask  10 .  FIG. 3  is a perspective view of an oronasal mask  10  showing the valve  28  in a closed or inaccessible position. The mask  10  may take any suitable configuration that can be used to deliver positive pressure ventilation for a user. In an embodiment, the mask  10  covers a user&#39;s nose and mouth. The mask  10  is non-invasive and does not require intubation of the user. Non-invasive positive pressure ventilation can be given by any suitable device (not shown), such as by way of non-limiting examples, volume ventilators, pressure controlled ventilators, bi-level positive airway pressure devices or continuous positive airway pressure devices. 
         [0013]    The mask  10  is preferably formed of clear plastic material and has a body  12 . The body  12  defines a peripheral edge  14  that contacts the user&#39;s face. Preferably, the rest of the body  12  extending from the peripheral edge  14  may be spaced from the user&#39;s face. The peripheral edge  14  may include a seal  16  thereon to provide a seal between the mask  10  and the user&#39;s face. Any suitable seal  16 , such as those known in the art, may be used. 
         [0014]    The mask  10  may include an air delivery aperture  18  therethrough for connection of an air supply tube (not shown) of a device for delivering positive pressure ventilation. More specifically, air delivery aperture  18  may include a connection segment  19  that can be secured to an air supply tube of a device for delivering positive pressure ventilation (not shown) as is well-known. 
         [0015]    The body  12  of the mask  10  may also include one or more connecting flanges  20 . The connecting flanges  20  may receive straps (not shown) used to secure the mask  10  on the user&#39;s face. The connecting flanges  20  may be placed at any suitable location on the body  12 . The use of such straps is well-known. While flanges  20  are shown to receive straps, it will be appreciated that any other suitable manner of securing the mask  10  about the user&#39;s nose and mouth is contemplated. By way of non-limiting example the flanges  20  may receive buckles or other devices which, in turn, receive straps. Alternatively buckles or other devices may be integrated into the body  12  for receiving straps or otherwise securing the mask  10 . 
         [0016]    The body  12  of the mask  10  may further include one or more access apertures  22 . The access aperture  22  may take any suitable configuration. As shown, the access aperture  22  is generally circular. The access aperture  22  allows objects to pass through the body  12  without the need to remove the mask  10 . This allows a caregiver to provide appropriate care to the user without interrupting the supply of air to the user. 
         [0017]    Each access aperture  22  may be bounded by a tubular portion  24 . The tubular portion  24  may extend from the body  12  in a direction generally away from the user&#39;s face. The tubular portion  24  may take any suitable configuration. As is shown, the tubular portion  24  has a generally circular cross-section. The tubular portion  24  may include an annular fastening groove  26 . The access aperture  22  and tubular portion provide an opening allowing access to the interior of the mask. That is, the interior referred to is the area between the body  12  of the mask and the user&#39;s face, when the mask  10  is properly positioned, is accessible. 
         [0018]    The access aperture  22  and the tubular portion  24  may be sized to allow medical devices, such as by way of non-limiting example, tubes, syringes or bronchoscopes to be inserted to the interior of the mask to perform therapeutic or diagnostic tasks. These tasks may include, but are not limited to oral care of the patient, nasal care of the patient or bronchoscopies. Further the opening may allow tubes, such as nasogastric tubes to be used. 
         [0019]    In order to reduce the risk of air leak from the access apertures  22 , a valve, generally indicated at  28  and best seen in  FIGS. 1 and 3  may be provided. The valve  28  is associated with the access aperture  22  and is moveable between an open position ( FIG. 1 ) and a closed position ( FIG. 4 ). In the open position, the valve  28  allows objects to pass through the body  12 . When in the closed position, the valve  28  prevents objects from passing through the body  12  and also closes the access aperture  22  to eliminate air loss therethrough. Thus, the valve  28  may be used to selectively allow access to the interior of the mask  10  in an open position and also to seal the mask  10  in a closed position. 
         [0020]    The valve  28  may include a base  30 . The base  30  may have an aperture  31  therethrough. An annular wall  32  may extend about the base  30  and is adapted to co-act with the tubular portion  24 . More specifically, the annular wall  32  may include a lip  34  that can be retained in the annular fastening groove  26  of the tubular portion  24 . 
         [0021]    The valve  28  may further include a plug generally indicated at  36  for selectively closing the aperture  31 . The plug  36  may include a frustoconical portion  38  having a contact wall  40  at one end of the frustoconical portion. The frustoconical portion  38  and contact wall  40  may be dimensioned so that the plug  36  can be inserted through the aperture  31  to close the aperture  32 . Preferably the contact wall  40  includes a generally flat surface that can be used to engage the base  30 . 
         [0022]    In one embodiment, the valve  28  may be made of any suitable resilient material. The base  30  and annular side wall  32  may be flexible so that the annular side wall  32  can be positioned about the tubular portion  24  and so that the lip  34  can be snap-fit into the annular fastening groove  26  of the tubular portion  24 . Similarly, the base  30  allows for insertion of the plug  36 , which may also be made of a resilient material, through the aperture  31 . Accordingly, the base  30  and or the plug  36  may flex in response to a force applied by the frustoconical portion  38  to open the aperture  31  sufficiently to allow the plug  36  to be inserted through the aperture  31 . The frustoconical portion  38  may act as a cam surface to expand the aperture  31 . It will be appreciated that the contact wall  40  may be sized so that it has a larger diameter than the diameter of the aperture  31 . This allows a seal to be made between the contact wall  40  and the base  30 . The positive air pressure during use of the mask  10  will urge the contact wall  40  into engagement with the base  30 . Further, it is preferred that the contact wall  40  be sized so that upon application of a suitable force, the plug  36  may be removed from the aperture  31 . 
         [0023]    The plug  36  may also be secured to a tab  42 . The tab  42  allows for a caregiver to grasp it and thereby exert a force on the plug  36 . The tab  42  can be used to apply an insertion force—to allow the plug  38  to be inserted through the aperture  31  and thereby close the valve  28 . Similarly, the tab  42  may be used to apply an extraction force—to pull the plug  38  through the aperture  31  outwardly to open the aperture  31  and thereby open the valve  28  to provide access to the interior of the mask  10 . 
         [0024]    The valve  28  may also include a suitable tether  44 . The tether  44  may be used to secure the body  30 , plug  36  and tab  42 . In this manner, the valve  28  may preferably comprise a one-piece unitary member that includes the body  30 , plug  36 , tab  42  and tether  44 . It will be appreciated, however, that the valve  28  may be formed of multiple pieces secured together. Further, the body may also include a second tab  46  on the annular side wall  32 . This second tab preferably is integrally formed as one-piece with the valve  28 . This second tab  46  may be used to facilitate removal of the valve  28  from the tubular portion  24  by providing an area that a caregiver can grasp. 
         [0025]    A valve  28  of the type described herein are known in the industry. Further, while one type of valve  28  is disclosed, it will be appreciated that any suitable valve can be used. It is preferred that the valve  28  allow selective access to the interior of the mask  10 . That is, when the valve  28  is in an open position, objects can pass through the body  12 . It is also preferred that the valve be moveable to a closed position to prevent objects from passing thought the body  12  and also minimizing air leakage. 
         [0026]    The aperture  31  is preferably sized so that it can receive various objects, such as tubes, syringes or bronchoscopes. When the plug  36  is removed from the aperture  31 , a tube or other object (not shown) can be placed through the aperture  31 . Preferably, the interior edge of the base  30  that defines the aperture  31  may contact the tube or other object to minimize air leakage. The tube or other object can be used to provide temporary oral or nasal care. Upon completion of the task, the tube or other object is removed and the plug  36  can be inserted through the aperture to close the valve  28 . Alternatively, the aperture  31  provides an access to allow a more permanent object, such as a nasogastric tube to pass trough the mask  10 . The base  30  can contact such a tube and provide a seal to minimize air leakage. 
         [0027]    In order to facilitate care giving, the access aperture  22  and tubular portion  24  may preferably be oriented on the body  12  such that they aid it providing care to the patient. That is, the access aperture  22  and tubular portion are preferably angled such that when an object is placed therethrough it may be directed to the user&#39;s mouth or nose. By having the access aperture  22  and tubular portion  24  angled in this manner, any tube, or other object entering through the access aperture  22  will most preferably be directed toward the user&#39;s mouth or nose. 
         [0028]    It will be appreciated that while one access opening  22  is shown in the drawings, any number of access openings  22  may be used. Similarly, a valve  28  may be supplied for each access opening. 
         [0029]    In use of the mask  10 , the mask  10  is placed on a user such that the seal  16  on the peripheral edge  14  is disposed about the user&#39;s mouth and nose. The mask  10  is secured to the user by any suitable means such as suitable stops. Preferably the mask  10  may be tightly fit to the user. The access aperture  22  may be closed by valve  28 . This may be achieved by placing the lip  34  into the annular fastening groove  26 . The valve  28  may be placed in the closed position by inserting the plug  36  through the aperture  31 . Positive pressure ventilation is then achieved by introducing air or oxygen into the interior of the mask  10  through the delivery aperture  18 . The positive pressure urges the contact wall  40  with the base  30  to minimize or eliminate air leakage through the valve  28 . 
         [0030]    When desired, access to the interior of the mask  10  can be achieved to perform tasks, such as oral or nasal care. In order to access the interior of the mask  10 , a caregiver may open the valve by grasping the tab  32  and removing the plug  36  from the aperture  31 . A tube or other object (not shown) may be inserted through the aperture  31 . Preferably, the tube or other object has a diameter close to or greater than that of the diameter of the aperture  31 . In this manner, the base  30  may engage the tube or other object and provide a seal to minimize air leakage during any procedure. The tube or other object is aided in being directed to the user&#39;s mouth or nose due to the orientation of the access opening  22  and tubular portion  24 . 
         [0031]    Upon completion of any operation, the caregiver may close the valve  28 . To accomplish this, the caregiver extracts the tube or other object from the access aperture  22  trough the aperture  31 . The tab  42  is grasped and the plug  36  is inserted through the diameter of the aperture  31  until the contact wall  40  passes through the aperture  31 . The contact wall  40  engages the base  30  to provide a seal. 
         [0032]    It will be appreciated that in some applications, the tube or other object may need to remain for a relatively longer duration. For example, a nasogastric tube may remain for a relatively longer time to facilitate care for the user. 
         [0033]    While the mask  10  described above is in connection with an oronasal mask, it will be appreciated that any type of non-invasive ventilation mask may be used. By way of non-limiting examples, a nasal mask or a full face mask may also be used. In each type of mask, the access openings may include any suitable valve thereon for allowing selective access to the interior of the mask and selective closing of the valve to restrict access to the interior of the mask and to minimize air leakage. 
         [0034]    The foregoing description is considered illustrative only. The terminology that is used is intended to be in the nature of words of description rather than of limitation. Many modifications and variations will readily occur to those skilled in the art in view of the description. Thus, the foregoing description is not intended to limit the invention to the embodiments described above. Accordingly the scope of the invention as defined by the appended claims.