Abstract:
A method for ventilating a patient in which nasal mask having an exhalation scoop formed of a flexible or resiliently deformable material, fixed adjacent a lower portion of mask, is positioned to overlie an upper lip of a patient. When needed, the exhalation scoop is folded back on itself to provide access to the patient&#39;s mouth.

Description:
CROSS REFERENCE TO RELATED APPLICATION 
     This application claims priority from U.S. Provisional Application Ser. No. 62/394,405, filed Sep. 14, 2016. 
    
    
     BACKGROUND OF THE INVENTION 
     The present invention relates to improvements in anesthesia masks and ventilation masks. 
     During surgery a patient usually is placed under anesthesia. The most common delivery system consists of canisters containing anesthesia gases and oxygen, a system of regulating the gas flow and the patient&#39;s breathing, and a device ensuring the potency of the patient&#39;s airway for breathing, oxygenation and the delivery of the anesthetic gas mixture. A ventilation mask is used to provide oxygen to the patient either during emergency and/or elective airway management, which includes but is not limited to: before a patient is anesthetized for surgery while the patient is sedated during the surgery or procedure; while the patient is recovering from anesthesia; after the patient has recovered from anesthesia; and during any event where a patient requires supplemental oxygen. However, conventional ventilation masks are less then ideal. 
     Moreover, situations may arise during surgery that require rapid intubation of a patient. Full face masks, i.e. masks covering both the nose and mouth of a patient are problematic in emergency situations since a mask must be removed to uncover the mouth of a patient for intubation. However, removing the mask also removes oxygen support. 
     In our co-pending PCT Application Serial Nos. PCT/US2014/44934, PCT/US2015/034277 and PCT/US2015/044341 (hereinafter the &#39;934, &#39;277 and &#39;341 PCT applications), we provide improved ventilation/anesthesia masks that overcome the aforesaid and other problems with the prior art by providing, in one aspect, a combination mask comprising a nasal portion or mask and an oral portion or mask defining respectively a nasal chamber and an oral chamber, detachably connected to one another wherein the nasal mask may be used separately or connected to the oral mask as a combination nasal/oral mask. We also provide a nasal mask with one or more ports, and various strap systems for holding the mask on a patient&#39;s face. We also provide a nasal only mask with one or more sensors for sensing end-tidal CO 2  or other gases, and for scavenging gases. See our co-pending PCT Application Serial No. PCT/US16/037070 (hereafter the &#39;070 PCT application). Such combination nasal/oral masks and nasal only masks are available commercially from Revolutionary Medical Devices, Inc. of Tucson, Ariz., under the trademark SuperNO 2 VA®. 
     SUMMARY OF THE INVENTION 
     The present invention provides improvements in nasal masks such as described in our aforesaid PCT applications, by providing an exhalation scoop adjacent the bottom of the nasal mask to overlay at least in part the upper lip of a patient, when the mask is worn. The exhalation scoop may be formed of a flexible, preferably resiliently deformable material, and fixed to the exterior of the mask by mechanical clips or the like, or an adhesive. Alternatively, the exhalation scoop may be formed with a lip to fit in a matching groove in the outer surface of the nasal mask, or formed integrally with the mask. The exhalation scoop is flexible so as to permit a surgeon to compress or push the exhalation scoop out of the way to permit access to the patient&#39;s mouth, while the nasal mask remains on the patient. Alternatively, the exhalation scoop may be folded back on itself leaving access to the patient&#39;s mouth, while the nasal mask remains on the patient. 
     In one aspect the invention provides a nasal mask having exhalation scoop formed of a the flexible or resiliently deformable material, fixed adjacent a lower portion of mask, adapted to overlie an upper lip of a patient when the mask is worn. 
     In another aspect the exhalation scoop is adapted to be pressed out of the way to permit access to the mouth of a patient. 
     In still another aspect the exhalation scoop is adapted to be folded back on itself to permit access to the mouth of a patient. 
     In yet another aspect, the mask includes an end-tidal CO 2  port for sampling exhaled CO 2  expelled from a mouth and/or nose of a patient. 
     In still yet another aspect the mask includes a ventilation port adapted to attach to an anesthesia machine, ventilation machine, hyperinflation bag or other ventilation or gas accessory. 
     In a still further aspect the mask further includes an oxygen port adapted for connection to an oxygen source for supplying oxygen to an interior of the mask. 
     In another aspect, the mask has tabs or eyelets for attaching one or more mask straps. 
     In yet another aspect the exhalation scoop is fixed to the mask or formed integrally with the mask. 
     The present invention also provides a method for ventilating a patient, comprising providing a nasal mask having exhalation scoop formed of a the flexible or resiliently deformable material, fixed adjacent a lower portion of mask, and adapted to overlie an upper lip of a patient when the mask is worn, and when needed, moving the exhalation scoop out of the way to provide access to the patient&#39;s mouth. 
     In one aspect of the method the exhalation scoop is pressed out of the way to permit access to the mouth of a patient. 
     In another aspect of the method the exhalation scoop is folded back on itself to permit access to the mouth of a patient. 
     In still yet another aspect the method includes providing a nasal mask with a exhalation scoop as described above, and monitoring end-tidal CO 2  port by sampling exhaled CO 2  expelled from a mouth and/or nose of a patient using an end-tidal CO 2  monitor. 
     In still yet another aspect, the mask is attached to an anesthesia machine, ventilation machine, hyperinflation bag or other ventilation or gas accessory, or to an oxygen source for supplying oxygen to an interior of the mask. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Further features and advantages of the present invention will be seen from the following detailed description, taken in conjunction with the accompanying, wherein 
         FIG. 1A-1D  are front, rear, top and perspective views respectively, of a nasal mask incorporating an exhalation scoop in accordance with the present invention; 
         FIG. 2  is a perspective view showing nasal mask with an exhalation scoop in accordance with the present invention on a patient; 
         FIG. 3  is a view similar to  FIG. 2 , showing the exhalation scoop compressed or pushed out of the way to provide oral access; 
         FIG. 4  is a view similar to  FIG. 2 , showing a nasal mask with an exhalation scoop folded out of the way to provide oral access. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     As used herein “nasal mask” preferably comprises a nasal mask similar to the nasal mask such as described in our aforesaid &#39;934, &#39;277, &#39;341, and &#39;070 PCT Applications including in particular a SuperNO 2 VA® nasal mask available commercially from Revolutionary Medical Devices, Inc. of Tucson, Ariz. 
       FIGS. 1A-1D  are front, rear, top and perspective views of a nasal mask  10  similar to the nasal mask described in our aforesaid PCT Application No. PCT/US16/37070, having a exhalation scoop  12  fixed to lower portion  14  of the mask. Exhalation scoop  12  is formed of a flexible, preferably resiliently deformable material. Exhalation scoop  12  may be formed of the same material forming the nasal membrane  15 , and preferably has a Shore A Hardness durometer of 2-10, more preferably 3-7, most preferably 5. 
     Referring also to  FIG. 2 , the mask  10  also includes a gas sampling device (shown in phantom at 16) has suction attached to an end-tidal (“ET”) CO 2  port  18  and adapted for drawing gas samples from both the oral and nasal exhalations of the patient. One opening  20  of the EtCO 2  manifold is behind the exhalation scoop  12  to overlie the upper lip of a patient, when the mask is worn by a patient, on the exterior of the nasal mask  10 , where a negative pressure (pressure less than atmospheric pressure) is created by a gas sampling device  16 . A second opening  22  of the manifold is below the nares on the interior of the nasal mask where a negative pressure is also created by the gas sampling device  16 . When the patient exhales, oral and nasal exhalation are collected through openings  20 ,  22  and proceed through the manifold and exit the EtCO 2  port that is connected to the gas sampling device  16  that provided the negative pressure. Concentration levels of the gas, such as CO 2  are then measured by gas sampling device  16 . 
     The nasal mask interior chamber is pressurized through a ventilation port  23  by an anesthesia machine or another ventilation device (shown in phantom at  24 ). Flow from the patient&#39;s nose is drawn to the negative pressure of the opening of the manifold interior of the nasal chamber. The patient&#39;s mouth is at atmospheric pressure and the flow of the oral exhalation is channeled by the exhalation scoop where it is drawn by the negative pressure presented by gas sampling system through the manifold opening. Samples of both the nasal and oral exhalation flow through a manifold, and exit the EtCO 2  port  18  to the gas sampling device  16 . The mask  10  also includes an oxygen port  25  for supplying oxygen from an oxygen source (shown in phantom at  27 ) to a patient. 
     One benefit of the flexible exhalation scoop design is that if the surgeon requires access to the patients mouth to employ a device such as an intubation tube or endoscope  26 , the exhalation scoop  12  can be flexed or pushed by the device in the nominal “y” direction, providing access to the patient&#39;s mouth as shown in  FIG. 3 . 
     Another benefit of one flexible exhalation scoop  12  design is that if the surgeon requires access to the patient&#39;s mouth, that there exists a bi-stable condition where the scoop  12  overlies the upper lip and/or mouth of the patient, as shown in  FIG. 2 , or the scoop  12  can be folded over itself about the nominal—“X” axis and remain stable with the scoop  12  no longer covering the mouth as shown in  FIG. 4 . This allows access to the patient&#39;s mouth as shown, and nasal Et CO 2  can still be collected. Once the endoscope  26  or other device is removed from the patient&#39;s mouth, should the clinician decide to continue collecting oral Et CO 2  samples, the flexible exhalation scoop  12  can be unfolded about the “X” axis, again covering the patient&#39;s mouth as in  FIG. 2 . 
     Completing the nasal mask are tabs\or eyelets  30  for attaching one or more head straps (not shown).