Patent Publication Number: US-2016228668-A1

Title: Respiration insert for induction mask

Description:
PRIORITY CLAIM 
     This application claims the benefit of U.S. Provisional Application Ser. No. 62/114,463 filed Feb. 10, 2015 and entitled DABILATOR, which is hereby incorporated herein by reference in its entirety. 
    
    
     FIELD OF THE INVENTION 
     This invention relates to ventilation and anesthesia delivery systems and methods. 
     BACKGROUND OF THE INVENTION 
     A typical operation will include the use of an induction mask coupled to an anesthesia circuit. Anesthesia is delivered through the induction mask prior to and during an operation. The induction mask is then removed and replaced with a so-called “simple mask” that delivers respiration gasses during transport to a recovery room. 
     The apparatus disclosed herein provides an improved approach for providing post-operation ventilation. 
     SUMMARY OF THE INVENTION 
     In one aspect of the invention, an apparatus is disclosed for use with an induction mask defining a flexible shroud adapted to cover a nose and mouth of a patient and an aperture adapted to and secured to an anesthesia circuit. The apparatus includes a first portion defining a central channel and sized to insert within the aperture and be elastically restrained by the aperture. A second portion defines first and second ports and is coupled to the first portion, the first and second ports being in fluid communication with the central channel. The apparatus further includes first and second strap receivers coupled to the second portion. 
     In some embodiments, the first portion is cylindrical and defines a central axis. The apparatus may further include a flange positioned between the first and second portions and extending outwardly perpendicular to the central axis. In some embodiments, the first and second strap receivers are formed on the flange. The first and second strap receivers may include first and second slots defined in the flange. 
     In some embodiments, the first and second ports include first and second tube stubs secured to the second portion and defining first and second channels in fluid communication with the central channel. In some embodiments, the central channel defines a central axis and the first and second channels are parallel with one another and with the central axis. 
     In some embodiments, the second portion defines a planar outer surface perpendicular to the central axis, the first and second tube stubs protruding from the planar outer surface. In some embodiments, an exhaust aperture extends through the planar surface and is in fluid communication with the central channel. In order to fit within standard induction masks, the first portion may be cylindrical and have an outer diameter of 0.87 inches. Also, in the preferred embodiment, the internal diameter of the first portion is sized to receive a child induction mask (0.625 inches). 
     In some methods of use, an anesthesia circuit is removed from the aperture of the induction mask and replaced with the respirator insert as recited above. A strap is engaged with the first and second strap receivers and is passed over a head of the patient such that the strap retains the induction mask and respirator insert over the nose and mouth of the patient. The first and second strap receivers may include first and second slots defined in the flange and the strap may be inserted within the first and second slots. 
     In some methods of use, a carbon dioxide monitoring system is coupled to the second port. In some embodiments, the second portion further defines a third port in fluid communication with the central channel and coupling the central channel to the atmosphere. The method may therefore include venting expiration gasses of the patient through the third port. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Preferred and alternative examples of the present invention are described in detail below with reference to the following drawings: 
         FIG. 1  is an isometric view of a respiration insert for an induction mask in accordance with an embodiment of the present invention; 
         FIG. 2  is a top view of the respiration insert of  FIG. 1 ; 
         FIG. 3  is a cross-sectional elevational view of the respiration insert of  FIG. 1  along line A-A; 
         FIG. 4  is a cross-sectional elevational view of the respirator insert of  FIG. 1  along line B-B; 
         FIG. 5  is a partial cross-sectional view of the flange of the respiration insert of  FIG. 1 ; 
         FIG. 6  is a bottom view of the respiration insert of  FIG. 1 ; 
         FIG. 7  is a side view of an induction mask in accordance with the prior art; 
         FIG. 8  is a top view of the induction mask of  FIG. 7 ; 
         FIG. 9  is an isometric view of an alternative embodiment of a respiration insert in accordance with an embodiment of the present invention; 
         FIG. 10  is a side view of the respiration insert of  FIG. 9 ; 
         FIG. 11  is a top view of the respiration insert of  FIG. 9 ; 
         FIG. 12  is a cross-sectional view of the respiration insert of  FIG. 9  along the line C-C; 
         FIG. 13  is another isometric view of the respiration insert of  FIG. 9 ; and 
         FIG. 14  illustrates an induction mask having a respiration insert in use with a patient in accordance with an embodiment of the present invention. 
     
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
     Referring to  FIGS. 1 and 2  a respiration insert  10  may be used in combination with an induction mask that has previously been used for delivery of anesthesia. The insert  10  may include a first portion  12  sized to insert within an aperture in the induction mask and be elastically retained within the aperture. The insert  10  further includes a portion  14  positioned outside of the induction mask when the first portion  12  is inserted within the aperture. 
       FIG. 3  illustrates the respiration insert  10  sectioned along line A-A shown in  FIG. 2  and  FIG. 4  illustrates the respiration insert  10  sectioned along line B-B. The first portion  12  and possibly the portion  14  define a central channel  16 , which may be cylindrical about a central axis  18 . The portions  12 ,  14  may also be cylindrical about the central axis  18 . A first port  20  and a second port  22  are defined on the portion  14 . In the illustrated embodiment, the first port  20  is defined by a tube stub  24  protruding from the portion  14 . The tube stub  24  may by cylindrical about the central axis  18  and is in fluid communication with the central channel  16 . The tube stub  24  may be sized to insert within or receive a tube for delivering oxygen or other mix of inhalation gasses to a patient. 
     The second port  22  may be defined by a tube stub  26  likewise protruding from the portion  14  and in fluid communication with the central channel  16 . In the illustrated embodiment, the tube stub  26  is cylindrical with the axis thereof perpendicular to the central axis  18 . The tube stub  26  may define an attachment interface  28  (e.g. twist lock, friction fit, or the like) for securement to any known gas measurement or delivery system. For example, the port  22  may couple to a system for measuring end tidal CO 2  (etCO 2 ), such as in the context of monitored anesthesia care (MAC), an adjunct to the distal end of a laryngeal mask airway (LMA), with an endotracheal tube or tracheostomy cannula for transport, or for intravenous anesthetic (TIVA) cases. In such applications, the use of the respiratory insert  10  reduces the need and corresponding expense of an anesthetic circuit specifically for TIVA cases. 
     The respiratory insert  10  further includes a flange  30  that protrudes outwardly from the first portion  12  and second portion  14  and is positioned between the first portion  12  and second portion  14 . In particular, the flange is a disk that radiates outwardly from the central axis  18  such that the upper and lower surfaces of the flange  30  are perpendicular to the central axis  18 . The flange  30  may have slots  32  formed therein in order to receive straps for securing the combination of the respiratory insert  10  and an induction mask to the face of a patient. 
     Referring to  FIGS. 5 and 6 , in the illustrated embodiment, the slots  32  include a straight portion  34  adjacent a first face of the flange  30  and a flared portion adjacent a second face opposite the first face of the flange  30 . The slots  32  each further include a wide entry portion  38  for receiving insertion of straps and a narrow portion  40 . The narrow portion of the slots  32  may be arcuate in shape with a radius of curvature centered on the central axis  18 . In use, an end of a strap is inserted through the widened portion  38 , tied into a knot, and then slid into the narrow portion  40  such that the knot will prevent removal of the strap. 
     Referring to  FIGS. 7 and 8 , the respiration insert  10  may be used with the illustrated induction mask  42 . The induction mask  42  may be any type or brand of induction mask known in the art. The typical induction mask  42  includes a flexible shroud  44  sized to cover the nose and mouth of a patient. Different sizes of induction masks  42  may exist with shrouds of different sizes to accommodate different patients, e.g. adult vs. child patients. 
     An aperture  46  may extend through the shroud  44  and may be defined by a tube stub  48  protruding from the shroud  44 . The first portion  12  of the insert  10  is sized to insert within the aperture  46 . In particular, the aperture  46  may be sized such that force is required to insert the first portion  12  within the aperture  46  such that friction maintains the first portion  12  within the aperture  46 . In many instances, the size of the aperture  46  is uniform for various sizes of induction masks  42 . Accordingly, the respiration insert  10  may be used for patients of various sizes. In some embodiments, the first portion  12  has a cylindrical surface with a diameter of 0.87 inches in order to insert within a standard-sized aperture  46 . Also, in the preferred embodiment, the internal diameter of the first portion  12  is sized to receive a child induction mask (0.625 inches or 15 mm). 
     In some embodiments, the induction mask may include a rim  50  surrounding the shroud  55 . The rim  50  may be more or less rigid than the shroud  44  and may further include folded or rounded shape such that the rim  50  provides a smooth and deformable surface in contact with the face of a patient, thereby providing a degree of sealing. 
     Referring to  FIGS. 9 through 13 , the respiration insert  10  may have various alternative configurations. For example, in addition to the ports  20 ,  22 , an additional exhaust port  52  may be defined on the second portion  14 . The exhaust port  52  may not provide for an attachment of a tube or other device. Accordingly, the exhaust port  52  may simply be an aperture through the second portion  14  in fluid communication with the central channel  16 . 
     The slots  32  may likewise have an alternative configuration. For example, the slots may include a flared portion  54  that extends to the edge of the flange  30 , thereby enabling a strap to slide readily into the slots  32 . The second portion  14  may include a planar outer face  56  that is perpendicular to the central axis  18 . The tube stubs  24 ,  26  may protrude from this face  56 . The exhaust port  52  may likewise pass through the planar outer face  56 . 
       FIG. 12  illustrates a cross-section of the respiration insert along line C-C shown in  FIG. 11 . The axes  58 ,  60  of the tube stubs  24 ,  26  may be parallel to the central axis  18 . and the channels of the tube stubs  24 ,  26  intersect the central channel  16  thereby enabling flow of gasses. As shown in  FIG. 11 , the arrangement of the exhaust port  52  and tube stubs  34 ,  26  may be arranged decoratively, such as in smiley face or other arrangement. 
       FIG. 14  illustrates the respiratory insert in use with an induction mask  42 . The first portion  12  is inserted into the aperture  46 . In each slot  32 , an end of a strap  62  is inserted. In particular, a knot  64  is tied at each end of the strap  62  and the strap  62  is inserted into the slot  32 , such that the slot  32  is positioned between the knot  64  and the head  66  of the patient. The strap is stretched around the head  66  of the patient such that the elasticity of the strap  62  holds the respiratory insert  10  and induction mask  42  against the face of the patient. The use of slots  32  with a strap  62  is just one example of how straps may be used to secure the respiration insert  10  and induction mask  42  to a patient&#39;s face. 
     One or more tubes  68 ,  79  may be attached to the tube stubs  24 ,  26 . Where only oxygen delivery is needed, only one tube stub  24  will have a tube  68  secured thereto. Where measurement of expiration gasses (e.g. etCO 2 ) is needed, a second tube  70  may be secured to the other tube stub  26 . In a typical method of use, an anesthesia circuit is removed from the aperture  46  and the respiration insert  10  is put in its place as shown in  FIG. 14 . In this manner a separate mask is not required for respiration, thereby reducing waste. 
     Various modifications of the respiration insert  10  may be made. For example, the ports  20 ,  22  and corresponding tube stubs  24 ,  26  may be different sizes. As shown above, the orientations of the tube stubs  24 ,  26  may be the same, e.g. parallel, or different, e.g. perpendicular or at some other angle relative to one another. The tube stubs  24 ,  26  may protrude both outside of the second portion  14  and may also protrude into the central channel  16 . Alternatively, the tube stubs  24 ,  26  may terminate at the central channel  16 . The tube stubs  24 ,  26  may be different colors then the first portion  12  or second portion  14  in order to facilitate identification. 
     As is apparent above, the exhaust port  52  has an arcuate shape that, with the ports  20 ,  22 , defines a smiley face. The arrangement and shape of the exhaust port  52  and ports  20 ,  22  may be different in order to provide a different decorative design. 
     As is apparent above, various configurations of the slots  32  are possible. In the illustrated embodiment, there are two slots  32  and a single strap  62  that passes around the head of a patient. In some embodiments, two straps  62  are used that pass around the ears of a patient. In such embodiments, four slots  32  may be use, with pairs of slots  32  on opposite sides of the second portion  14 . In that manner each pair of slots  32  may engage the ends of one of the two straps  62 . 
     In some embodiments, the central channel  16  may be coated with or otherwise treated with a scented substance, such as an essential oil in order to make the use of the respiration insert  10  more pleasant. 
     The respiration insert  10  in combination with an induction mask  42  may be used for various medical applications. For example, the respiration insert  10  may be used with the induction mask  42  to provide respiration during transportation, thereby improving the safety and comfort of the patient. The respiration insert  10  and induction mask  42  may be used during monitored anesthesia care (MAC) case to permit etCO2 monitoring. The respiration insert  10  in combination with the induction mask may be used as an adjunct to the distal end of a laryngeal mask airway (LMA) or an endotracheal tube or a tracheostomy cannula for transport and for total intravenous anesthetic (TIVA) cases. TIVA cases are the general anesthetic of choice in cases where nerve monitoring is required or if the patient has or has a family history of Malignant Hyperthermia. These applications would reduce the need/cost of an anesthetic circuit specifically for TIVA cases. 
     In all of the above medical application, hospital costs are reduced by using the combined respiration insert  10  and induction mask  42 . For example, use of the respiration insert  10  and induction mask  42 :
         Eliminates the cost and storage requirements for a separate “simple mask” during patient transport after an operation;   Eliminates the need to use a altered nasal cannula in the recovery room (the respiration insert  10  can be utilized in the recovery room to monitor respirations via the etCO2 port  22 );   Decreases carbon credit usage (currently, the induction mask  42  and any circuits are thrown away after use in the operating room); and   Decreases the need of large storage space (no need for storage of simple masks or as many circuits).       

     The use of the respiration insert and induction mask further enhances patient comfort and safety:
         It allows O 2  delivery and end tidal CO 2  (etCO 2 ) monitoring. (Monitoring etCO2 is vital when assessing patient ventilation status).   It permits reuse the induction mask  42  with the respiration insert  10  assures that the induction mask is readily available throughout transport and in the recovery room (the induction mask  42  is critical when a patient needs to be manually ventilated).   The induction mask  42  is more comfortable for patients compared to the simple mask. Kids induction masks  42  also smell better as flavored lip balm may be placed in the induction the masks  42 .   The simple mask is more prone to causing corneal abrasions, does not allow adequate assessment of patient ventilation, does not enable ventilation of patients in the emergency event of apnea, is uncomfortable, tends to shift up on the face thereby covering the patient&#39;s eyes and blowing oxygen in them.       

     While the preferred embodiments of the invention have been illustrated and described, as noted above, many changes can be made without departing from the spirit and scope of the invention. Accordingly, the scope of the invention is not limited by the disclosure of the preferred embodiment. Instead, the invention should be determined entirely by reference to the claims that follow. 
     The embodiments of the invention in which an exclusive property or privilege is claimed are defined as follows: