Patent Abstract:
The present invention relates generally to the field of laryngeal mask airway devices. The invention provides for dual passageways in a laryngeal mask which permits a physician to effectively isolate the trachea from the esophagus. In one embodiment, the physician separately inserts an instrumentality (e.g., an endotracheal tube) into a patient&#39;s esophagus in order to isolate the stomach from the lungs, respectively. In another embodiment, the physician inserts an instrumentality (e.g., an endotracheal tube) into the trachea and inserts another instrumentality (e.g., a drainage tube) in the second passageway within the laryngeal mask in order to remove particles or fluids contained in the laryngeal mask that may cause problems if allowed to flow through the patient&#39;s trachea to the lungs.

Full Description:
CROSS-REFERENCE TO RELATED APPLICATION 
     This application claims the benefit of U.S. Provisional Patent Application Ser. No. 60/789,975, filed Apr. 6, 2006, the entire disclosure of which is hereby incorporated by reference. 
    
    
     BACKGROUND 
     1. Technical Field 
     The present invention relates generally to the field of anesthesiology and to patient ventilating and anesthetizing and, more particularly, to a combination laryngeal mask airway with dual blocking and fluid removal features and method to ventilate a patient while isolating the trachea and the esophagus from each other. 
     2. Description of the Related Art 
     Airway devices are widely used in hospital surgical environments to provide respiratory assistance and to ventilate patents during medical procedures. Reference to ventilating includes providing breathable air or oxygen, for example, and removing gas, etc., e.g., exhalant exhaled by a patient, and providing anesthesia and/or other materials to and/or from the lungs of a patient. Ventilating also has the usual meaning as used in the field of medicine. The various gases, e.g., oxygen, air, anesthesia, etc., alone or in combination sometimes are referred to below collectively as gas mix. 
     While there are a multitude of airway devices currently on the market, one popular airway device is an endotracheal tube and another is a laryngeal mask airway (sometimes referred to in abbreviation as LMA). While the use of these devices is widespread, there are disadvantages associated with each of these devices. 
     As one example, endotracheal tubes are used to ventilate patients requiring anesthesia and/or respiratory assistance. An example of a conventional endotracheal tube is a plastic tube, which is inserted into a patient&#39;s mouth, is passed down the trachea through the vocal cords and is lodged in the trachea proximal (or above) to the lungs. The endotracheal tube may have a cuff or balloon portion surrounding the circumference of the endotracheal tube near the distal end that rests in the patient&#39;s trachea. After the endotracheal tube has been inserted properly, the cuff may be inflated to seal against walls of the trachea. Once sealed, positive pressure ventilation may be used to provide respiratory assistance and, if desired, anesthesia or other gas, gas mix, etc., to the patient though the endotracheal tube via a ventilator. The cuff provides a seal that tends to block liquids and solids from passing along the outside of the endotracheal tube between the tube and trachea walls and entering the patient&#39;s lungs. 
     While endotracheal tubes are ubiquitous in modern medicine, there are problems associated with the insertion of endotracheal tubes in patients. For example, there may be difficulty inserting the endotracheal tube into the proper position within the patient&#39;s trachea. A physician inserting the endotracheal tube may have difficulty viewing the trachea and there exists a possibility of inserting the endotracheal tube into the patient&#39;s esophagus, which leads to the patient&#39;s stomach rather than to the patient&#39;s lungs. If the tube is misdirected to the stomach, the lungs may not receive the proper air/oxygen mix. Additionally, the stomach may become filled with air possibly causing the patient to regurgitate, and the regurgitated material from the stomach may back flow and get into the patient&#39;s lungs. Another disadvantage of using an endotracheal tube is the invasive nature of intubation. 
     A laryngeal mask airway (LMA) overcomes many disadvantages associated with endotracheal tubes. An example of an LMA is disclosed in U.S. Pat. No. 6,634,354, issued Oct. 21, 2003 to Christopher, which is incorporated in its entirety by this reference. That LMA includes a hollow tube (sometimes referred to as a tubular guide, tube or guide) and a laryngeal mask. The laryngeal mask of the LMA is intended to fit in the mouth of a patient and to cover the two openings leading, respectively, to the esophagus and to the trachea, on the one hand, blocking the fluid path to and from the esophagus and stomach and, on the other hand, providing a fluid path to the trachea and lungs for ventilating the patient. The laryngeal mask may be positioned without requiring the physician to view the airway directly. The laryngeal mask has an inflatable cuff or rim area. Once the laryngeal mask is placed into the patient&#39;s mouth, the cuff can be inflated to seal against the walls of the inside of the mouth and, if positioned properly, to block flow to and from the esophagus. A rubber, plastic or like flexible, somewhat membranous support material extends from the cuff to form a recessed area, e.g., a space or volume, into which gas mix can be pumped through the tube or other instrumentality of the LMA to provide the requisite air and/or anesthesia to the patient. The tube is of relatively large diameter, as compared to the usually relatively narrower diameter passage of a conventional endotracheal tube, and such relatively large diameter facilitates gas mix and exhalant flow with relatively minimal interference, pressure drop, etc. The support material supports the cuff from the tube. Thus, the LMA can be used to supply gas mix to the recessed area and from there to the trachea. An advantage of an LMA is that the patient ordinarily does not have to be intubated with an endotracheal tube. If the LMA is not fully blocking flow to and from the esophagus, the gas mix primarily will flow to the lungs via the trachea because the trachea-lungs flow path generally has less resistance than the flow path from the esophagus to the stomach, and provided the pressure is not too great, the vast majority of the gas mix will flow into the lungs, and the stomach will not fill with the gas mix. 
     A drawback with the LMA is that the device cannot be used on all patients. For example, the device cannot be used on patients that are at risk for vomiting because if the laryngeal mask is not in the proper position, it does not fully isolate the airway to the trachea from the passageway to the esophagus. Thus, if the patient vomits during a medical procedure in which the LMA is used, the expelled fluid or solids could potentially flow from the esophagus to the trachea and enter the patient&#39;s lungs. An LMA ordinarily would not be used for patients that have eaten in the six hours prior to surgery, pregnant women, and trauma victims. 
     Thus, there is a need in the art to address the above mentioned and possibly other deficiencies and inadequacies of the prior art. 
     SUMMARY OF THE INVENTION 
     The present invention relates to a laryngeal mask airway and method for isolating a patient&#39;s trachea and esophagus during a medical procedure in which a laryngeal mask is used to supply ventilation or respiratory assistance to the patient. 
     An aspect of the invention relates to a laryngeal mask airway wherein the esophagus may be intubated for isolation from the trachea, drainage maybe provided for fluids from the esophagus, and a relatively unimpeded or broad path is provided for air, anesthesia, etc. to the trachea of a patient. 
     One aspect of the present invention relates to a laryngeal mask airway device including: a tubular guide including a distal portion and a proximal portion; a laryngeal mask attached to the distal portion of the tubular guide, wherein the laryngeal mask includes a recessed proximal portion and a distal portion; a first passageway extending from the proximal portion of the tubular guide to the recessed proximal portion of the laryngeal mask; and a second passageway extending through a distal portion of the laryngeal mask. 
     Another aspect of the present invention relates to a laryngeal mask airway device including: a tubular guide including a distal portion and a proximal portion; a laryngeal mask attached to the distal portion of the tubular guide, wherein the laryngeal mask further includes a support member; a first passageway extending from the proximal portion of the tubular guide to a position within the laryngeal mask located above the support member; and a second passageway extending generally along the tubular guide and extending through a distal portion of the laryngeal mask. 
     Another aspect of the present invention relates to a method for using a laryngeal mask airway device, the method including: inserting a portion of a laryngeal mask airway device including a laryngeal mask and a portion of a tubular guide into an associated patient&#39;s mouth; inflating the laryngeal mask; supplying air to the patient after insertion of the laryngeal mask airway device; inserting a first instrumentality through a first passageway of the laryngeal mask airway device into the patient&#39;s esophagus; inflating a cuff associated with the first instrumentality to effectively block the patient&#39;s esophagus; and providing a gas to the associated patient through a second passageway of the laryngeal mask airway device into the patient&#39;s trachea. 
     Another aspect of the present invention relates to a method for using a laryngeal mask airway device, the method including: inserting a portion of a laryngeal mask airway device including a laryngeal mask and a portion of a tubular guide into an associated patient&#39;s mouth; inflating the laryngeal mask; supplying air to the patient after insertion of the laryngeal mask airway device; inserting a first instrumentality through a first passageway of the laryngeal mask airway device into the patient&#39;s trachea; inflating a cuff associated with the first instrumentality to effectively seal the patient&#39;s trachea; providing a gas to the patient through the first instrumentality; inserting a second instrumentality through a second passageway of the laryngeal mask into the laryngeal mask; and removing at least one of fluids or particles released from the patient&#39;s stomach into the laryngeal mask through the second instrumentality. 
     These and other systems, methods, features, and advantages of the present invention will be or become apparent to one with ordinary skill in the art upon examination of the following drawings and detailed description. It is intended that all such additional systems, methods, features, and advantages be included within this description, be within the scope of the present invention, and be protected by the accompanying claims. 
     In the description and drawings, particular embodiments of the invention have been disclosed in detail as being indicative of some of the ways in which the principles of the invention may be employed, but it is understood that the invention is not limited correspondingly in scope. Rather, the invention includes all changes, modifications and equivalents coming within the spirit and terms of the claims appended hereto. 
     Features that are described and/or illustrated with respect to one embodiment may be used in the same way or in a similar way in one or more other embodiments and/or in combination with or instead of the features of the other embodiments. 
     It should be emphasized that the term “comprise/comprising” when used in this specification is taken to specify the presence of stated features, integers, steps or components but does not preclude the presence or addition of one or more other features, integers, steps, components or groups thereof. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Many aspects of the invention can be better understood with reference to the following drawings. The components in the drawings are not necessarily to scale, emphasis instead being placed upon clearly illustrating the principles of the present invention. Likewise, elements and features depicted in one drawing may be combined with elements and features depicted in additional drawings. Moreover, in the drawings, like reference numerals designate corresponding parts throughout the several views, and primed reference numerals represent parts that are similar to those parts designated by the same unprimed reference numeral. 
         FIG. 1A  is a front perspective view of an exemplary prior art laryngeal mask airway; 
         FIG. 1B  is a cross-sectional view of the distal portion of the exemplary laryngeal mask airway of  FIG. 1A ; 
         FIG. 2  is a cross-sectional view of the exemplary prior art laryngeal mask airway of  FIGS. 1A and 1B  and the patient&#39;s airway after the laryngeal mask has been inserted and inflated; 
         FIG. 3A  is a side elevation view partly in section and perspective of a laryngeal mask airway in accordance with an embodiment of the present invention with the laryngeal mask inflated and a passageway extending through part of the laryngeal mask for placement and holding of an endotracheal tube or the like; 
         FIG. 3B  is a top plan view partly in section of the distal portion of the laryngeal mask airway of  FIG. 3A . 
         FIG. 3C  is an enlarged side elevation view partly in section of part of the laryngeal mask and passageway shown in  FIGS. 3A and 3B ; 
         FIGS. 4A and 4   b  are schematic side elevation views showing respective embodiments of laryngeal mask airways as embodiments of the invention in use in the oral cavity of a patient; 
         FIGS. 5A and 5B  are front and rear perspective views of a laryngeal mask airway in accordance with an embodiment of the present invention including a passageway extending outside and held to the tube of the laryngeal mask; 
         FIGS. 6A and 6B  are front and rear perspective views of a laryngeal mask airway in accordance with an embodiment of the present invention including a passageway extending through a support portion of the laryngeal mask; 
         FIGS. 7A-7C  are schematic front views of the laryngeal mask in accordance with respective embodiments of the present invention with the passageway through the inflatable member, outside the laryngeal mask, and through the support member, respectively; 
         FIG. 8  is a cross-sectional view of a laryngeal mask airway in accordance with an embodiment of the present invention in a patient&#39;s airway after the laryngeal mask has been positioned and the endotracheal tube has been inserted in the esophagus; 
         FIGS. 9 and 10  are schematic side elevation views showing a laryngeal mask airway in various orientations in the oral cavity of a patient. 
     
    
    
     BRIEF DESCRIPTION OF PRIOR ART 
     FIGS.  1 A,  1 B, and  2   
     The following description is exemplary in nature and is not way intended to limit the scope of the invention as defined by the claims appended hereto. An exemplary laryngeal mask is described in U.S. Pat. No. 6,634,354 to Christopher, which is incorporated by reference as if fully rewritten herein. 
     In  FIGS. 1A. 1B  and  2  of the drawings, for example, a patient  1  is shown schematically with the mouth  2  in cross section and open and leading to the back of the throat  3  (sometimes the mouth and/or throat are referred to as the oral cavity of the patient) and from there (i) to the trachea  4  via the laryngeal inlet  5 , which provides an airway  6  that leads to the lungs, and (ii) to the esophagus  7 , which leads to the stomach; and exemplary laryngeal mask airway (LMA)  10  of the type generally described in the Christopher patent is in the patient. The LMA  10  includes a tubular guide  12 , e.g., a hollow tube, sometimes referred to below as a tube or guide, and a laryngeal mask  14  surrounding the distal end  12   d  of the tubular guide  12 . When in use, the proximal end  16  of the tubular guide  12  remains outside of the patient&#39;s mouth and, therefore, is accessible to the healthcare provider, e.g., physician, nurse or other individual. The proximal end  16  of the tubular guide  12  may be conveniently of size and shape to secure a variety of attachments to the tubular guide  12  (e.g., a syringe, an endoscope probe, an endotracheal tube, a gas mix supply connection to receive a gas mix for ventilating, anesthetizing, etc., a patient, a drainage tube, etc.). The laryngeal mask airway  10  further includes an inflation tube  18  and an air valve  20  for inflating and deflating an inflatable member  22 , e.g., a cuff, of the laryngeal mask  14 . In addition, the laryngeal mask airway  10 , includes a central support member  24 , e.g., a flexible and possibly somewhat elastic or yielding membranous material, as was mentioned above, which generally provides support for the laryngeal mask  14  including the cuff  22  and support member  24  from the tube  12 . 
     Typically, the size and shape of the tubular guide  12  are selected so that the distal portion  12   d  can be readily inserted into a patient&#39;s mouth and upper airway with the laryngeal mask  14  substantially sealing the laryngeal inlet  5  of the patient  1 . The tubular guide  12  is generally a J-shape to follow the profile of a typical patient&#39;s airway through the mouth, over the tongue, and into the laryngopharynx region of the patient just above the opening  5   a  to the larynx. The guide  12  is shaped to prevent the patient&#39;s tongue and collapsible pharynx from obstructing access to the trachea. The guide  12  further defines a passageway or channel  12   a  for ventilating a patient, e.g., to direct relatively unimpeded flow of gas mix to the lungs and exhalant from the lungs. The size of the passageway  12   a  may be suitable for possible later insertion of a tube or other suitable instrumentality. (e.g., endotracheal tube, endoscope, drainage tube, etc.) while still providing space for ventilating the patient. Placing additional tubes or other instrumentalities in the passageway  12   a  of the tubular guide  12 , though, may impede flow for ventilating purpose. 
     The guide  12  may be made, for example, of plastic with sufficient strength and rigidity to keep the patient&#39;s teeth apart and to prevent the patient from biting down and collapsing the guide  12 . The guide  12  may be made of other suitable material. The guide  12  is sized to accommodate a wide range of patient sizes and conditions. The distal opening  12   e  of the guide  12  is beveled to substantially match the angle of the patient&#39;s laryngeal inlet after insertion of the laryngeal mask airway  10  into the patient&#39;s airway. 
     Referring to  FIG. 1B , a top view of the laryngeal mask  14  of the LMA  10  is illustrated. The laryngeal mask  14  includes an upper portion  26 , a lower portion  28  and the central support member  24 . The central support member  24  extends outward from the guide  12  to the inflatable member  22  (cuff). The laryngeal mask  14  may be made, for example, of a soft, flexible material (e.g., a polymer or rubber) to enable the laryngeal mask  14  to be advanced into position without injury to the patient and to create, when the cuff is inflated, a substantially air-tight seal about the patient&#39;s laryngeal inlet, as is shown in  FIG. 2 . The degree of inflation of the laryngeal mask  14  member  22  can be adjusted via the inflation tube  18  and air valve  20 . 
     In the ideal use, the laryngeal mask  14  and its support member  22  are positioned in the patient so that the lower portion  28  of the laryngeal mask  14  substantially blocks the esophagus  7  to minimize the risk of regurgitation of stomach contents and the passage of air into the stomach. The upper portion  26  of the laryngeal mask  14  guides the distal end  12   d  of the guide  12  into alignment using the laryngeal inlet  5  of the patient  1  as a guide to insert along the patient&#39;s airway, which is partially represented by the arrow  6 . 
     As is shown in  FIGS. 1A and 2 , the laryngeal mask  14  may be boot-shape when inflated. The lower portion  28  of the laryngeal mask  14  forms the toe of the boot, which is designed to block the esophagus. The lower portion  28  of the laryngeal mask  14  also helps to align the distal opening  12   e  of the guide  12  with the patient&#39;s laryngeal inlet  5 . Once inserted, the inflatable member  22  (cuff) of the laryngeal mask  14  is inflated through the inflation tube  18  so that the upper portion  26  of the laryngeal mask  14  substantially fills the patient&#39;s laryngopharynx  5   b  at the level of the laryngeal inlet  5 , as is shown in  FIG. 2 . The upper portion  26  of the laryngeal mask  14  surrounds the laryngeal inlet  5  so that the distal opening  12   e  of the guide  12  is substantially sealed in fluid communication with the laryngeal inlet, e.g., pressing against walls of the oral cavity portions of the patient. Thus, substantially all of the gas inhaled or exhaled by the patient is intended to pass through the guide  12 . 
     While the conventional laryngeal mask  14  of the LMA  10  is designed to substantially block the esophagus and to minimize the risk of regurgitation of stomach contents into the patient&#39;s lungs, the laryngeal mask  14  may not completely isolate the esophagus from the trachea, especially if the LMA  10  is not properly positioned in the patient, and the problems discussed above limit the number and types of procedures in which the conventional laryngeal airway  10  may be used. 
     DESCRIPTION OF THE INVENTION 
     Referring to  FIGS. 3-9 , a laryngeal mask airway  50  (LMA) in accordance with embodiments of the present invention is illustrated. The LMA  50  includes two fluid conducting portions  51  and  52 , which may be cooperative as is described below and which also may provide independent flow paths, passageways or the like, as also is described below. In a sense the two fluid conducting portions  51 ,  52  of the LMA  50  complement each other; the portion  51  is similar to the LMA  10  (described above) and the portion  52  is similar to an endotracheal tube. The portion  52  may be an endotracheal tube  53   a , as is shown in  FIG. 4A . Alternatively, the portion  52  may be a tube or sleeve  53   b  through which an endotracheal tube  53   a  may be inserted, e.g., as is illustrated in  FIG. 4B , the sleeve facilitating such insertion. It will be appreciated that some other instrumentality may be the same as or similar to tubes  53   a ,  53   b  in form and function. 
     As is illustrated schematically in  FIGS. 4A and 4B , in using the LMA  50  it is preferred that the endotracheal tube portion  52  would have its distal end  52   d  inserted into the esophagus  7  of a patient  1 ; and it is preferred that the fluid conducting portion  51  would fit the patient such that the distal end  28  of the laryngeal mask  14  thereof would block fluid to and from the esophagus  7  of the patient. At least in part, the complementary relation of the portions  51 ,  52 , as is described below, in a sense is as respective backups or supplements for each other. For example, the endotracheal tube  53   a  can be positioned in the esophagus to block fluid flow to and from the esophagus except for flow through the tube  53   a ; and the laryngeal mask  14  of the portion  51  could be positioned also to block fluid flow to and from the esophagus, e.g., generally as is illustrated in  FIGS. 2 ,  4 A and  4 B. In such case ventilating of the patient can be carried out via the relatively large tube  12  of the portion  51  and laryngeal mask  14  and, if necessary, fluid or other waste can be withdrawn from the stomach and esophagus via the endotracheal tube  53   a . Positioning of the endotracheal tube in expanded relation of its sealing balloon  54  in the esophagus and the further positioning of a portion of the laryngeal mask  14  in the entrance to the esophagus provide added protection against fluid or other waste from the esophagus and stomach from reaching the trachea and lungs. Also, such use of the parts of the LMA  50  avoids the need for intubation of the patient, i.e., inserting of the endotracheal tube  53   a  into the trachea. 
     Turning to  FIGS. 3A ,  3 B,  3 C,  4 A and  4 B, the LMA  50  includes the first fluid conducting portion  51 , which includes a tube  12  and a laryngeal mask  14 . The LMA  50  also includes the second fluid conducting portion  52 , which includes an elongate hollow endotracheal tube  53   a  that has an expandable sealing balloon  54  at the distal end  53   d , e.g., as are similar to a conventional endotracheal tube, for example. As is shown in  FIG. 4B , the fluid conducting portion  52  includes a tube  53   b , and the endotracheal tube  53   a  is inserted in the through tube  53   b . The tube  53   b  is adequately long to extend beyond the laryngeal mask  14  toward the esophagus when in place in a patient and to extend out through the patient&#39;s mouth for easy access to insert the tube  53   a  or some other device therein to extend down to the patient&#39;s esophagus. 
     The endotracheal tube  53   a  and tube  53   b  may be made of plastic or of such other materials as endotracheal tubes typically are made or of some other suitable material. An inflation line  55  and air valve  56  may be used to expand the sealing balloon  54  to provide a seal with the wall of the esophagus  7  to prevent fluid flow along the outside of the tube  53   a , although fluid may flow through the tube  53   a . Applying air or other fluid to the sealing balloon  54  via the inflation line  55  and valve  56  after the endotracheal tube  52  has been inserted into the patient expands the balloon to form a seal; allowing that fluid to be withdrawn through the inflation line and air valve  56  allows the sealing balloon  54  to collapse to allow for relatively easy withdrawal of the endotracheal tube  52 . Alternatively, the sealing balloon  54  may be another type of seal that does not require selective inflating and deflating, e.g., a resilient, deformable sealing balloon or other device that is suitably large to provide sealing function and still is sufficiently flexible and/or deformable to allow it to be inserted and withdrawn from the patient, e.g., esophagus. 
     The laryngeal mask  14  has a guide hole opening  57  through it to allow a portion  58  of the endotracheal tube  53   a  to extend therethrough. The guide hole opening  57  is so located in the laryngeal mask  14  as to position to the endotracheal tube  53   a  in position relative to the laryngeal mask such that the distal end  53   d  of the tube  53   a  would tend relatively easily to be guided for insertion into the esophagus  7  of a patient when the LMA  50  is properly inserted through the oral cavity (mouth) of the patient. 
     The opening  57  may be formed in a reinforced material portion of the inflatable member (cuff)  22  of the laryngeal mask  14  or the central support member  24  thereof. The opening  57  may be formed in a small tube-like member  57   a  that is mounted in the inflatable member  22  and/or in the central support member  24 . The tube  53   a  may slide freely in the opening  57  or it may be fixed in that opening. In an exemplary embodiment, the tube  53   a  may slide relatively freely in the opening  57  when the inflatable member  22  of the laryngeal mask is uninflated, thereby to facilitate placing the distal end  53   d  of the tube  53   a  and the sealing balloon  54  in the esophagus  4 . However, with the inflatable member  22  being inflated, it may tend to expand so as to cause the material at the opening  57  to engage the tube  53   a  relatively securely to retain it in position relative to the laryngeal mask  14 . The inflatable member  22  may be inflated after it has been positioned in the oral cavity  3  of the patient so that the inflated walls of the inflatable member engage walls of the oral cavity to hold the laryngeal mask  14  in position in the oral cavity while also tending to hold the tube  53   a  in position. Thus, the portions  51 ,  52  of the LMA  50  would be held in relatively fixed position relative to the oral cavity and to the esophagus  7  and trachea  4 . 
     As is illustrated in  FIG. 4B , the tube  53   b  may be positioned relative to the fluid conducting portion  51  and the laryngeal mask  14  thereof in a manner similar to the manner described above for the endotracheal tube  53   a . In this case the endotracheal tube  53   a  may be inserted through the tube  53   b  to the illustrated location in the esophagus to provide the functions described herein for the endotracheal tube. 
     Briefly referring to  FIGS. 5A and 5B , another embodiment of LMA  50 ′ is illustrated. The parts of the LMA  50 ′ are similar to those described above with respect to  FIGS. 3A ,  3 B,  3 C,  4 A and  4 B, except that the endotracheal tube  53   a  of the fluid conducting portion  52  is attached to the exterior of the fluid conducting portion  51 . As is seen in the drawings, the portion of the tube  53   a  that is parallel to and substantially coextensive with the tube  12  is attached, e.g., by adhesive material or by some other fastening mechanism, such as, for example, a band  12   b , or a clamp, rivet or other device (not shown), to the exterior surface  12   f  of the tube  12 . In the area where the tube  53   a  passes adjacent the inflatable member  22  and support portion  24  of the laryngeal mask  14  rather than through either one of them, the tube  53   a  may be attached to the laryngeal mask material or may have sufficient rigidity to follow the J-shape configuration of the tube  12  just upstream of and at the area of the laryngeal mask. In  FIGS. 5A and 5B  the endotracheal tube  53   a  does not have a separate inflation line for the sealing balloon  54 ; rather the sealing balloon may be somewhat normally expanded and adequately flexible to slide into position in the esophagus (or in the trachea) of a patient while making sealing engagement with the adjacent wall of the esophagus or trachea. 
     In  FIGS. 6A and 6B , which are similar to  FIGS. 4A and 4B , another LMA  50 ′ is shown. An opening  57   b  is in the support portion  24  rather than in the inflatable member  22 ; and the tube  53   a  passes through such opening  57   b . Although not shown in the drawing, if desired suitable reinforcement material, e.g., a separate tube section or thickened material that forms the support portion  24 , may be provided at the area of the opening  57   a  to provide a suitable seal with the tube  53   a  and to avoid tearing of the support portion material on account of movement of the tube  53   a  relative to the support member. 
       FIGS. 7A ,  7 B and  7 C are schematic front plan views looking onto the laryngeal mask  14  to show exemplary locations at which the tube  53   a  extends outward therefrom, respectively, through the inflatable member  22  ( FIG. 6A ), outside the laryngeal mask and beneath (as illustrated) the inflatable member ( FIG. 6B ), and through the support member  24  ( FIG. 6C ). 
     The tubes  53   a ,  53   b  (sometimes referred to as passageways) may pass through the laryngeal mask  14  without interfering with the inflation or deflation of the laryngeal mask. One of ordinary skill in the art will readily appreciate that the tubes  53   a ,  53   b  may be secured above or below the central support member  12  and further that the tubes  53   a ,  53   b  may exit above or below the central support member  12 . The location of the distal opening  60 ,  61  of the tubes  53   a ,  53   b  is positioned to provide a convenient pathway to the patient&#39;s esophagus. 
     The tube  53   b  may be made of a similar material as the tube  53   a  (e.g., plastic with sufficient strength and rigidity to keep the patient&#39;s teeth apart and prevent the patient from biting down and altering or damaging the tube). The tube  53   b  may also be made of a material more compliant or elastic than the material that the tube  12  is made (e.g., rubber, relatively soft or flexible plastic, etc.) so that the material will not interfere with insertion of the laryngeal mask airway  50 . 
     Referring to  FIG. 8  as well as to the other drawing figures, methods for using the laryngeal mask airway  50  of embodiments of the present invention will now be described. The curved distal portion of the tubular guide  12  is first inserted into the patient&#39;s mouth and laryngopharynx with the laryngeal mask  14  deflated. After the distal portion of the tubular guide  12  and the laryngeal mask  14  are appropriately positioned relative to the patient&#39;s laryngeal inlet  5 , the laryngeal mask  14  is inflated via the inflation tube  18  and the air valve  20  to establish a seal around the patient&#39;s laryngeal inlet, as illustrated in  FIG. 8 . The lower portion  28  of the inflated laryngeal mask  14  substantially blocks the patient&#39;s esophagus. The upper portion  26  of the inflated laryngeal mask  14  substantially fills the patient&#39;s laryngopharynx adjacent to the laryngeal inlet  5 . The laryngeal mask  14  thereby seals the distal opening of the tubular guide  12  in fluid communication with the patient&#39;s laryngeal inlet. The side portions of the laryngeal mask may pinch the sides of the patient&#39;s epiglottis, which also tends to lift the epiglottis from the laryngeal inlet, thereby clearing an airway to the patient&#39;s trachea  4 . After the laryngeal mask  14  is properly positioned and inflated in the mouth of the patient, an instrumentality (e.g., an endotracheal tube  53   a , an endoscope, a drainage tube, etc.) can be inserted into the esophagus  7  through passageway (tube)  53   b  ( FIG. 4B , for example). 
     Alternatively, the tube  53   b  may be inserted through the guide hole  57  after the laryngeal mask  14  is in place in a patient; and thereafter another instrumentality can be inserted into the esophagus  7  through tube  53   b.    
     As another alternative, the instrumentality, e.g., an endotracheal tube  53   a , may be inserted through the guide hole after the laryngeal mask  14  has been placed in the patient; this may be difficult if the inflatable member  22  already has been inflated, but if it is not inflated it may be difficult to insert the instrumentality through the guide hole  57  due to the inflatable member  22  being somewhat flaccid. 
     Even another alternative is to have the instrumentality, e.g., endotracheal tube  53   a , in position in the guide hole and extending generally in the manner illustrated in  FIG. 8  and the other figures hereof, prior to placing the laryngeal mask  14  in the patient; and in this case the placing of the laryngeal mask  14  in the patient also would include guiding the distal end of such endotracheal tube  53   a  (or other instrumentality that is positioned by the guide hole  57 ) to the esophagus  7 . The inflatable member  22  may be inflated after positioning the laryngeal mask  14  properly in the patient as described above. 
     After the instrumentality, e.g., endotracheal tube  53   a , has been inserted into the esophagus a suitable distance, e.g., approximately three to four inches, so as to place the sealing balloon or cuff  54  in relation to the esophagus so that it can form a seal therewith, the sealing balloon is inflated via inflation tube  55  and air valve  56  from a suitable inflation source, e.g., an air pump or source of compressed air. In the present example, the cuff  54  is shaped to conform to the contours of the patient&#39;s esophagus. 
     Upon inflation of the sealing balloon or cuff  54 , the patient&#39;s esophagus  7  is isolated from the inlet  5  to the trachea  4 . The physician may then use the hollow tubular guide  12  and/or another instrumentality (e.g., an endotracheal tube, an endoscope, a drainage tube, etc.) (not shown) to provide air/oxygen to the patient via a ventilator/respirator (not shown) or perform other desired functions with the instrumentality. 
     By inserting the instrumentality  53   a , for example, through the tube or passageway  53   b  and into the esophagus  7  and inflating the sealing balloon or cuff  54 , any fluid regurgitated from the stomach may flow up through the instrumentality  53   a  and be removed outside the mouth of the patient through the instrumentality  53   a . Therefore, any regurgitated material and/or fluid may be prevented from entering the lungs of the patient. Thus, the isolation of the stomach and esophagus is accomplished by both the instrumentality  53   a  and cuff  54  and by the inflated laryngeal mask  14 , both of which block flow from the esophagus to the trachea. Meanwhile the patient may be ventilated via the tubular guide  12  without any interference with the passageway leading to the trachea for respiration and/or ventilation assistance. 
     Alternatively, as is illustrated schematically in  FIGS. 9 and 10  if instrumentality  53   a , e.g., endotracheal tube, were inserted through the tube  53   b  into the trachea (instead of the esophagus), the cuff  54  may be inflated within the patient&#39;s trachea to block the flow of fluids and particulates into the lungs. An air and/or anesthesia mix can be directed through the instrumentality  53   a  to the lungs in this instance. As shown in  FIG. 9  the laryngeal mask  14  may be positioned so that it does not seal the trachea  4  from the esophagus  7 , but it is open to at least the esophagus to provide a path to the passageway  12   a  of the tubular guide  12 . If the patient were to regurgitate, the fluid and particulates could be removed via the recessed area in the support portion  24  of the laryngeal mask  14  and withdrawn through the tubular guide  12  or another instrumentality that is in the tubular guide, e.g. a drainage tube in this particular instance. The proximal end of the drainage tube may in such case be connected to a suction device (not shown) to remove any undesirable fluids and particulates. As shown in  FIG. 10  the laryngeal mask  14  may be positioned to block the trachea  4  but not the esophagus  7 , while the instrumentality  53   a , e.g., endotracheal tube, and cuff  54  are in the trachea. In such case the laryngeal mask  14  still may have part exposed to the esophagus  7  to provide a fluid path for regurgitant or the like to be suctioned out via the passageway  12   a  of tubular guide  12  or if need another suction tube may be inserted to remove regurgitant, etc. 
     By effectively isolating the patient&#39;s esophagus from the trachea, the laryngeal mask airway  50  overcomes many drawbacks of the conventional laryngeal mask airway and may be used in many situations to provide a patient with an air/anesthesia mix and avoids the possibility of regurgitation or other material from entering the patient&#39;s lungs. 
     It should be appreciated that the above described device and method provides for a laryngeal mask that can be used in many more instances than a conventional laryngeal mask. Although the invention has been shown and described with respect to certain preferred embodiments, it is obvious that equivalents and modifications will occur to others skilled in the art upon the reading and understanding of the specification. The present invention includes all such equivalents and modifications, and is limited only by the scope of the following claims.

Technology Classification (CPC): 0