Abstract:
An apparatus for endotracheal intubation. The apparatus allows medical personnel to grip and stabilize a bougie inside the apparatus and maintain a curve position during intubation processes. The apparatus can be used for a solid bougie and/or a hollow bougie. The apparatus may further have a connector for connecting the apparatus to an external suction device or oxygen delivery device.

Description:
BACKGROUND OF THE INVENTION 
       [0001]    The present invention relates to a bougie device and method of use thereof, and more particularly relates to a device for gripping and directing a bougie device which is suitable for guiding insertion of an endotracheal tube into an airway of a person. 
         [0002]    A bougie may have numerous uses in medicine, but are commonly used to widen a passageway or guide another instrument into a passageway. An intubation aide commonly known as the “gum elastic bougie” is a thin, solid or hollow, cylinder of rubber, plastic or another material that a physician inserts into a body passageway. Within the art of tracheal intubation, bougies are frequently used as a guide for the correct placement of an endotracheal tube. Bougies are also used to provide suction or oxygen delivery within a body passageway. 
         [0003]    Bougies generally require a necessary level of flexibility so that they can navigate a body passageway, with the required flexibility resulting in bougies that are hard to grip. Devices have been designed to assist in intubation of the bougie, i.e. guiding the bougie, but such devices still have limitations in allowing for adequate gripping of the bougie so that it can he properly navigated during a procedure. 
         [0004]    In many medical situations endotracheal intubation is a critical procedure performed to secure a patient&#39;s airway. To facilitate insertion of an endotracheal tube, a physician, paramedic or other medical personnel will use a laryngoscope blade which is inserted down a patient&#39;s throat. The laryngoscope blade is primarily used to move the tongue and the epiglottis from the providers view in order to provide a clear passage to the vocal cords. Placement of the endotracheal tube correctly in the patient&#39;s trachea must be done quickly to avoid hypoxic brain injury to the patient. The task of endotracheal intubation becomes more challenging in emergent situations, patients with difficult airways and those that are at high risk for aspiration. 
         [0005]    Commonly in the operating room prior to induction of general anesthesia patients are given 100% oxygen to breath in effort to replace nitrogen in the lungs with oxygen. This process is known as preoxygenation and serves to fill the lungs with oxygen like a reservoir. When patients undergo general anesthesia they become apneic and must rely on the oxygen reservoir within the lungs to provide oxygen for the bodies basic metabolic needs. Sufficient preoxygenation adequately fills the lungs with oxygen to provide more time for the medical personnel to instrument the airway and attempt endotracheal intubation. 
         [0006]    Evaluation of a patient&#39;s airway allows physicians to gauge the difficulty that may be encountered when attempting endotracheal intubation. Certain clinical features of patient such a large neck circumference, obesity, history of sleep apnea, small mouth opening, and overbite among, others are predictors of a difficult endotracheal intubation. Once a patient has been deemed to have a difficult airway, the physician may obtain equipment such as a video laryngoscope or intubation aide like the bougie. A physician may have a poor view of a patient with a difficult airway of the vocal cords under direct laryngoscopy, which would make endotracheal intubation difficult. The bougie is vital tool in the difficult airway as it has a bended tip that facilitates its passage into the patient&#39;s trachea. 
         [0007]    Commonly found within hospitals is suction tubing with a handle attached, also known as a yankauer, which are used to aspirate fluid within the patient&#39;s airway. Under direct laryngoscopy, the yankauer provides direct vision of the patient&#39;s vocal cords. In an effort to overcome these problems, medical personnel often insert the yankauer to remove blood, oral secretions, or gastric content prior to proper placement of the endotracheal tube. After aspiration of fluid within the pharynx the suction device must be removed and an endotracheal tube must be inserted within the trachea. This two step procedure of clearing secretions, gastric contents, or blood with the suction tube removing it and then grabbing an endotracheal tube results in lost time. However, these prior art processes use valuable time, along with the patient&#39;s oxygen reservoir, switching between devices. Moreover, even when suction tube is inserted into the mouth it is possible fluids to reaccumulate in between the time suction tube is removed and endotracheal tube insertion. 
         [0008]    If an intubation attempt fails, then the patient must be ventilated with bag and mask device which can force air down the trachea as well as down the esophagus. When the stomach is extended with air, patient becomes more likely to vomit and aspirate. A distended abdomen also decreases a patient&#39;s lung compliance and makes it more difficult to ventilate. Moreover, repeated intubation involves instrumenting the airway with laryngoscope blade which causes trauma to the patient which can result in bleeding and edema. It is vital that endotracheal intubation be accomplished quickly, accurately, atraumatically and on consistently on the first attempt. Repeated attempts with intubation often make endotracheal intubation even more challenging. A distended abdomen from bag-mask ventilation, bleeding, or edema can obstruct the physician&#39;s view of the vocal cords and places the patient at risk for aspiration. This is a common problem with the current intubation procedure with a difficult airway has been taking time to exchange between using the bougie, yankauer, and the endotracheal tube. This lost time puts the patient at risk for aspiration pneumonia, aspiration pneumonitis, or hypoxic brain injury. 
         [0009]    U.S. Pat. No. 5,257,620 describes an airway device that has a suction stylet that telescopically disposed therein and attached to the endotracheal tube. The suction stylet is connected to a suction source which allows suction forces to withdraw fluids continuously. During the intubation process, if continuous suction forces at the distal suction stylet are present it can cause trauma to the vocal cords. Furthermore, a suction device that lacks complete control by the provider may be problematic as continuous suction in the oropharynx will also remove oxygen from the patient. Continuous suction of oxygen from the patient oropharynx will hasten the development of hypoxia. This takes away valuable time the provider has when attempting to intubate the patient and must revert to bag-mask ventilation. As hypoxia develops patients are at risk for developing anoxic brain injury and even cardiac arrest. 
         [0010]    U.S. Pat. No. 5,595,172 describes a device that includes a suction stylet that is inserted into an endotracheal tube and allows the provider to control suction. The stylet has a main body with a central passageway along the main body and a vent arm that extends off the main body. The vent arm has a vent port that allows the provider to utilize suction with occlusion of the vent port. This device may offer a suction stylet that can be only be used to clear secretions but does not function as an intubation aide. 
       SUMMARY OF THE INVENTION 
       [0011]    The present invention provides a gripping device for a solid or hollow bougie or bougies during an intubation procedure. The hollowed bougie can be connected to external tubing, e.g. suction tubing or oxygen tubing. 
         [0012]    The present invention may further comprise a suction bougie that can be used to aspirate fluids as well as an intubation guide for insertion of an endotracheal tube into the airway of a patient. Commonly, when a medical personnel performs a direct laryngoscopy of a patient&#39;s airway to assess for adequate visualization of the vocal cords, the presence of oral sections, blood, masses, or gastric contents. The airway device mentioned above is primarily used for patients with a difficult airway, or who are at risk for aspiration of gastric contents. Management of these patients often necessitates that an intubation guide commonly known in the field as gum elastic “bougie” and an oral suction device. The bougie may be used if there is poor visualization of the vocal cords and a suction apparatus is needed to clear oral secretions or gastric contents to provide an unobstructed view of the vocal cords. The use of either the bougie or suction requires the medical personnel to switch between handling either device. The proposed invention allows the medical personnel to use the bougie and suction simultaneously without having to spend time to exchange devices. This ultimately removes inherent delays in securing the airway. 
         [0013]    The invention as mentioned functions as an apparatus that attaches to a bougie to facilitate endotracheal intubation. The apparatus may be attached to a pre-existing bougie intubation aid as well a suction bougie. The suction bougie is designed as a hollow tube to be used as a suction bougie. The suction bougie may comprise of an elongated body that is hollow at both the proximal and distal ends. The distal of the tube would have several open ports to allow for passage of oral secretions, blood, or gastric contents. The proximal end would be connected to a curved bougie holder. The body of the bougie device may be formed from Teflon, polytetrafluoroethylene, or plastic polymer which would result in a self lubricated device. This would reduce the need for the bougie device to be lubricated for insertion into the airway of a patient. 
         [0014]    The present invention is designed with a curved handle that has a curved side opening, e.g. a channel, to receive either a solid or hollow bougie. The curved handle preferably will generally be rigid and preferably manufactured from a hard plastic material. 
         [0015]    The proximal end of the handle will encompass a hollow tube with one end to be attached to the proximal end of the suction bougie or an oxygen delivery bougie. The handle is designed with a curved and enclave where the bougie is meant to reside within with an outside force, i.e. the gripping force of the user&#39;s fingers, which allows the bougie to be moved to a curved patter, and also stabilizes the bougies by increasing the gripping area during intubation. After the bougie is attached to the proximal end of the handle, the bougie will then be bent around itself with its distal portion nestled within the curved handle. The other end of the hollow tube of proximal handle will be connected to suction tubing or oxygen tubing commonly found within the hospital. The hollow tube will have a vent port that when occluded by the medical personnel&#39;s finger will allow suction force from the distal tip of the suction bougie. When the vent port is not occluded there will be no suction force at the tip of the suction bougie. The importance of having a vent port allows the medical personnel to have complete control over when to utilize the suction function. Moreover, a suction device that lacks complete control by the provider because continuous suction of oxygen from the patient oropharynx may cause hypoxia. The invention can be used as an oxygen delivery device, as well. 
         [0016]    The present invention also allows for telescopically advancement of an endotracheal tube over a bougie prior to advancement of a bougie into a patient&#39;s trachea. The endotracheal tube can be immediately advances over the bougie into the trachea. 
         [0017]    The apparatus may be used with the pre-existing bougie to provide a more ergonomic way to use the bougie. The bougie is commonly must be manipulated by the medical personnel to incorporate a curve for endotracheal insertion. The curve of the bougie is meant to follow the natural curvature of the patient&#39;s oropharynx. However a common problem that is encounter with the bougie use has been its difficulty navigating a patient&#39;s oropharynx. The physical properties of the bougie make it flimsy and bendable which can make it difficult for the medical personnel to control. The apparatus will be designed with a curved and enclave where the bougie is nested within. Once the bougie is nested within the apparatus there will be a latch that will secure the bougie to the apparatus. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0018]      FIG. 1  is a side planar view of a gripping device according to the present invention, with a bougie attached the device. 
           [0019]      FIG. 2  is a side planar device shown in  FIG. 1 . 
           [0020]      FIG. 3  is a front perspective view of the device of  FIG. 1 . 
           [0021]      FIG. 4  is a front perspective view of the device shown in  FIG. 1  with a bougie attached to the device. 
           [0022]      FIG. 5  is a side planar view of the gripping device of  FIG. 1 , with a hollow connector attached to the device. 
           [0023]      FIG. 6  is a front perspective view of the device shown in  FIG. 5 , demonstrating a suction control opening. 
           [0024]      FIG. 7  is a front perspective view of the device shown in  FIG. 6 , with a cap located on the suction control opening. 
           [0025]      FIG. 8  is a rear perspective view of the device of  FIG. 1 , with another arrangement of a hollow connector attached to the device. 
           [0026]      FIG. 9  is a rear perspective view of the device shown in  FIG. 6 , with a bougie connected to the device. 
           [0027]      FIG. 10  is a front perspective view of the device shown in  FIG. 9 , with a cap located on the suction control opening. 
           [0028]      FIG. 11  is front perspective view of the device of  FIG. 1  including a bougie, with means for locking the bougie within the device demonstrated. 
           [0029]      FIG. 12  is another perspective view of the device as shown in  FIG. 10 , with the device further supporting intubation tubing. 
       
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENT 
       [0030]    Although the disclosure hereof is detailed and exact to enable those skilled in the art to practice the invention, the physical embodiments herein disclosed merely exemplify the invention which may be embodied in other specific structures. While the preferred embodiment has been described, the details may be changed without departing from the invention, which is defined by the claims. 
         [0031]    As will be seen, the present invention overcomes many problems associated with prior art with intubation of a difficult airway, high risk of aspiration, or emergent endotracheal intubation. Upon induction of general anesthesia, unconscious patients, certain medical conditions render patients at risk for aspiration of gastric contents. Conditions like morbid obesity, diabetic gastroparesis, pregnancy, hiatal hernia, full stomach increases the risk aspiration upon induction of general anesthesia. The invention allows the operator to clear oral secretions, gastric contents, blood from the operator&#39;s field of view to safely intubate the patient. 
         [0032]      FIG. 1  depicts an intubation control system  10  according to the present invention. The system  10  generally comprises a griping device  12  which is designed to encircle the length of a bougie  14 , which is used for intubation. The gripping device  12  has a top end  16  and a bottom end  18 , with a gripping surface  20  located on the outside of the gripping device  12 . An extension support area  22  extends from the gripping surface  20 , with the extension support area  22  also forming part of the gripping surface  20 . The gripping device  12  preferably has a curvilinear shape that will be shaped to assist in inserting the bougie  14  into a passageway. 
         [0033]      FIGS. 2 and 3  provide further views of the gripping device  12 . The gripping device  12  further comprises an inner surface  24  and an exterior surface  26 . The inner surface  24  forms an opening to receive the bougie  14 . As previously noted, the inner surface  24  preferably comprises a curvilinear or longitudinally curved groove  28  shape, which can extend the length of the body. The inner surface may also comprise a semicircle shape, which will allow the bougie  14  to be nestled within the gripping device  12  and to be held in place within the gripping device  12  during an intubation process. The gripping device  12  is designed so that the bougie  14  can be forced into place by hand and, the bougie  14  will retain a curved shape with the curved groove  28  during a procedure. 
         [0034]    Referring further to  FIGS. 2 and 3 , the exterior surface  20  comprises a plurality of ridges  30 , which assist the user in gripping and properly holding and positioning the device  12 . The ridges  30  may comprise a semi-rigid material that would conform to a user&#39;s hand, but it is understood that the exterior surface  28  may comprise any surface or arrangement, e.g. a surface contoured for fingers or a rough or textured surface, that will assist in holding the device  12 . 
         [0035]    Referring to  FIG. 4 , the device  12  is shown with the bougie  14  nestled within the groove  28 . The proximal end  32  extends outward past the extension support area  22 , which will allow for the proximal end  32  to be eventually intubated. As shown, the proximal end  32  has an opening  34 , which allows fluid flow, e.g. air or oxygen flow, through the bougie  14  to distal end  36  of the bougie  14 . The control of fluid flow by using the device  12  is discussed further, below. 
         [0036]    Referring to  FIGS. 5 and 6 , the device  12  is shown comprising a connector  38 , which assists in fluid flow through a bougie  14  when using the device  12 . The connector  38  has a first end  40  and a second end  42 , with a hollow passageway passing from the first end  40  to the second end  42 , which allows the connector  38  to receive a bougie  14  (not shown) for fluid passage. For example, the connector  38  assists in passing oxygen through a bougie  14 , or for using the bougie  14  for suction purposes. The connector  38  may also comprise a suction control opening  46 , which intersects the hollow passageway in the connector  38  and allows for the user to manually control suction when the device  12  is in use. 
         [0037]      FIGS. 5 and 6  also show another feature of the gripping device  12  that will assist in retaining a bougie within the gripping device  12 . A locking ring  48  is shown on the extension support area  22 . The locking ring  48 , e.g. a C-ring, can be rotated so that is will hold and retain a bougie  14  in place (see  FIG. 10 ) during an incubation process. 
         [0038]      FIG. 7  shows a further feature of the device  12 , comprising a cap  50  located on the suction control opening  46 . Such an arrangement allows for continuous suction and/or air flow, e.g. oxygen, through the bougie  14 . If manual control is required, the cap  50  can be removed. 
         [0039]      FIG. 8  demonstrates a further arrangement of the device  12  shown in  FIGS. 5 and 6 . The device  12  has the connector  38  located on the device  12  as previously shown and described. However, the first end  40  is perpendicular to the second end  42 , and the suction control opening  46  is parallel to the first end  40 . Such an arrangement may be preferable in certain instances and for certain uses. However, it is understood that the arrangements shown in  FIGS. 5 and 8  operate in the same manner and can provide air or oxygen flow and/or suction as discussed, above. 
         [0040]      FIG. 9  demonstrates the device  12  being used as a suction tool during an intubation process. As previously discussed, a bougie  14  is positioned within the device  12 . The proximal end  32  of the bougie  14  is shown extending past the extension support area  22 , with the opening  34  being arranged for eventual intubation. The distal end  36  of the bougie is then positioned and inserted into the first end  40  of the connector  38 . The second end  42  will be connected to an external fluid or air source (not shown), which allows the user to control suction control with the suction control opening  46 . The used controls suction by placing a finger on, by either right hand or left hand, or removing a finger from, the control opening  46 . 
         [0041]      FIG. 10  demonstrates the device  12  being used for oxygen delivery. The arrangement is similar to that shown in  FIG. 9 , with the exception that the cap  50  is located on the suction control opening  46 . The locking ring  48  is also shown holding the bougie  14  in place.  FIG. 10  also demonstrates that the bougie  14  can form a one-loop coil, which further allows for the device  12  to provide an improved gripping arrangement for intubation procedures. 
         [0042]      FIG. 11  further demonstrates the adaptability of the gripping device  12 . In  FIG. 11 , the device is shown holding both the bougie  14  and an intubation tubing  52 . The device  12  can adapt so that both the tubing  52  and the bougie  14  can be nestled in the groove  28 , with the locking ring  48  being used, if necessary. 
         [0043]      FIG. 12  further exemplifies the use of the gripping device  12  in connection with the intubation tubing  52 . The intubation tubing  52  is shown supported by the bougie  14 , with the gripping device  12  allowing the bougie in a coiled arrangement, as previously discussed. The arrangement also allows for the potential use of a balloon  54 , which may inserted along with the tubing into the trachea for certain procedures, and inflated by way of vent  56 , if necessary. 
         [0044]    The foregoing is considered as illustrative only of the principles of the invention. Furthermore, since numerous modifications and changes will readily occur to those skilled in the art, it is not desired to limit the invention to the exact construction and operation shown and described. While the preferred embodiment has been described, the details may be changed without departing from the invention, which is defined by the claims.