Patent Publication Number: US-2009227984-A1

Title: System and methods of intubation

Description:
FIELD OF THE INVENTION 
     The present invention generally relates to a medical system and methods and, more particularly, to a system and methods for nasogastric intubation. 
     The present invention is discussed in the following largely with reference to nasogastric intubation, but the present invention may be applicable to a variety of intubation procedures, for example, orogastric or orotracheal. 
     BACKGROUND OF THE INVENTION 
     Nasogastric or nasotracheal intubation is a medical procedure involving the insertion of a tube, referred to herein as a nasogastric tube (“NG tube”), into a body cavity, such as through the nose, past the phyarnx, down through the esophagus and into the stomach. 
     Before a NG tube is inserted into the body cavity, a health care provider, such as a nurse or doctor, typically measures the distance from the tip of the patient&#39;s nose, to their ear and down to the xyphoid process. The NG tube is then marked at this level to ensure that the tube has been inserted far enough into the patient&#39;s stomach. The conventional insertion process begins with the first lubrication of the end of the NG tube, then its insertion into and through one of the patient&#39;s nostrils. The NG tube is then moved through the nasal cavity and down into the throat. Once the NG tube is past the pharynx, it is rapidly inserted down into the esophagus and stomach. 
     During insertion, great care must be taken to ensure that the NG tube is positioned properly and that it has not passed through the windpipe and down into the lungs. To ensure proper placement, it is a known method to inject air into the tube; if the air is heard in the stomach with a stethoscope, then the NG tube is in the correct position. Another method to ensure proper placement of the NG tube is to aspirate fluid from the tube with a syringe. This fluid is then tested with pH paper to determine the acidity of the fluid. If the pH is below a certain level, such as 5.5 pH, then the NG tube is in the correct position. Otherwise, verification of tube position may be obtained with an X-ray of the chest/abdomen. 
     The main use of a NG tube is for feeding and the administration of oral agents, such as drugs. Another use of a NG tube is for nasogastric aspiration, or suction, to drain contents from the stomach. Nasogastric aspiration is mainly used to remove gastric secretions and swallowed air in a patient with gastrointestinal obstructions. Nasogastric aspiration can also be used when a potentially toxic liquid, such as poison, has been ingested. Nasogastic aspiration is also used for preparation before surgery under anesthesia, and to extract samples of gastric liquid for analysis. 
     Nasogastric intubation may cause trauma such as nose bleeds, sinusitis, and a sore throat. More significant trauma may occur including erosion of the nose where the tube is anchored, esophageal perforation, pulmonary aspiration, a collapsed lung, or intracranial placement of the NG tube. 
     Overall, it is recognized that the currently available instruments to facilitate nasogastric intubation are not without serious shortcomings. Accordingly, there is a need for improved nasogastric intubation to ensure proper placement of the device within the body cavity as well as to minimize trauma and to achieve greater patient comfort both during and after an intubation procedure. 
     SUMMARY OF THE INVENTION 
     The present invention is directed to various embodiments by which nasogastric intubation can be facilitated. With the use of these embodiments, nasogastric intubation may be quick and safe: proper placement of the NG tube may be ensured, complications minimized, and patient comfort achieved both during and after an intubation procedure. 
     The present invention is discussed in the following in reference to nasogastric intubation, but the present invention is applicable to a variety of intubation procedures, for example, orogastric or orotracheal. 
     As shown in  FIG. 1 , the pharynx  100 , which is the part of the neck and throat, is situated immediately posterior to the oral cavity or mouth  102  and nasal cavity  104 . The pharynx  100  includes a nasopharynx  106 , oropharynx  108  and hypopharynx  110 . The nasopharynx  106  lies behind the nasal cavity  104  and typically extends from the hard and soft palates to the base of the skull. The oropharynx  108  lies behind the oral cavity  102 . The hypopharynx  110 , sometimes called the laryngopharynx, extends to the larynx  112 , which is situated just below the junction that diverges into the trachea  114  and esophagus  116 . The esophagus  116  leads to the stomach, or abdomen. For purposes of this application, “pharynx” refers to the nasophayrnx, oropharynx, hypopharynx and sometimes larynx. 
     The present invention includes devices to properly position a nasogastric tube (“NG tube”) through a nostril of the nose, past the pharynx, down through the esophagus and into the stomach. 
     One embodiment the present invention is a slider device that includes a collapsed state and an erected state. The slider device may be inserted into the pharynx in a collapsed state. The slider device achieves an erected state upon an instrument, such as a NG tube or other instruments, threaded therethrough. 
     Another embodiment of the present invention is a stylet device with a pellet element positioned on one end thereof. The pellet element may be weighted to assist in positioning the stylet device within the pharynx. The stylet device guides instruments, such as a NG tube or other instruments, into the pharynx by allowing the instruments to be threaded over the stylet device or following alongside the stylet device. 
     Yet another embodiment of the present invention is a director device. The director device includes a guide element that may be manipulated by a user to curve or angle one end or a portion of the director device for proper positioning within the pharynx. Upon proper positioning of the director device, an instrument is inserted therethrough. 
     Yet another embodiment of the present invention is a swallower device that includes one or more bladder elements. The bladder element achieves an inflated state from a deflated state when injected with a substance. The bladder element anchors the instrument prior to insertion within the pharynx as well as simulates a food bolus to assist the patient in advancing the swallower device, including instruments, into his or her stomach. 
     For purposes of this application, the term “instrument” includes not only a NG tube, but also a slider device, stylet device, swallower device, and director device. Thus, the devices according to the present invention may be used in conjunction with one another for insertion into the nostril and in the pharynx of a patient so that a NG tube can be positioned through a nostril of the nose, past the pharynx, down through the esophagus and into the stomach. 
     For example, in one embodiment the director device may be used with the swallower device to insert and position a NG tube. The director device may be inserted into the nostril and in the pharynx of a patient. The NG tube may be positioned on the swallower device, which is then threaded within the director device. 
     In another embodiment, the slider device may be used with the swallower device. The slider device may be inserted into the nostril and in the pharynx of a patient. The NG tube may be positioned on the swallower device, which is then threaded within the slider device, thereby erecting the slider device. 
     In yet another embodiment, the slider device may be used with the director device. The slider device may be inserted into the nostril and in the pharynx of a patient. The director device may be threaded through the slider device, thereby erecting the slider device, and properly positioned within the pharynx. The NG tube may be then inserted in the director device. 
     In another embodiment, the stylet device may be used with the director device. The director device may be inserted into the nostril and in the pharynx of a patient. The NG tube may be positioned on the stylet device, which is then threaded within the director device. 
     In another embodiment, the stylet device may be used with the swallower device. The stylet device is inserted into the nostril and in the pharynx of a patient. The NG tube is positioned on the swallower device, which is then threaded over the stylet device, thereby erecting the slider device. Once positioned, the stylet device may be removed from the NG tube. This embodiment is contemplated for use with larger diameter NG tubes. 
     In another embodiment, the stylet device may be used with the slider device. The slider device may be inserted into the nostril and in the pharynx of a patient. The NG tube may be positioned on the stylet device, which is then threaded within the slider device, thereby erecting the slider device. 
     In yet another embodiment, the slider device, director device and swallower device may all be used in combination. The slider device may be inserted into the nostril and in the pharynx of a patient. The director device may be threaded through the slider device, thereby erecting the slider device, and inserted into the pharynx. The NG tube may be positioned on the swallower device, which is then threaded within the erected slider device including director device. 
     In yet another embodiment, the slider device, director device and stylet device may all be used in combination. The slider device may be inserted into the nostril and in the pharynx of a patient. The director device may be threaded through the slider device, thereby erecting the slider device, and properly positioned within the pharynx. The NG tube may be positioned on the stylet device, which is then threaded within the slider device including director device. 
     In yet another embodiment, the stylet device, slider device and swallower device may all be used in combination. The stylet device is inserted into the nostril and in the pharynx of a patient. The slider device is threaded over the stylet device thereby erecting the slider device. Once positioned, the stylet device may be removed. The NG tube is positioned on the swallower device and inserted through the erected slider device. 
     In yet another embodiment, the stylet device, slider device, director device and swallower device may all be used in combination. The stylet device is inserted into the nostril and in the pharynx of a patient. The slider device is threaded over the stylet device, thereby erecting the slider device. Once positioned, the stylet device may be removed. The director device is inserted through the erected slider device. The swallower device with the NG tube positioned thereon, may then be inserted into the director device. Once positioned, the director device may be removed. 
     The present invention and its attributes and advantages will be further understood and appreciated with reference to the detailed description below of presently contemplated embodiments, taken in conjunction with the accompanying drawings. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a cross-sectional view of a pharynx; 
         FIG. 2A  is a perspective view of a slider device in a collapsed state according to the present invention; 
         FIG. 2B  is a perspective view of a slider device in an erected state according to the present invention; 
         FIG. 3  is a perspective view of a stylet device according to the present invention; 
         FIG. 4  is a perspective view of a director device according to the present invention; 
         FIG. 5A  is a perspective view of a swallower device with deflated bladders according to the present invention; and 
         FIG. 5B  is a perspective view of a swallower device with inflated bladders according to the present invention. 
     
    
    
     DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION 
     The slider device  200 , as shown in  FIGS. 2A and 2B , includes a body component  202  extending from a first end  204  to a second end  206 . The body component  202  is cylindrical in shape with an inside surface  208  and an outside surface  210 , but any shape that can be inserted into the nostril and in the pharynx of a patient is contemplated. The slider device  200  may be made from any flexible material, such as plastic or rubber. The flexible material may further include porous properties to allow nasal secretions to lubricate the slider device  200 . It is also contemplated that the flexible material may also include a water activated lubricant. Lubrication of the slider device  200  assists in inserting the device into the nostril and into the pharynx of a patient. 
     The second end  206  of the slider device  200  is inserted into the nostril of a patient and in the pharynx prior to insertion of the NG tube or other instrument. In one embodiment, the slider device  200  may be used in conjunction with the stylet device  300  discussed more fully in reference to  FIG. 3 . In another embodiment, the slider device  200  may be used in conjunction with the director device  400  discussed more fully in reference to  FIG. 4  and yet in another embodiment, the slider device  200  may be used in conjunction with the swallower device  500  discussed more fully in reference to  FIG. 5 . 
     The first end  204  may either be completely inserted into the nostril or may be exposed outside the nostril. The slider device  200  is inserted into the patient in a collapsed state, as shown in  FIG. 2A . Upon positioning within the pharynx, the slider device  200  achieves an erected state as shown in  FIG. 2B . 
     In one embodiment, the slider device  200  is erected by threading an instrument, for example, a NG tube, stylet device, swallower device, and director device, through the first end  204 , within the inside surface  208  of the body component  202 , and through the second end  206 . In another embodiment, the first end  204  includes a lumen end  205  that maintains an open position to facilitate the insertion of an instrument into the collapsed state of the slider device  200 . The lumen end  205  is desirable in embodiments wherein the first end  204  of the slider device  200  is exposed, such as when a patient has a deviated septum within the nose or constricted areas within the pharynx. 
     In other embodiments, the slider device  200  includes a weak adhesion element  250  on the inside surface  208  to maintain the collapsed state shown in  FIG. 2A . When an instrument is threaded through the slider device  200 , the weak adhesion element  250  breaks to achieve the erected state shown in  FIG. 2B . The weak adhesion element  250  may be an adhesive or spot weld of a portion of the inside surface  208  together with another portion of the inside surface  208  of the body component  202 . 
     The stylet device  300 , as shown in  FIG. 3 , includes a shaft component  301  extending from a near end  302  to a far end  304 . The shaft component  301  is cylindrical in shape, but any small cross-sectional shape that can be inserted into the nostril and in the pharynx of a patient is contemplated. The shaft component  301  of the stylet device  300  may be made from any flexible material, such as plastic or rubber. 
     The near end  302  includes a handle element  306 . In one embodiment, the far end  304  of the stylet device  300  includes a pellet element  308 . The pellet element  308  may be made from any flexible material, such as plastic or rubber. The pellet element  308  may be spherical in shape, but any shape is contemplated that may be inserted into the nostril and in the pharynx of a patient. Further, the pellet element  308  may be weighted to assist in location of the stylet device  300 . 
     The far end  304  of the stylet device  300  is inserted into the nostril and in the pharynx of a patient such that the near end  302  is exposed outside the nostril. Instruments such as a NG tube, slider device, swallower device, and director device, are inserted into the nostril and in the pharynx of a patient using the stylet device  300  as a guide. For example, a NG tube can be guided by the stylet device  300  by engulfing the shaft component  301  prior to insertion into the nostril and in the pharynx of a patient. As another example, the stylet device  300  may be inserted into the nostril and in the pharynx of a patient and then the NG tube is inserted into the nostril and in the pharynx to follow alongside the shaft component  301 . In another embodiment, the stylet device  300  may be used in conjunction with the director device  400  discussed more fully in reference to  FIG. 4 . In another embodiment, the stylet device  300  may be used in conjunction with the swallower device  500  discussed more fully in reference to  FIG. 5 . 
     The director device  400 , as shown in  FIG. 4 , includes a tubular component  402  extending from a proximal end  404  to a distal end  406 . The tubular component  402  is cylindrical in shape with an interior surface  408  and an exterior surface  410 , but any shape that can be inserted into the nostril and in the pharynx of a patient is contemplated. The tubular component  402  of the director device  400  may be made from any flexible material, such as plastic or rubber. 
     The proximal end  404  includes a guide element  450  made from any flexible material, such as metal, plastic or rubber, that extends through the interior surface  408  and attaches at the distal end  406 . The guide element  450  attaches to the interior surface  408  of the tubular component  402  by any locking means known to those skilled in the art, for example, adhesive. 
     The distal end  406  of the director device  400  is inserted into the nostril and in the pharynx of a patient such that the proximal end  404  is exposed outside the nostril. The guide element  450  is then manipulated, for example to curve or angle the distal end  406  downward towards and past the pharynx, specifically the oropharynx. 
     Upon positioning the director device  400 , instruments such as a NG tube, slider device, swallower device, and director device, are inserted through the interior surface  408 . In one embodiment, the director device  400  may be used in conjunction with the swallower device  500  discussed more fully in reference to  FIG. 5 . In another embodiment, the director device  400  may be used in conjunction with the slider device  200  along with the stylet device  300 . 
     The swallower device  500 , as shown in  FIGS. 5A and 5B , includes a conduit component  502  extending from a bottom end  504  to a tip end  506 . The conduit component  502  is cylindrical in shape, but any shape that can be inserted into the nostril and in the pharynx of a patient is contemplated. The conduit component  502  of the swallower device  500  may be made from any flexible material, such as plastic or rubber. 
     The tip end  506  includes a first bladder element  508  and a second bladder element  510 . Each bladder element  508 ,  510  is made from any flexible material, such as plastic or rubber. The first bladder element  508  includes a first cavity  509  and the second bladder element  510  includes a second cavity  511 . The bladder elements  508 ,  510  inflate as shown in  FIG. 5B  when injected with a substance, such as air, saline or water. The bladder elements  508 ,  510  may be injected with a substance, for example, via a syringe inserted into the bottom end  504  of the conduit component  502 . 
     Prior to injection, the bladder elements  508 ,  510  are deflated as shown in  FIG. 5A  to position an instrument, such as a NG tube, slider device, stylet device, and director device, over the conduit component  502  such that the first bladder  508  extends outside the instrument and the second bladder  510  remains inside the instrument as shown in  FIG. 5B , wherein the instrument is a NG tube  600 . After positioning of the NG tube  600  about the swallower device  500 , the second cavity  511  of the second bladder element  510  is inflated to anchor the NG tube  600 . The tip end  506  of the swallower device  500  is inserted into the nostril and in the pharynx of a patient. Upon the tip end  506  located beyond the nasopharynx and into the oropharynx, the first cavity  509  of the first bladder element  508  is inflated to provide the patient with the sensation that a food bolus is in his or her pharynx to assist the patient in advancing the swallower device including NG tube into his or her stomach. 
     Once the swallower device  500  including instrument are located within the stomach, the first cavity  509  of the first bladder element  508  and second cavity  511  of the second bladder element  510  are deflated such as by retracting the substance via the syringe that is inserted into the bottom end  504  of the conduit housing  502  so that the swallower device  500  can be removed while allowing the instrument to remain. 
     In one embodiment, the swallower device  500  may be used in conjunction with the director device  400 . In another embodiment, the swallower device  500  may be used in conjunction with the slider device  200  along with the director device  400 . In another embodiment, the swallower device  500  may be used in conjunction with the slider device  200  along with the stylet device  300 . In yet another embodiment, the swallower device  500  may be used in conjunction with the slider device  200  along with the stylet device  300  along with the director device  400 . 
     While the disclosure is susceptible to various modifications and alternative forms, specific exemplary embodiments thereof have been shown by way of example in the drawings and have herein been described in detail. It should be understood, however, that there is no intent to limit the disclosure to the particular embodiments disclosed, but on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the scope of the disclosure as defined by the appended claims.