Intubation system and methods of use thereof

Details Intubation system and methods of use thereof Intubation system and methods of use thereof

2001-07-25

2004-04-13

Lewis, Aaron J. (Department: 3761)

Surgery

Respiratory method or device

Means placed in body opening to facilitate insertion of...

C128S207140

Reexamination Certificate

active

06718970

ABSTRACT:

This invention relates to an intubation system and methods of use thereof, and particularly relates to an intubation system, which includes components such as an intubation slide and a directing guide wire assembly, and to methods of using the slide and the assembly. The invention further relates to a kit for containing the components of the intubation system.
BACKGROUND OF THE INVENTION
Basic cardio-pulmonary resuscitation (CPR) begins with the establishment and maintenance of an adequate airway. Physicians on a daily basis face situations which require tracheal intubation for airway management. Since there are many patients in which placing an endotracheal tube is extremely difficult to near impossible, many devices have been developed over the past 20 to 30 years to facilitate intubation in these patients. Each one of these devices has drawbacks. The American Society of Anesthesiologists has established a “difficult airway” algorithm, by which the above-noted many devices have attempted to achieve tracheal intubation. However, while each device has experienced limited success, failure of such devices has resulted, in many instances, in a surgical airway being necessitated by an incision in the neck and into the trachea. Furthermore, many of the devices may not be useful based on the design or clinical situation. The new intubation system of this invention combines multiple features to facilitate tracheal intubation. In addition, these multiple features allow the system to be used in almost any airway situation as opposed to the devices currently on the market which present deficiencies of one kind or another.
Prior Art United States Patents Cited
Frankel (U.S. Pat. No. 4,825,858) teaches flexible guides for an endotracheal tube. However, based on anatomy, this is essentially a guide into the esophagus, in which the endotracheal tube apparently follows its course into the mouth, then disengages at the level of the larynx. Further, the patent does not have the esophageal obturator; therefore, tube will enter the esophagus. Secondly, the potential exists for aspirating stomach contents since the airway is unprotected. In addition, Frankel lacks an intubating slide, and therefore no alignment with the vocal cord opening (glottis) is present; just blind endotracheal tube maneuvering. Frankel also lacks directing guide, accordingly there is no definitive line (i.e., guide) into the trachea.
Hedberg (U.S. Pat. No. 4,825,858) is directed to a stylet, similar to the directing guide of the herein disclosed invention, however, the Hedberg stylet is different in that the stylet has suction ports which are not needed and impractical. Further, the Hedberg stylet lacks a directing guide monofilament line to assist alignment with glottis. Overall, Hedberg 1) lacks an esophageal obturator, therefore this airway is unprotected from vomited stomach contents, and lack of esophageal blockage can cause the stylet to end up in esophagus; 2) further lacking an intubating slide, does not allow for tracheal alignment but only blind passage. Accordingly, this stylet may end up in the esophagus; essentially in the position of the esophageal obturator.
Ovassapian et al (U.S. Pat. No. 5,024,218) teaches an oropharyngeal airway adapted to facilitate tracheal intubation. The airway is designed to protect a fiberoptic endoscope from damage by the patient's teeth, and is distinct from the intubation device of this invention in that Ovassapian is for an oropharyngeal device which essentially holds the mouth open and is used to visualize the airway via fiberoptic camera. Blind passages of the endotracheal tube through this airway will end up in the esophagus, and not the trachea. To be effective Ovassapian requires visualization via a camera; the herein disclosed invention does not require fiberoptics.
Augustine (U.S. Pat. No. 5,042,469) teaches a tracheal intubation guide comprising a tubular member having a curved forward end shaped to follow the curvature of the back of the tongue and throat of a patient, and a rear end for projecting out through the mouth of the patient, and an anterior guide surface extending along at least part of the length of the member to its forward end for guiding the member into the throat into a position opposite the opening into the larynx. The tubular member has a through bore for holding an endotracheal tube, and the guide surface has a forward edge of concave shape for engaging the front of the epiglottis and seating over the hyoepiglottic ligament when the member is accurately positioned. This device is essentially an enclosed laryngoscope which is used routinely to intubate. The Augustine device adds no real advantage in either an easy or difficult airway since it can end up being positioned anywhere in the posterior pharynx. The abstract states “correct positioning can be detected by external palpation of the neck”. This is virtually impossible in patients with large necks such as patients who are morbidly obese. It is for this difficult airway patient that the airway intubation system of this invention has been developed.
Parker (U.S. Pat. No. 5,174,283) teaches a device to facilitate rapid, accurate, blind access to the larynx or esophagus such as for emergency intubation of a patient's trachea and suctioning of the hypopharynx or esophagus. This guide is essentially a partially enclosed Ovassapian airway which lacks components of the esophageal obturator which protects from aspiration and prevents endotracheal tube passage into the esophagus.
Price (U.S. Pat. No. 5,353,787) teaches an oral airway to be used with an endotracheal tube along with inflatable balloon. This was a combination of two existing devices and does not allow proper alignment with the trachea since it lacks a slide which the herein disclosed invention embodies. Furthermore, it lacks both the esophagus obturator which leaves the airway “unprotected” and also lacks a directing guide to facilitate tracheal intubation. Lacking the directing guide and attempting to blindly place the larger endotracheal tube through the vocal cords becomes much more difficult, if not impossible.
Heinen, Jr. (U.S. Pat. No. 5,372,131) is for a multilumen intratracheal tube device. An inflation cuff is also taught. This device is not an emergency intubating device, but an endotracheal tube with a suction port.
Christopher (U.S. Pat. No. 5,694,929) teaches a mask with an additional port to assist with directly visualized fiberoptic guided intubation.
Gomez (U.S. Pat. No. 6,053,166) teaches an intubating assembly for positioning an intubation tube. This hinged device add an additional unnecessary step during an emergency. Furthermore, this device lacks the esophageal obturator and directing guide.
In summary, none of the prior art patents cited shows the unique intubation system of this invention; namely, the esophageal obturator, the intubating slide and the directing guide. Using one or more of the components of the intubation system will allow for the fool-proof placement of the endotracheal tube.
SUMMARY OF THE INVENTION
An object of this invention is to produce a system for efficiently intubating the airway, especially under emergency conditions and in situations involving “difficult airway” patients.
A further object of this invention is to intubate the airway without accidentally intubating the esophagus.
With these and other objects in mind, this invention contemplates an intubation system which includes a directing guide wire assembly having an end portion positionable in the trachea of a patient, an intubation slide for directing the end portion of the directing guide wire assembly toward the trachea, and an airway tube having an end portion positionable over and guidable by the directing guide wire assembly into the trachea.
In addition, this invention contemplates a directing guide wire assembly which includes a directing guide wire having a flexible end portion, a filament attached at one end thereof to the flexible end portion of the directing guide wire at a distal end thereof, and means for mounting th

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