Surgery – Respiratory method or device – Respiratory gas supply means enters mouth or tracheotomy...
Reexamination Certificate
1999-10-08
2004-01-06
Lo, Weilun (Department: 3761)
Surgery
Respiratory method or device
Respiratory gas supply means enters mouth or tracheotomy...
C128S200260, C128S899000
Reexamination Certificate
active
06672308
ABSTRACT:
CROSS-REFERENCES TO RELATED APPLICATIONS
Not applicable.
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT
Not applicable.
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates generally to devices for the endotracheal intubation of a patient. More particularly, it relates to a control assembly for guiding the placement of an endotracheal tube during the intubation of a patient.
2. Description of the Related Art
In a medical context, it is important to maintain a patent airway in a patient so that the patient's respiration can be maintained either through the patient's own efforts or through external assistance. Even if the patient presents for medical care with a patent airway, it may be necessary to ensure that the airway remains patent, such as in assisted respiration by positive ventilation. Under these and other like circumstances it may become necessary to insert a tube from the exterior of the patient into the trachea so that respiratory or other gases can be ventilated directly to the lungs. This is accomplished by inserting an endotracheal tube through the mouth and ultimately into the trachea with the distal end of the tube disposed beyond the vocal chords. It is important that the endotracheal tube enter the trachea and not the esophagus so that any positive pressure is applied to the trachea and lungs and not the esophagus and gastrointestinal tract. Previously, in order to ensure this positioning, medical personnel performing this intubation visualized the vocal chords as the endotracheal tube was passing between the vocal chords and into the trachea beyond the vocal chords, thereby avoiding entry into the esophagus.
In the course of intubating a patient, the patient is typically placed in a prone position and the patient's head is extended and the lower jaw raised. From a position behind the patient's head the physician attempts to visualize the patient's vocal chords and then proceed with the intubation. Under certain circumstances, such as traumatic injury to the cervical spine or suspected injury to the cervical spine, movement of the patient or the patient's head, neck or lower jaw is contraindicated. In other circumstances the neck may not be able to be manipulated at all, such as rheumatoid arthritis or ankalosing spondylitis. In addition, patients presenting with preexisting abnormalities, such as, but not limited to,
anatomical abnormalities of the neck or jaw;
abnormally large tongue
anatomical abnormalities of the lips or palate;
arthritic cervical spine or tempomandibular joint;
inelastic scar tissue of the face, neck or mouth;
burns of the face, mouth, or throat;
tumors or inflammation of the pharynx, larynx, trachea, esophagus, tonsils, uvala,
retropharyngal space, or vocal chords;
crush injuries to the larynx;
jaw fractures;
facial fractures;
thyroid disease;
spatial deviation of the epiglottis, vocal cords or trachea from the midline of the body;
micrognathia;
foreign body in the airway;
caustic injections; and
allergic reactions.
To further add to the difficulty of successful intubation, in traumatic intubation the foregoing problems may be overshadowed by additional concerns of a trauma patient, such as unstable cervical spine, flail chest, tension pneumothorax. These additional concerns decrease the amount of time available to secure the patency of the airway. Further, rather than wait until the patient is hospitalized, it would be desirable to provide a patent airway as rapidly and as reliably as possible. And it would also be highly desirable to provide a means for nonspecialist physicians and other nonphysician medical personnel, including physician extender personnel, such as physician assistants and respiratory therapists, to intubate reliably, rapidly and competently.
Previously, the options available for securing a patent airway in the emergency room or before hospital admittance were essentially either nasotracheal or orotracheal intubation requiring a high level of physician skill at the specialist level and the visualization of the vocal chords or a surgical procedure, such as cricthyrotomy, tracheotomy or transtracheal jet ventilation.
Techniques that utilized magnetic means for guiding a stylet into the trachea required skill in properly placing an external magnet with respect to the patient's anatomical landmarks vis a vis the esophageal/tracheal juncture and required continued manual stabilization of the external magnet and retention of that required placement during the intubation procedure. As a consequence two people were needed to perform these techniques. This was particularly undesirable in emergency, trauma and other critical medical emergencies where requiring the physician to use one hand to retain the placement of the external magnet severely reduced the ability of a single physician to intubate the patient.
BRIEF SUMMARY OF THE INVENTION
It is therefore an object of the present invention to desirably provide a means for performing endotracheal intubation without requiring manual retention of the intubation guide means in a fixed alignment position.
It is a further object to desirably provide a means for trauma specialist; emergency medicine physicians and anesthesiologists to perform endotracheal intubation more rapidly and more reliably in a variety of difficult situations.
It is a still further object to desirably provide a means for non specialist physicians and even physician extender personnel, such as physician assistants and respiratory therapists to perform endotracheal intubation.
These and other objects may be desirably provided by a control assembly for guiding the placement of an endotracheal tube during the intubation of a patient configured in accordance with the present invention that comprises
a. A flexible stylet comprising a first magnetic means distally disposed on said stylet and
b. An alignment fixture comprising a second magnetic means and adapted for positioning the second magnetic means over the cricothyroid cartilage of the patient to be intubated and retaining the second magnetic means in position over the cricothyroid cartilage of the patient.
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JNC Medical, LLC
McConoughey David M.
Patel Mital
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