Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Electrical therapeutic systems
Reexamination Certificate
1999-01-25
2001-03-06
Getzow, Scott M. (Department: 3762)
Surgery: light, thermal, and electrical application
Light, thermal, and electrical application
Electrical therapeutic systems
C607S047000
Reexamination Certificate
active
06198970
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to a method and apparatus for effectively treating oropharyngeal, respiratory, and oral motor neuromuscular disorders. In particular, the present invention relates to a method and apparatus for treating oropharyngeal, respiratory and oral motor neuromuscular disorders by providing electrical stimulation to specific muscle regions of a patient using one or more snap electrodes.
BACKGROUND OF THE INVENTION
Asymptomatic and symptomatic oropharyngeal disorders can lead to an inability to swallow or difficulty in swallowing. These disorders may be caused, for example, by stroke, neurodegenerative diseases, brain tumors or respiratory disorders.
Swallowing is a complicated action whereby food is moved from the mouth through the pharynx and esophagus to the stomach. The act of swallowing may be initiated voluntarily or reflexively but is always completed reflexively.
The act of swallowing occurs in three stages and requires the integrated action of the respiratory center and motor functions of multiple cranial nerves, and the coordination of the autonomic system within the esophagus. In the first stage, food or some other substance is placed on the surface of the tongue. The tip of the tongue is placed against the hard palate. Elevation of the larynx and backward movement of the tongue forces the food through the isthmus of the fauces in the pharynx. In the second stage, the food passes through the pharynx. This involves constriction of the walls of the pharynx, backward bending of the epiglottis, and an upward and forward movement of the larynx and trachea. Food is kept from entering the nasal cavity by elevation of the soft palate and from entering the larynx by closure of the glottis and backward inclination of the epiglottis. During this stage, respiratory movements are inhibited by reflex. In the third stage, food moves down the esophagus and into the stomach. This movement is accomplished by momentum from the second stage, peristaltic contractions, and gravity.
Although the main function of swallowing is the propulsion of food from the mouth into the stomach, swallowing also serves as a protective reflex for the upper respiratory tract by removing particles trapped in the nasopharynx and oropharynx, returning materials refluxed from the stomach into the pharynx, or removing particles propelled from the upper respiratory tract into the pharynx. Therefore, the absence of adequate swallowing reflex greatly increases the chance of pulmonary aspiration.
In the past, patients suffering from oropharyngeal disorders have undergone dietary changes or thermal stimulation treatment to regain adequate swallowing reflexes. Thermal stimulation involves immersing a mirror or probe in ice or another cold substance. The tonsillar fossa is stimulated with the mirror or probe, and the patient closes his mouth and attempts to swallow. While these traditional methods are usually effective for treating oropharyngeal disorders, in some patients these methods require that the patient endure weeks or months of therapy. It is also difficult to distinguish these patients who require more extensive treatments from patients who recover spontaneously. Thus, it is desirable to have a simple, non-invasive method and device for treating oropharyngeal disorders and artificially promoting swallowing which is effective within a relatively short treatment period.
Electrical stimulation has been used as a method for alleviating pain and stimulating nerves, as well as a means for treating disorders of the spinal cord or peripheral nervous system. Electrical stimulation has further been used to facilitate muscle reeducation and with other physical therapy treatments. In the past, electrical stimulation was not recommended for use in the neck because of the theoretical concerns that the patient would develop spasms of the laryngeal muscles, resulting in closure of the airway or difficulty in breathing. Further, the introduction of electrical current into the neck near the carotid body may cause cardiac arrhythmia.
More recently, electrical stimulation has been used to stimulate the recurrent laryngeal nerve to stimulate the laryngeal muscles to control the opening of the vocal cords to overcome vocal cord paralysis, to assist with the assessment of vocal cord function, to aid with intubation, and other related uses. There have been no adverse reactions to such treatment techniques. However, electrical stimulation has not been used in the treatment of oropharyngeal disorders to promote the swallowing reflex, which involves the integrated action of the respiratory center and motor functions of multiple cranial nerves.
The oral motor skills needed to effectively speak, chew and swallow include the ability to open and close the mouth, the ability to elevate the tongue, the ability to laterals the tongue, and the ability to purse the lips. Deficiencies in one or more of these oral motor skills as sometimes occurs in children and stroke victims, for example, can delay or cause a complete inability of a patient to achieve safe oral intake.
Known treatment techniques for oral motor skills deficiencies typically require lengthy treatment periods to achieve the skills necessary to speak and swallow. Thus, there is a need for a method of treatment that enables development of these skills with relatively fewer treatments performed within a shorter period of time.
Chronic respiratory disorders, including asthma, bronchitis, asthma-like symptoms, chronic obstructive pulmonary disease, and actelectasis are common and often debilitating disorders. Individuals suffering from one or more of these disorders may incur the expense of high-cost medications and may be severely limited in terms of the physical activities they are able to undertake. These individuals may also be placed on ventilators because they are unable to breathe deeply enough without the aid of a ventilator. Such ventilator dependence substantially increases the cost to the patient and severely restricts the patient's mobility. Thus, there is a need for a simple, inexpensive treatment for chronic respiratory disorders that reduces the coughing and inflammation associated with such disorders, for example, to allow the patient to be extubated from a ventilator and/or to reduce or eliminate the medications needed by the patient, thereby substantially reducing the costs of the treatment and improving the quality of life of the patient.
SUMMARY OF THE INVENTION
The present invention provides a simple, non-invasive method and device for treating oropharyngeal disorders and artificially promoting swallowing. The present invention further provides a simple, non-invasive method and device for treating respiratory disorders such as asthma, bronchitis, and chronic obstructive pulmonary disease to provide improved respiratory capacity of a patient. The present invention also provides a simple, non-invasive method and device for treating oral motor neuromuscular damage and disorders to provide improved control and usage of oral motor muscles.
According to one embodiment of the present invention, a method and device provide electrical stimulus to the pharyngeal region of a patient (a human or other animal) to stimulate muscles and nerves located in the pharyngeal region in order to promote swallowing.
The method and device for electrical pharyngeal neuromuscular stimulation according to the present invention are more effective for treating oropharyngeal disorders than traditional treatment methods, such as thermal stimulation. Further, the method and device of the present invention are effective for treating worst-case dysphagia resulting from neurodegeneration and strokes.
According to another embodiment of the present invention, a method and device provide electrical stimulus to the intercostal muscle regions between the ribs of a patient to enable improved respiratory functions of the patient, treating respiratory disorders such as asthma, bronchitis or chronic obstructive pulmonary disease, and further treating ventilator depend
Freed Marcy L.
Tucker Howard
Covington & Burling
ESD Limited Liability Company
Getzow Scott M.
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