Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Electrical therapeutic systems
Reexamination Certificate
1999-06-25
2001-05-15
Layno, Carl H. (Department: 1609)
Surgery: light, thermal, and electrical application
Light, thermal, and electrical application
Electrical therapeutic systems
C607S117000
Reexamination Certificate
active
06233488
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to a new method for suppressing chemical substance craving comprising electrical stimulation of the spinal cord using one or more implantable leads containing at least two conducting electrodes. The method may be used to suppress craving for alcohol, narcotics, cocaine and amphetamines. The method is particularly suited to the suppression of nicotine craving.
Tobacco related deaths are the largest single cause of premature death in developed countries. More than 400,000 deaths per year are linked to smoking related illness in the U.S. alone. However, despite the well publicized risks and consequences associated with tobacco use, more than 25% of adults in the United States continue to smoke with prevalence rates varying according to demographics.
The benefits of smoking cessation are substantial. Immediate benefits accrue to smokers who quit, including those with smoking-related disease. The risk of disease declines with smoking cessation and continues to drop through periods of abstinence. After 10-15 years of abstinence, mortality risks are equal to those of non-smokers. Smoking cessation decreases the risk of stroke, aortic aneurysm, peripheral vascular disease and myocardial reinfarction in individuals with myocardial infarction. Similar risk reduction exists in the incidence of smoking related cancers, chronic obstructive pulmonary disease and pregnancy related complications. An effective treatment for smoking addiction would result in a significant public health advance.
Previous attempts to effect smoking cessation can be divided into two categories, non-pharmacologic interventions and pharmacologic interventions. Non-pharmacologic interventions focus on altering the behavioral conditioning of smokers so that smoking is avoided or is a disfavored activity. Pharmacologic interventions are geared toward lessening the craving for nicotine and are divided into the current mainstay, nicotine replacement therapy (the only pharmacologic therapy with FDA approval) and other forms of drug therapy. The patented pharmacologic therapies employ transdermal azapirones (U.S. Pat. Nos. 5,837,280; 5,817,679; 5,633,009), nicotine receptor agonists and antagonists (U.S. Pat. Nos. 5,817,331; 5,691,365), nicotine lozenge (U.S. Pat. Nos. 5,662,920; 5,549,906), cotinine (U.S. Pat. No. 5,612,357), transdermal nicotine systems including subsaturated prolonged activity patches (U.S. Pat. Nos. 5,004,610; 4,839,174), and methods for anticholinergic blockage of withdrawal symptoms (U.S. Pat. No. 4,555,397). Unfortunately, as discussed below, none of the varied therapies, whether used singly or in combination, are very effective.
The effectiveness of various methods for smoking cessation was studied and reported in a large meta-analysis derived from 188 randomized controlled trials evaluating multiple interventions intended for smoking cessation (See Law, M. An Analysis of the Effectiveness of Interventions Intended to Help People Stop Smoking.
Archives Internal Medicine.
1995; 155:1933-1941). In the meta-analysis, previously investigated interventions were evaluated and their outcomes given.
The meta-analysis found that even the most effective therapies (nicotine replacement) showed a marginal success rate of 13%. No other therapy or therapies in combination showed success rates of greater than 5% except in the rare instance of special risk groups (pregnant women, patients with ischemic heart disease or previous myocardial infarction) who exhibited up to an 8% quit rate when given advice and encouragement to quit based on their special risk. Non-pharmacologic therapies fared poorly with the success rates no greater than that achieved with physician advice. More recently, a Mar. 2, 1999
New York Times
article indicated new success using a combination therapy with sustained buproprion, nicotine replacement and counseling, citing an Oct. 23, 1997 article in the
New England Journal of Medicine
(Vol. 337, No. 17, pg. 1195). However, despite initial promise, one year follow-up cessation rates were 24.4% at the highest buproprion dose compared to 10.5% cessation rate for placebo. This rate advantage over placebo was consistent with the poor success rate using other methods. These low success rates illustrate the limitations and failures of the prior interventions and highlight the need for improved treatments to effect smoking cessation.
Clearly, there exists a real need in the art for effective therapies and specifically more effective non-pharmacologic therapies in the treatment of nicotine addiction. There is also a need in the art to develop non-pharmacologic therapies for the treatment of addictions to other chemical substances such as alcohol, narcotics, cocaine and amphetamines.
SUMMARY OF THE INVENTION
The present invention relates to a method for treating addiction to nicotine and other chemical substances comprising electrical stimulation of the spinal cord or nervous system of the patient using one or more commercially available implantable spinal cord stimulation leads for a time period sufficient to suppress or extinguish the nicotine craving of the patient. The inventive method may be used either alone or in combination with drug or behavioral therapies.
The effectiveness of the inventive method is believed to be related to the presence of nicotine receptors in the spinal cord which can be activated by spinal cord stimulation. Receptor and receptor systems, nerve and nerve endings of varying size, and neurotransmitters are distributed at all levels in the spinal cord. In particular, nicotine receptors are found in the central nervous system (brain and spinal cord) and analgesia is produced by nicotine both systemically and in the spinal cord. Potential mechanisms proposed for the production of analgesia by spinal cord stimulation suggest that stimulation of the dorsal horn of the spinal cord activates endogenous inhibitory systems which can modulate or block the sensation of pain. These inhibitory systems include, but are not limited to, endorphin and enkephalin systems (opiate systems), serotonergic, adenosingergic, adrenergic, dopinamergic and finally cholinergic systems. Nicotine receptors are found within the cholinergic system. Stimulation of the cholinergic (inhibitory) systems in the spinal cord produces antinociception (pain relief). Therefore, stimulation of the cholinergic and thereby the nicotinic system in the spinal cord should also mimic the presence of nicotine by activating the nicotinic receptors, but by a non-pharmacologic method. Thus, stimulation of the nicotinic system should mimic nicotine both systemically and locally in the central nervous system. As a net result of this stimulation, a patient treated with spinal cord stimulation should experience decreased craving for nicotine and an ability to interrupt behavioral components thereby allowing the patient to overcome the addiction.
The inventive method uses one or more implantable leads which are comprised of a plurality of conducting electrodes adapted for accurate placement within the human body, in particular the area of the spinal cord or nervous system to be stimulated. Various devices for spinal cord stimulation used in chronic pain management and movement disorders are disclosed in U.S. Pat. Nos. 3,654,933, 4,044,77, 4,379,462, 5,058,584, 5,417,719, 5,501,703 and 5,643,330 which are all herein incorporated by reference in their entirety.
The method described is also applicable to the treatment of addiction to alcohol, narcotics, cocaine. amphetamines and other chemical substances since receptor systems (e.g. opiate receptors for narcotics) specific for these substances are also found in the spinal cord.
In clinical practice, the suitability of the inventive method for a particular patient is determined by first screening the patient using various psychological criteria to determine if he is a suitable candidate for the procedure. If the patient passes the screening procedure, a trial implantation and stimulation is carried out. The results of the
Layno Carl H.
Morgan & Finnegan , LLP
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