Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Electrical therapeutic systems
Reexamination Certificate
1999-09-30
2001-05-29
Evanisko, George R. (Department: 3737)
Surgery: light, thermal, and electrical application
Light, thermal, and electrical application
Electrical therapeutic systems
Reexamination Certificate
active
06238423
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates generally to apparatus and methods for treating constipation in humans. More particularly, it relates to treating chronic, severe constipation by using an anticonstipation apparatus to electrically stimulate the muscles associated with the afflicted portion of the gut. This may be done by stimulating portions of the autonomic nervous system associated with those muscles, or by directly stimulating those muscles themselves.
SUMMARY OF THE INVENTION
Constipation is a life-disturbing problem that afflicts millions of Americans, from the very young to the elderly. Although relatively rare among the young, it is a very common problem in middle age, and is a nearly ubiquitous problem in the elderly.
Chronic constipation is a major problem for many individuals, and frequently causes extreme discomfort to the afflicted. Such discomfort may be a major obstacle to leading a normal life, and may consume an enormous amount of the afflicted person's energy and time.
Besides causing severe discomfort, chronic constipation may also be harmful to the patient. For example, chronic constipation may result in an intestinal obstruction that may cause the patient great pain; or that may even cause the patient's death, unless surgically corrected. Chronic constipation may also prevent the patient from receiving the benefit of certain needed prescription medications, because the medications may have undesirable side effects on an already constipated gut.
Chronic constipation may result, for example, from bowel denervation, a neuro-reflex dysfunction, or a neuro-smooth muscle disorder. Such conditions may arise from such causes as diabetes, spinal injury, or primary degenerative neurologic diseases.
Conventional therapies for chronic constipation are often distasteful and unpleasant, at best, since they may involve such treatments as the repeated consumption of large quantities of laxatives such as milk of magnesia, the repetitive use of enemas, or both. Repeatedly consuming large quantities of laxatives may be harmful to the patient, since they may result in dehydration or even renal failure. The repetitive use of enemas may be harmful since they may irritate or physically harm the treated portion of the patient's gut.
Chronic constipation is usually thought of in association with problems of the large intestine. However, other parts of the patient's gut may also exhibit chronic constipation-like problems, such as the esophagus, the stomach, and less frequently, the small intestine. Such problems may include depressed motility of the esophagus, stomach and/or small intestine.
For simplicity, chronic constipation, or chronic constipation-like problems, of any portion of the patient's gut from the esophagus to the anus will be referred to hereafter as simply “constipation”.
In general, the present invention may comprise an apparatus and a method for treating constipation of any portion of the patient's gut from the esophagus to the anus. All, or part, of the apparatus may be located inside of the patient's body.
In basic form, the anticonstipation apparatus of the present invention may comprise an electrical stimulus generator; at least one pair of electrodes; and at least one lead for electrically connecting the pair of electrodes to the stimulus generator. The stimulus generator may include an electrical pulse generator. Any particular pair of electrodes may be anchored at a respective stimulation site to stimulate the muscles associated with the constipated target portion of the gut. The stimulation site may be located on the part of the autonomic nervous system that is associated with those muscles, or the stimulation site may be located directly on those muscles themselves.
When the pulse generator is activated, it may commence production of the desired electrical stimuli. The electrical stimuli may then be conveyed to the gut's target portion by the lead(s) and pair(s) of electrodes.
Only one pair of electrodes may be provided, in which case all of the desired electrical stimuli may be provided to that pair of electrodes. Alternatively, at least two pairs of sequential electrodes may be provided, in which case the desired electrical stimuli may be provided sequentially to the at least two pairs of electrodes.
The electrical stimuli may help to initiate or enhance the patient's natural peristaltic waves in a proximal to caudad direction along at least the gut's target portion, in order to help alleviate the constipation. Alternatively, where the patient's body is incapable of producing any natural peristaltic waves on its own, the electrical stimuli may artificially produce the needed peristaltic waves. When the desired electrical stimulation has been provided, the pulse generator may then be turned off.
The stimulus generator may comprise, in addition to the pulse generator, a controller that may include a suitably programmed microprocessor. The controller may control the pulse generator in such a way that, when the pulse generator is activated, the pulse generator may produce any particular desired stimulus, combination of stimuli, sequence of stimuli, and/or timing of stimuli.
By way of example, the electrical stimulation provided by the pulse generator may comprise monophasic waveform stimuli, biphasic waveform stimuli, and/or multiphasic waveform stimuli.
The anticonstipation apparatus of the present invention may also comprise a constipation sensing means for detecting when a particular portion of the patient's gut is constipated. When a “constipated” signal is received by the controller from the constipation sensing means, the controller may automatically activate the pulse generator; or the controller may alert the patient, or the patient's health care provider, so that the pulse generator may be manually activated.
The anticonstipation apparatus of the present invention may also electrically stimulate other portions of the patient's gut besides the constipated target portion. For example, if the gut's target portion is located in the descending colon, then the apparatus may also electrically stimulate the rectum and/or the anus, in order to aid the patient in defecating.
The method of the present invention may comprise using an anticonstipation apparatus to treat constipation by electrically stimulating the muscles associated with the constipated target portion of the gut. The method may include using the apparatus to electrically stimulate the part of the autonomic nervous system that is associated with those muscles, or to electrically stimulate those muscles themselves. The method may also include electrically stimulating other portions of the patient's gut besides the constipated target portion.
It should be understood that the foregoing summary of the present invention does not set forth all of its features, advantages, characteristics, structures, methods and/or processes; since these and further features, advantages, characteristics, structures, methods and/or processes of the present invention will be directly or inherently disclosed to those skilled in the art to which it pertains by all of the disclosures herein.
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Electric Stimulation of the Gastrointestinal Tract—GP Apr. 1994.
Gastrointestinal Pacing—A New Concept in the Treatment of Ileus—Biomedical Sciences Instrumentation vol. 1. 1963 (A.M. Bilgutay, R. Wingrove, W.O. Griffen, R.C. Bonnabeau and C.W. Lillehei).
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Evaluation of the Intrinsic Innervation of the Internal Anal Sphincter using Electrical Stimulation—Gut, 19
Evanisko George R.
Jaro Michael J.
Medtronic Inc.
Patton Harold
Woods Thomas F.
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