Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Electrical therapeutic systems
Reexamination Certificate
2001-02-06
2002-02-26
Kamm, William E. (Department: 3762)
Surgery: light, thermal, and electrical application
Light, thermal, and electrical application
Electrical therapeutic systems
Reexamination Certificate
active
06351674
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to improved methods for the non-invasive treatment of various disease conditions using an improved process of transcutaneous electrical stimulation. In particular, provided herein are improved methods of non-invasively treating symptoms of tremor disorders including essential tremors and tremors associated with Parkinson's Disease; symptoms of dementia disorders including cortical dementia, such as is found in Alzheimer's disease and Pick's disease, subcortical dementia, such as is found in Parkinson's disease, Huntington's chorea and supranuclear palsy, and multi-infarct dementia; and symptoms of painful degenerative disorders, such as fibromyalgia and reflex sympathetic dystrophy by using transcutaneous electrical nerve stimulation programs of variable intensity and variable frequency. Also provided are apparatus for performing such methods.
BACKGROUND OF THE INVENTION
Transcutancous electrical nerve stimulation (TENS) is a well known medical treatment used primarily for symptomatic relief and management of chronic intractable pain and as an adjunctive treatment in the management of post surgical and post traumatic acute pain. TENS involves the application of electrical pulses to the skin of a patient, which pulses are generally of a low frequency and are intended to affect the nervous system in such a way as to suppress the sensation of pain that would indicate acute or chronic injury or otherwise serve as a protective mechanism for the body. Typically, two electrodes are secured to the skin at appropriately selected locations. Mild electrical impulses are then passed into the skin through the electrodes to interact with the nerves lying thereunder. As a symptomatic treatment, TENS has proven to effectively reduce both chronic and acute pain of patients. However, TENS has shown no capacity for curing the causes of pain, rather the electrical energy simply interacts with the nervous system to suppress or relieve pain.
The human nervous system essentially serves as a communication system for the body wherein information concerning the state of the body is communicated to the spinal cord (and/or brain) and behavioral instructions are communicated from the brain (and/or spinal cord) to the rest of the body. Thus, there are ascending neural pathways, such as the ascending pain pathways, and descending neural pathways, such as the descending inhibitory pathway (DIP), within the nervous system.
Briefly, pain impulses received by the free nerve endings of nociceptive nerve fibers (in particular, A&dgr; and C fibers) are conducted, through various synapses, to the brain. In particular, these first order neurons enter the dorsal horn of the spinal cord and synapse with second order neurons, which are either relay cells, projecting into the brain stem or thalamus, or interneurons, synapsing to other interneurons or to relay cells. The second order neurons then (mostly) cross the spinal cord and become the anterolateral system, comprised of the neospinothalamic tract (or lateral spinothalamic tract) and paleospinothalamic tract. The nerve fibers of the anterolateral system then terminate in various regions of the brain, including the brain stem, midbrain and thalamus.
Inhibition (or modulation) of pain, by the body, can occur anywhere from the point of origin of the pain through the successive synaptic junctions in the pain's central pathway. For example, following the descending inhibitory pathways (DIP) of pain inhibition/modulation, stimulation in the cerebral cortex of the brain descends to the thalamus and then to the periaqueductal gray (PAG) of the midbrain. The PAG region is rich in opiate receptors responsible for secreting morphine-like enkephalins and endorphins. Nerve fibers from the PAG then descend to the nucleus raphe magnus (NRM) in the brainstem. The NRM is responsible for the secretion of serotonin, a compound that is instrumental in elevating pain threshold levels and combating depression. Fibers from the NRM then descend into the spinal cord, synapsing with other inhibitory interneurons to cause secretion of additional powerful anti-pain neurotransmitters such as gamma-aminobutyric acid (GABA).
While prior art TENS devices and methods have been shown to be capable of affecting the ascending pathways of pain perception, they have shown little or no ability to affect the descending inhibitory pathways of the nervous system. The precise mechanisms by which these prior art TENS methods operate to affect pain are not known; however, one theory suggests that, by producing fast electrical waves that travel up the A&bgr; nociceptive fibers, the TENS electrical stimulation pulses block pain stimulus traveling up the A&dgr; and C fibers. One frequently reported problem with the prior art TENS methods is acclimation or accommodation; that is, the patient acclimates to the transcutaneous stimulation and the pain returns. The intensity of the treatment, in such cases, is increased to overcome the patient's accommodation of the treatment, but shortly, a maximum level of intensity is reached and further treatment is ineffective.
A TENS simulator such as that shown in U.S. Pat. No. 5,052,391 is, in effect, an electrical pulse generator which delivers electrical pulses (or impulses), transcutaneously, at a predetermined fixed or variable frequency. Typically, TENS stimulators deliver electrical pulses at frequencies in the range of about 50 to 200 Hertz (Hz). Most commonly, variable frequency TENS devices operate by beginning stimulation at the lowest frequency setting then increasing the frequency of stimulation until a pre-defined event occurs, such as motor nerve response or patient comfort achieved. Such increases in frequency may be controlled by a doctor or other medical personnel or, more often, are controlled by the patient him/herself. In addition to increasing the frequency of the stimulation pulses, the patient may be treated by simultaneously increasing the intensity (or amplitude) of the stimulation output of the device.
For example, the patient may have a choice of different “levels” of stimulation, each sequential level providing an increased frequency and intensity of stimulation as compared to the previous level. In either case, the output parameters generally start at their lowest level and are increased over the duration of the treatment.
Normally, when the patient (or other operator) increases the stimulation level of the TENS machine, in accordance with his/her doctor's instructions, the new, higher level is somewhat uncomfortable at first. However, as the patient knows from experience, his/her body accommodates to the new higher level of stimulation within a tolerable length of time. Once stimulation at one level becomes fully accommodated, that is, no longer works well to relieve the symptoms for which the treatment is being administered, the patient increases the stimulation level. Thus, as mentioned previously, the body is able to adjust to the electrical stimulation, requiring ever increasing levels of stimulation to achieve the same level of pain relief, often until no amount of stimulation is effective. The use of devices of this general type for dental anesthesia is shown in U.S. Pat. Nos. 4,924,880 and 4,550,733. These devices generally employed a biphasic symmetrical sinusoidal waveform at a peak voltage of only 2 volts and a peak current of only 0.87 milliamps.
In some cases, the treatment frequency of the TENS device is fixed by design, or is established as a preselected, generally arbitrary, rate at the time of treatment, and only adjustment of the intensity (or amplitude) of the electrical pulses is allowed. The typical intensity level of TENS stimulators is in the range of 30-200 volts. The waveform characteristic of the electrical pulses varies and includes, for example, symmetrical sinusoidal waveforms, symmetrical biphasic waveforms and DC needle spikes. Generally, the different waveforms are believed to offer some advantage over other waveforms; howev
Fitch Even Tabin & Flannery
Kamm William E.
Synaptic Corporation
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