Optimal method and apparatus for neural modulation for the treatment of neurological disease, particularly movement disorders
First Claim
1. A neural modulation system for use in treating disease which provides stimulus intensity which may be varied, comprising a stimulating and recording unit, said stimulating and recording unit further comprising a reference module in communication with a patient interface module and a supervisory module, said reference module further comprising a memory register for the storage of control law reference values, said patient interface module facilitating monitoring and adjustment of said reference values by a patient and said supervisory module facilitating monitoring and adjustment of reference values by a health care provider.
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Abstract
A neurological control system for modulating activity of any component or structure comprising the entirety or portion of the nervous system, or any structure interfaced thereto, generally referred to herein as a “nervous system component.” The neurological control system generates neural modulation signals delivered to a nervous system component through one or more intracranial (IC) stimulating electrodes in accordance with treatment parameters. Such treatment parameters may be derived from a neural response to previously delivered neural modulation signals sensed by one or more sensors, each configured to sense a particular characteristic indicative of a neurological or psychiatric condition. Neural modulation signals include any control signal which enhances or inhibits cell activity. Significantly the neurological control system considers neural response, in the form of the sensory feedback, as an indication of neurological disease state and/or responsiveness to therapy, in the determination of treatment parameters.
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Citations
45 Claims
- 1. A neural modulation system for use in treating disease which provides stimulus intensity which may be varied, comprising a stimulating and recording unit, said stimulating and recording unit further comprising a reference module in communication with a patient interface module and a supervisory module, said reference module further comprising a memory register for the storage of control law reference values, said patient interface module facilitating monitoring and adjustment of said reference values by a patient and said supervisory module facilitating monitoring and adjustment of reference values by a health care provider.
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28. A neurological control system for modulating the activity of at least one nervous system component, the neurological control system comprising:
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at least one intracranial stimulating electrode, each constructed and arranged to deliver a neural modulation signal to at least one nervous system component;
at least one sensor, each constructed and arranged to sense at least one parameter, including but not limited to physiologic values and neural signals, which is indicative of at least one of disease state, magnitude of symptoms, and response to therapy; and
a stimulating and recording unit constructed and arranged to generate said neural modulation signal based upon a neural response sensed by said at least one sensor in response to a previously delivered neural modulation signal, said stimulating and recording unit further comprising a reference module in communication with a patient interface module and a supervisory module, said reference module further comprising a memory register for the storage of control law reference values, said patient interface module facilitating monitoring and adjustment of said reference values by a patient and said supervisory module facilitating monitoring and adjustment of reference values by a health care provider. - View Dependent Claims (29, 30, 31, 32, 33, 34)
a signal processor constructed and arranged to determine neural system states; and
a control module for adjusting said at least one neural modulation signal based upon said neural system state.
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32. The system of claim 28, wherein each of said at least one sensor generates one or more neural response signals, and wherein said stimulating and recording unit further comprises:
a signal conditioner, interposed between said at least one sensor and said signal processor, constructed and arranged to modify said neural response signals appropriately for said signal processor.
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33. The system of claim 32, wherein said signal conditioner comprises:
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at least one amplifier, each constructed and arranged to amplify said neural response signals generated by an associated one of said at least one sensor; and
at least one signal filter, each constructed and arranged to filter said amplified neural response signals generated by an associated one of said at least one sensor and an associated at least one amplifier.
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34. The system of claim 33, wherein said at least one signal filter performs at least one of lowpass filtering, highpass filtering, bandpass filtering and notch filtering of said amplified neural response signal.
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35. An apparatus for modulating the activity of at least one nervous system component, said system comprising:
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means for delivering neural modulation signal to said nervous system component;
means for sensing neural response to said neural modulation signal, and a stimulating and recording unit, said stimulating and recording unit further comprising a reference module in communication with a patient interface module and a supervisory module, said reference module further comprising a memory register for the storage of control law reference values, said patient interface module facilitating monitoring and adjustment of said reference values by a patient and said supervisory module facilitating monitoring and adjustment of reference values by a health care provider. - View Dependent Claims (36, 37, 38, 39, 40, 41, 42, 43, 44, 45)
signal conditioning means for conditioning sensed neural response signals, said conditioning including but not limited to at least one of amplification, lowpass filtering, highpass filtering, bandpass filtering, notch filtering, root-mean square calculation, envelope determination, and rectification;
signal processing means for processing said conditioned sensed neural response signals to determine neural system states, including but not limited to a single or plurality of physiologic states and a single or plurality of disease states; and
controller means for adjusting neural modulation signal in response to sensed neural response to signal.
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37. The apparatus of claim 36, wherein said activity is indicative of a neurologic and psychiatric disease.
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38. The apparatus of claim 36, wherein said disease state includes but is not limited to Parkinson'"'"'s disease, Huntington'"'"'s disease, hmiballism, choreoathetosis, dystonia, akinesia, bradykinesia, restless legs syndrome, other movement disorder, epilepsy, Alzheimer'"'"' disease, dementia, other neurologic disorder, depression, mania, bipolar disorder, other affective disorder, anxiety disorder, phobia disorder, borderline personality disorder, schizophrenia, multiple personality disorder, and other psychiatric disorder.
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39. The apparatus of claim 38, wherein said disease is a movement disorder.
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40. The apparatus of claim 39, wherein said means for delivering neural modulation signal to said nervous system component includes electrodes implemented into at least one of the globus pallidus internus (GPi), including globus pallidus internus internal segment (Gpi,i) and globus pallidus internus external segment (Gpi,e), globus pallidus externus (Gpe), ventral medial (Vim) thalamic nucleus, other portion of the thalamus, subthalamic nucleus (STN), caudate, putamen, other basal ganglia components, cingulate gyrus, other subcortical nuclei, nucleus locus ceruleus, pedunculopontine nuclei of the recitcular formation, red nucleus, substantia nigra, other brainstem structure, cerebellum, internal capsule, external capsule, corticospinal tract, pyramidal tract, ansa lenticularis, white matter tract, motor cortex, premotor cortex, supplementary motor cortex, other motor cortical regions, somatosensory cortex, other sensory cortical regions, Broca'"'"'s area, Wernicke'"'"'s area, other cortical regions, other central nervous system structure, other peripheral nervous system structure, other neural structure, sensory organs, muscle tissue, or other non-neural structure.
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41. The apparatus of claim 39, wherein said means for sensing neural response includes but is not limited to at least one of measures of disease state and response to therapy.
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42. The apparatus of claim 39, wherein said means for sensing neural response includes at least one of accelerometers electromyography electrodes, acoustic sensors, intracranial electrodes, electroencephalography electrodes, and peripheral nerve electrodes.
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43. The apparatus of claim 39, wherein said means for sensing neural response includes a weighted aggregate of processed signals derived from at least one of accelerometers, electromyography electrodes, acoustic sensors, intracranial electrodes, electroencephalography electrodes, and peripheral nerve electrodes.
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44. The apparatus of claim 38, wherein said controller means for generating a neural modulation signal employs a control law using as input signals derived from at least one of accelerometers, electromyography electrodes, acoustic sensors, intracranial electrodes, electroencephalography electrodes, and peripheral nerve electrodes.
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45. The apparatus of claim 40, wherein said controller means for generating a neural modulation signal employs a control law using as input a weighted aggregate of processed signals derived from at least one of accelerometers, electromyography electrodes, acoustic sensors, intracranial electrodes, electroencephalography electrodes, and peripheral nerve electrodes.
Specification