Optimal method and apparatus for neural modulation for the treatment of neurological disease, particularly movement disorders

• US 6,819,956 B2
• Filed: 11/11/2001
• Issued: 11/16/2004
• Est. Priority Date: 08/05/1998
• Status: Expired due to Term

• Current Assignee: Cyberonics, Inc, DiLorenzo Biomedical, LLC
• Original Assignee: Daniel J. Dilorenzo
• Inventors: DiLorenzo, Daniel J.
• Primary Examiner(s): Getzow, Scott M.
• Application Number:
  US10/008,576
• Publication Number:
  US 20020177882A1
• Time in Patent Office: 1,101 Days
• Field of Search: 607/2, 607/39-49, 600/544, 600/545
• US Class Current: 607/45
• CPC Class Codes: A61B 5/11 Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb for measuring pulse A61B5/02 ;A61B5/1038 takes precedence; motion detection to correct for motion artifacts in physiological signals A61B5/721
• CPC Class Codes: A61B 5/374 Detecting the frequency distribution of signals, e.g. detecting delta, theta, alpha, beta or gamma waves
• CPC Class Codes: A61B 5/389 Electromyography [EMG]
• CPC Class Codes: A61B 5/395 Details of stimulation, e.g. nerve stimulation to elicit EMG response
• CPC Class Codes: A61B 5/4082 Diagnosing or monitoring movement diseases, e.g. Parkinson, Huntington or Tourette
• CPC Class Codes: A61B 5/4528 Joints A61B5/4533, A61B5/4538 take precedence
• CPC Class Codes: A61B 5/7217 of noise originating from a therapeutic or surgical apparatus, e.g. from a pacemaker
• CPC Class Codes: A61B 7/00 Instruments for auscultation
• CPC Class Codes: A61N 1/0529 Electrodes for brain stimulation
• CPC Class Codes: A61N 1/36025 for treating a mental or cerebral condition
• CPC Class Codes: A61N 1/3605 Implantable neurostimulators for stimulating central or peripheral nerve system
• CPC Class Codes: A61N 1/36064 Epilepsy
• CPC Class Codes: A61N 1/36067 Movement disorders, e.g. tremor or Parkinson disease stimulating motor muscle A61N1/36003
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease

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.

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.

2. The system of claim 1, wherein said stimulation is at least one of activating, inhibitory, and a combination of activating and inhibitory.

3. The system of claim 1, wherein said disease is at least one of neurologic and psychiatric.

4. The system of claim 3, wherein said neurologic disease includes at least one of Parkinson'"'"'s disease, Huntington'"'"'s disease, Parkinsonism, rigidity, hemiballism, choreoathetosis, dystonia, akinesia, bradykinesia, hyperkinesia, other movement disorder, epilepsy, or the seizure disorder.

5. The system of claim 4, wherein said psychiatric disease includes at least one of depression, bipolar disorder, other affective disorder, anxiety, phobia, schizophrenia, multiple personality disorder.

6. The system of claim 3, wherein said psychiatric disorder includes substance abuse, attention deficit hyperactivity disorder, impaired control of aggression, or impaired control of sexual behavior.

7. A system as set forth in claim 4, wherein a control law is used in the determination of the stimulus intensity as a function of input which is a combination of at least one of sensory feedback signals, preprogrammed parameters, time of day, recumbency, level of activity, adaptive parameters, estimates of system performance, and user determined input.

8. The system as of claim 7, wherein said user determined input includes at least one of magnet movement over implanted sensor, muscle contraction, joint movement, audible input, switch activation, head position, head movement, shoulder position, and shoulder movement.

9. The system as of claim 7, wherein said control law is a combination of at least one of proportional function, derivative function, integral function, nonlinear function, multivariable function, sliding function, model reference function, adaptive function, filter function, and time-varying function of said input.

10. The system of claim 7, wherein said control law is proportional.

11. The system of claim 7, wherein said control law is of the proportional-derivative type.

12. The system of claim 7, wherein said control law is nonlinear.

13. The system of claim 7, wherein said control law is multivariable.

14. The system of claim 7, wherein said control law is sliding.

15. The system of claim 7, wherein said control law is adaptive.

16. The system of claim 7, wherein said control law is model reference.

17. The system of claim 1, wherein said stimulus intensity is time-varying.

18. The system of claim 17, wherein said time-varying stimulus intensity is preprogrammed.

19. The system of claim 18, wherein said time-varying stimulus intensity varies as a function of time, including but not limited to time of day, time relative to food intake, time of year, time since implantation, time since system was reprogrammed, and time since system was evaluated.

20. The system of claim 19, wherein sensory feedback is used to estimate mental state.

21. The system of claim 20, wherein said estimated psychiatric state includes at least one of:

mood, elation, depression, anxiety level, and psychosis.

22. The system of claim 1, wherein sensory feedback is used in the determination of said stimulus intensity.

23. The system of claim 22, wherein said sensory feedback consists of at least one of electromyographic signals, accelerometers, electrodes, acoustic transducers, force sensors, pressure sensors, velocity sensors, neurotransmitter sensors, and chemical sensors.

24. The system of claim 23, wherein said sensory feedback electrodes may also function as stimulating electrodes.

25. The system of claim 23, wherein said sensory feedback electrodes record signals from at least one of the globus pallidus internus, globus pallidus externus, internal capsul, thalamus, the subthalamic nucleus, the caudate, the putamen, the ansa lenticularis, the corticospinal tract, the substantia nigra, the nigrostriatal tract, cerebral cortex, motor cortex, premotor cortex, sensory cortex, cerebellum, cerebellar cortex, cerebellar nuclei, cerebellar projections, the brain stem, the spinal cord, central nervous system, the cranial nerves the peripheral nervous system, peripheral nerves, ganglia, sensory organs, golgi tendons, muscle stetch receptors, intrafusal fibers, and extrafusal fibers.

26. The system of claim 23, wherein said accelerometer measures movement of at least one of the head, eyes, face, jaw, neck, axial skeleton, appendicular skeleton, arms, legs, hands, feet, fingers, toes, vertebral column, and pelvis.

27. The system of claim 22, wherein said electromyographic signal arise from at least one of facial muscles, extraocular muscles, muscles of mastication, neck muscles, shoulder muscles, arm muscles, wrist muscles, hand muscles, torso muscles, chest muscles, abdominal muscles, back muscles, buttock muscles, peroneal muscles, leg muscles, calf muscles, foot muscles, and visceral muscles.

28. A neurological control system for modulating the activity of at least one nervous system component, the neurological control system comprising:

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.

29. The system of claim 28, wherein said particular characteristic is indicative of at least one of a neurological and psychiatric condition.

30. The system of claim 28, wherein said stimulating and recording unit generates said neural modulation signal in accordance with predetermined treatment parameters to treat at least one of a neurological and psychiatric disease.

31. The system of claim 28, wherein said stimulating and recording unit comprises:

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.

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.

33. The system of claim 32, wherein said signal conditioner comprises:

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.

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.

35. An apparatus for modulating the activity of at least one nervous system component, said system comprising:

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.

36. The apparatus of claim 35, wherein said delivery means comprises means for generating said neural modulation signal, said generating means comprising:

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.

37. The apparatus of claim 36, wherein said activity is indicative of a neurologic and psychiatric disease.

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.

39. The apparatus of claim 38, wherein said disease is a movement disorder.

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.

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.

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.

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.

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.

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.