Closed-loop feedback-driven sympathetic neuromodulation for affect control

• US 9,345,880 B1
• Filed: 01/17/2006
• Issued: 05/24/2016
• Est. Priority Date: 08/05/1998
• Status: Active Grant

• Current Assignee: DiLorenzo Biomedical, LLC
• Original Assignee: Daniel John Dilorenzo
• Inventors: DiLorenzo, Daniel John
• Primary Examiner(s): Getzow, Scott
• Application Number:
  US11/333,979
• Time in Patent Office: 3,780 Days
• Field of Search: 607/45
• US Class Current: 1/1
• CPC Class Codes: A61B 5/1101 Detecting tremor
• CPC Class Codes: A61B 5/369 Electroencephalography [EEG] devices for psychotechnics A61B5/16
• CPC Class Codes: A61B 5/389 Electromyography [EMG]
• CPC Class Codes: A61B 5/4035 Evaluating the autonomic nervous system
• CPC Class Codes: A61B 5/4082 Diagnosing or monitoring movement diseases, e.g. Parkinson, Huntington or Tourette
• CPC Class Codes: A61B 5/6852 Catheters
• CPC Class Codes: A61B 5/6864 Burr holes
• CPC Class Codes: A61B 5/6868 Brain
• CPC Class Codes: A61B 5/6882 Anchoring means
• CPC Class Codes: A61B 5/7217 of noise originating from a therapeutic or surgical apparatus, e.g. from a pacemaker
• CPC Class Codes: A61N 1/0529 Electrodes for brain stimulation
• CPC Class Codes: A61N 1/0531 Brain cortex electrodes
• CPC Class Codes: A61N 1/0534 Electrodes for deep brain stimulation
• CPC Class Codes: A61N 1/0539 Anchoring of brain electrode systems, e.g. within burr hole
• CPC Class Codes: A61N 1/36025 for treating a mental or cerebral condition
• CPC Class Codes: A61N 1/36031 using physiological parameters for adjustment
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
• CPC Class Codes: A61N 1/36085 Eating disorders or obesity

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 neuromodulators, comprising intracranial (IC) and peripheral stimulating electrodes and other actuators, in accordance with treatment parameters. The neurological control system may directly or indirectly control a portion of the autonomic nervous system, including the sympathetic and parasympathetic nervous system. Such treatment parameters may be derived from a neural or physiological 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.

Claims

1. A system for modulation of the sympathetic nervous system in the treatment of disease, comprising:

A. a sensing-module, configured to sense an input related to affect;

B. a signal processor in communication with sensing module and which calculates a neural state;

C. a control module-in communication with signal processor and which is configured to generate-a signal which modulates the sympathetic nervous system;

D. an output module in communication with said control module; and

E. a modulator configured to interface with a portion of the sympathetic nervous system.

2. A system as recited in claim 1, wherein sensing module comprises an electrode array and a signal conditioning circuit.

3. A system as recited in claim 1, wherein sensing module comprises at least one of patient interface module and supervisory module.

4. A system as recited in claim 1, wherein modulator comprises an electrode array configured to interface with an intracranial portion of the sympathetic nervous system.

5. A system as recited in claim 1, further comprising a signal processor configured to calculate a neural state which is related to at least one symptom of depression.

6. A system as recited in claim 1, further comprising a signal processor configured to calculate a neural state which is related to at least one sign of depression.

7. A system as recited in claim 1, further comprising a signal processor configured to calculate a neural state which is related to at least one of a symptom of euphoria and a symptom of mania.

8. A system as recited in claim 1, further comprising a signal processor configured to calculate a neural state which is related to at least one of a sign of euphoria and a sign of mania.

9. A system as recited in claim 1, further comprising a signal processor configured to calculate a neural state which is a function of patient input and which is controlled to remain within a normal range.

10. A system as recited in claim 1, further comprising a signal processor configured to calculate a neural state which is a function of clinician input and which is controlled to remain within of a normal range.

11. A system as recited in claim 1, further comprising a signal processor configured to calculate a neural state which is a function of input from a patient interface module and further comprising a control circuit which is configured to produce an output which prevents the occurrence of at least one of a neurological signs and a neurological symptoms of depression.

12. A system as recited in claim 1, further comprising a signal processor configured to calculate a neural state which is a function of input from at least one of a patient interface module and a supervisory module, and further comprising a control circuit which is configured to produce an output which prevents the occurrence of at least one of a neurological signs and a neurological symptoms of mania.

13. A system as recited in claim 1, further comprising a signal processor configured to calculate a neural state which is a function of input from a supervisory module and further comprising a control circuit which is configured to produce an output which prevents the occurrence of at least one of a neurological signs and a neurological symptoms of depression.

14. A system as recited in claim 1, further comprising a signal processor configured to calculate a neural state which is a function of input from at least one of a patient interface module and a supervisory module, and further comprising a control circuit which is configured to produce an output which induces the occurrence of at least one of a neurological signs and a neurological symptoms of euphoria.

15. The system as recited in claim 1, said state is related to at least one sign or symptom of depression.

16. The system as recited in claim 1, said control module is configured to generate a signal which controls affect.

17. The system as recited in claim 16, said control module is configured to generate a signal, the magnitude of which is a function of neural state.

18. The system as recited in claim 16, said control module is configured to generate a signal, the amplitude of which is a function of neural state.

19. The system as recited in claim 16, said control module is configured to generate a signal, the pulse width of which is a function of neural state.

20. The system as recited in claim 16, said control module is configured to generate a signal, the voltage which is a function of neural state.

21. The system as recited in claim 16, said control module is configured to generate a signal, the current which is a function of neural state.

22. The system as recited in claim 16, said control module is configured to generate a signal, the frequency which is a function of neural state.

23. The system as recited in claim 16, said control module is configured to generate a signal, the waveform of which is a function of neural state.

24. The system as recited in claim 1, said sensing module is configured to interface with a portion of the sympathetic nervous system.

25. The system as recited in claim 1, said output module is configured to interface with a portion of the sympathetic nervous system.

26. A system for direct or indirect neural modulation of components of the sympathetic nervous system in the treatment of depression, comprising:

A. a signal processor in communication with at least one of a sensor, said signal processor configured to calculate at least one state related to at least one sign or symptom of depression;

B. a control circuit in communication with said signal processor and which is configured to generate a signal which modulates affect;

C. an output stage circuit in communication with said control circuit; and

D. a neuromodulator array in communication with said output stage circuit and configured to be interfaced with a portion of the sympathetic nervous system.

27. A system as recited in claim 26, further comprising a signal processor configured to calculate a neural state which is representative of affect, and further comprising a control circuit which is configured to produce an output which modulates the sympathetic nervous system to cause affect to remain within a desired range.

28. A system as recited in claim 26, further comprising a signal processor configured to calculate a neural state which is representative of affect, and further comprising a control circuit which is configured to produce an output which modulates the sympathetic nervous system to prevent at least one of a signs or a symptoms of depression.

29. A system as recited in claim 26, further comprising a signal processor configured to calculate a neural state which is representative of affect, and further comprising a control circuit which is configured to produce an output which modulates the sympathetic nervous system to prevent at least one of a sign or a symptom of mania.

30. A system as recited in claim 26, wherein said sensor comprises at least one of an electrode, a patient interface module, and a supervisory module.

31. A system as recited in claim 26, wherein neuromodulator array comprises an intracranial electrode array which is configured to be in communication with an intracranial neural structure involved in affect.

32. A system as recited in claim 26, wherein said neuromodulator array is configured to be in communication with at least one structure comprising at least one of:

peripheral sympathetic nervous system components, central sympathetic nervous system components, intracranial sympathetic nervous system components, extracranial sympathetic nervous system components, other sympathetic nervous system components, and structures the modulation of which modulate activity of at least one sympathetic nervous system component.

33. A system as recited in claim 32, wherein said neuromodulator array is configured to be in communication with at least one neural structure comprising at least one of frontal cortex, other region of cortex, other subcortical areas, globus pallidus internus (GPi), globus pallidus internus internal segment (GPi,i), globus pallidus internus external segment (GPi,e), globus pallidus externus (GPe), ventral medial (Vim) thalamic nucleus, subthalamic nucleus (STN), caudate, putamen, other basal ganglia components, cingulate gyrus, other subcortical nuclei, nucleus locus ceruleus, pedunculopontine nuclei of the reticular formation, red nucleus, substantia nigra, other brainstem structure, cerebellum, internal capsule, external capsule, corticospinal tract, pyramidal tract, ansa lenticularis, white matter tracts, motor cortex, premotor cortex, supplementary motor cortex, other motor cortical regions, somatosensory cortex, other sensory cortical regions, Broca'"'"'s area, Wernicke'"'"'s area, cerebral cortex, cerebellar cortex, brainstem, spinal cord, cranial nerves, peripheral nervous system, peripheral nerves, ganglia, 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.

34. A system as recited in claim 26, at least one of said sensor or said control circuit facilitates manual adjustment of treatment parameters.

35. A method for the treatment of depression comprising:

A. Selecting a patient with an affective disorder for treatment;

B. Sensing a signal representative of affect in said patient with an affective disorder;

C. Processing said signal to form a processed signal;

D. Determining therapy magnitude as a function of said processed signal; and

E. Delivering said therapy, whereby a neural structure comprising a component of the sympathetic nervous system is modulated to treat said affective disorder.

36. The method as in claim 35 wherein said therapy comprises electrical stimulation.

37. The method as in claim 36, said electrical stimulation modulates activity of at least a portion of the cingulate gyrus.

38. The method as in claim 37, said electrical stimulation increases activity of at least a portion of the cingulate gyrus.

39. The method as in claim 37, said electrical stimulation decreases activity of at least a portion of the cingulate gyrus.

40. The method as in claim 36, said electrical stimulation modulates activity of at least a portion of the frontal cortex.

41. The method as in claim 40, said electrical stimulation increases activity of at least a portion of the frontal cortex.

42. The method as in claim 40, said electrical stimulation decreases activity of at least a portion of the frontal cortex.

43. The method as in claim 36, said electrical stimulation modulates activity of at least a portion of the premotor cortex.

44. The method as in claim 36, said electrical stimulation modulates activity of at least a portion of the substantia nigra.

45. The method as in claim 36, said electrical stimulation modulates activity of at least one of the caudate and the putamen.

46. The method as in claim 36, said electrical stimulation modulates activity of at least a portion of the subthalamic nucleus.

47. The method as in claim 36, said electrical stimulation modulates activity of at least a portion of the motor cortex.

48. The method as in claim 36, said electrical stimulation modulates activity of at least a portion of the thalamus.

49. The method as in claim 35 delivering said therapy comprises delivering a pharmacologic treatment.

50. The method as in claim 35 further comprising implanting an electrode array in a patient with an affective disorder.

51. The method as in claim 35 wherein the sensed signal is obtained from a patient interface module.

52. The method as in claim 35 wherein the controller further obtains an input from a physician interface module.

53. The claim as recited in claim 35, said affective disorder comprises at least one of depression, bipolar disorder, and mania.

54. The method as in claim 35 further comprising placing a modulator in communication with a patient with an affective disorder.

55. The method as in claim 35 further comprising placing a modulator in communication with a patient with depression.

56. A system for neural modulation of the sympathetic nervous system, comprising:

A. a sensor array, configured to sense activity of a component of the sympathetic nervous system;

B. a signal conditioning circuit, in electronic communication with said sensor array;

C. a signal processor in electronic communication with said signal conditioning circuit, whereby said signal processor performs disease state estimation and generates a neural state representative of affect;

D. a control circuit in electronic communication with said signal processor and which is configured to generate a signal which modulates affect;

E. an output stage circuit in electronic communication with said control circuit; and

F. a stimulating electrode array, in electronic communication with said output stage circuit.

57. A system for neural modulation of the sympathetic nervous system, comprising:

A. a sensor array;

B. a signal conditioning circuit, in electronic communication with said sensor array;

C. a signal processor in electronic communication with said signal conditioning circuit, whereby said signal processor performs disease state estimation;

D. a control circuit in electronic communication with said signal processor and which generates a signal which is a function of affective disease state and which modulates affect;

E. an output stage circuit in electronic communication with said control circuit; and

F. a stimulating electrode array, configured to interface with a component of the sympathetic nervous system, in electronic communication with said output stage circuit.

58. A system for neural modulation of the sympathetic nervous system, comprising:

A. a sensor array, configured to interface with a component of the sympathetic nervous system;

B. a signal conditioning circuit, in electronic communication with said sensor array;

C. a signal processor, configured to estimate the neural state of a component of the sympathetic nervous system, in electronic communication with said signal conditioning circuit;

D. a control circuit in electronic communication with said signal processor and configured to generate a signal to modulate affect;

E. an output stage circuit in electronic communication with said control circuit; and

F. a stimulating electrode array, in electronic communication with said output stage circuit.

59. A system for neural modulation of the sympathetic nervous system, comprising:

A. a sensor array;

B. a signal conditioning circuit, in electronic communication with said sensor array;

C. a signal processor, configured to estimate the neural state of a component of the sympathetic nervous system, said neural state is representative of affect, in electronic communication with said signal conditioning circuit;

D. a control circuit in electronic communication with said signal processor and configured to generate a signal to modulate affect;

E. an output stage circuit in electronic communication with said control circuit; and

F. a stimulating electrode array, configured to interface with a component of the sympathetic nervous system, in electronic communication with said output stage circuit.

60. A method for neural modulation of the sympathetic nervous system, comprising:

A. placing a sensor array in communication with a user with an affective disorder;

B. sensing a signal from said sensor array and representative of activity of a portion of the sympathetic nervous system;

C. Processing said signal to form a processed signal, said signal is representative of neural state;

D. Determining therapy magnitude for treatment of affective disorder; and

E. Delivering said therapy to said user with an affective disorder.

61. The method as in claim 60, wherein therapy magnitude is determined as a function of said processed signal.

62. The method as recited in claim 60, said affective disorder comprises at least one of depression, bipolar disorder, and mania.

63. A method for neural modulation of the sympathetic nervous system, comprising:

A. sensing a signal representative of affect from a user with an affective disorder;

B. Processing said signal to form a processed signal, which is calculated as a function of the difference between desired affect and present affect;

C. Determining therapy magnitude as a function of said processed signal and which modulates a component of the sympathetic nervous system; and

D. Delivering said therapy to the user to treat the affective disorder.

64. The method as in claim 63, sensed signal is sensed from at least one of a patient interface module and a physician interface module.

65. A method for neural modulation of the sympathetic nervous system, comprising:

A. selecting a user who has been diagnosed with an affective disorder;

B. sensing a signal representative of affect from said user;

C. Processing said signal to form a processed signal;

D. Determining therapy magnitude as a function of said processed signal to treat said affective disorder; and

E. Delivering said therapy to a component of the sympathetic nervous system.

66. The method as in claim 65, said sensing a signal comprises sensing a signal from at least one of a patient interface module, a physician interface module, and an electrode array.