Selective neurostimulation for treating epilepsy

• US 20070100392A1
• Filed: 10/28/2005
• Published: 05/03/2007
• Est. Priority Date: 10/28/2005
• Status: Active Grant

• Current Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Original Assignee: Cyberonics, Inc
• Inventors: Brannan, Stephen, Maschino, Steven
• Granted Patent: US 7,555,344 B2
• Time in Patent Office: Days
• US Class Current: 607/45
• CPC Class Codes: A61M 2005/1726 the body parameters being measured at, or proximate to, the infusion site
• CPC Class Codes: A61M 2205/054 with electrotherapy
• CPC Class Codes: A61M 2205/3523 using telemetric means
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2210/0693 Brain, cerebrum
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• 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 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
• CPC Class Codes: A61N 2/006 for magnetic stimulation of nerve tissue

Abstract

A method and device for treating epilepsy are disclosed which provide for electrical, chemical or magnetic stimulation of certain areas of the brain to modulate neuronal activity of areas associated with symptoms of epilepsy. Deep brain stimulation is combined with vagus nerve stimulation to enhance symptomatic relief of the disorder. Some embodiments also employ a sensing capability to optimize the therapeutic treatment regimen.

Claims

1. A method of treating an individual suffering from epilepsy, the method comprising:

coupling a first stimulator to a stimulation site comprising a volume of neural tissue in an area of the individual'"'"'s brain selected from the group consisting of insula, subcallosal area, cingulate, thalamus, prefrontal cerebral cortex, mesial temporal lobe, cerebellum, hypothalamus, hippocampus, amygdala, brain stem, occipital lobe, temporal lobe, frontal lobe, parietal lobe, Wernicke'"'"'s area, area tempestas, basal ganglia, globus pallidus, superior colliculus, striatum, ventral striatum, ventral pallidum, caudate nucleus, putamen, nucleus accumbens, substantia nigra, ventral tegmentum, Brodmann areas 24, 25, 32, piriform cortex, ventricular region, ventral pallidum, and forebrain circumventricular organs, reticulate substantia innominata, rostral midbrain, red nucleus, periaqueductal gray, and white matter tracts leading to an aforementioned area or nucleus;

coupling a second stimulator to a site on the vagus nerve of the individual;

applying a first stimulation signal to said first stimulator such that said first stimulation signal causes modulation of the neuronal activity of neural tissue in said selected area of the brain; and

applying a second stimulation signal to said second stimulator such that said second stimulation signal causes modulation of the neuronal activity in said vagus nerve, wherein said combination of modulations attenuate at least one epilepsy symptom and/or deter recurrence of an epileptic event.

2. The method of claim 1 wherein said second stimulation signal causes stimulation of a site on the vagus nerve, whereby at least one vagus nerve pathway or neural activating circuit is affected causing a responsive effect on neural activity in at least one area of the brain to further attenuate the same or different epilepsy symptom and/or to further deter recurrence of an epileptic event.

3. The method of claim 2 wherein said vagus nerve pathway or neural activating circuit is chosen from the group consisting of gustatory pathways, olfactory pathways, pro-inflammatory or anti-inflammatory pathways, respiratory pathways, cardiac pathways, baroreceptor pathways, somatosensory pathways, noradrenergic pathways, serotoninergic pathways, dopaminergic pathways, catecholaminergic pathways, GABAergic pathways, opioidergic pathways, cholinergic pathways, circuit of Papez, mesolimbic pathway, mesocortical pathway and nigrostriatal pathway.

4. The method of claim 3 wherein said responsive effect on said area of the brain is excitatory or inhibitory and potentiates acute and/or long-term changes in neuronal activity of said area of the brain.

5. The method of claim 1 wherein said first and/or second stimulation signal causes modulation of neuronal activity in at least one brain area of said individual different than said area coupled to said first stimulator.

6. The method of claim 1 wherein said first stimulation signal comprises a first acute stimulation component and a first chronic stimulation component and/or said second stimulation signal comprises a second acute stimulation component and a second chronic stimulation component.

7. The method of claim 6 wherein said first acute stimulation component comprises a higher intensity level of stimulation and shorter duration than said first chronic stimulation component and/or said second acute stimulation component comprises a higher intensity level of stimulation and shorter duration than said second chronic stimulation component.

8. The method of claim 6 wherein said first and/or second acute stimulation component comprises a duration in the range of one day to six months.

9. The method of claim 1 wherein said area of the individual'"'"'s brain comprises a portion of the cingulate gyrus comprising the anterior cingulate or the posterior cingulate.

10. The method of claim 1 wherein said area of the individual'"'"'s brain comprises a portion of the cortex chosen from the group consisting of motor cortex, prefrontal cortex, orbitofrontal cortex, premotor cortex, somatosensory cortex, cingulate cortex, anterior cingulate cortex, insular cortical region and Brodmann areas 8, 9, 10, 11.

11. The method of claim 1 wherein said area of the individual'"'"'s brain comprises a portion of the thalamus chosen from the group consisting of ventral medial thalamic nucleus, ventral posterior medial thalamic nucleus, parafascicular nucleus, subthalamic nucleus, dorsomedial thalamic nucleus, intralaminar thalamic nuclei, midline thalamic nuclei, anterior thalamus, anterior thalamic nuclei, nucleus reticularis thalami, and centromedian nucleus of the thalamus.

12. The method of claim 1 wherein said area of the individual'"'"'s brain comprises a portion of the hypothalamus chosen from the group consisting of lateral hypothalamus, paraventricular nucleus of the hypothalamus, the bed nucleus of the stria terminalis, mamillary bodies, supraoptic nucleus, dorsomedial nucleus of the hypothalamus, lateral nucleus of the hypothalamus, tuberal nucleus of the hypothalamus.

13. The method of claim 1 wherein said area of the individual'"'"'s brain comprises a portion of the brainstem/medulla chosen from the group consisting of locus ceruleus, dorsal raphe nucleus, nucleus of the solitary tract, the entirety of the solitary tract, the caudal ventrolateral medulla, rostral ventrolateral medulla and parabrachial nucleus.

14. The method of claim 1 wherein said first stimulator is a first electrode and said second stimulator is a second electrode, and said method further comprises:

providing at least one programmable electrical signal generator coupled to said first and second electrodes;

programming said at least one electrical signal generator to define each of said first and second stimulation signals by a plurality of electrical parameters comprising a current magnitude, a pulse frequency, and a pulse width, wherein said parameters are selected to attenuate or deter the occurrence of at least one symptom of epilepsy.

15. The method of claim 1 wherein said first and/or second stimulator comprises at least one chemical dispensing assembly comprising a chemical-filled reservoir and a catheter in communication with a pump, said catheter comprising a dispensing end located on or near said nerve or brain area, and said first and/or second stimulation signal each comprises a therapeutic pumping signal, said method comprising:

operating at least one said pump such that said chemical contacts said brain area and/or vagus nerve, whereby the neuronal activity of the contacted brain area and/or nerve is modified, and such modification of neuronal activity causes attenuation or deterrence of at least one symptom of epilepsy.

16. The method of claim 15 wherein said chemical agent is selected from the group consisting of inhibitory neurotransmitter agonists, excitatory neurotransmitter antagonists, agents that increase the level of an inhibitory neurotransmitter, agents that decrease the level of an excitatory neurotransmitter, and local anesthetic agents.

17. The method of claim 1 wherein said area of the individual'"'"'s brain comprises the thalamus or a white matter tract leading to a portion of the thalamus.

18. A method of treating an individual suffering from epilepsy, the method comprising:

providing a controller comprising a signal generator and processor in communication with a first electrode and a second electrode;

coupling said first electrode to a site on the vagus nerve of the individual;

coupling said second electrode to a volume of neural tissue in an area of the individual'"'"'s brain selected from the group consisting of insula, subcallosal area, cingulate, thalamus, prefrontal cerebral cortex, mesial temporal lobe, cerebellum, hypothalamus, hippocampus, amygdala, brain stem, occipital lobe, temporal lobe, frontal lobe, orbitofrontal cortex, parietal lobe, Wernicke'"'"'s area, area tempestas, basal ganglia, globus pallidus, superior colliculus, striatum, ventral striatum, ventral pallidum, caudate nucleus, putamen, nucleus accumbens, substantia nigra, ventral tegmentum, Brodmann areas 24, 25, 32, piriform cortex, ventricular region, ventral pallidum, and forebrain circumventricular organs, reticulate substantia innominata, rostral midbrain, red nucleus, periaqueductal gray, and white matter tracts leading from an aforementioned area or nucleus;

applying a predetermined electrical signal to said first electrode;

sensing electrical activity in said selected volume of brain tissue by said second electrode;

comparing the resulting sensed electrical activity to a predetermined electrical state of said selected area; and

determining from said comparison whether said application of said predetermined electrical signal to said first electrode causes a modulation of electrical activity of said brain area, wherein said modulation of electrical activity corresponds to attenuate, or deter the occurrence of, at least one symptom of epilepsy.

19. The method of claim 18 further comprising adjusting said predetermined signal according to said comparison results, to alter said modulation of neuronal activity in said selected brain area to further attenuate, or deter the occurrence of, at least one symptom of epilepsy.

20. An adaptive brain stimulation process for treating a patient suffering from an epilepsy syndrome, the process comprising:

(a) providing a system comprising at least one sensor for coupling with a status indicator site on the patient to sense a present state of at least a first brain region or set of brain regions;

a first stimulating circuit for coupling at least said first brain region or set of brain regions by at least one stimulation electrode, to carry out stimulation according to a first set of stimulation parameters;

a comparator adapted for coupling with said at least one sensor, said comparator adapted for receiving data related to the present state and comparing said present state data with reference state data, such that said comparing results in a positive outcome or a negative outcome; and

at least one control circuit coupled with at least said first stimulating circuit and adapted for being adjusted according to the outcome of said comparing of said present and reference states, to control said stimulation parameters;

(b) stimulating at least a first brain region or a first set of brain regions of the patient according to a first set of stimulation parameters;

(c) stimulating at least one site on the vagus nerve of the patient according to a second set of stimulation parameters;

(d) sensing a present state of said patient to provide sensed data;

(e) comparing said sensed data with reference state data to derive comparison results;

(f) determining from said comparison results whether a change in the first and/or second stimulation parameters is necessary for treating the patient'"'"'s epilepsy syndrome;

(g) if a change is determined to be necessary, determining what changes are to be made in said first and/or second stimulation parameters;

(h) changing said first and/or second set of stimulation parameters as determined in step (f); and

(i) repeating steps (e)-(h) with the resulting changed stimulation parameters, until no further change is determined to be necessary in step (f).

21. The a process of claim 20 wherein step (d) comprises sensing a state of one or more peripheral regions of the patient'"'"'s body.

22. The process of claim 20 wherein, in step (h), changing said stimulation parameters comprises adjusting parameters of said stimulation signal to stimulate a site on the vagus nerve to activate at least one vagus nerve pathway or neural activating circuit chosen from the group consisting of the gustatory pathways, olfactory pathways, pro-inflammatory or anti-inflammatory pathways, respiratory pathways, cardiac pathways, baroreceptor pathways, somatosensory pathways, noradrenergic pathways, serotoninergic pathways, dopaminergic pathways, catecholaminergic pathways, GABAergic pathways, opioidergic pathways, cholinergic neurotransmitter pathways, circuit of Papez, mesolimbic pathway, mesocortical pathway and nigrostriatal pathway.

23. An adaptive brain stimulation system comprising:

at least one first biological sensor for coupling with a first brain region or first set of brain regions, to sense the present state of at least one biological parameter of said first region or set of regions in a patient;

at least one second biological sensor for coupling with a neural tissue or set of neural tissues, other than said first brain region or first set of brain regions, to sense the present state of at least one biological parameter of said neural tissue or set of neural tissues, in said patient;

a first stimulating circuit comprising at least one first stimulation electrode for coupling with said first brain region or set of brain regions, to stimulate said first region or set of regions according to a first set of stimulation parameters;

a second stimulating circuit comprising at least one second stimulation electrode for coupling with said neural tissue or set of neural tissues, to stimulate said neural tissue or set of neural tissues according to a second set of stimulation parameters;

a comparator coupled with said first and second sensors to receive data related to said present states and compare a present set data with a reference state data, said comparing leading to a positive outcome or a negative outcome; and

control circuits coupled with said comparator and with said first and second stimulating circuits, for controlling the first and second set of stimulation parameters according to the outcome of said comparing of the present and reference states.

24. The system of claim 23 wherein said neural tissue comprises at least one site on the vagus nerve.