Selective neurostimulation for treating epilepsy

• US 7,555,344 B2
• Filed: 10/28/2005
• Issued: 06/30/2009
• Est. Priority Date: 10/28/2005
• Status: Active Grant

• Current Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Original Assignee: Cyberonics, Inc
• Inventors: Brannan, Stephen K., Maschino, Steven E.
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): Gedeon; Brian T
• Application Number:
  US11/261,182
• Publication Number:
  US 20070100392A1
• Time in Patent Office: 1,341 Days
• Field of Search: 607/45, 607/118
• 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:

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, prefrontal cerebral cortex, mesial temporal lobe, 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, 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 attenuates or deters the occurrence of, at least one symptom of epilepsy.

2. The method of claim 1 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.

3. 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;

a second stimulating circuit for coupling at least one site on a vagus nerve of the patient by at least one stimulatory electrode to carry out stimulation according to a second set of stimulation parameters; and

at least one control circuit coupled with said stimulating circuits 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 said first set of stimulation parameters;

(c) stimulating at least one site on the vagus nerve of the patient according to said 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).

4. The process of claim 3 wherein step (d) comprises sensing a state of one or more peripheral regions of the patient'"'"'s body.

5. The process of claim 3 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.

6. An adaptive brain stimulation system comprising:

a first biological sensing means for sensing the present state of at least one biological parameter of a first brain region or set of brain regions in a patient;

a second biological sensing means 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 stimulation means for stimulating said first region or set of regions according to a first set of stimulation parameters;

a second stimulation means for stimulating said neural tissue or set of neural tissues according to a second set of stimulation parameters;

a comparator configured to receive data related to said present states and compare a present state data with a reference state data, said comparing leading to a positive outcome or a negative outcome; and

means for controlling the first and second set of stimulation parameters according to the outcome of said comparing of the present and reference states.

7. The system of claim 6 wherein said neural tissue comprises at least one site on the vagus nerve.