Microburst electrical stimulation of cranial nerves for the treatment of medical conditions

• US 8,660,666 B2
• Filed: 03/10/2009
• Issued: 02/25/2014
• Est. Priority Date: 03/29/2006
• Status: Active Grant

• Current Assignee: Catholic Healthcare West (CommonSpirit Health (Illinois))
• Original Assignee: Catholic Healthcare West (CommonSpirit Health (Illinois))
• Inventors: Craig, Arthur D.
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): LEE, ERICA SHENGKAI
• Application Number:
  US12/400,970
• Publication Number:
  US 20100063563A1
• Time in Patent Office: 1,813 Days
• Field of Search: 607115-118, 607/45, 607/1, 607 30- 32, 607/46, 607 58- 60, 600/544, 600372-373, 600/377, 600/378, 600/545
• US Class Current: 607/118
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/352 Detecting R peaks, e.g. for synchronising diagnostic apparatus; Estimating R-R interval
• CPC Class Codes: A61B 5/353 Detecting P-waves
• CPC Class Codes: A61B 5/355 Detecting T-waves
• CPC Class Codes: A61B 5/369 Electroencephalography [EEG] devices for psychotechnics A61B5/16
• CPC Class Codes: A61B 5/4094 Diagnosing or monitoring seizure diseases, e.g. epilepsy
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/3605 Implantable neurostimulators for stimulating central or peripheral nerve system
• CPC Class Codes: A61N 1/36053 adapted for vagal stimulation A61N1/36114 takes precedence
• CPC Class Codes: A61N 1/36064 Epilepsy
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
• CPC Class Codes: A61N 1/3611 Respiration control stimulating respiratory organs A61N1/3601
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/36178 Burst or pulse train parameters

Abstract

Disclosed herein are methods, systems, and apparatus for treating a medical condition in a patient using an implantable medical device by applying an electrical signal characterized by having a number of pulses per microburst, an interpulse interval, a microburst duration, and an interburst period to a portion of a cranial nerve of said patient, wherein at least one of the number of pulses per microburst, the interpulse interval, the microburst duration, or the interburst period is selected to enhance cranial nerve evoked potentials.

Claims

1. A method of treating a brain disorder in a patient having a brain and a vagus nerve, comprising:

applying to the vagus nerve of the patient a first pulsed electrical signal configured to modulate the brain of the patient to treat the brain disorder, the first pulsed electrical signal comprising a plurality of microbursts, wherein each microburst of the plurality of microbursts is patterned and comprises;

from 2 to 6 pulses per microburst;

at least one interpulse interval, each interpulse interval of the at least one interpulse interval occurring between adjacent pulses of the microburst, each interpulse interval ranging from about 2 to about 10 milliseconds; and

a microburst duration of less than or equal to 100 milliseconds;

wherein each microburst of the plurality of microbursts is separated from an adjacent microburst by an interburst period of at least 100 milliseconds;

measuring a first enhanced Vagal Evoked Potential (eVEP) in a target area of the patient'"'"'s brain;

changing at least one of the number of pulses per microburst, the interpulse interval between adjacent pulses of the microburst, the microburst duration, and the interburst period to provide a second pulsed electrical signal comprising a plurality of microbursts;

applying said second pulsed electrical signal to the vagus nerve of the patient;

measuring a second eVEP in the target area of the patient'"'"'s brain;

comparing said first eVEP and said second eVEP;

selecting one of the first electrical signal and the second electrical signal for continued application to the vagus nerve of the patient based upon said comparing; and

applying said selected electrical signal to said vagus nerve of the patient.

2. The method of claim 1, wherein the brain disorder is selected from the group consisting of epilepsy, neuropsychiatric disorders including but not limited to depression, eating disorders including obesity, traumatic brain injury/coma, addiction disorders, dementia, sleep disorders, pain, and migraine.

3. The method of claim 1 wherein each pulse in each of the plurality of microbursts further comprises a pulse width ranging from about 0.05 to about 1.0 milliseconds and a current magnitude ranging from about 0.10 to about 6.0 milliamps.

4. The method of claim 1, wherein each microburst of the plurality of microbursts is separated from an adjacent microburst by an interburst period ranging from about 1 second to about 5 seconds.

5. The method of claim 1, wherein each microburst of the plurality of microbursts comprises from 3 to 5 pulses per microburst.

6. The method of claim 1, wherein the interpulse intervals separating the pulses comprising a microburst are selected from the group consisting of:

a) a series of equal intervals;

b) a series of increasing intervals; and

c) a series of random intervals within a preselected range.

7. The method of claim 1, wherein said target area of the patient'"'"'s brain is selected from the group consisting of the right thalamus, the right striatum, and the left insular cortex.

8. The method of claim 1, wherein said measuring of a first eVEP and measuring of a second eVEP are both performed by processing EEG signals from the brain of the patient.

9. A method of treating a brain disorder in a patient having a vagus nerve and a brain, comprising:

applying to the vagus nerve of the patient a pulsed electrical signal configured to modulate the brain of the patient to treat the brain disorder, the pulsed electrical signal comprising a plurality of microbursts, wherein each microburst of the plurality of microbursts is patterned and comprises;

from 2 to 6 pulses per microburst;

at least one interpulse interval, each interpulse interval of the at least one interpulse interval occurring between adjacent pulses of the microburst, each interpulse interval ranging from about 2 to about 10 milliseconds; and

a microburst duration of less than or equal to 100 milliseconds,

wherein at least one of the number of pulses per microburst, the interpulse interval, the microburst duration, and the interburst period is selected to enhance vagus nerve evoked potentials, and

wherein each microburst of the plurality of microbursts is separated from an adjacent microburst by an interburst period comprising a time interval greater than that at which the enhanced vagus nerve evoked potentials significantly diminish or disappear.

10. The method of claim 9, further comprising:

providing at least one electrode;

coupling said at least one electrode to the vagus nerve of the patient;

providing an electrical signal generator coupled to the electrode;

generating said pulsed electrical signal using said electrical signal generator; and

applying said pulsed electrical signal to said at least one electrode.

11. The method of claim 10, wherein said step of coupling at least one electrode to the vagus nerve of the patient comprises coupling the at least one electrode to one of a vagus nerve in the neck of the patient, a vagus nerve near the patient'"'"'s diaphragm, and a vagus nerve at the patient'"'"'s esophagus/stomach junction.

12. The method of claim 9, wherein each microburst is characterized by a microburst duration of at least about 5 milliseconds.

13. The method of claim 9, wherein said pulsed electrical signal is further characterized by an on-time and an off-time, wherein the plurality of microbursts separated from adjacent microbursts by the interburst periods are applied to the vagus nerve of the patient during the on-time of the pulsed electrical signal, and wherein no microbursts are applied to the vagus nerve of the patient during the off-time of the pulsed electrical signal.

14. The method of claim 9, further comprising:

detecting a body parameter of the patient;

determining from said detected body parameter whether treatment of the patient'"'"'s brain disorder is indicated;

if treatment of the patient'"'"'s brain disorder is indicated, applying said pulsed electrical signal comprising a plurality of microbursts to said vagus nerve; and

if treatment of the patient'"'"'s brain disorder is not indicated, repeating said detecting and determining steps.

15. The method of claim 14 wherein detecting a body parameter comprises detecting one of a body temperature and a cardiac parameter of the patient.

16. The method of claim 9, wherein each microburst of the plurality of microbursts is separated from an adjacent microburst by an interburst period of from about 500 milliseconds to about 6 seconds.