Vagus nerve stimulation method

• US 8,150,508 B2
• Filed: 03/29/2007
• Issued: 04/03/2012
• 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): MALAMUD, DEBORAH LESLIE
• Application Number:
  US11/693,421
• Publication Number:
  US 20070233192A1
• Time in Patent Office: 1,832 Days
• Field of Search: 607 1- 2, 607 6- 7, 607/9, 607/45, 607/115, 607118-119
• US Class Current: 607/2
• 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

An implanted electrical signal generator delivers a novel exogenous electrical signal to a vagus nerve of a patient. The vagus nerve conducts action potentials originating in the heart and lungs to various structures of the brain, thereby eliciting a vagal evoked potential in those structures. The exogenous electrical signal simulates and/or augments the endogenous afferent activity originating from the heart and/or lungs of the patient, thereby enhancing the vagal evoked potential in the various structures of the brain. The exogenous electrical signal includes a series of electrical pulses organized or patterned into a series of microbursts including 2 to 20 pulses each. No pulses are sent between the microbursts. Each of the microbursts may be synchronized with the QRS wave portion of an ECG. The enhanced vagal evoked potential in the various structures of the brain may be used to treat various medical conditions including epilepsy and depression.

Claims

1. A method of treating a medical condition in a patient having a brain, a vagus nerve, and a heart that generates a cardiac signal having a QRS wave portion, the method comprising:

identifying a select portion of the QRS wave portion of the patient'"'"'s cardiac signal;

after identifying the select portion of the QRS wave portion and before identifying a select portion of a next sequential QRS wave portion, generating a plurality of microbursts, each microburst of the plurality of microbursts being patterned and comprising 2 to 20 electrical pulses, adjacent ones of the electrical pulses being separated from one another by an interpulse interval of less than about 40 milliseconds; and

delivering the plurality of microbursts directly to a selected location on the vagus nerve of the patient, the plurality of microbursts delivered to the vagus nerve evoking a response in the brain of the patient,

wherein sequential microbursts of the plurality of microbursts are separated by at least 100 milliseconds.

2. The method of claim 1, further comprising:

generating additional electrical pulses after identifying the next sequential QRS wave portion of the cardiac signal.

3. The method of claim 1, further comprising:

after identifying the select portion of the QRS wave portion, waiting a predetermined delay period before generating the plurality of microbursts.

4. The method of claim 1, wherein the electrical pulses of each microburst of the plurality of microbursts are generated in a series having a first pulse and a last pulse, and wherein the interpulse interval increases sequentially along the series from the first pulse to the last pulse.

5. The method of claim 1, wherein the electrical pulses of the plurality of microbursts have a pulse width ranging from about 50 microseconds to about 1000 microseconds, and have a pulse current amplitude ranging from about 0.25 mA to about 8 mA.

6. The method of claim 1, wherein the interpulse interval was determined empirically for the patient.

7. The method of claim 1, wherein the interpulse interval ranges from about 3 milliseconds to about 10 milliseconds.

8. The method of claim 1 for use with a patient having a brain, lungs, a vagus nerve, and a heart that generates a cardiac signal having a QRS wave portion, the cardiac signal also comprising an inspiration portion corresponding to an inspiration of air by the lungs and an expiration portion corresponding to an expiration of air by the lungs, the inspiration portion having a series of R wave portions, the expiration portion having a series of R wave portions, the vagus nerve evoking a vagal evoked potential in the brain, wherein:

the select portion of the QRS wave portion of the patient'"'"'s cardiac signal identified comprises a selected R wave portion of the inspiration portion of the cardiac signal and excludes the R wave portions of the expiration portion of the cardiac signal.

9. The method of claim 8, wherein the pulses of each microburst of the plurality of microbursts are spaced apart to simulate endogenous afferent activity occurring at a particular time during inspiration of air by the lungs.

10. The method of claim 1, wherein the pulses of each microburst of the plurality of microbursts are spaced apart to simulate endogenous afferent activity occurring at a particular time in the cardiac signal.

11. The method of claim 1, wherein the plurality of microbursts are spaced apart to simulate endogenous afferent activity occurring at a particular time in the cardiac signal and enhance the vagal evoked potential evoked in the brain.

12. The method of claim 1, wherein sequential microbursts of the plurality of microbursts are separated by an interburst period ranging from about 100 milliseconds to about 10 seconds.

13. The method of claim 1, wherein sequential microbursts of the plurality of microbursts are separated by an interburst period ranging from about 100 milliseconds to about 6 seconds.

14. The method of claim 1, wherein, within at least one microburst of the plurality of microbursts, at least one interpulse interval is selectively varied from the other interpulse intervals.

15. A method of treating a medical condition in a patient that is breathing and has a brain, a vagus nerve, and a heart with a heart rate variability, the heart generating a cardiac signal having a QRS wave portion, the method comprising:

restricting the patient'"'"'s breathing to increase the heart rate variability;

detecting a portion of the QRS wave portion of the patient'"'"'s cardiac signal;

after detecting the portion of the QRS wave portion, generating a microburst comprising 2 to 20 electrical pulses; and

delivering the microburst to the vagus nerve of the patient, the microburst delivered to the vagus nerve evoking a response in the brain of the patient.

16. A method of treating a medical condition in a patient having a brain, a vagus nerve, and a heart that generates a cardiac signal having a QRS wave portion, the method comprising:

identifying the QRS wave portion of the cardiac signal;

after identifying the QRS wave portion and before identifying a next sequential QRS wave portion, generating a plurality of microbursts, each microburst of the plurality of microbursts being patterned and comprising a series of electrical pulses, sequential electrical pulses of each microburst being separated by an interpulse interval, the sum of the interpulse intervals separating the pulses of each microburst being less than about 60 milliseconds; and

delivering the plurality of microbursts directly to a selected location on the vagus nerve of the patient, the plurality of microbursts delivered to the vagus nerve evoking a response in the brain of the patient,

wherein sequential microbursts of the plurality of microbursts are separated by at least 100 milliseconds.

17. The method of claim 16, further comprising:

after identifying the QRS wave portion, waiting a predetermined delay period before applying the plurality of microbursts to the vagus nerve.

18. The method of claim 16, further comprising:

after identifying the QRS wave portion, waiting less than about 500 milliseconds before applying the microburst plurality of microbursts to the vagus nerve.

19. The method of claim 16, wherein the electrical pulses of each microburst of the plurality of microbursts have a pulse width ranging from about 50 microseconds to about 1000 microseconds.

20. The method of claim 16, wherein each of the interpulse intervals is less than about 40 milliseconds.

21. The method of claim 16, wherein each of the interpulse intervals is determined empirically for the patient.

22. The method of claim 16, wherein each of the interpulse intervals ranges from about 3 milliseconds to about 12 milliseconds.

23. A method of treating a medical condition in a patient that is breathing and has a brain, a vagus nerve, and a heart with a heart rate variability, a heart generating a cardiac signal having a QRS wave portion, the method comprising:

restricting the patient'"'"'s breathing to increase the heart rate variability;

detecting the QRS wave portion of the cardiac signal;

generating a microburst comprising a series electrical pulses separated by an interpulse interval, the sum of the interpulse intervals separating the pulses being less than 60 milliseconds; and

delivering the microburst to the vagus nerve of the patient, the microburst delivered to the vagus nerve evoking a response in the brain of the patient.

24. A system for treating a medical condition in a patient having a brain, a vagus nerve, and a heart that generates a cardiac signal having a QRS wave portion, the system comprising:

a communication interface configured to receive at least a select portion of the QRS wave portion of the cardiac signal;

an electrical signal generator configured to generate a plurality of microbursts after the receipt of the select portion of the QRS wave portion by the communication interface and before receiving a select portion of a next sequential QRS wave portion by the communication interface, each microburst of the plurality of microbursts being patterned, comprising a series of electrical pulses, and having a duration of less than about one second, adjacent ones of the electrical pulses of each microburst being separated from one another by an interpulse interval of less than about 40 milliseconds, sequential microbursts of the plurality of microbursts being separated by at least 100 milliseconds; and

an electrode in electrical communication with the vagus nerve, the electrode being configured to deliver the plurality of microbursts to a select location on the vagus nerve of the patient, the plurality of microbursts delivered to the vagus nerve evoking a response in the brain of the patient.

25. The system of claim 24, wherein the duration of each microburst of the plurality of microbursts is less than about 100 milliseconds.

26. The system of claim 24, wherein the electrical signal generator is configured to wait a predetermined delay period after receipt of the select portion of the QRS wave portion wave before applying the plurality of microbursts.

27. The system of claim 24, wherein the interpulse interval between adjacent ones of the electrical pulses ranges from about 3 milliseconds to about 10 milliseconds.

28. A non-transitory computer readable medium having computer executable components for

identifying a QRS wave portion of a cardiac cycle;

after identifying a first QRS wave portion of the cardiac cycle and before identifying a next sequential QRS wave portion of the cardiac cycle, generating a plurality of microbursts, each microburst of the plurality of microbursts being patterned and having 2 to 20 electrical pulses, adjacent ones of the electrical pulses being separated from one another by an interpulse interval of less than about 40 milliseconds; and

delivering the plurality of microbursts via an electrode to a select location on the vagus nerve of a patient, the plurality of microbursts delivered to the vagus nerve evoking a response in a brain of the patient,

wherein sequential microbursts of the plurality of microbursts are separated by at least 100 milliseconds.

29. The computer readable medium of claim 28, wherein the computer readable medium further comprises computer executable components for determining the duration of each of the interpulse intervals.

30. A method of maximizing a vagal evoked potential (VEP) in a patient having a brain, a vagus nerve, and a heart that generates a cardiac signal having a QRS wave portion, the method comprising:

identifying a select portion of the QRS wave portion of the patient'"'"'s cardiac signal;

after identifying the select portion of the QRS wave portion and before identifying a select portion of a next sequential QRS wave portion, generating a plurality of microbursts, each microburst of the plurality of microbursts being patterned and comprising a plurality of electrical pulses, adjacent ones of the electrical pulses being separated from one another by an interpulse interval of less than about 40 milliseconds; and

delivering the plurality of microbursts directly to a selected location on the vagus nerve of the patient, the plurality of microbursts delivered to the vagus nerve evoking a response in the brain of the patient,

wherein sequential microbursts of the plurality of microbursts are separated by an interburst interval of at least 100 milliseconds, and

wherein, within at least one microburst of the plurality of microbursts, at least one interpulse interval is selectively varied from the other interpulse intervals.

31. The method of claim 30, wherein, within at least one microburst of the plurality of microbursts, the interpulse interval is increased between successive pulses of the plurality of pulses.

32. The method of claim 30, wherein, within at least one microburst of the plurality of microbursts, the interpulse interval is decreased between successive pulses of the plurality of pulses.

33. The method of claim 30, wherein, within at least one microburst of the plurality of microbursts, the interpulse interval is randomly determined within a pre-selected range.

34. The method of claim 33, wherein the pre-selected range ranges from about 5 milliseconds to about 10 milliseconds.

35. The method of claim 30, wherein at least one of the interpulse interval, the interburst interval, and the number of pulses within each respective microburst are selectively varied to optimize stimulation of the patient.