Vagal nerve stimulation techniques for treatment of epileptic seizures

• US 6,587,727 B2
• Filed: 11/09/2001
• Issued: 07/01/2003
• Est. Priority Date: 04/30/1999
• Status: Active Grant

• Current Assignee: Ivan Osorio, Mark G. Frei
• Original Assignee: Ivan Osorio, Mark G. Frei
• Inventors: Frei, Mark G., Osorio, Ivan
• Primary Examiner(s): Jastrzab, Jeffrey R.
• Application Number:
  US10/047,179
• Publication Number:
  US 20020072776A1
• Time in Patent Office: 599 Days
• Field of Search: 607/9, 607/45, 607/17
• US Class Current: 607/45
• CPC Class Codes: A61B 2560/0475 Special features of memory means, e.g. removable memory cards
• CPC Class Codes: A61B 5/02405 Determining heart rate variability
• CPC Class Codes: A61B 5/02455 provided with high/low alarm devices
• 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 5/4094 Diagnosing or monitoring seizure diseases, e.g. epilepsy
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61B 5/7282 Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence
• 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 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/36135 using physiological parameters

Abstract

The present invention uses electrical stimulation of the vagus nerve to treat epilepsy with minimized or no effect on the heart. Treatment is carried out by an implantable signal generator, one or more implantable electrodes for electrically stimulating a predetermined stimulation site of the vagus nerve, and a sensor for sensing characteristics of the heart such as heart rate. The heart rate information from the sensor can be used to determine whether the vagus nerve stimulation is adversely affecting the heart. Once threshold parameters are met, the vagus nerve stimulation may be stopped or adjusted. In an alternative embodiment, the invention may include a modified pacemaker to maintain the heart in desired conditions during the vagus nerve stimulation. In yet another embodiment, the invention may be simply a modified pacemaker having circuitry that determines whether a vagus nerve is being stimulated. In the event that the vagus nerve is being stimulated, the modified pacemaker may control the heart to maintain it within desired conditions during the vagus nerve stimulation.

Claims

1. A method of pacing a heart with a pacemaker comprising the steps of:

(a) monitoring an electrocardiogram signal of the heart;

(b) processing the signal to determine whether a vagus nerve is being stimulated; and

(c) if the vagus nerve is being stimulated, operating the pacemaker to maintain a heart beat parameter at a predetermined level.

2. A system for controlling the operation of a heart during vagus nerve stimulation comprising in combination:

(a) an implantable pacemaker coupled to stimulate the heart;

(b) at least one sensor coupled to the pacemaker capable of measuring an electrocardiogram signal; and

(c) means for processing the signal to determine whether the vagus nerve is being stimulated, whereby the pacemaker may control the heart during vagus nerve stimulation.

3. The system of claim 2, further comprising:

(d) means for providing a sensory stimulus responsive to the sensor signal for alerting the patient of an undesired effect on the heart from the vagus nerve.

4. The system of claim 2, further comprising:

(d) a control algorithm responsive to the sensor for activating the pacemaker to regulate the heart.

5. The system of claim 2, wherein the sensor is capable of measuring a heart rate of the heart.

6. The system of claim 2, wherein the sensor is capable of detecting a QRS.

7. The system of claim 2, wherein the sensor is capable of detecting an R-wave.

8. The system of claim 2, wherein the sensor is capable of measuring blood pressure.

9. The system of claim 2, wherein the sensor is capable of measuring R—

R variability.

10. A method of pacing a heart with a pacemaker comprising the steps of:

(a) monitoring a characteristic of the heart;

(b) processing the signal to determine whether a vagus nerve is being stimulated; and

(c) if the vagus nerve is being stimulated, operating the pacemaker to maintain a heart beat parameter at a predetermined level.

11. The method of claim 10, wherein the step of monitoring includes the step of monitoring a heart rate of the heart.

12. The method of claim 11, wherein the step of monitoring the heart rate includes the step of monitoring QRS detection.

13. The method of claim 11, wherein the step of monitoring the heart rate includes the step of monitoring R-wave detection.

14. The method of claim 10, wherein the step of monitoring includes the step of monitoring blood pressure.

15. The method of claim 10, wherein the step of monitoring includes the step of monitoring R—

R variability .

16. A method of monitoring a heart with a pacemaker comprising the steps of:

(a) monitoring a characteristic of the heart for changes that are indicative of an occurrence of a seizure;

(b) identifying abnormal heart function indicative of a possible occurrence of the seizure; and

(c) warning the patient of the possible occurrence of the seizure, whereby the patient may act accordingly to minimize a risk injury or sudden unexpected death.

17. The method of claim 16, wherein the step of monitoring includes the step of monitoring an electro-cardiogram signal of the heart.

18. The method of claim 16, wherein the step of monitoring includes the step of monitoring a he art rate of the heart.

19. The method of claim 18, wherein the step of monitoring the heart rate includes the step of monitoring QRS detection.

20. The method of claim 18, wherein the step of monitoring the heart rate includes the step of monitoring R-wave detection.

21. The method of claim 16, wherein the step of monitoring includes the step of monitoring blood pressure.

22. The method of claim 16, wherein the step of monitoring includes the step of monitoring R—

R variability.

23. The method of claim 16, further comprising the step of:

(d) enabling the patient to deactivate operation of a vagus nerve stimulator (VNS).

24. A system for controlling operation of a heart during vagus nerve stimulation comprising in combination:

(a) an implantable signal generator providing stimulation energy;

(b) at least one electrode having a proximal end coupled to the signal generator and a distal end adapted to provide the stimulation energy to a vagus nerve of a patient;

(c) at least one sensor coupled to a pacemaker capable of measuring a characteristic of the heart indicative that the signal generator is stimulating the vagus nerve; and

(d) an implantable pacemaker coupled to regulate the heart in response to the sensor.

25. The system of claim 24, wherein the sensor is capable of measuring a heart rate of the heart.

26. The system of claim 24, wherein the sensor is capable of detecting a QRS.

27. The system of claim 24, wherein the sensor is capable of detecting an R-wave.

28. The system of claim 24, wherein the sensor is capable of measuring blood pressure.

29. The system of claim 24, wherein the sensor is capable of measuring R—

R variability.

30. The system of claim 24, wherein the sensor provides indication that the signal generator is stimulating the vagus nerve further comprising:

(e) a control algorithm responsive to the sensor for activating the pacemaker to regulate the heart.

31. The system of claim 24, wherein the sensor provides indication that the signal generator is stimulating the vagus nerve further comprising:

(e) a control algorithm responsive to undesirable heart activity during vagus nerve stimulation to shut down the vagus nerve stimulation.

32. The system of claim 24 further comprising:

(e) a sensory stimulus responsive to the sensor signal and alerting the patient of an undesired effect on the heart from the vagus nerve.