Vagal nerve stimulation techniques for treatment of epileptic seizures

• US 7,457,665 B1
• Filed: 10/29/2005
• Issued: 11/25/2008
• Est. Priority Date: 04/30/1999
• Status: Expired due to Fees

• Current Assignee: Flint Hills Scientific, LLC
• Original Assignee: Flint Hills Scientific, LLC
• Inventors: Frei, Mark G., Osorio, Ivan
• Primary Examiner(s): Layno; Carl H.
• Assistant Examiner(s): MORALES, JON ERIC C
• Application Number:
  US11/262,362
• Time in Patent Office: 1,123 Days
• Field of Search: 607/1, 607/2, 607/4, 607/5, 607/9, 607/14, 607/17
• US Class Current: 607/9
• 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 system for controlling operation of a heart comprising in combination:

(a) at least one sensor capable of measuring a characteristic of the heart indicative of an occurrence of a seizure, the sensor being capable of measuring R-R variability,

(b) means for processing the measured characteristic to determine whether there is a possible occurrence of a seizure; and

(c) an implantable pacemaker coupled to the at least one sensor to regulate the operation of the heart in response to the characteristic measured by the at least one sensor.

2. The system of claim 1, wherein the sensor is capable of measuring a heart rate of the heart.

3. The system of claim 1, wherein the sensor is capable of detecting a QRS complex.

4. The system of claim 1, wherein the sensor is capable of detecting an R-wave.

5. The system of claim 1, wherein the sensor is capable of measuring blood pressure.

6. The system of claim 1, wherein the sensor is capable of measuring a relationship between heart rate and heart rate variability.

7. The system of claim 1, wherein the characteristic of the heart is indicative of a serious or life-threatening state.

8. The system of claim 1, further comprising:

(d) an implantable signal generator providing stimulation energy; and

(e) at least one electrode having a proximal end coupled to said signal generator and a distal end adapted to provide stimulation to a vagus nerve of a patient.

9. The system of claim 8, wherein operation of a heart may be controlled by altering the stimulation energy provided to the vagus nerve.

10. The system of claim 1, wherein the sensor provides indication of vagus nerve stimulation and further comprising:

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

11. The system of claim 1, wherein the sensor provides indication of vagus nerve stimulation and further comprising:

(d) a control algorithm responsive to undesirable heart activity resulting from vagus nerve stimulation to shut down or modify the vagus nerve stimulation.

12. The system of claim 1, wherein the sensor provides indication of vagus nerve stimulation and further comprising:

(d) a sensory stimulus responsive to the sensor for alerting the patient of an undesired effect on the heart from the possible occurrence of the seizure.