Vagal nerve stimulation techniques for treatment of epileptic seizures

• US 8,634,922 B1
• Filed: 11/22/2008
• Issued: 01/21/2014
• Est. Priority Date: 04/30/1999
• Status: Expired due to Term

• Current Assignee: Flint Hills Scientific, LLC
• Original Assignee: Flint Hills Scientific, LLC
• Inventors: Osorio, Ivan, Frei, Mark G.
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Morales, Jon Eric C
• Application Number:
  US12/313,538
• Time in Patent Office: 1,886 Days
• Field of Search: None
• 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

A system using electrical stimulation of the vagus nerve to treat epilepsy with minimized or no effect on the heart. Treatment includes 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. 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. An alternative embodiment includes a modified pacemaker to maintain the heart in desired conditions during vagus nerve stimulation. In another embodiment, a modified pacemaker determines whether a vagus nerve is being stimulated, whereupon the modified pacemaker may control the heart to maintain it within desired conditions during the vagus nerve stimulation.

Claims

1. A system for detecting and responding to a seizure in a patient having epilepsy, comprising:

(a) at least one sensor configured to sense at least one of a heart rate and a beat interval;

(b) a microprocessor configured to determine an onset of the seizure based on one or more heart characteristics, the one or more heart characteristics including a non-exertional increase in heart rate, a decrease in heart rate, an increase in R-R variability and a decrease in R-R variability;

wherein the microprocessor is further configured to provide a warning of the seizure based on a determination of a seizure onset to a second device.

2. The system of claim 1, further comprising at least one electrode coupled to a vagus nerve of the patient and an electrical signal generator configured to provide an electrical stimulation to the vagus nerve.

3. The system of claim 2, wherein the microprocessor is further configured to provide an electrical stimulation based on the determination of the seizure onset.

4. The system of claim 3, wherein the electrical stimulation is provided in a first stimulation mode which is an open loop stimulation and a second stimulation mode which is a closed loop stimulation.

5. The system of claim 4, wherein the second stimulation mode is configured to turn on in response to a signal from a sensor which indicates the seizure onset.

6. The system of claim 5, wherein the sensor is located in a brain of the patient.

7. The system of claim 4, wherein the second stimulation mode is configured to determine a heart phase where the electrical stimulation has a reduced negative effect on a heart.

8. The system of claim 7, wherein the second stimulation mode provides the electrical stimulation during the heart phase.

9. The system of claim 1, wherein the second device is an external device.

10. The system of claim 9, wherein the external device is a mobile device.

11. The system of claim 9, wherein the microprocessor is further configured to provide an electrical stimulation based on the determination of the seizure onset.

12. The system of claim 11, wherein the electrical stimulation is provided in a first stimulation mode which is an open loop stimulation and a second stimulation mode which is a closed loop stimulation.

13. The system of claim 12, wherein the second stimulation mode is configured to turn on in response to a signal from a sensor which indicates the seizure onset.

14. The system of claim 13, wherein the sensor is located in a brain of the patient.

15. The system of claim 12, wherein the second stimulation mode is configured to determine a heart phase where the electrical stimulation has a reduced negative effect on a heart.

16. The system of claim 15, wherein the second stimulation mode provides the electrical stimulation during the heart phase.

17. The system of claim 1, wherein the microprocessor is further configured to transmit the warning of the seizure to a third party via an external device.

18. The system of claim 1, wherein the microprocessor is further configured to transmit the warning of the seizure to an external device, the external device being a non-patient device.

19. The system of claim 1, wherein the one or more heart characteristics being further based on one or more learned heart rate variability characteristics of the patient.

20. A system for detecting and responding to a seizure in a patient having epilepsy, comprising:

(a) at least one sensor configured to sense a heart rate;

(b) a microprocessor configured to determine an onset of the seizure based on one or more heart rate characteristics;

wherein the microprocessor is further configured to provide a warning of the seizure based on a determination of a seizure onset to a second device; and

(c) at least one electrode coupled to a cranial nerve of the patient and an electrical signal generator configured to provide an electrical stimulation to the cranial nerve.

21. The system of claim 20, wherein the electrical stimulation is provided in a first stimulation mode which is an open loop stimulation and a second stimulation mode which is a closed loop stimulation.

22. An apparatus for responding to a seizure in a patient having epilepsy, comprising:

a microprocessor configured to receive at least one of a heart rate and a heart beat interval from a sensor, the microprocessor further configured to determine an onset of the seizure based on one or more heart characteristics, the one or more heart characteristics including one or more of a non-exertional increase in heart rate, a decrease in heart rate, an increase in R-R variability and a decrease in R-R variability;

wherein the microprocessor is further configured to provide a warning of the seizure based on a determination of a seizure onset to a second device.

23. The apparatus of claim 22, further comprising an electrical signal generator configured to couple to at least one electrode configured to couple to a cranial nerve, wherein the electrical signal generator is configured to provide an electrical stimulation to the cranial nerve of the patient via the at least one electrode based on the determination of the seizure onset.