Contingent cardio-protection for epilepsy patients

• US 9,314,633 B2
• Filed: 08/31/2012
• Issued: 04/19/2016
• Est. Priority Date: 01/25/2008
• Status: Active Grant

• Current Assignee: Flint Hills Scientific, LLC, LivaNova USA, Inc. (LivaNova Plc)
• Original Assignee: Cyberonics, Inc, Flint Hills Scientific, LLC
• Inventors: Osorio, Ivan, Scott, Timothy L.
• Primary Examiner(s): Patton, Amanda
• Application Number:
  US13/601,099
• Publication Number:
  US 20120330369A1
• Time in Patent Office: 1,327 Days
• US Class Current: 1/1
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0556 Cuff electrodes
• 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 1/36117 for treating hypertension
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration

Abstract

Disclosed are methods and systems for treating epilepsy by stimulating a main trunk of a vagus nerve, or a left vagus nerve, when the patient has had no seizure or a seizure that is not characterized by cardiac changes such as an increase in heart rate, and stimulating a cardiac branch of a vagus nerve, or a right vagus nerve, when the patient has had a seizure characterized by cardiac changes such as a heart rate increase.

Claims

1. A method of treating a patient having epilepsy via an implantable medical device which includes an electrical signal generator coupled to a first electrode and a second electrode where the first electrode is coupled to a main trunk of a vagus nerve of the patient and a second electrode is coupled to a cardiac branch of the vagus nerve of the patient, the method comprising:

receiving at least one body data stream;

analyzing the at least one body data stream using a seizure detection algorithm to determine an epileptic seizure state;

applying a first electrical signal from the electrical signal generator to the main trunk of the vagus nerve using the first electrode as a cathode, based on a determination that the epileptic seizure state of the patient is a first state where an epileptic seizure is not detected; and

applying a second electrical signal from the electrical signal generator to the cardiac branch of the vagus nerve using the second electrode as the cathode, based on a determination that the epileptic seizure state of the patient is a second state where the epileptic seizure is detected.

2. The method of claim 1, wherein the second electrical signal is configured to reduce a heart rate of the patient.

3. The method of claim 1, wherein applying the first electrical signal is based on a programmed duty cycle having at least a programmed on-time and a programmed off-time.

4. The method of claim 1, wherein based on the determination that the epileptic seizure state of the patient is the second state where the epileptic seizure is detected, the method further comprises identifying an increase in a patient'"'"'s heart rate, and applying the second electrical signal to reduce the patient'"'"'s heart rate.

5. The method of claim 4, further comprising:

sensing the patient'"'"'s heart rate in response to applying the second electrical signal, and interrupting the second electrical signal if a decrease in the patient'"'"'s heart rate reaches a lower heart rate threshold.

6. The method of claim 4 further comprising:

sensing the patient'"'"'s heart rate in response to applying the second electrical signal, and modifying the second electrical signal to maintain the patient'"'"'s heart rate between an upper rate threshold and the lower heart rate threshold.

7. The method of claim 1 wherein the first electrode is proximal to a brain of the patient relative to the second electrode, wherein applying the first electrical signal comprises using the first electrode as the cathode and the second electrode as an anode, and wherein applying the second electrical signal comprises using the second electrode as the cathode and first electrode as the anode to reduce a patient'"'"'s heart rate.

8. The method of claim 7, wherein the implantable medical device includes a polarity reversal unit capable of reversing a polarity of the first electrode and the second electrode to apply the first electrical signal and the second electrical signal.

9. The method of claim 1, wherein the implantable medical device includes a third electrode coupled to the main trunk of the vagus nerve and to a programmable signal generator,

wherein applying the first electrical signal comprises applying the first electrical signal to the vagus nerve using the first electrode as the cathode and the third electrode as an anode.

10. The method of claim 1, wherein at least one of the first electrical signal and the second electrical signal is a microburst electrical signal characterized by having a number of pulses per microburst from 2 pulses to about 25 pulses, an interpulse interval of about 2 msec to about 50 msec, an interburst period of at least 100 msec, and a microburst duration of less than about 1 sec.

11. The method of claim 1, wherein based on the determination that the epileptic seizure state of the patient is the second state where the epileptic seizure is detected, the method further comprises identifying an increase in a patient'"'"'s heart rate and applying both:

the first electrical signal from the electrical signal generator to the main trunk of the vagus nerve using the first electrode as the cathode, and

the second electrical signal from the electrical signal generator to the cardiac branch of the vagus nerve using the second electrode as the cathode.

12. The method of claim 11, wherein the first electrical signal and the second electrical signal are applied to the vagus nerve in at least one of a sequential fashion, a simultaneous fashion, and in alternating and repeating fashion.

13. A method of treating a patient having epilepsy comprising:

sensing a cardiac signal and a kinetic signal of the patient;

analyzing at least one of the cardiac signal and the kinetic signal;

determining whether or not the patient has had an epileptic seizure based on the analyzing;

in response to a determination that the patient has had the epileptic seizure, determining whether or not the epileptic seizure is characterized by an increase in a patient'"'"'s heart rate;

applying a first electrical signal to a main trunk of a vagus nerve of the patient using a first electrode as a cathode based on one of;

a) a determination that the patient has not had the epileptic seizure, and b) a determination that the patient has had the epileptic seizure that is not characterized by the increase in the patient'"'"'s heart rate, wherein the first electrode is coupled to the main trunk; and

applying a second electrical signal to a cardiac branch of the vagus nerve of the patient using a second electrode as the cathode based on a determination that the patient has had the epileptic seizure characterized by the increase in the patient'"'"'s heart rate, wherein the second electrode is coupled to the cardiac branch.

14. The method of claim 13, wherein applying the first electrical signal is based on a programmed duty cycle having at least a programmed on-time and a programmed off-time.

15. The method of claim 13, wherein the second electrical signal is configured to reduce the patient'"'"'s heart rate.

16. The method of claim 13 further comprising:

applying the first electrical signal comprises using the first electrode as the cathode and the second electrode as an anode; and

applying the second electrical signal comprises using the second electrode as the cathode and the first electrode as the anode;

wherein the first electrode is proximal to a brain of the patient relative to the second electrode.

17. The method of claim 16 further comprising utilizing a polarity reversal unit capable of reversing a polarity of the first electrode and the second electrode to apply the first electrical signal and the second electrical signal.

18. The method of claim 17 further comprising:

applying the first electrical signal at a first point in time based on a determination that the patient has not had the epileptic seizure characterized by the increase in the patient'"'"'s heart rate,

reversing the polarity of the first electrode and the second electrode, and

applying the second electrical signal at a second point in time based on a determination that the patient has had the epileptic seizure characterized by the increase in the patient'"'"'s heart rate.

19. A method of treating a patient having epilepsy comprising:

applying a first electrical signal to a main trunk of a vagus nerve of the patient, wherein the first electrical signal is an open-loop electrical signal having a programmed on-time and a programmed off-time;

sensing at least one body signal of the patient, determining a start of an epileptic seizure based on the at least one body signal, determining whether or not the epileptic seizure is characterized by an increase in a patient'"'"'s heart rate;

applying a second, closed-loop electrical signal to the main trunk of the vagus nerve based on a determination that the epileptic seizure is not characterized by the increase in the patient'"'"'s heart rate; and

applying a third, closed-loop electrical signal to a cardiac branch of the vagus nerve based on a determination that the epileptic seizure is characterized by the increase in the patient'"'"'s heart rate, wherein the third electrical signal is applied to reduce the patient'"'"'s heart rate.

20. A method of treating a patient having epilepsy comprising:

sensing at least one body signal of the patient;

determining whether or not the patient has had an epileptic seizure based on the at least one body signal;

sensing a cardiac signal of the patient;

in response to a determination that the patient has had the epileptic seizure, determining whether or not the epileptic seizure is characterized by an increase in a patient'"'"'s heart rate;

applying a first electrical signal to a left vagus nerve of the patient using a first electrode as a cathode based on one of a) a determination that the patient has not had the epileptic seizure, and b) a determination that the patient has had the epileptic seizure that is not characterized by the increase in the patient'"'"'s heart rate, wherein the first electrode is coupled to the left vagus nerve; and

applying a second electrical signal to a right vagus nerve of the patient using a second electrode as the cathode based on a determination that the patient has had the epileptic seizure characterized by the increase in the patient'"'"'s heart rate, wherein the second electrode is coupled to the right vagus nerve.