CHANGEABLE ELECTRODE POLARITY STIMULATION BY AN IMPLANTABLE MEDICAL DEVICE

• US 20110213437A9
• Filed: 01/25/2008
• Published: 09/01/2011
• Est. Priority Date: 01/28/2005
• Status: Active Grant

• Current Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Original Assignee: Cyberonics, Inc
• Inventors: Scott, Timothy L., Maschino, Steven E., Armstrong, Randolph K.
• Granted Patent: US 8,565,867 B2
• Time in Patent Office: Days
• US Class Current: 607/40
• 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 1/36146 specified by the stimulation parameters
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration

Abstract

We disclose a method of treating a medical condition in a patient using an implantable medical device including coupling at least a first electrode and a second electrode to a cranial nerve of the patient, providing a programmable electrical signal generator coupled to the first electrode and the second electrode, generating a first electrical signal with the electrical signal generator, applying the first electrical signal to the electrodes, wherein the first electrode is a cathode and the second electrode is an anode, reversing the polarity of the first electrode and the second electrode, yielding a configuration wherein the first electrode is an anode and the second electrode is a cathode, generating a second electrical signal with the electrical signal generator, applying the second electrical signal to the electrodes, reversing the polarity of the first electrode and the second electrode, yielding a configuration wherein the first electrode is a cathode and the second electrode is an anode, generating a third electrical signal with the electrical signal generator, and applying the third electrical signal to the electrodes. Each of the electrical signals can independently contain one or more pulses or one or more bursts. The number of pulses need not be equal between any two of the electrical signals.

Claims

1. A method of treating a medical condition in a patient using an implantable medical device, comprising:

coupling at least a first electrode and a second electrode to a cranial nerve of the patient,

providing a programmable electrical signal generator coupled to the first electrode and the second electrode,

generating a first electrical signal with the electrical signal generator,

applying the first electrical signal to the electrodes, wherein the first electrode is a cathode and the second electrode is an anode,

reversing the polarity of the first electrode and the second electrode, yielding a configuration wherein the first electrode is an anode and the second electrode is a cathode,

generating a second electrical signal with the electrical signal generator,

applying the second electrical signal to the electrodes,

reversing the polarity of the first electrode and the second electrode, yielding a configuration wherein the first electrode is a cathode and the second electrode is an anode,

generating a third electrical signal with the electrical signal generator, and

applying the third electrical signal to the electrodes.

2. The method of claim 1, wherein the first electrical signal contains one or more pulses, the second electrical signal contains one or more pulses, and the third electrical signal contains one or more pulses.

3. The method of claim 2, wherein the first electrical signal contains one pulse, the second electrical signal contains one pulse, and the third electrical signal contains one pulse.

4. The method of claim 2, wherein the first electrical signal contains a first number of pulses, the second electrical signal contains a second number of pulses, and the third electrical signal contains a third number of pulses, wherein the first number of pulses is not equal to the second number of pulses or the second number of pulses is not equal to the third number of pulses.

5. The method of claim 1, wherein the first electrical signal contains one or more bursts, the second electrical signal contains one or more bursts, and the third electrical signal contains one or more bursts.

6. The method of claim 5, wherein the first electrical signal contains one burst, the second electrical signal contains one burst, and the third electrical signal contains one burst.

7. The method of claim 5, wherein the first electrical signal contains a first number of bursts, the second electrical signal contains a second number of bursts, and the third electrical signal contains a third number of bursts, wherein the first number of bursts is not equal to the second number of bursts or the second number of bursts is not equal to the third number of bursts.

8. The method of claim 1, wherein at least one of the first electrical signal, the second electrical signal, and the third electrical signal is 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.

9. The method of claim 1, wherein the medical condition is selected from the group consisting of neurological disorders, neuropsychiatric disorders, gastrointestinal disorders, pancreatic disorders, kidney disorders, and diabetes.

10. The method of claim 1, wherein, after performance of a prior applying step, the subsequent applying step is performed after an action potential induced by the prior applying step in A-fibers of the cranial nerve has passed the anode of the subsequent applying step and before an action potential induced by the prior applying step in C-fibers of the cranial nerve reaches the anode of the subsequent applying step.

11. In a method of neuromodulation effected by delivery, using at least two electrodes, to a cranial nerve of an electrical signal characterized by a number of electrical pulses, the improvement comprising:

delivering a first electrical signal using a first electrode as a cathode and a second electrode as an anode;

reversing the polarity of the first electrode and the second electrode, yielding a configuration wherein the first electrode is an anode and the second electrode is a cathode;

delivering a second electrical signal using the first electrode and the second electrode;

reversing the polarity of the first electrode and the second electrode, yielding a configuration wherein the first electrode is a cathode and the second electrode is an anode; and

delivering a third electrical signal using the first electrode and the second electrode.

12. The method of claim 11, wherein the first electrical signal contains a first number of pulses, the second electrical signal contains a second number of pulses, and the third electrical signal contains a third number of pulses, wherein the first number of pulses is not equal to the second number of pulses or the second number of pulses is not equal to the third number of pulses.

13. The method of claim 11, wherein the first electrical signal contains one or more bursts, the second electrical signal contains one or more bursts, and the third electrical signal contains one or more bursts.

14. The method of claim 13, wherein the first electrical signal contains one burst, the second electrical signal contains one burst, and the third electrical signal contains one burst.

15. The method of claim 13, wherein the first electrical signal contains a first number of bursts, the second electrical signal contains a second number of bursts, and the third electrical signal contains a third number of bursts, wherein the first number of bursts is not equal to the second number of bursts or the second number of bursts is not equal to the third number of bursts.

16. The method of claim 11, wherein at least one of the first electrical signal, the second electrical signal, and the third electrical signal is 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.

17. The method of claim 11, wherein the neuromodulation treats a medical condition selected from the group consisting of neurological disorders, neuropsychiatric disorders, gastrointestinal disorders, pancreatic disorders, kidney disorders, and diabetes.

18. The method of claim 11, wherein the cranial nerve is a vagus nerve.

19. A system for treating a medical condition in a patient, comprising:

at least two electrodes coupled to at least one cranial nerve of a patient, and

an implantable device operatively coupled to the electrodes and comprising an electrical signal generator capable of applying an electrical signal to the cranial nerve using the electrodes to treat the medical condition and an electrode polarity reversal unit capable of reversibly reversing the configuration of the electrodes.

20. An implantable medical device to treat a medical condition in a patient, comprising:

two or more electrodes;

a controller capable of receiving internal data and/or external data and generating and delivering a stimulation signal to target tissues of the patient'"'"'s body;

a stimulation unit capable of generating and delivering an electrical signal therapy signal to the two or more electrodes; and

an electrode polarity reversal unit capable of reversing the polarity of the two or more electrodes.

21. The implantable medical device of claim 20, wherein the electrode polarity reversal unit comprises:

an electrode configuration switching unit comprising a switching controller; and

one or more switches, wherein the switching controller transmits signals to the one or more switches.