NEURAL ELECTRODE TREATMENT

• US 20100094375A1
• Filed: 12/15/2009
• Published: 04/15/2010
• Est. Priority Date: 08/17/2005
• Status: Active Grant

• Current Assignee: ReShape LifeSciences, Inc.
• Original Assignee: EnteroMedics, Inc. (ReShape LifeSciences, Inc.)
• Inventors: Weijand, Koen J., Knudson, Mark B., Donders, Adrianus P.
• Granted Patent: US 8,103,349 B2
• Time in Patent Office: Days
• US Class Current: 607/40
• CPC Class Codes: A61N 1/36053 adapted for vagal stimulation A61N1/36114 takes precedence
• CPC Class Codes: A61N 1/36085 Eating disorders or obesity
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/36146 specified by the stimulation parameters

Abstract

An apparatus for applying a signal to a nerve for the treatment of a disorder includes a first electrode and a second electrode. Each of the electrodes is adapted to be secured to a nerve of a patient. A signal generator is electrically connected to each of the first and second electrodes. The signal generator is adapted to create a signal having a first waveform at the first electrode and a second waveform at the second electrode. The waveforms have parameters selected to block propagation of neural action potentials. The waveforms have a repeating pattern of cycles of pulses with a delay period between at least selected ones of said pulses. In one embodiment, the first and second waveforms are out of phase for a cycle of one of the waveforms to occur during a delay period of the other of the waveforms.

Claims

1. An apparatus for applying a signal to a nerve for the treatment of a disorder, said apparatus comprising:

a first electrode and a second electrode, each adapted to be secured to a vagus nerve of a patient;

a first anode connected to the first electrode and a second anode connected to the second electrode;

a signal generator electrically connected to each of said first and second electrodes;

said signal generator providing for selection of a first and a second waveform, a pulse duration, and a duty cycle comprising an on period and an off period; and

said signal generator adapted to create the first waveform at the first electrode and the second waveform at said second electrode, wherein each of said first and second waveforms have parameters selected to block propagation of neural action potentials;

wherein the parameters comprise a duty cycle, wherein said on period comprises a repeating pattern of cycles of pulses and a delay period between at least selected ones of said cycles of pulses, wherein each cycle of pulses includes at least a negative pulse and a positive pulse, and wherein said delay period is less than a time period identified as sufficient for a recovery of the vagus nerve from a neural block induced by said cycle; and

wherein said first and second waveforms are out of phase with each other such that during each on period a cycle of one of said waveforms occurs during the delay period of the other of said waveforms.

2. The apparatus according to claim 1, wherein said delay period is at least equal to a time interval of one complete cycle.

3. The apparatus of according to claim 1, wherein the delay period of the first waveform is equal to the cycle time of the second waveform.

4. The apparatus according to claim 1, wherein said waveforms have an amplitude between 0.5 mA and 8 mA.

5. The apparatus according to claim 1, wherein said waveforms have a cycle frequency in excess of 250 Hz.

6. The apparatus according to claim 5, wherein said waveforms have a cycle frequency of at least 2500 Hz.

7. The apparatus according to claim 1, wherein the on time is at least 2 minutes.

8. The apparatus according to claim 7, wherein the off time is at least 5 minutes.

9. The apparatus according to claim 1, wherein the total cumulative charge delivered to the nerve during an on time is at least 0.1000 coulombs.

10. The apparatus according to claim 1 wherein said electrodes include a contact surface area enhanced by a surface treatment selected to increase said surface area by creating a plurality of protuberances with opposing surfaces of protuberances sized to present an atraumatic surface to opposing tissue.

11. The apparatus according to claim 10, wherein the surface of the electrodes is enhanced with nanoparticles.

12. The apparatus according to claim 1, wherein the first and second anodes are placed on the same vagus nerves as the first and second electrodes respectively.

13. The apparatus according to claim 1, wherein the first and second anodes are placed on the stomach.

14. The apparatus according to claim 1, wherein the first and second electrodes are each placed on the esophagus.

15. The apparatus according to claim 1, wherein the first electrode is placed on the anterior vagus nerve and the second electrode is placed on the posterior vagus nerve.

16. The apparatus according to claim 1, further comprising a signal amplifier connected across at least one of said electrodes and selected to identify a depolarization of a nerve.

17. A method for the treatment of a disorder susceptible to down-regulation of neural activity, said method comprising:

placing a first electrode on said first vagal nerve and a second electrode on said vagal second nerve;

connecting a first anode to the first electrode and placing the first anode on or near said first vagus nerve at a location that differs from the location of the first electrode, and connecting a second anode to the second electrode and placing the second anode on or near the second electrode at a location that differs from the second electrode;

electrically connecting a signal generator to each of said first and second electrodes;

said signal generator adapted to create a signal having a first waveform at said first electrode and a second waveform at said second electrode, wherein each of said first and second waveforms have parameters selected to block propagation of neural action potentials;

wherein the parameters comprise an “

on”

period and an “

off”

period, wherein said “

on”

period comprises a repeating pattern of cycles of pulses and a delay period between at least selected ones of said cycles of pulses, wherein each cycle of pulses includes at least a negative pulse and a positive pulse and wherein said delay period is less than a time period identified as sufficient for a recovery of the vagus nerve from a neural block induced by said cycle; and

wherein said first and second waveforms are out of phase with each other such that during each “

on”

period a cycle of one of said waveforms occurs during a delay period of the other of said waveforms; and

activating said signal generator to apply said waveforms to said first and second nerves.

18. The method according to claim 17, wherein said delay period is at least equal to a time interval of one complete cycle.

19. The method of according to claim 17, wherein the delay period of the first waveform is equal to the cycle time of the second waveform.

20. The method according to claim 17, wherein said waveforms have an amplitude between 0.5 mA and 8 mA.

21. The method according to claim 17, wherein said waveforms have a cycle frequency in excess of 250 Hz.

22. The method according to claim 17, wherein the on time is at least 2 minutes.

23. The method according to claim 17, wherein the off time is at least 5 minutes.

24. The method according to claim 17, wherein the first and second anodes are placed on the same vagus nerves as the first and second electrodes respectively.

25. The method according to claim 17, wherein the first and second anodes are each placed on the stomach.

26. The method according to claim 17, wherein the first and second electrodes are each placed on the esophagus.

27. The method according to claim 17, wherein the first electrode is placed on the anterior vagus nerve and the second electrode is placed on the posterior vagus nerve.