Neural modulation devices and methods

• US 8,825,164 B2
• Filed: 06/07/2011
• Issued: 09/02/2014
• Est. Priority Date: 06/11/2010
• Status: Active Grant

• Current Assignee: ReShape LifeSciences, Inc.
• Original Assignee: EnteroMedics, Inc. (ReShape LifeSciences, Inc.)
• Inventors: Tweden, Katherine S., Waataja, Jonathan J., Donders, Adrianus P., Knudson, Mark B.
• Primary Examiner(s): Patel, Niketa
• Assistant Examiner(s): Flory, Christopher A
• Application Number:
  US13/154,846
• Publication Number:
  US 20110307023A1
• Time in Patent Office: 1,183 Days
• Field of Search: 607/2, 607/40, 607/116, 607/133
• US Class Current: 607/40
• CPC Class Codes: A61N 1/0509 Stomach and intestinal electrodes
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• 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 1/36117 for treating hypertension
• CPC Class Codes: A61N 1/36171 Frequency
• CPC Class Codes: A61N 1/36178 Burst or pulse train parameters
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer
• CPC Class Codes: A61N 1/3787 from an external energy source

Abstract

A system for designing a therapy or for treating a gastrointestinal disorder or a condition associated with excess weight in a subject comprising at least one electrode configured to be implanted within a body of the patient and placed at a vagus nerve, the electrode also configured to apply therapy to the vagus nerve upon application of a therapy cycle to the electrode; an implantable neuroregulator for placement in the body of the patient beneath the skin layer, the implantable neuroregulator being configured to generate a therapy cycle, wherein the therapy cycle comprises an on time during which an electrical signal is delivered, the electrical signal comprising: a) a set of pulses applied at a first selected frequency of about 150-10,000 Hz, wherein each pulse of the set of pulses has a pulse width of at least 0.01 milliseconds and less than the period of the first selected frequency.

Claims

1. A method of treating a gastrointestinal disorder or a condition associated with excess weight in a subject in need thereof comprising:

programming an implantable neuroregulator to apply a therapy cycle to an electrode placed at a vagus nerve, wherein each therapy cycle comprises a) a high frequency burst of electrical signal having a first selected frequency of at least 1000 Hz, wherein the high frequency burst of electrical signals comprises one or more pulses that have a pulse width of about 0.01 milliseconds to about 0.09 milliseconds, and a current of about 0.1 to 20 mAmps;

b) more than one burst of a second low frequency electrical signal, each burst having a second selected frequency of at least 40 Hz and less than 150 Hz, wherein each of the bursts of low frequency electrical signals comprises one or more pulses that have a pulse width of about 0.05 microseconds to about 0.5 microseconds, a current of about 0.1 to 20 mAmps and a delay period between each burst;

wherein the high frequency burst and low frequency burst are delivered during the same therapy cycle and at least partially downregulate activity on the nerve;

c) an on period of at least 2 minutes d) an off period, wherein the off period is selected to allow at least partial recovery of nerve activity; and

e) a total charge of about 5 to 1000 microcoulombs or less per therapy cycle.

2. The method according to claim 1, wherein the low frequency signal precedes the high frequency signal and follows the high frequency signal.

3. The method according to claim 1, wherein the gastrointestinal disorder or condition is selected from the group consisting of obesity, hypertension, diabetes, and combinations thereof.

4. The method of claim 1, further comprising administering one or more agents that treat the gastrointestinal disorder or condition or affect weight loss.

5. The method of claim 4, wherein the agents that affect weight loss are selected from the group consisting of agents that enhance the sensation of satiety, agents that decrease appetite, agents that block the absorption of fat or other nutrients, agents that inhibit enzymes that digest fat, agents that are thermogenic, and combinations thereof.

6. The method of claim 5, wherein the agent that enhances a sensation of satiety is selected from the group consisting of somatostatin receptor agonists, GLP-1 agonists, GLP-1 variants, peptide PYY, POMC agonists, neuropeptide Y inhibitors, topiramate, tegretol, bupropion, naltrexone, zonisamide, amylin, amylin analogues, oxyntomodulin and combinations thereof.

7. The method of claim 5, wherein the agent that decreases appetite is selected from the group consisting of phentermine, fenfluramine, dexfenfluramine, endocannabinoid receptor antagonists, ghrelin antagonists, orexin antagonists, somatostatin receptor agonist, GLP-1, PYY, cholecystokinin agonists, and combinations thereof.

8. The method of claim 5, wherein the agent that block absorption of fat or other nutrients is selected from the group consisting of orlistat, a lipin inhibitor, and combinations thereof.

9. The method of claim 5, wherein the agent that is thermogenic is selected from the group consisting of sibutramine, leptin, leptin agonists, leptin analogues, CNTF, CNTF analogues, and combinations thereof.

10. The method of claim 1, wherein the first selected frequency is selected from about 1000 to 5000 Hz.

11. The method of claim 1, wherein the one or more set of pulses has about 1-20 pulses.

12. The method of claim 1, wherein the low frequency electrical signal has a current amplitude of about 1 mAmp or less.

13. The method of claim 1, further comprises a treatment period having one or more therapy cycles.

14. The method of claim 13, wherein the treatment period is at least 6 hours.