Neural modulation devices and methods

• US 9,358,395 B2
• Filed: 08/06/2014
• Issued: 06/07/2016
• Est. Priority Date: 06/11/2010
• Status: Expired due to Fees

• 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): Flory, Christopher A
• Application Number:
  US14/453,183
• Publication Number:
  US 20140350632A1
• Time in Patent Office: 671 Days
• Field of Search: 607/2, 607/40, 607/116, 607/133
• US Class Current: 1/1
• 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 system for treating a gastrointestinal disorder or a condition associated with excess weight in a subject in need thereof comprising:

at least one electrode adapted to be placed at a vagus nerve;

an implantable neuroregulator configured to apply a therapy cycle to the electrode, 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 having a low frequency, each burst having a second selected low 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 and low frequency 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 system according to claim 1, wherein a first burst of low frequency signal precedes the high frequency signal and a second burst of low frequency signal follows the high frequency signal.

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

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

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

7. The system of claim 1, wherein the implantable neuroregulator is further configured to apply one or more therapy cycles in a treatment period.

8. The method of claim 7, wherein the treatment period is at least 6 hours.

9. A method of selecting parameters for a therapy cycle for an implantable device in a subject comprising:

selecting parameters of a therapy cycle to be applied to a vagus nerve, wherein the therapy cycle comprises an electrical signal comprising i)) a set of pulses applied at a first selected frequency of at least 1000 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;

b) communicating the selected parameters to the implantable device comprising the system of claim 1; and

c) determining the amount of actual therapy delivered over a time period and adjusting the length of the treatment period to increase the amount of excess weight loss, to affect the blood pressure, and/or diabetes of the subject.

10. The method of claim 9, further comprising selecting the parameters of an electrical signal that comprises:

a) a set of pulses applied at a second selected frequency of at least 40 Hz and less than 150 Hz, wherein each pulse of the set of pulses has a pulse width of at least 0.05 microseconds and less than the period of the second selected frequency.