NEURAL MODULATION DEVICES AND METHODS

• US 20110307023A1
• Filed: 06/07/2011
• Published: 12/15/2011
• 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., Donders, Adrianus P., Knudson, Mark B., Waataja, Jonathan J.
• Granted Patent: US 8,825,164 B2
• Time in Patent Office: Days
• US Class Current: 607/3
• 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 of 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.

3. A system according to claim 1, wherein the implantable neuroregulator further comprises a power source.

4. The system according to claim 1, wherein the power source is a primary battery or a rechargeable battery.

5. The system according to claim 1, further comprising an external charger adapted to communicate therapy instructions and power to the neuroregulator, wherein the implantable neuroregulator is adapted to communicate with the external charger.

6. The system according to claim 1, wherein the therapy cycle comprises an electrical signal that further comprises:

a) a set of pulses applied at a second selected frequency of about 1-10,000 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.

8. The system of claim 6, wherein the set of pulses applied at a first selected frequency of 150 Hz or greater has a frequency of 1000 Hz or greater, and wherein the set of pulses applied at a second selected frequency of about 1 to 10,000 Hz have a frequency of 40 Hz or greater.

9. The system of claim 6, wherein the set of pulses at a first selected frequency and at a second selected frequency have a current of 0.1 to 20 mAmps, and a total delivered charge of about 200,000 microcoulombs or less.

10. The system of claim 9, wherein the set of pulses are applied at a first selected frequency of 150 Hz or greater, a pulse width of at least 0.09 milliseconds, and a current of about 6 to 20 mAmps, and wherein the set of pulses applied at a second selected frequency of 40 Hz or greater comprise a plurality of a set of about 1 to 20 pulses, each pulse having a pulse width of about 0.05 to 0.5 microseconds, and a delay period between the each set of pulses of 2.5 milliseconds or greater.

12. The system of claim 1, wherein the therapy cycle has an off time, wherein the off time is an amount of time that allows at least partial recovery of the nerve.

14. The system of claim 1, wherein the implantable neuroregulator is configured to deliver therapy for a treatment period.

15. The system of claim 14, wherein the treatment period is at least 6 hours.

17. The system of claim 1, further comprising an external programmer.

18. The system of claim 17, wherein the external programmer is configured to obtain patient data, wherein the patient data comprises data obtained from the implantable component concerning actual therapy delivered, and patient data concerning the health profile of the patient.

19. The system of claim 18, wherein the health profile comprises the presence or absence of conditions selected from the group consisting of diabetes, hypertension, cardiac condition, liver disorder, a renal disorder and combinations thereof.

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

a) selecting parameters of a therapy cycle, wherein the therapy cycle comprises an electrical signal comprising;

i) 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;

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 parameters of the therapy cycle to achieve delivery of at least 6 hours of treatment or adjusting the other parameters of the therapy cycle or both to increase the amount of excess weight loss, to affect the blood pressure, and/or diabetes of the subject.

21. The method of claim 20, further comprising selecting the parameters of the therapy cycle based on the starting body mass index of the subject.

22. The method of claim 21, wherein the subject has a body mass index of at least 25 or greater.

23. The method of claim 20, further comprising selecting the parameters of the therapy cycle based on the starting blood pressure of the subject.

24. The method of claim 23, wherein the subject has a systolic blood pressure of at least 140 mmHg.

25. The method of claim 20, further comprising selecting the parameters of the therapy cycle based on the starting % HbAlC of the subject.

26. The method of claim 25, wherein the subject has a % of HbAlC of 6.5% or greater.

2. A system for treating a gastrointestinal disorder or a condition associated with excess weight of 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 that have a frequency of about 150 Hz or greater; and

b) a total amount of charge delivered to the nerve of about 5 microcoulombs to 200,000 microcoulombs during the therapy cycle.

7. (canceled)

11. (canceled)

13. (canceled)

16. (canceled)

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

programming an implantable neuroregulator to apply a therapy cycle to an electrode placed at a vagus nerve, wherein each therapy cycle comprises a high frequency electrical signal having a first selected frequency of at least 150 Hz, a low frequency electrical signal having a second selected frequency of less than 150 Hz, an on period of at least 30 seconds, and an off period, wherein the off period is selected to allow at least partial recovery of nerve activity.

28. The method according to claim 27, wherein the first selected frequency of the high frequency electrical signal is at least 1000 Hz.

29. The method according to claim 27, wherein the frequency of the low frequency electrical signal is at least 40 Hz.

30. The method according to claim 27, wherein the low frequency signal precedes the high frequency signal and follows the high frequency signal.

32. The method according to claim 27, 31, wherein the condition is selected from the group consisting of obesity, hypertension, diabetes, and combinations thereof.

33. The method of claim 27, further comprising administering one or more agents that treat the gastrointestinal condition or affect weight loss.

34. The method of claim 33, wherein the agents that affect weight loss comprise 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, or combinations thereof.

31. (canceled)