Controlled vagal blockage therapy

• US 8,538,533 B2
• Filed: 10/19/2011
• Issued: 09/17/2013
• Est. Priority Date: 02/03/2003
• Status: Expired due to Fees

• Current Assignee: ReShape LifeSciences, Inc.
• Original Assignee: EnteroMedics, Inc. (ReShape LifeSciences, Inc.)
• Inventors: Knudson, Mark B., Wilson, Richard R., Tweden, Katherine S., Conrad, Timothy R.
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Sarcione, Jessica
• Application Number:
  US13/276,638
• Publication Number:
  US 20120041509A1
• Time in Patent Office: 699 Days
• Field of Search: 607/40, 607/62
• US Class Current: 607/40
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/321 Electromedical belts
• 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 1/36071 Pain
• 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 1/36178 Burst or pulse train parameters

Abstract

Systems and methods for treating at least one of a plurality of disorders characterized at least in part by vagal activity. In embodiments, a method for treating obesity comprises positioning a first electrode on a vagus nerve of an obese patient at a location below a vagal innervation of the heart; treating the patient'"'"'s obesity by applying an electrical treatment signal to the electrode with the electrical treatment signal having: a frequency selected for the signal to at least partially downregulate nerve impulses on the vagal nerve, wherein the signal has a frequency in excess of 200 Hz, and without simultaneously applying a neural impulse-inducing secondary electrical signal to the vagus nerve on a proximal side of the location whenever the electrical treatment signal is applied; and b) a plurality of on-times separated by a plurality of off-times, the signal applied during the on-times and not applied during the off-times, wherein the duration of the off-times is selected in response to a signal from a sensing electrode representing at least 50% of the activity of the vagal nerve as compared to baseline.

Claims

1. A method for treating obesity comprising:

positioning a first electrode on a vagus nerve of an obese patient at a location below a vagal innervation of the heart, with the vagus nerve innervating at least one alimentary tract organ;

treating the patient'"'"'s obesity by

measuring a vagal nerve activity and sending a signal that represents activity of said vagus nerve to an implanted controller; and

applying an electrical treatment signal to the electrode using the implanted controller with the electrical treatment signal having;

a) a frequency selected for said signal to at least partially downregulate nerve impulses on said vagal nerve, wherein said signal has a frequency in excess of 200 Hz, and without simultaneously applying a neural impulse-inducing secondary electrical signal to the vagus nerve on a proximal side of said location whenever the electrical treatment signal is applied; and

b) a plurality of on-times separated by a plurality of off-times, said signal applied during said on-times and not applied during said off-times, wherein duration of the off-times are each selected to end upon receipt at the implanted controller of a signal that represents at least 50% of the activity of said vagal nerve as compared to baseline.

2. A method according to claim 1, wherein application of said electrical signal is variable by a controller to alter a characteristic of said electrical treatment signal.

3. A method according to claim 2, wherein said electrical treatment signal is regulated to heighten a sensation of satiety of said patient.

4. A method according to claim 1, wherein the duration of said off-times are also selected to increase weight loss.

5. A method according to claim 1, wherein said frequency is selected to block afferent signals on the vagus nerve.

6. A method according to claim 1, wherein said frequency is selected to block efferent signals on the vagus nerve.

7. A method according to claim 1, wherein said frequency is selected to block both afferent and efferent signals on the vagus nerve.

8. A method according to claim 1, wherein said frequency is at least 500 Hz.

9. A method according to claim 1, wherein the vagal nerve activity is measured by a sensing electrode is located in the first electrode.

10. A method according to claim 1, wherein the vagal nerve activity is measured by a sensing electrode is located distal to the first electrode.

11. A method according to claim 1, wherein the electrical treatment signal is applied to a vagal trunk.

12. A method according to claim 1, wherein the electrical treatment signal is applied to both an anterior vagus nerve and a posterior vagus nerve of the patient.

13. A method according to claim 1, further comprising monitoring a vagal activity of said patient.

14. A method according to claim 13, wherein said monitoring includes electrically monitoring a neural activity of said patient using a sensing electrode.

15. A method according to claim 1, wherein said off-times are varied to obtain an average vagal activity of at least 30%.

16. A method according to claim 1, wherein said on-times are about two to five minutes.

17. A method according to claim 1, wherein the vagal nerve activity is determined by measuring pancreatic exocrine secretion per unit of time or by a patient'"'"'s sensation of bloated feelings or normalcy of gastrointestinal motility.