Electrode band system and methods of using the system to treat obesity

• US 8,862,233 B2
• Filed: 02/04/2013
• Issued: 10/14/2014
• Est. Priority Date: 02/03/2003
• Status: Expired due to Term

• 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): ANTHONY, JESSICA LYNN
• Application Number:
  US13/758,223
• Publication Number:
  US 20130197600A1
• Time in Patent Office: 617 Days
• Field of Search: 607/40, 607115-116, 607/118, 607/133
• US Class Current: 607/40
• CPC Class Codes: A61F 5/0026 Anti-eating devices using electrical stimulation
• 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 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer

Abstract

At least one of a plurality of disorders of a patient characterized at least in part by vagal activity innervating at least one of a plurality of organs of the patient is treated by a method that includes positioning an electrode on a vagus nerve. An electrical signal is applied to the electrode to modulate vagal activity by an amount selected to treat the disorder. In some embodiments, the disorder is obesity. The signal may be a blocking or a stimulation signal. In some embodiments, the signal is selected to, at least in part, downregulate neural activity on the vagus nerve. In embodiments, a system comprises a band comprising a first electrode array and a second electrode array; a signal generator electrically connected to each of said first, and second electrode array; an external programmer configured to: communicate at least one parameter for the neural conduction blocking signal to the implantable controller, wherein the parameter is selected for the neuroconduction blocking signal to i) at least partially downregulate the vagus nerve, ii) allow at least partial recovery of the nerve activity following discontinuation of the neural conduction blocking signal, and iii) reduce pancreatic and biliary output via inhibition of pancreo-biliary output; and an external coil.

Claims

1. A system for treating obesity in a patient comprising:

a) a band comprising a first electrode array and a second electrode array;

b) a signal generator electrically connected to each of said first and second electrode array;

said signal generator comprising an induction coil, at least one circuit for generating a neural conduction blocking signal connected to at least one of the first or second electrode array, a battery, and a central processing unit comprising program storage and memory;

c) an external programmer configured to;

communicate at least one parameter for the neural conduction blocking signal to the signal generator, wherein the parameter is selected for the neuroconduction blocking signal to i) at least partially downregulate a vagus nerve, ii) allow at least partial recovery of a nerve activity following discontinuation of the neural conduction blocking signal, and iii) reduce pancreatic and biliary output via inhibition of pancreo-biliary output, and

d) an external coil adapted to be worn by the patient and adapted to inductively couple to the induction coil of the signal generator.

2. The system of claim 1, wherein the band is adapted to be placed on an upper portion of a stomach of the patient.

3. The system of claim 1, wherein the band is adjustable.

4. The system of claim 1, wherein the first array or second array of electrodes are positioned at an angle to a cylindrical axis of the band.

5. The system of claim 1, wherein the first or second array of electrodes comprises at least three electrodes.

6. The system of claim 1, further comprising a second band comprising a third electrode array and a fourth electrode array, each array of the second band electrically connected to the signal generator.

7. The system of claim 6, wherein the second band is adapted to be placed on the lower portion of a stomach of the patient.

8. A method of treating obesity comprising

a) implanting a band comprising a first electrode array and a second electrode array;

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

said signal generator comprising an induction coil, at least one circuit for generating a neural conduction blocking signal connected to at least one of the first or second electrode array, a battery, and a central processing unit comprising program storage and memory into an obese patient; and

b) treating obesity of the patient by applying a neuroconduction blocking signal to at least one electrode in the first or second electrode array, wherein the neuroconduction blocking signal is selected to i) at least partially downregulate the vagus nerve, ii) allow at least partial recovery of the nerve activity following discontinuation of the neural conduction blocking signal, and iii) reduce pancreatic and biliary output via inhibition of pancreo-biliary output.

9. The method of claim 8, wherein the band is placed at the cardiac notch of the obese patient.

10. The method according to claim 8 wherein the signal has a frequency of at least 500 Hz.

11. The method according to claim 10 wherein the signal is applied to both an anterior vagus nerve and a posterior vagus nerve of the patient.

12. The method of claim 8 wherein the neuroconduction blocking signal is applied to the first electrode array.

13. The method of claim 9, wherein a neuroconduction stimulating signal is applied to the second electrode array.

14. A method of treating obesity comprising

a) implanting a band comprising a first electrode array and a second electrode array;

b) implanting a second band comprising a third electrode array and a fourth electrode array;

c) implanting a signal generator electrically connected to each of said band and second band;

said signal generator comprising an induction coil, at least one circuit for generating a neural conduction blocking signal connected to at least one of the first, second, third or fourth electrode array, a battery, and a central processing unit comprising program storage and memory into an obese patient; and

d) treating obesity of the patient by applying a neuroconduction blocking signal to at least one electrode in the first, second, third or fourth electrode array, wherein the neuroconduction blocking signal is selected to i) at least partially downregulate the vagus nerve, ii) allow at least partial recovery of the nerve activity following discontinuation of the neural conduction blocking signal, and iii) reduce pancreatic and biliary output via inhibition of pancreo-biliary output.

15. The method of claim 14, wherein the band is placed at a cardiac notch of the obese patient, and the second band is placed on a stomach of the obese patient.

16. A method according to claim 14 wherein the signal has a frequency of at least 500 Hz.

17. A method according to claim 16 wherein the signal is applied to both an anterior vagus nerve and a posterior vagus nerve of the patient.

18. The method of claim 14 wherein the neuroconduction blocking signal is applied to the first electrode array of the band.

19. The method of claim 14, wherein a neuroconduction stimulating signal is applied to the fourth electrode array of the second band.