Identification of electrodes for nerve stimulation in the treatment of eating disorders

• US 7,310,557 B2
• Filed: 04/29/2005
• Issued: 12/18/2007
• Est. Priority Date: 04/29/2005
• Status: Active Grant

• Current Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Original Assignee: Cyberonics, Inc
• Inventors: Maschino, Steven E., Armstrong, Scott A., Parnis, Steven M.
• Primary Examiner(s): Bockelman; Mark
• Application Number:
  US11/118,861
• Publication Number:
  US 20060247721A1
• Time in Patent Office: 963 Days
• Field of Search: 607/40, 607/116, 607/118, 607/133, 607/62
• US Class Current: 607/40
• CPC Class Codes: A61F 5/0026 Anti-eating devices using electrical stimulation
• CPC Class Codes: A61F 5/005 Gastric bands
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration
• CPC Class Codes: A61N 1/3686 configured for selecting the electrode configuration on a lead A61N1/3688 takes precedence
• CPC Class Codes: Y02A 90/10 Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

Abstract

A method and apparatus for treatment of an eating disorder includes electrically, mechanically and/or pharmaceutically/chemically stimulating a of the vagus nerve of the lower esophagus, cardia, esophageal/cardia junction, cardia/fundus junction or upper stomach so as to induce afferent action potentials on the vagus nerve. The device may be noninvasively adjusted after implantation to provide increased or decreased restriction on the patient'"'"'s gastrointestinal tract. Each stimulus may be administered as a series of programmed pulses of defined amplitude, duration and period, to evoke a responsive signal to the brain by the target nerve, effective for producing a temporary feeling of satiety in the person. An implantable stimulus generator may be operatively coupled to a nerve electrode, pressure device or chemical outlet to apply a defined signal to a selected nerve branch. The implantable stimulus generator is programmable to allow clinician programming of defined signal parameters effective to treat the eating disorder of the patient. Methods are also provided to identify electrodes nearest to a branch of the vagus nerve to apply an electrical stimulation signal with improved efficiency.

Claims

1. A method of selecting one or more electrodes from a plurality of electrodes for providing an electrical stimulation signal to a vagus nerve, comprising:

(a) providing an implantable gastric band having a plurality of stimulation electrodes and a plurality of sensing electrodes, each of said stimulation and sensing electrodes having an address from which its position on said band is known;

(b) surgically coupling said implantable gastric band to at least a portion of the patient'"'"'s gastrointestinal tract, said step comprising electrically coupling at least one of said plurality of stimulation electrodes and at least one of said plurality of sensing electrodes to a vagus nerve on said at least a portion of the gastrointestinal tract;

(c) generating an electrical stimulation test signal capable of inducing an action potential on a vagus nerve if applied thereto;

(d) applying said electrical stimulation test signal to at least one of said plurality of stimulating electrodes;

(e) sensing for an induced action potential on a vagus nerve using at least one of said plurality of sensing electrodes; and

(f) if an induced action potential is sensed,

(1) using said addresses to identify at least a first sensing electrode sensing said induced action potential

(2) using said addresses to identify the address of at least a first stimulation electrode comprising the electrode among said plurality of stimulation electrodes nearest said first sensing electrode.

2. The method of claim 1 further comprising the step of storing the address of said first stimulation electrode.

3. The method of claim 1, further comprising the steps of:

(g) generating a therapeutic stimulation signal and

(h) applying said therapeutic stimulation signal to said first stimulation electrode.

4. The method of claim 3 further comprising the step of

(i) inducing afferent action potentials on the patient'"'"'s vagus nerve with said therapeutic stimulation signal.

5. The method of claim 1 wherein said step of identifying the address of at least a first stimulation electrode comprises identifying the addresses of at least a first and a second stimulation electrode nearest among said plurality of electrodes to said first sensing electrode.

6. The method of claim 1 wherein said step of identifying the address of at least a first stimulation electrode comprises identifying the addresses of a plurality of stimulation electrodes nearest, among said plurality of electrodes, to said first sensing electrode.

7. The method of claim 6 further comprising the steps of:

generating a therapeutic stimulation signal and

applying said therapeutic stimulation signal to said plurality of stimulation electrodes nearest to said first sensing electrode.

8. The method of claim 1 wherein the step of identifying at least a first sensing electrode comprises identifying a first plurality of sensing electrodes sensing an action potential and identifying a first plurality of stimulation electrodes nearest, among said plurality of stimulation electrodes, to said first plurality of sensing electrodes.

9. The method of claim 1 further comprising the step of:

(g) repeating steps (c) through (f) at periodic intervals.

10. The method of claim 9 wherein said periodic interval is an interval ranging from once per day to once per year.

11. The method of claim 1 wherein said step of generating an electrical stimulation test signal comprises generating a pulsed electrical signal defined by a plurality of stimulation parameters including at least a current magnitude, a frequency, and a pulse width.

12. The method of claim 1 wherein said step of providing an implantable gastric band comprises providing a band having an adjustment element capable of wireless and noninvasively adjusting the constriction provided by said band on the patient'"'"'s gastrointestinal tract.

13. The method of claim 1 wherein said step of applying said electrical stimulation test signal to at least one of said plurality of stimulating electrodes comprises simultaneously applying said electrical stimulation test to all electrodes in said plurality of stimulating electrodes.

14. The method of claim 1 wherein said step of applying said electrical stimulation test signal to at least one of said plurality of stimulating electrodes comprises sequentially applying said electrical stimulation test to one of said plurality of stimulating electrodes until said test signal has been applied to each of said plurality of stimulating electrodes.

15. The method of claim 1 wherein said plurality of stimulating electrodes comprises a plurality of stimulating electrode pairs and said plurality of sensing electrodes comprise a plurality of sensing electrode pairs, each said electrode pair comprising a cathode and an anode.

16. The method of claim 15 wherein said step of sensing for an induced action potential on a vagus nerve comprises simultaneously sensing for an induced action potential using all of said sensing electrode pairs.

17. The method of claim 1, further comprising the step of:

(g) storing the voltage magnitude of the detected action potential in a memory.

18. A gastric band system for providing an electrical stimulation signal to a vagus nerve of a patient having an eating disorder, comprising:

(a) an implantable gastric band having a plurality of stimulation electrodes and a plurality of sensing electrodes, each of said stimulation and sensing electrodes having an address from which its position on said band is known;

(b) an implantable pulse generator capable of generating an electrical test signal and an electrical therapeutic signal and applying said signals to a desired combination of said plurality of stimulation electrodes;

(c) a testing and stimulation controller for determining which electrodes among said plurality of stimulation electrodes to use to deliver said therapeutic signal, said controller comprising a testing algorithm causing said pulse generator to;

(1) generate said test signal and apply said test signal to at least one of said plurality of stimulating electrodes;

(2) sense for an induced action potential on a vagus nerve using at least one of said plurality of sensing electrodes; and

(3) if an induced action potential is sensed, identify the electrodes among said plurality of sensing electrodes that sensed the action potential and identify at least a first stimulation electrode among said plurality of stimulation electrodes nearest said identified sensing electrodes.

19. The gastric band system of claim 18 wherein said controller further comprises a memory for storing the addresses of said stimulation and sensing electrodes, said identified sensing electrodes, and said first stimulation electrode.

20. The gastric band system of claim 18, wherein said testing algorithm causes said pulse generator to identify a first group of stimulation electrodes among said plurality of stimulation electrodes nearest said identified sensing electrodes.

21. The gastric band system of claim 20, wherein said controller further comprises a stimulation algorithm for causing said pulse generator to:

(1) generate said electrical therapeutic signal; and

(2) apply said electrical therapeutic signal to said first group of stimulation electrodes.

22. The gastric band system of claim 18, wherein said controller further comprises a stimulation algorithm for causing said pulse generator to generate said electrical therapeutic signal and apply said electrical therapeutic signal to said first stimulation electrode.

23. The gastric band system of claim 18 wherein said controller further comprises a stimulation algorithm and said system further comprises an external programmer for programming said testing algorithm and said therapeutic algorithm in said implantable pulse generator.

24. The gastric band system of claim 18 wherein said controller automatically repeats said testing algorithm at a periodic interval.

25. The gastric band system of claim 18 wherein said periodic interval is an interval ranging from once per day to once per year.

26. The gastric band system of claim 18 further comprising an external programmer capable of causing said controller to repeat said testing algorithm upon command.

27. The gastric band system of claim 18 wherein said electrical test signal comprises a pulsed electrical signal defined by a plurality of stimulation parameters including at least a current magnitude, a frequency, and a pulse width.

28. The gastric band system of claim 18 wherein said gastric band comprises an adjustment element capable of wirelessly and noninvasively adjusting the constriction provided by said band on the patient'"'"'s gastrointestinal tract.

29. The gastric band system of claim 18 wherein said testing algorithm causes said pulse generator to generate said test signal and apply said test signal simultaneously to all electrodes in said plurality of stimulating electrodes.

30. The gastric band system of claim 18 wherein said testing algorithm causes said pulse generator to generate said test signal and apply said test signal sequentially to each of said plurality of stimulating electrodes until said test signal has been applied to each of said plurality of stimulating electrodes.

31. The gastric band of claim 18 wherein said plurality of stimulating electrodes comprises a plurality of stimulating electrode pairs and said plurality of sensing electrodes comprise a plurality of sensing electrode pairs, each said electrode pair comprising a cathode and an anode.