Treatment of obesity by sub-diaphragmatic nerve stimulation

• US 20040039427A1
• Filed: 08/18/2003
• Published: 02/26/2004
• Est. Priority Date: 01/02/2001
• Status: Active Grant

• Current Assignee: Cyberonics, Inc
• Original Assignee: Cyberonics, Inc
• Inventors: Roslin, Mitchell S., Barrett, Burke T.
• Granted Patent: US 7,340,306 B2
• Time in Patent Office: Days
• US Class Current: 607/58
• 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

Abstract

A method and apparatus for treating obese or other patients with compulsive overeating disorder includes unilaterally or bilaterally stimulating one or both of the left and right branches of a patient'"'"'s vagus nerve directly or indirectly with an electrical pulse signal generated by an implantable neurostimulator with at least one operatively coupled nerve electrode to apply the pulse signal to the selected nerve branch at a location below the patient'"'"'s diaphragm. The implantable neurostimulator is programmable to enable physician programming of electrical and timing parameters of the pulse signal, to induce weight loss of the patient.

Claims

1. A method of treating obese patients, which comprises the step of stimulating a patient'"'"'s vagus nerve with an electrical signal applied directly or indirectly thereto at a location below the patient'"'"'s diaphragm, including programming electrical and timing parameters of said electrical signal, to induce weight loss of the patient.

2. The method of claim 1, wherein the step of stimulating the patient'"'"'s vagus nerve comprises performing unilateral sub-diaphragmatic stimulation of either the left branch or the right branch of the vagus nerve.

3. The method of claim 1, wherein the step of stimulating the patient'"'"'s vagus nerve comprises performing bilateral sub-diaphragmatic stimulation of the left and right branches of the vagus nerve.

4. The method of claim 1, including implanting at least one signal generator and electrodes operatively coupled thereto for generating and applying said electrical signal to the vagus nerve at said location.

5. The method of claim 1, including implanting at least one signal generator and electrodes operatively coupled thereto for generating and applying said electrical signal internally to a portion of the patient'"'"'s nervous system other than the vagus nerve to indirectly stimulate the vagus nerve at said location.

6. The method of claim 1, wherein said stimulating electrical signal comprises a sequence of electrical pulses.

7. The method of claim 1, wherein the step of stimulating comprises applying said electrical signal to the vagus nerve at a location in a range of from about two to about three inches below the patient'"'"'s diaphragm.

8. The method of claim 1, wherein the step of stimulating includes applying said electrical signal intermittently, in alternating on and off intervals according to a predetermined duty cycle.

9. The method of claim 1, wherein the step of stimulating includes applying said electrical signal continuously.

10. The method of claim 1, wherein the step of stimulating comprises applying said electrical signal bilaterally and synchronously to both branches of the vagus nerve.

11. The method of claim 1, wherein the step of stimulating comprises applying said electrical signal endoscopically from a portion of the patient'"'"'s gastrointestinal tract.

12. The method of claim 1, wherein the step of stimulating comprises applying said electrical signal non-invasively to a portion of the patient'"'"'s nervous system other than the vagus nerve to indirectly stimulate the vagus nerve at said location.

13. A method of treating patients exhibiting compulsive overeating disorder or obesity, which comprises the steps of:

implanting at least one programmable electrical pulse generator in the patient together with at least one electrical lead having at least one distal nerve electrode and at least one proximal electrical connector operatively coupled to said pulse generator,

implanting a distal nerve electrode of a said electrical lead on at least one branch of the vagus nerve at a location below the patient'"'"'s diaphragm, and

activating said pulse generator to stimulate said at least one branch of the vagus nerve with electrical pulses according to a programmed regimen, to induce weight loss of the patient.

14. The method of claim 13, including programming the implanted pulse generator to adjust the electrical parameters and application times of the pulsed electrical signal.

15. The method of claim 14, including implanting said at least one nerve electrode at said location on one of the right and left branches of the vagus nerve in a range of from approximately two inches to approximately three inches below the patient'"'"'s diaphragm.

16. A method of treating patients with compulsive eating disorder by stimulating a selected cranial nerve of the patient with an electrical signal applied to induce a signal up the nerve toward the brain from a location below the diaphragm, including programming electrical and timing parameters of said electrical signal to control said eating disorder.

17. The method of claim 16, including applying said electrical signal directly to the selected cranial nerve at said sub-diaphragmatic location.

18. The method of claim 16, including applying said electrical signal internally to a portion of the patient'"'"'s nervous system remote from the selected cranial nerve to indirectly stimulate the selected cranial nerve at said location.

19. The method of claim 16, wherein said stimulating electrical signal comprises a sequence of electrical pulses.

20. The method of claim 16, wherein the step of stimulating comprises applying said electrical signal to the selected cranial nerve at said location in a range of from about two to about three inches below the patient'"'"'s diaphragm.

21. The method of claim 16, wherein the selected cranial nerve is the vagus nerve, and the step of stimulating comprises applying said electrical signal bilaterally and synchronously to right and left branches of the vagus nerve.

22. The method of claim 16, wherein the step of stimulating comprises applying said electrical signal endoscopically from a portion of the patient'"'"'s gastrointestinal tract.

23. The method of claim 16, including implanting at least one pulse generator with nerve electrodes coupled thereto into the patient to generate and apply said electrical signal as a pre-programmed sequence of electrical impulses for controlling said eating disorder of the patient.

24. Apparatus for treating obese or other patients with compulsive overeating disorder, comprising a pulse generator sanctioned by government authority for implantation in a patient together with electrode means for stimulation of a selected cranial nerve of the patient with a predetermined sequence of electrical impulses from said pulse generator applied to the selected cranial nerve at a location below the patient'"'"'s diaphragm, for inducing weight loss of the patient.

25. The apparatus of claim 24, wherein said pulse generator is programmable to enable physician programming of the electrical and timing parameters of said sequence of electrical impulses.

26. The apparatus of claim 24, wherein the selected cranial nerve is the vagus nerve, and said electrode means comprises at least one nerve electrode for implantation on the patient'"'"'s vagus nerve for direct stimulation thereof at said location.

27. The apparatus of claim 26, wherein said electrode means comprises a pair of nerve electrodes for implantation of a respective one of said pair on left and right branches of the patient'"'"'s vagus nerve for direct bilateral stimulation thereof at said location.

28. The apparatus of claim 24, wherein said electrode means comprises at least one electrode for implantation internally to a portion of the patient'"'"'s nervous system remote from the selected cranial nerve to indirectly stimulate the selected cranial nerve in the vicinity of said location.